Tuesday, 20 March 2012

aspirin/caffeine/propoxyphene


Generic Name: aspirin/caffeine/propoxyphene (AS pir in/CAF feen/proe POX ih feen)

Brand Names: Darvon Compound 32, Darvon Compound-65, PC-CAP, Propoxyphene Compound 65


What is aspirin/caffeine/propoxyphene?

Propoxyphene (related to codeine) is in a class of drugs called narcotic analgesics. It relieves pain.


Aspirin is a less potent pain reliever, as well as an anti-inflammatory and a fever reducer. Aspirin increases the effects of propoxyphene.


Caffeine constricts blood vessels. This is believed to help relieve tension headaches by constricting dilated blood vessels in the head.


The combination, aspirin/caffeine/propoxyphene, is used to treat moderate-to-severe pain.


Aspirin/caffeine/propoxyphene may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about aspirin/caffeine/propoxyphene?


Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose. Avoid alcohol while taking aspirin/caffeine/propoxyphene. Alcohol can increase drowsiness and dizziness caused by the medication which could be dangerous. Also, alcohol increases the risk of stomach bleeding when taking aspirin. Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Do not take other over-the-counter and prescription products that contain aspirin. Too much aspirin could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.


Drowsiness or dizziness caused by aspirin/caffeine/propoxyphene may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.


What should I discuss with my healthcare provider before taking aspirin/caffeine/propoxyphene?


Before taking this medication, tell your doctor if you have


  • kidney disease;

  • liver disease;


  • a bleeding or blood clotting disorder;




  • a stomach ulcer;




  • asthma;




  • urinary retention;




  • an enlarged prostate;




  • hypothyroidism;




  • seizures or epilepsy;




  • gallbladder disease;




  • a head injury;




  • Addison's disease; or




  • a history of drug or alcohol addiction.



You may not be able to take aspirin/caffeine/propoxyphene, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Propoxyphene may cause addiction and withdrawal symptoms as well as other harmful effects in an unborn baby. Do not take aspirin/caffeine/propoxyphene without first talking to your doctor if you are pregnant or could become pregnant during treatment. Propoxyphene may also cause addiction and withdrawal symptoms in a nursing baby. Do not take aspirin/caffeine/propoxyphene without first talking to your doctor if you are breast-feeding a baby. If you are older than 60 years of age, you may be more likely to experience side effects from this therapy. Your doctor may prescribe a lower dose of the medication. Do not use any product that contains aspirin to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

How should I take aspirin/caffeine/propoxyphene?


Take aspirin/caffeine/propoxyphene exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.


Take each dose with a full glass of water. Aspirin/caffeine/propoxyphene can be taken with food or milk if it causes stomach upset. Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor. Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose. Constipation may be a side effect of treatment with aspirin/caffeine/propoxyphene. Increasing the amount of fiber and water (six to eight full glasses) in the diet may reduce constipation.

Do not share this medication with anyone else.


Store aspirin/caffeine/propoxyphene at room temperature away from moisture and heat.

See also: Aspirin/caffeine/propoxyphene dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking the next dose.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of an aspirin/caffeine/propoxyphene overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, small pupils, nausea, vomiting, ringing in the ears, and sweating.


What should I avoid while taking aspirin/caffeine/propoxyphene?


Avoid alcohol while taking aspirin/caffeine/propoxyphene. Alcohol can increase drowsiness and dizziness caused by the medication which could be dangerous. Also, alcohol increases the risk of stomach bleeding when taking aspirin. Use caution when driving, operating machinery, or performing other hazardous activities. Propoxyphene may cause drowsiness. If you experience drowsiness, avoid these activities.

Do not take other over-the-counter and prescription products that contain aspirin. Too much aspirin could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.


Drowsiness or dizziness caused by aspirin/caffeine/propoxyphene may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.


Aspirin/caffeine/propoxyphene side effects


If you experience any of the following serious side effects, stop taking aspirin/caffeine/propoxyphene and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);




  • slow, weak breathing;




  • seizures;




  • cold, clammy skin;




  • severe weakness or dizziness;




  • unconsciousness; or




  • black, bloody, or tarry stools or blood in your urine or vomit.



Other, less serious side effects may be more likely to occur. Continue to take aspirin/caffeine/propoxyphene and talk to your doctor if you experience



  • constipation;




  • dry mouth, nausea, vomiting, or decreased appetite;




  • dizziness, tiredness, or lightheadedness;




  • muscle twitches;




  • sweating;




  • itching




  • decreased urination;




  • decreased sex drive; or




  • ringing in the ears.




Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Aspirin/caffeine/propoxyphene Dosing Information


Usual Adult Dose for Pain:

ASA/caffeine/propoxyphene was voluntarily withdrawn from the US market by the manufacturer in November 2010 due to new data showing that the propoxyphene component can cause serious toxicity to the heart, even when used at therapeutic doses. The following dosage information applied to when ASA/caffeine/propoxyphene was available in the US:

For use in the relief of mild to moderate pain:

1 capsule orally every four hours as needed for pain.

