PAROXETINE HYDROCHLORIDE- paroxetine hydrochloride hemihydrate tablet, film coated, extended release 
Bryant Ranch Prepack

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Medication Guide

Paroxetine Hydrochloride (PA-rox-eh-tine HY-dro-chlo-ride) Controlled-Release Tablets

Read the Medication Guide that comes with Paroxetine Hydrochloride Controlled-Release Tablets before you start taking them 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 Paroxetine Hydrochloride Controlled-Release Tablets?

Paroxetine Hydrochloride 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. Paroxetine Hydrochloride Controlled-Release Tablets 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: Paroxetine Hydrochloride 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 Paroxetine Hydrochloride Controlled-Release Tablets without first talking to your healthcare provider. Stopping Paroxetine Hydrochloride Controlled-Release Tablets too quickly may cause serious symptoms including:

What are Paroxetine Hydrochloride Controlled-Release Tablets?

Paroxetine Hydrochloride 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. Paroxetine hydrochloride is also used to treat:

Talk to your healthcare provider if you do not think that your condition is getting better with treatment using Paroxetine Hydrochloride Controlled-Release Tablets.

Who should not take Paroxetine Hydrochloride Controlled-Release Tablets?

Do not take Paroxetine Hydrochloride Controlled-Release Tablets if you:

What should I tell my healthcare provider before taking Paroxetine Hydrochloride Controlled-Release Tablets? Ask if you are not sure.

Before starting Paroxetine Hydrochloride Controlled-Release Tablets, 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. Paroxetine Hydrochloride Controlled-Release Tablets 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 Paroxetine Hydrochloride Controlled-Release Tablets with your other medicines. Do not start or stop any medicine while taking Paroxetine Hydrochloride Controlled-Release Tablets without talking to your healthcare provider first.

If you take Paroxetine Hydrochloride Controlled-Release Tablets, you should not take any other medicines that contain paroxetine, including PAXIL, PAXIL CR, and PEXEVA® (paroxetine mesylate).

How should I take Paroxetine Hydrochloride Controlled-Release Tablets?

  • Take Paroxetine Hydrochloride Controlled-Release Tablets exactly as prescribed. Your healthcare provider may need to change the dose of Paroxetine Hydrochloride Controlled-Release Tablets until it is the right dose for you.
  • Paroxetine Hydrochloride Controlled-Release Tablets may be taken with or without food.
  • Paroxetine Hydrochloride Controlled-Release Tablets should not be chewed or crushed and should be swallowed whole.
  • If you miss a dose of Paroxetine Hydrochloride Controlled-Release Tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Paroxetine Hydrochloride Controlled-Release Tablets at the same time.
  • If you take too many Paroxetine Hydrochloride Controlled-Release Tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
  • Do not stop taking Paroxetine Hydrochloride Controlled-Release Tablets suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking Paroxetine Hydrochloride Controlled-Release Tablets, your healthcare provider can tell you how to safely stop taking it.

What should I avoid while taking Paroxetine Hydrochloride Controlled-Release Tablets?

Paroxetine Hydrochloride Controlled-Release Tablets 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 Paroxetine Hydrochloride Controlled-Release Tablets affect you. Do not drink alcohol while using Paroxetine Hydrochloride Controlled-Release Tablets.

What are possible side effects of Paroxetine Hydrochloride Controlled-Release Tablets?

Paroxetine Hydrochloride Controlled-Release Tablets may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about Paroxetine Hydrochloride Controlled-Release Tablets?”

Common possible side effects in people who take Paroxetine Hydrochloride Controlled-Release Tablets include:

  • nausea
  • sleepiness
  • feeling anxious or trouble sleeping
  • sexual problems
  • sweating
  • shaking
  • constipation
  • yawning
  • blurred vision
  • diarrhea
  • dry mouth
  • decreased appetite
  • weakness

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 Paroxetine Hydrochloride Controlled-Release Tablets. 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 Paroxetine Hydrochloride Controlled-Release Tablets?

  • Store Paroxetine Hydrochloride Controlled-Release Tablets at or below room temperature (77F or 25C).
  • Keep Paroxetine Hydrochloride Controlled-Release Tablets away from light.
  • Keep bottle of Paroxetine Hydrochloride Controlled-Release Tablets closed tightly.

Keep Paroxetine Hydrochloride Controlled-Release Tablets and all medicines out of the reach of children.

General information about Paroxetine Hydrochloride Controlled-Release Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Paroxetine Hydrochloride Controlled-Release Tablets for a condition for which it was not prescribed. Do not give Paroxetine Hydrochloride Controlled-Release Tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Paroxetine Hydrochloride Controlled-Release Tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Paroxetine Hydrochloride Controlled-Release Tablets that is written for healthcare professionals.

For more information about Paroxetine Hydrochloride Controlled-Release Tablets call 1-800-706-5575.

What are the ingredients in Paroxetine Hydrochloride Controlled-Release Tablets?

Active ingredient: paroxetine hydrochloride

Inactive ingredients: 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. 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.

Manufactured by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Manufactured for:

Apotex Corp.

Weston, FL33326

July 2011 PCA-AP:3MG

Revised: 05/2010
 
Bryant Ranch Prepack