CITALOPRAM HYDROBROMIDE- citalopram hydrobromide tablet 
Sun Pharmaceutical Industries, Inc.

----------

Medication Guide

Citalopram Hydrobromide Tablets, USP

Read the Medication Guide that comes with citalopram hydrobromide tablets, USP 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 hydrobromide tablets, USP?

Citalopram hydrobromide tablets, USP and other antidepressant medicines may cause serious side effects, including:

1.
Suicidal thoughts or actions:
Citalopram hydrobromide tablets, USP and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
Watch for these changes and call your healthcare provider right away if you notice:
New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
Pay particular attention to such changes when citalopram hydrobromide tablets, USP 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:

attempts to commit suicide
acting on dangerous impulses
acting aggressive or violent
thoughts about suicide or dying
new or worse depression
new or worse anxiety or panic attacks
feeling agitated, restless, angry or irritable
trouble sleeping
an increase in activity or talking more than what is normal for you
other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Citalopram hydrobromide tablets, USP may be associated with these serious side effects:

2.
Changes in the electrical activity of your heart (QT prolongation and Torsade de Pointes).

This condition can be life threatening. The symptoms may include:

chest pain
fast or slow heartbeat
shortness of breath
dizziness or fainting
3.
Serotonin Syndrome. This condition can be life-threatening and may include:
agitation, hallucinations, coma or other changes in mental status
coordination problems or muscle twitching (overactive reflexes)
racing heartbeat, high or low blood pressure
sweating or fever
nausea, vomiting, or diarrhea
muscle rigidity
4.
Severe allergic reactions:
trouble breathing
swelling of the face, tongue, eyes or mouth
rash, itchy welts (hives) or blisters, alone or with fever or joint pain
5.
Abnormal bleeding: Citalopram hydrobromide tablets, USP 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:
greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual
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:
headache
weakness or feeling unsteady
confusion, problems concentrating or thinking or memory problems
10.
Visual problems
eye pain
changes in vision
swelling or redness in or around the eye

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 Citalopram hydrobromide tablets, USP without first talking to your healthcare provider.

Stopping citalopram hydrobromide tablets, USP too quickly may cause serious symptoms including:

anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion

What is Citalopram hydrobromide tablets, USP?

Citalopram hydrobromide tablets, USP 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 hydrobromide tablets, USP is also used to treat:

Major Depressive Disorder (MDD)

Talk to your healthcare provider if you do not think that your condition is getting better with citalopram hydrobromide tablets, USP treatment.

Who should not take Citalopram hydrobromide tablets, USP?

Do not take citalopram hydrobromide tablets, USP if you:

are allergic to citalopram hydrobromide or escitalopram oxalate or any of the ingredients in citalopram hydrobromide tablets, USP. See the end of this Medication Guide for a complete list of ingredients in citalopram hydrobromide tablets, USP.
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
Do not take an MAOI within 2 weeks of stopping citalopram hydrobromide tablets, USP unless directed to do so by your physician.
Do not start citalopram hydrobromide tablets, USP if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take Citalopram hydrobromide tablets, USP 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
confusion
loss of consciousness (pass out)
take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
have a heart problem including congenital long QT syndrome

What should I tell my healthcare provider before taking Citalopram hydrobromide tablets, USP? Ask if you are not sure.

Before starting citalopram hydrobromide tablets, USP, tell your healthcare provider if you

Are taking certain drugs such as:
Medicines for heart problems
Medicines that lower your potassium or magnesium levels in your body
Cimetidine
Triptans used to treat migraine headache
Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, amphetamines, or antipsychotics
Tramadol
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 citalopram hydrobromide tablets, USP 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 citalopram hydrobromide tablets, USP may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking citalopram hydrobromide tablets, USP.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Citalopram hydrobromide tablets, USP 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 hydrobromide tablets, USP with your other medicines. Do not start or stop any medicine while taking citalopram hydrobromide tablets, USP without talking to your healthcare provider first.

How should I take Citalopram hydrobromide tablets, USP?

Take citalopram hydrobromide tablets, USP exactly as prescribed. Your healthcare provider may need to change the dose of citalopram hydrobromide tablets, USP until it is the right dose for you.
Citalopram hydrobromide tablets, USP may be taken with or without food.
If you miss a dose of citalopram hydrobromide tablets, USP, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of citalopram hydrobromide tablets, USP at the same time.
If you take too much citalopram hydrobromide tablets, USP, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking Citalopram hydrobromide tablets, USP?

Citalopram hydrobromide tablets, USP 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 hydrobromide tablets, USP affects you. Do not drink alcohol while using citalopram hydrobromide tablets, USP.

What are the possible side effects of Citalopram hydrobromide tablets, USP?

Citalopram hydrobromide tablets, USP may cause serious side effects, including:

See “What is the most important information I should know about Citalopram hydrobromide tablets, USP?”

Common possible side effects in people who take citalopram hydrobromide tablets, USP include:

Nausea
Sleepiness
Weakness
Dizziness
Feeling anxious
Trouble sleeping
Sexual problems
Sweating
Shaking
Not feeling hungry
Dry mouth
Constipation
Diarrhea
Respiratory Infections
Yawning
 
Other side effects in children and adolescents include:
increased thirst
abnormal increase in muscle movement or agitation
nose bleed
urinating more often
heavy menstrual periods
possible slowed growth rate and weight change. Your child's height and weight should be monitored during treatment with citalopram hydrobromide tablets, USP.

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 hydrobromide tablets, USP. 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 Citalopram hydrobromide tablets, USP?

Store citalopram hydrobromide tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).
Keep citalopram hydrobromide tablets, USP bottle closed tightly.

Keep citalopram hydrobromide tablets, USP and all medicines out of the reach of children.

General information about Citalopram hydrobromide tablets, USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use citalopram hydrobromide tablets, USP for a condition for which it was not prescribed. Do not give citalopram hydrobromide tablets, USP to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about citalopram hydrobromide tablets, USP. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about citalopram hydrobromide tablets, USP that is written for healthcare professionals.

For more information about citalopram hydrobromide tablets USP, call 1-800-406-7984

What are the ingredients in Citalopram hydrobromide tablets, USP?

Active ingredient: citalopram hydrobromide

Inactive ingredients: Copolyvidone, Corn Starch, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Colloidal Silicon Dioxide, Microcrystalline Cellulose, Titanium Dioxide, Hypromellose 6, and Polyethylene Glycol-4000, iron oxide red and yellow iron oxide (10 mg only), iron oxide red and black iron oxide (20 mg ohly), polysorbate 80 (40 mg only)

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Sun Pharmaceutical Industries Ltd.

Halol-Baroda Highway,

Halol-389 350, Gujarat, India.

Distributed by:

Sun Pharmaceutical Industries Inc.

Cranbury, NJ 08512

Rev.02/17

Revised: 2/2017
Sun Pharmaceutical Industries, Inc.