Maximum dose: based on 390 mg per day of propoxyphene hydrochloride

Usual Geriatric Dose for Pain:

ASA/caffeine/propoxyphene was voluntarily withdrawn from the US market by the manufacturer in November 2010 due to new data showing that the propoxyphene component can cause serious toxicity to the heart, even when used at therapeutic doses. The following dosage information applied to when ASA/caffeine/propoxyphene was available in the US:

Regarding "Usage in the Elderly", the manufacturer of aspirin/caffeine/propoxyphene states that "The rate of propoxyphene metabolism may be reduced in some patients. Increased dosing interval should be considered."

Therefore, the dose recommended for use in geriatric patients for use in the relief of mild to moderate pain is 1 capsule orally every six hours as needed for pain.


What other drugs will affect aspirin/caffeine/propoxyphene?


Aspirin/caffeine/propoxyphene may increase the effects of oral anticoagulants such as warfarin (Coumadin) which could lead to bleeding. It may also increase the effects of carbamazepine (Tegretol) leading to toxicity. Be sure your doctor is aware if you are taking either of these medications.


Do not take aspirin/caffeine/propoxyphene if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result.


Drowsiness or dizziness caused by aspirin/caffeine/propoxyphene may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.


Do not take other over-the-counter and prescription products that contain aspirin. Too much aspirin could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.


Drugs other than those listed here may also interact with aspirin/caffeine/propoxyphene. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More aspirin/caffeine/propoxyphene resources


  • Aspirin/caffeine/propoxyphene Side Effects (in more detail)
  • Aspirin/caffeine/propoxyphene Dosage
  • Aspirin/caffeine/propoxyphene Use in Pregnancy & Breastfeeding
  • Aspirin/caffeine/propoxyphene Drug Interactions
  • Aspirin/caffeine/propoxyphene Support Group
  • 2 Reviews for Aspirin/caffeine/propoxyphene - Add your own review/rating


Compare aspirin/caffeine/propoxyphene with other medications


  • Pain


Where can I get more information?


  • Your pharmacist has additional information about aspirin/caffeine/propoxyphene written for health professionals that you may read.

See also: aspirin/caffeine/propoxyphene side effects (in more detail)


Sunday, 18 March 2012

Stronazon 400 micrograms MR Capsules






Stronazon 400micrograms MR capsules



(tamsulosin hydrochloride)



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have further questions, ask your doctor or your pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.



In this leaflet:



  • 1 What Stronazon is and what it is used for


  • 2 Before you take


  • 3 How to take


  • 4 Possible side effects


  • 5 How to store


  • 6 Further information




What Stronazon is and what it is used for


Stronazon modified-release capsules are used to treat symptoms caused by an enlarged prostate gland (benign prostatic hyperplasia BPH). The prostate gland surrounds the urethra (the tube with which urine passes from the bladder). When the prostate gland is enlarged it presses on the urethra causing it to narrow, so that it is difficult to pass urine.


Stronazon modified-release capsules relax the muscles in the prostate gland, making the urethra wider and easing the passing of urine.


Before starting treatment with Stronazon, your doctor may want to carry out tests to check that you do not have any other conditions which are causing your symptoms.




Before you take



Do not take Stronazon and tell your doctor if you:


  • are allergic (hypersensitive) to tamsulosin hydrochloride or one of the other ingredients (see section 6). Symptoms include sudden swelling of hands or feet, difficulty in breathing and/or itch and rash (angioedema).

  • have a history of being dizzy or fainting when standing suddenly caused by low blood pressure (orthostatic hypotension).

  • have severe liver problems.



Check with your doctor or pharmacist before taking Stronazon if you:


  • suffer from severe kidney problems

  • have cataracts.



Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:


  • alpha 1A-blockers e.g. doxazosin, prazosin and indoramin. If you take these with Stronazon your blood pressure may fall.

  • diclofenac (an anti-inflammatory painkiller) and warfarin (used to thin blood) may affect the way that Stronazon is handled by your body.



Pregnancy and breast-feeding


Stronazon is intended for males only.




Driving and using machines


Stronazon should not affect your ability to drive or use machinery. However, in some people Stronazon may cause dizziness, if you are affected do not drive or use machinery.





How to take


Always take Stronazon exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.



Take after the first meal of the day whilst standing or sitting upright (not lying down). Swallow whole with a glass of water. Do not open the capsule this will affect how the medicine works.


Doses:


One capsule a day.


Your doctor has prescribed a suitable dose for you and your illness, and has specified the duration of the treatment.


You should not change the dose without speaking to your doctor first.



If you take more than you should


If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.




If you forget to take the capsules


Do not take a double dose to make up for a forgotten dose. If you forget to take a dose after the first meal of the day, it can be taken later the same day after food. If you have missed a day skip the forgotten dose and then take the next dose at the right time.





Possible side effects


Like all medicines, Stronazon can cause side effects, although not everybody gets them.



Stop taking Stronazon and contact your doctor at once if you experience sudden swelling of hands or feet, difficulties in breathing and/or itch and rash, caused by an allergic reaction (angiooedema).



Tell your doctor if you notice any of the following side effects or notice any other effects not listed:



  • Common (occurs in less than 1 in 10 users):dizziness.


