PAXIL - paroxetine hydrochloride tablet, film coated
Physicians Total Care, Inc.
Tablets and Oral Suspension
Read the Medication Guide that comes with PAXIL before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about PAXIL?
PAXIL and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. PAXIL may be associated with these serious side effects:
2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:
3. Severe allergic reactions:
4. Abnormal bleeding: PAXIL and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. Seizures or convulsions
6. Manic episodes:
7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
Do not stop PAXIL without first talking to your healthcare provider. Stopping PAXIL too quickly may cause serious symptoms including:
What is PAXIL?
PAXIL is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. PAXIL is also used to treat:
Talk to your healthcare provider if you do not think that your condition is getting better with treatment using PAXIL.
Who should not take PAXIL?
Do not take PAXIL if you:
What should I tell my healthcare provider before taking PAXIL? Ask if you are not sure.
Before starting PAXIL, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. PAXIL and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take PAXIL with your other medicines. Do not start or stop any medicine while taking PAXIL without talking to your healthcare provider first.
If you take PAXIL, you should not take any other medicines that contain paroxetine, including PAXIL CR and PEXEVA® (paroxetine mesylate).
How should I take PAXIL?
What should I avoid while taking PAXIL?
PAXIL can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how PAXIL affects you. Do not drink alcohol while using PAXIL.
What are possible side effects of PAXIL?
PAXIL may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about PAXIL?”
Common possible side effects in people who take PAXIL include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PAXIL. For more information, ask your healthcare provider or pharmacist.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 or 1-800-332-1088.
How should I store PAXIL?
Keep PAXIL and all medicines out of the reach of children.
General information about PAXIL
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PAXIL for a condition for which it was not prescribed. Do not give PAXIL to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about PAXIL. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about PAXIL that is written for healthcare professionals.
For more information about PAXIL call 1-888-825-5249 or go to www.us.gsk.com.
What are the ingredients in PAXIL?
Active ingredient: paroxetine hydrochloride
Inactive ingredients in tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.
Inactive ingredients in suspension for oral administration: polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD&C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.
PAXIL and PAXIL CR are registered trademarks of GlaxoSmithKline. The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Research Triangle Park, NC 27709
©2011, GlaxoSmithKline. All rights reserved.
July 2011 PXL:6MG