CITALOPRAM HYDROBROMIDE - citalopram  tablet 
Exelan Pharmaceuticals Inc.

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MEDICATION GUIDE
Citalopram Tablets,USP
(sih-TAL-oh-pram
What is the most important information I should know about Citalopram? Citalopram may cause serious side effects, including:
  • Increased risk of suicidal thoughts and actions. Citalopram and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults especially within the first few months of treatment or when the dose is changed. Citalopram is not for use in children.
    • Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

  • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency medical help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • new or worse depression
  • feeling very agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, being angry, or violent
  • an extreme increase in activity or talking (mania)
  • attempts to commit suicide
  • new or worse anxiety
  • acting on dangerous impulses
  • panic attacks
  • new or worse irritability
  • other unusual changes in behavior or mood
What is Citalopram?

Citalopram is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults.

It is not known if Citalopram is safe and effective for use in children.

Who should not take Citalopram? Do not take Citalopram if you:
  • take a Monoamine Oxidase Inhibitor (MAOI)
  • have stopped taking an MAOI in the last 14 days
  • are being treated with the antibiotic linezolid or intravenous methylene blue
  • take pimozide
  • are allergic to citalopram or any of the ingredients in Citalopram. See the end of this Medication Guide for a complete list of ingredients in Citalopram.

Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including MAOIs such as linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you stop treatment with Citalopram.

Before taking Citalopram, tell your healthcare provider about all your medical conditions, including if you:
  • have or have a family history of suicide, depression, bipolar disorder, mania or hypomania
  • have an abnormal heart rhythm called QT prolongation
  • have or had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
  • have low potassium, magnesium, or sodium levels in your blood
  • have or had bleeding problems
  • have or had seizures (convulsions)
  • have high pressure in the eye (glaucoma)
  • have or had kidney or liver problems
  • are pregnant or plan to become pregnant. Citalopram may harm your unborn baby. Taking Citalopram late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the risks and benefits of treating depression during pregnancy.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Citalopram.
    • There is a pregnancy registry for females who are exposed to Citalopram during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Citalopram and their baby. If you become pregnant during treatment with Citalopram, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or visiting online at https:// womensmentalhealth.org/research/pregnancyregistry/antidepressants.
  • are breastfeeding or plan to breastfeed. It is not known if Citalopram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Citalopram.
    • If you breastfeed during treatment with Citalopram, call your healthcare provider right away if your baby develops sleepiness or fussiness, or is not feeding or gaining weight well.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Citalopram and other medicines may affect each other causing possible serious side effects. Citalopram may affect the way other medicines work and other medicines may affect the way Citalopram works.
  • Especially tell your healthcare provider if you take:
  • medicines used to treat migraine headaches known as triptans
  • tricyclic antidepressants
  • fentanyl
  • lithium
  • tramadol
  • tryptophan
  • buspirone
  • amphetamines
  • St. John’s Wort
  • medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) and warfarin
  • diuretics
  • methadone
  • gatifloxacin or moxifloxacin
  • medicines used to control your heart rate or rhythm (antiarrhythmics)
  • medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
  • Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Citalopram with your other medicines.
  • Do not start or stop any other medicines during treatment with Citalopram without talking to your healthcare provider first. Stopping Citalopram suddenly may cause you to have serious side effects. See, “What are the possible side effects of Citalopram?”
  • Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Citalopram?

  • Take Citalopram exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Citalopram without first talking to your healthcare provider.
  • Your healthcare provider may need to change the dose of Citalopram until it is the right dose for you.
  • Take Citalopram 1 time each day with or without food.

If you take too much Citalopram, call your healthcare provider or poison control center at 1-800-222-1222, or go tothe nearest hospital emergency room right away

What are the possible side effects of Citalopram? Citalopram may cause serious side effects, including:

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

  • Low sodium levels in your blood (hyponatremia). Low sodium levels in your blood may be serious and may cause death. Elderly people may be at greater risk for this. Tell your healthcare provider right away if you develop any signs or symptoms of low sodium levels in your blood during treatment with Citalopram. Signs and symptoms of low sodium levels in your blood may include:
In severe or more sudden cases, signs and symptoms include:
  • hallucinations (seeing or hearing things that are not real)
  • seizures
  • stopping breathing
  • fainting
  • coma
  • death
  • Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including Citalopram, may cause sexual problems.

    Symptoms in males may include:

    • Delayed ejaculation or inability to have an ejaculation
    • Decreased sex drive
    • Problems getting or keeping an erection

    Symptoms in females may include:

    • Decreased sex drive
    • Delayed orgasm or inability to have an orgasm
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 1800-FDA-1088.

How should I store Citalopram?

  • Store citalopram tablets at 20°C to 25°C (68°F to 77°F)
  • Keep citalopram tablets bottle closed tightly.

Keep Citalopram and all medicines out of the reach of children.

General information about the safe and effective use of Citalopram

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 Exelan Pharmaceuticals Inc. at 1-866-604-3268.

What are the ingredients in Citalopram? Tablets, USP?

Active ingredient: citalopram hydrobromide, USP

Inactive ingredients:

Tablets: Copovidone, Croscarmellose, sodium , lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beig (HPMC 2910/hypromellose 6cp,titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titaniumdioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose3cp,HPMC2910/hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coating agents in the beige (10 mg), pink (20 mg) and white (40 mg) tablets.

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

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.


Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788


Manufactured for:

Exelan pharmaceuticals, Inc.

Boca Raton,FL 33432


Rev: 03/2022

Barcode-208-03-2022

Barcode-208-03-2022

Revised: 3/2022
Exelan Pharmaceuticals Inc.