  • Uncommon (occurs in less than 1 in 100 users): headache, rapid or irregular heart beat, dizziness especially when sitting or standing up, nasal inflammation causing a runny nose, constipation, diarrhoea, feeling sick, being sick, rash, itching, abnormal ejaculation, feeling of weakness.


  • Rare (occurs in less than 1 in 1,000 users): swelling of hands or feet, difficulties in breathing and/or itch and rash (angio-oedema). Symptoms of low blood pressure (dizziness, fainting or weakness) occur rarely, sit or lie down straight away until the symptoms disappear. If you do not feel better please contact your doctor.


  • Very rare (occurs in less than 1 in 10,000 users): painful, prolonged, unwanted erection (priapism).

Changes in the eye have been noticed during cataract surgery.



If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.




How to store


Keep out of the reach and sight of children.


Store in the original package.


Do not use Stronazon after the expiry date stated on the label. The expiry date refers to the last day of that month.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



What Stronazon contains


  • The active substance (the ingredient that makes the capsule work) is tamsulosin hydrochloride.

  • The other ingredients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium laurilsulfate, triethyl citrate and talc.The capsule body ingredients are gelatine, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), and printing ink (black iron oxide E 172, shellac, propylene glycol).



What Stronazon looks like and contents of the pack


The Stronazon modified-release capsules are orange/ olive-green in colour with a black stripe at both ends of the capsule body.


Pack sizes are 30




Marketing Authorisation Holder



Actavis

Barnstaple

EX32 8NS

UK




Manufacturer



Synthon Hispania S. L.

Castelló, 1

Polígono Las Salinas

Sant Boi de Llobregat

Spain




Date of revision: September 2008




Actavis

Barnstaple

EX32 8NS

UK


SYNPL017





Friday, 16 March 2012

chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine


Generic Name: chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine (KLOR fen IR a meen, gwye FEN e sin, HYE droe KOE done, SOO doe ee FED rin)

Brand Names: Z-Tuss 2


What is chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.


Hydrocodone is a narcotic cough suppressant similar to codeine. Hydrocodone affects the signals in the brain that trigger cough reflex.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine is used to treat sinus congestion, runny nose, sneezing, itching, watery eyes, cough, and chest congestion caused by allergies, upper respiratory infections, or the common cold.


This medication will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine?


Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not give this medication to a child younger than 6 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, allergy, or sleep medicine. Chlorpheniramine, guaifenesin, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, decongestant, or expectorant.

What should I discuss with my healthcare provider before taking chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine?


Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:



  • heart disease or high blood pressure;




  • asthma, COPD, sleep apnea, or other breathing disorders;




  • diabetes;




  • glaucoma;




  • a thyroid disorder;




  • epilepsy or other seizure disorder;




  • kidney or liver disease;




  • enlarged prostate or urination problems;




  • a stomach or intestinal disorder;




  • a history of head injury or brain tumor;




  • Addison's disease or other adrenal gland disorders; or




  • a history of drug or alcohol addiction.




FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Older adults may be more likely to have side effects from this medication.

How should I take chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken for only a short time until your symptoms clear up.


Do not give this medication to a child younger than 6 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medication with food or milk if it upsets your stomach.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Drink plenty of water or other fluids to help loosen congestion and prevent dry mouth or throat. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


Store at room temperature, away from heat, light, and moisture. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

See also: Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?


Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include fast or uneven heart rate, extreme drowsiness, feeling restless or hyperactive, confusion, hallucinations, warmth or redness in your face, cold or clammy skin, blue-colored lips or fingernails, weak or shallow breathing, fainting, or seizure (convulsions).


What should I avoid while taking chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, guaifenesin, or hydrocodone. Ask a doctor or pharmacist before using any other cough, cold, allergy, or sleep medicine. Chlorpheniramine, guaifenesin, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, decongestant, or expectorant.

Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, anxiety, restless feeling, nervousness, or tremor;




  • fast, pounding, or uneven heartbeats;




  • slow heartbeat, weak pulse, shallow breathing;




  • confusion, hallucinations, unusual thoughts or behavior;




  • ringing in your ears;




  • painful or difficult urination;




  • pale skin, easy bruising or bleeding, unusual weakness; or




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).



Less serious side effects may include:



  • dizziness, drowsiness, headache;




  • blurred vision;




  • dry mouth, nose, or throat;




  • nausea, stomach pain, constipation; or




  • restless or excitability (especially in children).



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine Dosing Information


Usual Adult Dose for Cough and Nasal Congestion:

Chlorpheniramine/guaifenesin/hydrocodone/pseudoephedrine 2 mg-100 mg-2.5 mg-30 mg/5 mL oral liquid:
10 mL orally every 4 to 6 hours not to exceed 4 doses daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Chlorpheniramine/guaifenesin/hydrocodone/pseudoephedrine 2 mg-100 mg-2.5 mg-30 mg/5 mL oral liquid:
6 to 11 years: 5 mL orally every 4 to 6 hours not to exceed 4 doses daily.
12 years or older: 10 mL orally every 4 to 6 hours not to exceed 4 doses daily.


