PAROXETINE - paroxetine hydrochloride hemihydrate tablet, film coated 
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SPL Medguide Section

Paroxetine Tablets, USP

Read the Medication Guide that comes with paroxetine 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 tablets?

Paroxetine tablets 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 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 tablets 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 tablets without first talking to your healthcare provider. Stopping paroxetine tablets too quickly may cause serious symptoms including:

What are paroxetine tablets?

Paroxetine tablets are 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 tablets are also used to treat: 

Talk to your healthcare provider if you do not think that your condition is getting better with treatment using paroxetine tablets. 

Who should not take paroxetine tablets? 

Do not take paroxetine tablets if you: 

What should I tell my healthcare provider before taking paroxetine tablets? Ask if you are not sure. 

Before starting paroxetine 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 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 tablets with your other medicines. Do not start or stop any medicine while taking paroxetine tablets without talking to your healthcare provider first. 

If you take paroxetine tablets, you should not take any other medicines that contain paroxetine, including PAXIL CR and PEXEVA® (paroxetine mesylate).

How should I take paroxetine tablets?

What should I avoid while taking paroxetine tablets? 

Paroxetine 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 tablets affect you. Do not drink alcohol while using paroxetine tablets. 

What are possible side effects of paroxetine tablets? 

Paroxetine 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 tablets?” 

Common possible side effects in people who take paroxetine tablets 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 paroxetine 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 tablets? 

Keep paroxetine tablets and all medicines out of the reach of children. 

General information about paroxetine tablets 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use paroxetine tablets for a condition for which it was not prescribed. Do not give paroxetine tablets to other people, even if they have the same condition. They may harm them. 

This Medication Guide summarizes the most important information about paroxetine tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about paroxetine tablets that is written for healthcare professionals. 

For more information about paroxetine tablets call 1-866-850-2876. 

What are the ingredients in paroxetine tablets? 

Active ingredient: paroxetine hydrochloride 

Inactive ingredients in tablets: dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 AluminumLake and FD&C Yellow #6 AluminumLake. 20 mg and 40 mg tablets contain D&C Red #30 AluminumLake. 30 mg tablet contains FD&C Blue #2 AluminumLake. 

All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. 

This Medication Guide has been approved by the U.S. Food and Drug Administration. 

Manufactured by:
Aurobindo Pharma LLC
Dayton, NJ 08810 
 

Manufactured for:
Aurobindo Pharma USA, Inc.
Dayton, NJ 08810  

Revised: 08/2011 

 

Revised: 03/2014
 
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