SERTRALINE- sertraline hydrochloride tablet, film coated
Hikma Pharmaceuticals USA Inc.
Sertraline Tablets, USP
Read the Medication Guide that comes with Sertraline 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 sertraline tablets?
Sertraline 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. Sertraline 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: Sertraline 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:
• greatly increased energy
• unusually grand ideas
|• severe trouble sleeping||• excessive happiness or irritability|
|• racing thoughts||• talking more or faster than usual|
|• reckless behavior|
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 sertraline tablets without first talking to your healthcare provider. Stopping sertraline tablets too quickly may cause serious symptoms including:
What are SertralineTablets?
Sertraline 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. Sertraline tablets are also used to treat:
Talk to your healthcare provider if you do not think that your condition is getting better with sertraline tablet treatment.
Who should not take sertraline tablets?
Do not take sertraline tablets if you:
People who take sertraline tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
What should I tell my healthcare provider before taking sertraline tablets? Ask if you are not sure. Before starting sertraline tablets, tell your healthcare provider if you:
Talk to your healthcare provider about the best way to feed your baby while taking sertraline tablets.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sertraline 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 sertraline tablets with your other medicines. Do not start or stop any medicine while taking sertraline tablets without talking to your healthcare provider first.
If you take sertraline tablets, you should not take any other medicines that contain sertraline (sertraline HCl, sertraline hydrochloride, etc.).
How should I take sertraline tablets?
What should I avoid while taking sertraline tablets?
Sertraline 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 sertraline tablets affect you. Do not drink alcohol while using sertraline tablets.
What are the possible side effects of sertraline tablets?
Sertraline tablets may cause serious side effects, including:
Common possible side effects in people who take sertraline tablets include:
Other side effects in children and adolescents 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 sertraline 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.
How should I store sertraline tablets?
Keep sertraline tablets and all medicines out of the reach of children.
General information about sertraline tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline tablets for a condition for which it was not prescribed. Do not give sertraline tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about sertraline tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline tablets that is written for healthcare professionals.
For more information about sertraline tablets contact West-Ward Pharmaceutical Corp. at 1-877-233-2001 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the ingredients in Sertraline Tablets, USP?
Active ingredient: Sertraline Hydrochloride, USP
Inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/ Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FDC Blue #2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/ Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake, and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.
† The brand names mentioned in this Medication Guide are registered trademarks of their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration
InvaGen Pharmaceuticals Inc.
Hauppauge, NY 11788
West-Ward Pharmaceutical Corp.
Eatontown, New Jersey 07724
Issued September 2012