What other drugs will affect chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine?


Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, guaifenesin, or hydrocodone.

Tell your doctor about all other medicines you use, especially:



  • sibutramine (Meridia);




  • memantine (Namenda);




  • methyldopa (Aldomet);




  • reserpine;




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others; or




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.



This list is not complete and other drugs may interact with chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine resources


  • Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine Dosage
  • Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine Drug Interactions
  • Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine Support Group
  • 0 Reviews for Chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine - Add your own review/rating


Compare chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine with other medications


  • Cold Symptoms
  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine, guaifenesin, hydrocodone, and pseudoephedrine.


Mirtazapine 15mg & 45mg Tablets (Actavis UK Ltd)






Mirtazapine 15mg and 45mg film-coated tablets



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:



  • 1. What Mirtazapine is and what it is used for


  • 2. Before you take Mirtazapine


  • 3. How to take Mirtazapine


  • 4. Possible side effects


  • 5. How to store Mirtazapine


  • 6. Further information




What Mirtazapine is and what it is used for


Mirtazapine is one of a group of medicines called antidepressants.


Mirtazapine is used to treat depressive illness.




Before you take Mirtazapine



Do not take Mirtazapine if you are


  • allergic (hypersensitive) to mirtazapine or any of the other ingredients of Mirtazapine. If so, you must talk to your doctor as soon as you can before taking Mirtazapine.

  • taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is).



Take special care with Mirtazapine



Use in children and adolescents under 18 years of age


Mirtazapine should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Mirtazapine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Mirtazapine for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Mirtazapine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Mirtazapine in this age group have not yet been demonstrated.



Thoughts of suicide and worsening of your depression


If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.


You may be more likely to think like this:


  • if you have previously had thoughts about killing or harming yourself.

  • if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.



You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.



Also take special care with Mirtazapine if you have, or have ever had one of the following conditions. Tell your doctor about these conditions before taking Mirtazapine, if not done previously


  • seizures (epilepsy). If you develop seizures or your seizures become more frequent, stop taking Mirtazapine and contact your doctor immediately;

  • liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapine and contact your doctor immediately;

  • kidney disease;

  • heart disease, or low blood pressure;

  • schizophrenia. If psychotic symptoms, such as paranoid thoughts become more frequent or severe, contact your doctor straight away;

  • manic depression (alternating periods of feeling elated/overactivity and depressed mood). If you start feeling elated or over-excited, stop taking Mirtazapine and contact your doctor immediately;

  • diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines);

  • eye disease, such as increased pressure in the eye (glaucoma);

  • difficulty in passing water (urinating), which might be caused by an enlarged prostate.

  • if you develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers.

  • Stop taking Mirtazapine and consult your doctor immediately for a blood test.

    • In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow. While rare, these symptoms most commonly appear after 4-6 weeks of treatment.

  • if you are an elderly person. You could be more sensitive to the side-effects of antidepressants.



Taking other medicines


Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in the following list.



Do not take Mirtazapine in combination with:


  • monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Mirtazapine during the two weeks after you have stopped taking MAO inhibitors. If you stop taking Mirtazapine, do not take MAO inhibitors during the next two weeks either.
    Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson’s disease).



Take care when taking Mirtazapine in combination with:


  • antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St. Johns Wort – Hypericum perforatum preparations (a herbal remedy for depression). In very rare cases Mirtazapine alone or the combination of Mirtazapine with these medicines, can lead to a so-called serotonin syndrome. Some of the symptoms of this syndrome are: inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. If you get a combination of these symptoms, talk to your doctor immediately.

  • the antidepressant nefazodone. It can increase the amount of Mirtazapine in your blood. Inform your doctor if you are using this medicine. It might be needed to lower the dose of Mirtazapine, or when use of nefazodone is stopped, to increase the dose of Mirtazapine again.

  • medicines for anxiety or insomnia such as benzodiazepines; medicines for schizophrenia such as olanzapine; medicines for allergies such as cetirizine; medicines for severe pain such as morphine.

    In combination with these medicines Mirtazapine can increase the drowsiness caused by these medicines.

  • medicines for infections; medicines for bacterial infections (such as erythromycin, medicines for fungal infections (such as ketoconazole) and medicines for HIV/AIDS (such as HIVprotease inhibitors).

    In combination with Mirtazapine these medicines can increase the amount of Mirtazapine in your blood. Inform your doctor if you are using these medicines. It might be needed to lower the dose of Mirtazapine, or when these medicines are stopped, to increase the dose of Mirtazapine again.

  • medicines for epilepsy such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin.
    In combination with Mirtazapine these medicines can reduce the amount of Mirtazapine in your blood. Inform your doctor if you are using these medicines. It might be needed to increase the dose of Mirtazapine, or when these medicines are stopped to lower the dose of Mirtazapine again.


  • medicines to prevent blood clotting such as warfarin. Mirtazapine can increase the effects of warfarin on the blood. Inform your doctor if you are using this medicine. In case of combination it is advised that a doctor monitors your blood carefully.



