PAXIL CR- paroxetine hydrochloride hemihydrate tablet, film coated, extended release
PAXIL CR® (PAX-il) (paroxetine hydrochloride)
Read the Medication Guide that comes with PAXIL CR 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 CR?
PAXIL CR 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 CR 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. Visual problems
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
4. Severe allergic reactions:
5. Abnormal bleeding: PAXIL CR 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.
6. Seizures or convulsions
7. Manic episodes:
8. Changes in appetite or weight.
Children and adolescents should have height and weight monitored during treatment.
9. Low salt (sodium) levels in the blood.
Elderly people may be at greater risk for this. Symptoms may include:
Do not stop PAXIL CR without first talking to your healthcare provider. Stopping PAXIL CR too quickly may cause serious symptoms including:
What is PAXIL CR?
PAXIL CR 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 CR 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 CR.
Who should not take PAXIL CR?
Do not take PAXIL CR if you:
What should I tell my healthcare provider before taking PAXIL CR? Ask if you are not sure.
Before starting PAXIL CR, 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 CR 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 CR with your other medicines. Do not start or stop any medicine while taking PAXIL CR without talking to your healthcare provider first.
If you take PAXIL CR, you should not take any other medicines that contain paroxetine, including PAXIL and PEXEVA® (paroxetine mesylate).
How should I take PAXIL CR?
What should I avoid while taking PAXIL CR?
PAXIL CR 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 CR affects you. Do not drink alcohol while using PAXIL CR.
What are possible side effects of PAXIL CR?
PAXIL CR 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 CR?”
Common possible side effects in people who take PAXIL CR 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 CR. 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 CR?
Keep PAXIL CR and all medicines out of the reach of children.
General information about PAXIL CR
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PAXIL CR for a condition for which it was not prescribed. Do not give PAXIL CR to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about PAXIL CR. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about PAXIL CR that is written for healthcare professionals.
For more information about PAXIL CR call 1-800-706-5575.
What are the ingredients in PAXIL CR?
Active ingredient: paroxetine hydrochloride
Inactive ingredients in tablets: hypromellose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, titanium dioxide, polyethylene glycols, and 1 or more of the following colorants: Yellow ferric oxide, red ferric oxide, D&C Red No. 30 aluminum lake, FD&C Yellow No. 6 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake.
PAXIL and PAXIL CR are registered trademarks of GlaxoSmithKline.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Research Triangle Park, NC 27709
Weston, FL 33326
June 2014 PCR-AP:5MG