ESCITALOPRAM OXALATE - escitalopram tablet, film coated
Aphena Pharma Solutions - Tennessee, LLC
Read the Medication Guide that comes with escitalopram 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 escitalopram tablets?
Escitalopram 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. Escitalopram 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: Escitalopram 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:
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 escitalopram tablets without first talking to your healthcare provider.
Stopping escitalopram tablets too quickly may cause serious symptoms including:
What are escitalopram tablets?
Escitalopram 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.
Escitalopram tablets are also used to treat:
Talk to your healthcare provider if you do not think that your condition is getting better with escitalopram tablets treatment.
Who should not take escitalopram tablets?
Do not take escitalopram tablets if you:
• are allergic to escitalopram or citalopram or any of the ingredients in escitalopram tablets. See the end of this Medication Guide for a complete list of ingredients in escitalopram tablets.
• Take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or a pharmacist if you are not sure if you take an MAOI, including linezolid.
• Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by your physician.
• Do not start escitalopram if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take escitalopram 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:
• high fever
• uncontrolled muscle spasms
• stiff muscles
• rapid changes in heart rate or blood pressure
• loss of consciousness (pass out)
• Do not take Escitalopram tablet with Orap® (pimozide) because taking these two drugs together can cause serious heart problems.
What should I tell my healthcare provider before taking escitalopram tablets? Ask if you are not sure.
Before starting escitalopram tablets, tell your healthcare provider if you:
• Are taking certain drugs such as:
• Triptans used to treat migraine headache
• Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, amphetamines, or antipsychotics
• Over-the-counter supplements such as tryptophan or St. John’s Wort
• 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 escitalopram tablets 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 escitalopram may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking escitalopram tablets.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Escitalopram 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 escitalopram tablets with your other medicines. Do not start or stop any medicine while taking escitalopram tablets without talking to your healthcare provider first.
|If you take escitalopram tablets, you should not take any other medicines that contain escitalopram or citalopram including: Celexa.
How should I take escitalopram tablets?
What should I avoid while taking escitalopram tablets?
Escitalopram 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 escitalopram tablets affect you. Do not drink alcohol while using escitalopram tablets.
What are the possible side effects of escitalopram tablets?
Escitalopram 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 escitalopram tablets?”
Common possible side effects in people who take escitalopram 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 escitalopram 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 escitalopram tablets?
Keep escitalopram tablets and all medicines out of the reach of children.
General information about escitalopram tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use escitalopram tablets for a condition for which it was not prescribed. Do not give escitalopram tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about escitalopram tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about escitalopram tablets that is written for healthcare professionals.
For more information about escitalopram tablets call Exelan Pharmaceuticals, Inc., at 1-866-604-3268.
What are the ingredients in escitalopram tablets, USP?
Active ingredient: escitalopram oxalate, USP
Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, talc, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cP, hypromellose 6cP, macrogol and polysorbate 80).
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Exelan
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788
Exelan Pharmaceuticals, Inc.
Boca Raton, FL 33432
This Medication Guide has been approved by the U.S. Food and Drug Administration.
SAP Code: 21082269