Taking Mirtazapine with food and drink


You may get drowsy if you drink alcohol while you are taking Mirtazapine. You are advised not to drink any alcohol.


You can take Mirtazapine with or without food.




Pregnancy and breast-feeding


Ask your doctor or pharmacist for advice before taking any medicine.


Limited experience with Mirtazapine administration to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.


If you are taking Mirtazapine and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Mirtazapine. If you use Mirtazapine until, or shortly before birth, your baby should be supervised for possible adverse effects.


Ask your doctor whether you can breast-feed, while taking Mirtazapine.




Driving and using machines


Mirtazapine can affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery.




Important information about some of the ingredients of Mirtazapine


Mirtazapine tablets contain lactose. If you have been told by your doctor that you have an intolerance for some sugars, contact your doctor before taking this medicinal product.





How to take Mirtazapine


Always take Mirtazapine exactly as your doctor or pharmacist tells you to. You should check with your doctor or pharmacist if you are not sure.



How much to take


The usual starting dose is 15mg or 30mg every day. Your doctor may advise you to increase your dose after a few days to the amount that is best for you (between 15mg and 45mg per day). The dose is usually the same for all ages. However, if you are an elderly person or if you have renal or liver disease, your doctor may adapt the dose.




When to take Mirtazapine


Take Mirtazapine at the same time each day. It is best to take Mirtazapine as a single dose before you go to bed. However your doctor may suggest you to split your dose of Mirtazapine – once in the morning and once at night-time before you go to bed. The higher dose should be taken before you go to bed. Take your tablets orally.


Swallow your prescribed dose of Mirtazapine without chewing, with some water.




When can you expect to start feeling better


Usually Mirtazapine will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.


It is important that, during the first few weeks of the treatment, you talk with your doctor about the effects of Mirtazapine:


2 to 4 weeks after you have started taking Mirtazapine, talk to your doctor about how this medicine has affected you.


If you still don’t feel better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2 to 4 weeks.


Usually you will need to take Mirtazapine until your symptoms of depression have disappeared for 4 to 6 months.




If you take more Mirtazapine than you should


If you or someone else have taken too much Mirtazapine, call a doctor straight away.


The most likely signs of an overdose of Mirtazapine (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.




If you forget to take Mirtazapine


If you are supposed to take your dose once a day


  • If you have forgotten to take your dose of Mirtazapine, do not take the missed dose. Just skip it. Take your next dose at the normal time.

If you are supposed to take your dose twice a day


  • if you have forgotten to take your morning dose, simply take it together with your evening dose.

  • if you have forgotten to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses.

  • if you have forgotten to take both doses, do not attempt to make up for the missed doses. Skip both doses and continue the next day with your normal morning and evening doses.



If you stop taking Mirtazapine


Only stop taking Mirtazapine in consultation with your doctor.


If you stop too early, your depression might come back. Once you are feeling better, talk to your doctor. Your doctor will decide when treatment can be stopped.


Do not suddenly stop taking Mirtazapine, even when your depression has lifted. If you suddenly stop taking Mirtazapine you may feel sick, dizzy, agitated or anxious, and have headaches. These symptoms can be avoided by stopping gradually. Your doctor will tell you how to decrease the dose gradually.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Possible side effects


Like all medicines, Mirtazapine can cause side effects, although not everybody gets these side effects.


Some side effects are more likely to occur than others. The possible side effects of Mirtazapine are listed below and can be divided as:



Very common (affects more than 1 user in 10):


  • increase in appetite and weight gain

  • drowsiness or sleepiness

  • headache

  • dry mouth


Common (affects 1 to 10 users in 100):


  • lethargy

  • dizziness

  • shakiness or tremor

  • nausea and vomiting

  • diarrhoea

  • rash or skin eruptions (exanthema)

  • pain in your joints (arthralgia) or muscles (myalgia)

  • back pain

  • feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)

  • swelling (typically in ankles or feet) caused by fluid retention (oedema)

  • tiredness

  • vivid dreams

  • confusion

  • feeling anxious

  • sleeping problems


Uncommon (affects 1 to 10 users in 1,000):


  • abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia)

  • restless legs

  • fainting (syncope)

  • sensations of numbness in the mouth (oral hypoaesthesia)

  • low blood pressure

  • nightmares

  • feeling agitated

  • hallucinations

  • urge to move


Rare (affects 1 to 10 users in 10,000):


  • muscle twitching or contractions (myoclonus)


Not known (cannot be estimated from the available data):


  • In rare cases Mirtazapine can cause disturbances in the production of blood cells (bone marrow depression). Some people become less resistant to infection because Mirtazapine can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Mirtazapine can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).

  • thoughts of harming or killing yourself. Contact your doctor or go to a hospital straight away.

  • abnormal sensations in the mouth (oral paraesthesia)

  • swelling in the mouth (mouth oedema)

  • hyponatraemia

  • inappropriate anti-diuretic hormone secretion


Stop taking Mirtazapine and tell your doctor straight away if you have any of the following:


  • feeling elated or emotionally ‘high’ (mania).

  • yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice).

  • signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis).

  • epileptic attack (convulsions).

