CITALOPRAM- citalopram hydrobromide tablet, film coated
Mylan Pharmaceuticals Inc.
CITALOPRAM TABLETS, USP
(cye tal′ oh pram hye″ droe broe′ mide)
10 mg, 20 mg and 40 mg
Read the Medication Guide that comes with citalopram 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 citalopram tablets?
Citalopram tablets and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
2. Changes in the electrical activity of your heart (QT prolongation andTorsade de Pointes).
3. Serotonin Syndrome. This condition can be life threatening and may include:
4. Severe allergic reactions:
5. Abnormal bleeding: Citalopram 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.
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 citalopram tablets without first talking to your healthcare provider. Stopping citalopram tablets too quickly may cause serious symptoms including:
What is citalopram?
Citalopram 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. Citalopram is also used to treat:
Talk to your healthcare provider if you do not think that your condition is getting better with citalopram treatment.
Who should not take citalopram tablets?
Do not take citalopram tablets if you:
People who take citalopram 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 citalopram tablets? Ask if you are not sure.
Before starting citalopram tablets, tell your healthcare provider if you
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Citalopram 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 citalopram tablets with your other medicines. Do not start or stop any medicine while taking citalopram tablets without talking to your healthcare provider first.
If you take citalopram tablets, you should not take any other medicines that contain citalopram hydrobromide or escitalopram oxalate including: Lexapro®*.
How should I take citalopram tablets?
What should I avoid while taking citalopram tablets?
Citalopram 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 citalopram tablets affect you. Do not drink alcohol while using citalopram tablets.
What are the possible side effects of citalopram tablets?
Citalopram tablets may cause serious side effects, including:
See “What is the most important information I should know about citalopram tablets?”
Common possible side effects in people who take citalopram 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 citalopram 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 FDA at 1-800-FDA-1088.
How should I store citalopram tablets?
Keep citalopram tablets and all medicines out of the reach of children.
General information about citalopram tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use citalopram tablets for a condition for which it was not prescribed. Do not give citalopram tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about citalopram tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about citalopram tablets that is written for healthcare professionals.
For more information about citalopram tablets call Mylan Pharmaceuticals Inc. toll free at 1-877-446-3679 (1-877-4-INFO-RX).
What are the ingredients in citalopram tablets?
Active ingredient: citalopram hydrobromide, USP
Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide and triacetin. The 10 mg and 20 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. The 20 mg tablets also contain FD&C Red No. 40 Aluminum Lake.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
* The brand names mentioned are registered trademarks of their respective manufacturers.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured in India by:
Mylan Laboratories Limited
Hyderabad — 500 034, India
Code No.: MH/DRUGS/25/NKD/89
REVISED JANUARY 2013