PAROXETINE- paroxetine hydrochloride hemihydrate tablet
International Labs, Inc.
Read the Medication Guide that comes with paroxetine tablets 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 paroxetine?
Paroxetine and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
• New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
• Pay particular attention to such changes when paroxetine is started or when the dose is changed.
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 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:
Paroxetine 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 paroxetine without first talking to your healthcare provider. Stopping paroxetine too quickly may cause serious symptoms including:
What is paroxetine?
Paroxetine 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 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.
Who should not take paroxetine tablets?
Do not take paroxetine tablets if you:
• high fever
• uncontrolled muscle spasms
• stiff muscles
• rapid changes in heart rate or blood pressure
• loss of consciousness (pass out)
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:
• triptans used to treat migraine headache
• other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics
• drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
• certain drugs used to treat irregular heart beats
• certain drugs used to treat schizophrenia
• certain drugs used to treat HIV infection
• certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen
• certain drugs used to treat epilepsy
• have liver problems
• have kidney problems
• have heart problems
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have a history of a stroke
• have high blood pressure
• have or had bleeding problems
• have glaucoma (high pressure in the eye)
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Paroxetine 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 hydrochloride.
How should I take paroxetine tablets?
What should I avoid while taking paroxetine?
Paroxetine 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 affects you. Do not drink alcohol while using paroxetine.
What are possible side effects of paroxetine?
Paroxetine 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?"
Common possible side effects in people who take paroxetine 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. 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 they were not prescribed. Do not give paroxetine 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. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about paroxetine that is written for healthcare professionals.
Address medical inquiries to, Telephone: 1-877-993-8779 (MedicalAffairs@zydususa.com).
What are the ingredients in paroxetine tablets, USP?
Active ingredient: paroxetine hydrochloride, USP
Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.
* are the registered trademarks of their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Cadila Healthcare Ltd.
Cadila Healthcare Ltd.
International Labs, Inc.
St. Petersburg, FL 33710
Bentonville, AR 72716
Rev. 10/14 LI0001