  • a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. In very rare cases these can be signs of serotonin syndrome.


If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How to store Mirtazapine


Keep out of the reach and sight of children.


Do not use Mirtazapine after the expiry date which is stated on the carton and the blister or bottle after EXP. The expiry date refers to the last day of that month.


This medicinal product does not require any special storage conditions


Medicines should not be disposed of via wastewater or household waste.


Ask your pharmacist how to dispose of medicines no longer required.


These measures will help to protect the environment.




Further information



What Mirtazapine contains


  • The active substance is mirtazapine.
    1 tablet contains 15mg and 45mg respectively.

  • The other ingredients are:

    Core: lactose monohydrate, pregelatinised maize starch, anhydrous colloidal silica, croscarmellose sodium, magnesium stearate.
    Core of Mirtazapine 15mg film-coated tablets also contains yellow iron oxide (E172) and red iron oxide (E172).
    Coating: hypromellose, macrogol 8000, titanium dioxide (E171)



What Mirtazapine looks like and contents of the pack


15mg tablets: Yellow, scored on both sides, oval, biconvex, film-coated tablets. Marked with "I" on one side. The tablet can be divided into equal halves


45mg tablets: White, oval, biconvex, film-coated tablets. Marked with "I" on one side.



Pack sizes


28 tablets in blister.




Marketing Authorisation Holder and Manufacturer



Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

IS-220 Hafnarfjordur

Iceland




Manufacturer



Actavis hf.

Reykjavikurvegi 78

PO Box 420

IS-222 Hafnarfjordur

Iceland


Or



Actavis Ltd.

B16, Bulebel Industrial Estate




This medicinal product is authorised in the Member States of the EEA under the following names:





Austria: Mirtazapin Actavis 15mg Filmtabletten, Mirtazapin Actavis 30mg Filmtabletten, Mirtazapin Actavis 45mg Filmtabletten

Belgium: Mirtazapin Actavis 15mg filmomhulde tableten, Mirtazapin Actavis 30mg filmomhulde tableten, Mirtazapin Actavis 45mg filmomhulde tableten

Czech Republic: Mirtabs 15mg potahované tablety, Mirtabs 30mg potahované tablety, Mirtabs 45mg potahované tablety

Denmark: Mirtazapin Actavis

Italia: Mirtazapina Actavis PTC 15mg compresse rivestite con film, Mirtazapina Actavis PTC 30mg compresse rivestite con film, Mirtazapina Actavis PTC 45mg compresse rivestite con film

Malta: Remirta 15mg, Remirta 30mg, Remirta 45mg

Norway: Mirtazapin Actavis

Poland: Remirta

Portugal: Mirtazapina Actavis

Sweded: Mirtazapin Actavis

United Kingdom: Mirtazapine 15mg Tablets, Mirtazapine 45mg Tablets







This leaflet was last revised in December 2008.




Actavis

Barnstaple

EX32 8NS

UK


ACTPL068





Analpram E


Generic Name: hydrocortisone and pramoxine topical (HYE droe KOR ti sone and pra MOX een)

Brand Names: Analpram E, Analpram-HC, Epifoam, HC Pramoxine, Hydropram, Novacort, Pramosone, Proctofoam HC, Rectocort HC, ZyPram


What is Analpram E (hydrocortisone and pramoxine topical)?

Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.


Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.


The combination of hydrocortisone and pramoxine topical is used to treat pain, itching, or inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, psoriasis, insect bites, and minor burns or scrapes. This medication is also used on the rectal area to treat itching and inflammation caused by hemorrhoids, anal fissures, or other rectal irritation.


Hydrocortisone and pramoxine topical may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Analpram E (hydrocortisone and pramoxine topical)?


You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or "numbing medicines."


Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.


Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.


Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone. Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.


What should I discuss with my health care provider before using Analpram E (hydrocortisone and pramoxine topical)?


You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or "numbing medicines." Also tell your doctor if you have:



  • liver disease;




  • diabetes;




  • problems with your eyes;




  • a stomach or intestinal disorder;




  • a rectal sore or infection; or




  • if you use any drugs that weaken the immune system, including steroids.



Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.


FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using hydrocortisone and pramoxine topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone and pramoxine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

How should I use Analpram E (hydrocortisone and pramoxine topical)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.


Hydrocortisone and pramoxine topical is usually applied 3 or more times daily, depending on which form of this medication you use. Follow the label directions or your doctor's instructions about how much of this medication to use and how often. Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.


Wash your hands before and after applying this medication, unless you are using hydrocortisone and pramoxine topical to treat a hand condition.

When using this medication on the skin, apply just enough of the medication to cover the area to be treated. Rub in gently.


Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.


Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Before apply the rectal form of this medication (cream, lotion, or foam), clean the rectal area with mild soap and pat dry.


Use only a small amount of medicine when applying hydrocortisone and pramoxine around the outside of the rectum. You may first place the medicine onto a clean tissue and then wipe it gently onto your rectum.


When using this medication inside the rectum, insert only the applicator tip of the medicine tube or foam can into the anus, no deeper than 1 inch.


