SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated
SERTRALINE HYDROCHLORIDE TABLETS USP (ser′ tra leen)
25 mg, 50 mg and 100 mg
Read the Medication Guide that comes with sertraline hydrochloride 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 sertraline hydrochloride tablets?
Sertraline hydrochloride 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 hydrochloride tablets may be associated with these serious side effects:
2. Serotonin Syndrome
This condition can be life-threatening and may include:
3. Severe allergic reactions:
4. Abnormal bleeding: Sertraline 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:
9. 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.
Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider. Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including:
What are sertraline hydrochloride tablets?
Sertraline hydrochloride tablets are 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 hydrochloride tablets are also used to treat:
Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride tablets treatment.
Who should not take sertraline hydrochloride tablets?
Do not take sertraline hydrochloride tablets if you:
People who take sertraline hydrochloride 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 hydrochloride tablets? Ask if you are not sure.
Before starting sertraline hydrochloride tablets, tell your healthcare provider if you:
• Are taking certain drugs such as:
▪ Medicines used to treat migraine headaches such as:
▪ Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
▪ Medicines used to treat seizures such as:
▪ Medicines used to treat pain such as:
▪ Medicines used to thin your blood such as:
▪ Medicines used to control your heartbeat such as :
▪ Medicines used to treat type II diabetes such as:
▪ Cimetidine used to treat heartburn
▪ Over-the-counter medicines or supplements such as:
• 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
• are pregnant or plan to become pregnant. It is not known if sertraline will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
• are breast-feeding or plan to breast-feed. Some sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride tablets.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sertraline hydrochloride 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 hydrochloride tablets with your other medicines. Do not start or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.
If you take sertraline hydrochloride tablets, you should not take any other medicines that contain sertraline (sertraline HCl, sertraline hydrochloride, etc.).
How should I take sertraline hydrochloride tablets?
What should I avoid while taking sertraline hydrochloride tablets?
Sertraline hydrochloride 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 affects you. Do not drink alcohol while using sertraline hydrochloride tablets.
What are the possible side effects of sertraline hydrochloride tablets?
Sertraline hydrochloride tablets may cause serious side effects, including:
Common possible side effects in people who take sertraline hydrochloride 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 hydrochloride 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 hydrochloride tablets?
Keep sertraline hydrochloride tablets and all medicines out of the reach of children.
General information about sertraline hydrochloride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride tablets for a condition for which they were not prescribed. Do not give sertraline hydrochloride 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 hydrochloride tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride tablets that is written for healthcare professionals.
For more information about sertraline hydrochloride tablets call Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit at www.lupinpharmaceuticals.com.
What are the ingredients in sertraline hydrochloride tablets?
Active ingredient: sertraline hydrochloride
Inactive ingredients: D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide
The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
MADE IN INDIA
Revised: October 2014 ID#: 238577
Sertraline Tablets USP, 25 mg, 50 mg and 100 mg are available from Cardinal Health in cards of 28 tablets and in cards of 30 tablets.
Zanesville, OH 43701