CITALOPRAM HYDROBROMIDE- citalopram hydrobromide tablet 
Preferred Pharmaceuticals, Inc.

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Medication Guide

Citalopram (si TAL o pram) Tablets, USP

Rx Only

Read the Medication Guide that comes with citalopram 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 citalopram tablets?

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

1.         Suicidal thoughts or actions:

Citalopram tablets 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 tablets are 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 tablets 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 tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin, 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

Do not stop citalopram tablets without first talking to your healthcare provider. Stopping citalopram tablets 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

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.

What are Citalopram Tablets?

Citalopram 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. Citalopram tablets are 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 tablets treatment.

Who should not take citalopram tablets?

Do not take citalopram tablets if you:

are allergic to citalopram hydrobromide or escitalopram oxalate or any of the ingredients in citalopram tablets. See the end of this Medication Guide for a complete list of ingredients in citalopram tablets.
If you 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 tablets unless directed to do so by your physician.
Do not start citalopram tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

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:

           •            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 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 tablets? Ask if you are not sure.

Before starting citalopram tablets, 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, 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 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 citalopram may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking citalopram tablets.

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 oxalateincluding: Lexapro.

How should I take citalopram tablets?

Take citalopram tablets exactly as prescribed. Your healthcare provider may need to change the dose of citalopram tablets until it is the right dose for you.
Citalopram tablets may be taken with or without food.
If you miss a dose of citalopram tablets, 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 tablets at the same time.
If you take too much citalopram tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

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 tablet?

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:

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 tablets.

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 THE FDA AT 1-800-FDA-1088.

How should I store citalopram tablets?

Store at 20º-25°C (68º-77°F); excursions permitted to 15°-30°C (59º-86°F) [see USP Controlled Room Temperature].
Keep citalopram tablets bottle closed tightly.

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 1-269-544-2299.

What are the ingredients in citalopram tablets?

Active ingredient: citalopram hydrobromide, USP

Inactive ingredients:

  Tablets: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide.

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

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Manufactured by:

TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For:

TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920

8050573                                                                                             Revised August 2014

Repackaged by Preferred Pharmaceuticals, Inc.

Revised: 10/2014
 
Preferred Pharmaceuticals, Inc.