Shake the hydrocortisone and pramoxine rectal foam before each use. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days, or if your condition clears up and then comes back. Do not stop using hydrocortisone and pramoxine topical suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using the medication. Store this medication at room temperature away from moisture and heat. Keep the rectal foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

What happens if I miss a dose?


Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone and pramoxine topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.


What should I avoid while using Analpram E (hydrocortisone and pramoxine topical)?


Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin. If it does get into any of these areas, wash with water. Do not use hydrocortisone and pramoxine topical on deep skin wounds, blistered skin, severe burns, irritated skin, or large skin areas. Also avoid using this medication in open wounds.

Avoid applying other skin medications on the same treatment area with hydrocortisone and pramoxine topical, unless your doctor has told you to.


Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.


Hydrocortisone pramoxine topical side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • blurred vision, or seeing halos around lights;




  • uneven heartbeats;




  • sleep problems (insomnia);




  • ongoing headache;




  • weight gain, puffiness in your face;




  • increased thirst or urination, weight loss, unusual weakness;




  • fever, sore throat, tired feeling;




  • severe pain, burning, or irritation of treated skin;




  • rectal bleeding;




  • any new redness or swelling where the medicine was applied; or




  • itching, oozing, or other signs of infection.



Less serious side effects may include:



  • mild skin redness, burning, itching, dryness, or peeling;




  • acne;




  • changes in the color of treated skin;




  • thinning of your skin;




  • blistering skin; or




  • stretch marks.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Analpram E (hydrocortisone and pramoxine topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone and pramoxine. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Analpram E resources


  • Analpram E Side Effects (in more detail)
  • Analpram E Use in Pregnancy & Breastfeeding
  • Analpram E Drug Interactions
  • Analpram E Support Group
  • 0 Reviews for Analpram E - Add your own review/rating


  • Analpram-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Epifoam Prescribing Information (FDA)

  • Epifoam Foam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Novacort MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pramosone Prescribing Information (FDA)

  • Pramosone Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Proctocream HC Prescribing Information (FDA)

  • Proctofoam HC Prescribing Information (FDA)

  • Proctofoam HC Foam MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Analpram E with other medications


  • Dermatitis
  • Dermatological Disorders
  • Hemorrhoids
  • Psoriasis


Where can I get more information?


  • Your pharmacist can provide more information about hydrocortisone and pramoxine topical.

See also: Analpram E side effects (in more detail)


Tuesday, 13 March 2012

Boots Paracetamol 500 mg Capsules (P -32)





Boots Paracetamol 500 mg Capsules



Read all of this leaflet carefully because it contains important information for you.


This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.


  • Keep this leaflet, you may need to read it again

  • Ask your pharmacist if you need more information or advice




What this medicine is for


This medicine contains a painkiller to relieve mild to moderate pain and fever.


It can be used to relieve headaches, migraine, rheumatic aches and pains, muscular pain and back pain, neuralgia, toothache, sore throat, period pain, fever and the symptoms of colds and flu.




Before you take this medicine


This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.



Do not take:



  • If you are allergic to any of the ingredients



Talk to your pharmacist or doctor:


  • If you have severe kidney problems or severe liver problems (including a disease caused by drinking alcohol)

  • If you are pregnant

You can take this medicine if you are breastfeeding.




Other important information



Information about some of the ingredients: Propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) in this medicine may cause allergic reactions (possibly delayed).




If you take other medicines



This medicine contains paracetamol.


Do not take with any other paracetamol-containing products.


Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:


  • Metoclopramide or domperidone (for feeling sick or being sick)

  • Colestyramine (to reduce blood fat levels)

  • Warfarin or other blood thinners - If you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.





How to take this medicine


Check the foil is not broken before use. If it is, do not take that capsule.




Adults and children of 12 years and over: Take one or two capsules three or four times a day, if you need to.
Don’t take more than 8 capsules in any 24 hours. Don’t take more often than every 4 hours.




Swallow each capsule with water.


Do not give to children under 12 years.


Do not take more than the amount recommended above.


If symptoms do not go away talk to your doctor.




If you take too many capsules: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.





Possible side effects


Most people will not have problems, but some may get some.



If you get any of these serious side effects, stop taking the capsules. See a doctor at once:


  • Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)



These other effects are less serious. If they bother you talk to a pharmacist:


  • Skin rash

  • Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood


If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.





How to store this medicine


Do not store above 25°C.


Store in the original package.


Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.


Use by the date on the end flap of the carton.




What is in this medicine


Each hard gelatin capsule contains Paracetamol 500 mg, which is the active ingredient.


As well as the active ingredient, the capsules also contain pregelatinised maize starch, magnesium stearate, sodium laurilsulfate. The capsule shell contains titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104), Patent Blue V (E131), gelatin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).


The pack contains 32 hard gelatin capsules with a red cap and white body.




Who makes this medicine


Manufactured for



The Boots Company PLC

Nottingham

NG2 3AA


by the Marketing Authorisation holder



Bristol Laboratories Ltd

Unit 3 Canalside

Northbridge Road

Berkhamsted

Hertfordshire

HP4 1EG



Leaflet prepared July 2007


If you would like any further information about this medicine, please contact



The Boots Company PLC

Nottingham

NG2 3AA


3448-32eMC-Xpil





Saturday, 10 March 2012

Cytra-K


Generic Name: citric acid and potassium citrate (SIT rik AS id and poe TASS ee um SIT rayt)

Brand Names: Cytra-K, Poly-Citra K Crystals, Polycitra-K


What is Cytra-K (citric acid and potassium citrate)?

Citric acid is an alkalinizing agent that make the urine less acidic.


Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.


The combination of citric acid and potassium citrate is used to treat or prevent hypokalemia (low levels of potassium in the blood). Citric acid and potassium citrate is also used to treat digitalis overdose.


Citric acid and potassium citrate may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Cytra-K (citric acid and potassium citrate)?


You should not use this medication if you have kidney failure, a urinary tract infection, uncontrolled diabetes, a peptic ulcer in your stomach, Addison's disease, severe burns or other tissue injury, if you are dehydrated, if you take certain diuretics (water pills), or if you have high levels of potassium in your blood (hyperkalemia).

You should not take citric acid and potassium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.


Avoid lying down for at least 30 minutes after you take this medication.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.


Serious side effects of citric acid and potassium citrate include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or around your mouth.


Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.

What should I discuss with my healthcare provider before taking Cytra-K (citric acid and potassium citrate)?


You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:

  • high levels of potassium in your blood (hyperkalemia);




  • a serious heart rhythm disorder called ventricular fibrillation;




  • kidney failure with sodium loss;




  • Addison's disease (an adrenal gland disorder);




  • a large tissue injury such as a severe burn; or




  • if you are severely dehydrated.



You should not take citric acid and potassium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.


Before using citric acid and potassium citrate, tell your doctor if you are allergic to any drugs, or if you have:


  • kidney disease;


  • if you are taking a "potassium-sparing" diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).




  • a urinary tract infection;




  • untreated or uncontrolled diabetes;




  • a peptic ulcer in your stomach;




  • congestive heart failure, enlarged heart, or history of heart attack;




  • other heart disease or high blood pressure;




  • diabetes;




  • a blockage in your stomach or intestines; or




  • chronic diarrhea (such as ulcerative colitis, Crohn's disease).



If you have any of these conditions, you may need a dose adjustment or special tests to safely take citric acid and potassium citrate.


It is not known whether this medication is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether potassium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Cytra-K (citric acid and potassium citrate)?


Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.


Measure the liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


The liquid form of this medication should be mixed with at least 8 ounces (one cup) of cold water or fruit juice. Drink the mixture slowly, over 5 to 10 minutes in all. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Citric acid and potassium citrate is usually taken 3 times daily after meals. Follow your doctor's instructions.


Avoid lying down for at least 30 minutes after you take this medication. Your treatment may include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.


Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store citric acid and potassium citrate at room temperature away from moisture, heat, or freezing. Keep the medication in a closed container.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include numbness and tingling, confusion, heavy feeling in your arms or legs, muscle weakness, limp feeling, slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).


What should I avoid while taking Cytra-K (citric acid and potassium citrate)?


Avoid taking potassium supplements or using other foods or products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.


You may also need to avoid eating potassium-rich foods while you are taking this medication. Foods that are high in potassium include many green leafy vegetables, squash, yams, beets, avocado, lima beans, kidney beans, pinto beans, lentils, split peas, soybeans, papaya, figs, prunes, and fish such as halibut, cod, snapper, and tuna.


It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.


Cytra-K (citric acid and potassium citrate) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • severe stomach pain, ongoing diarrhea or vomiting;




  • black, bloody, or tarry stools;




  • coughing up blood;




  • fast, slow, or uneven heart rate;




  • muscle weakness, pain, or twitching;




  • numbness or tingly feeling in your hands or feet, or around your mouth;




  • confusion, anxiety, weakness, mood changes, or feeling irritable;




  • swelling in your ankles or feet; or




  • seizure (convulsions).



Less serious side effects may include:



  • mild nausea, vomiting, or upset stomach;




  • mild or occasional diarrhea; or




  • appearance of a citric acid and potassium citrate tablet in your stool.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Cytra-K (citric acid and potassium citrate)?


The following drugs can interact with citric acid and potassium citrate. Tell your doctor if you are using any of these:



  • eplerenone (Inspra);




  • candesartan (Atacand), losartan (Cozaar, Hyzaar), valsartan (Diovan), or telmisartan (Micardis);




  • quinidine (Quinaglute, Quinidex, Quin-Release);




  • an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or




  • any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).



This list is not complete and there may be other drugs that can interact with citric acid and potassium citrate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Cytra-K resources


  • Cytra-K Side Effects (in more detail)
  • Cytra-K Use in Pregnancy & Breastfeeding
  • Cytra-K Drug Interactions
  • Cytra-K Support Group
  • 0 Reviews for Cytra-K - Add your own review/rating


  • Cytra-K Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cytra-K Powder Pack MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Cytra-K with other medications


  • Urinary Alkalinization
  • Urinary Tract Stones


Where can I get more information?


  • Your pharmacist can provide more information about citric acid and potassium citrate.

See also: Cytra-K side effects (in more detail)