Citalopram tablets USP 20mg

Citalopram tablets USP 10mg
Citalopram tablets USP 20mg
Citalopram tablets USP 40mg

Package leaflet: Information for the patient

Important things you need to know about citalopram

Read all of this leaflet carefully before you start taking this medicine.

  • Citalopram treats depression and panic disorders but it will not work straight away. Like all medicines, it can have side-effects. It is important that you and your doctor talk about the benefits and the possible unwanted effects of the medicine before you start taking it.
  • Citalopram should not be taken by children or teenagers under 18 (see section 6 on page 4).
  • Citalopram will not work straight away. You may feel worse before feeling better after starting the medicine. Your doctor should ask to see you again 2 or 3 weeks after you first start taking the medicine. Tell your doctor if you feel no better. (see section 3 on page 2).
  • You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior (see section 2 on page 1).
  • If you feel restless or feel like you cannot keep still, go to your doctor. If you keep on taking more citalopram each day, it may make these feelings worse. (see section 5 on page 3).
  • Talk to your doctor before you stop taking citalopram. If you stop taking it suddenly or miss a dose you may get unwanted effects. (see section 4, on page 3).
  • Taking some other medicines with citalopram can cause problems. You may need to talk to your doctor first. (See section 2 on page 1).
  • If you are pregnant or planning to get pregnant, talk to your doctor before taking citalopram. (See section 2 on page 1).

 Read the rest of this leaflet carefully before taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 5.

What is in this leaflet
1. What citalopram is and what it is used for
2. What you need to know before you take citalopram
3. How to take citalopram
4. Stopping citalopram
5. Possible side effects
6. Children and adolescents under 18
7. How to store citalopram
8. Contents of the pack and other information

1. What  Citalopram is and what it is used forCitalopram belongs to a group of antidepressants called SSRIs (selective serotonin reuptake inhibitors).

Citalopram is used to treat:

  • Depression
  • Panic disorders including fear of wide-open spaces (agoraphobia) or crowds

Other medicines or psychotherapy can also treat these conditions. Treating your condition properly is important to help you get better. Without treatment, your condition may get worse and be more difficult to treat.

2. What you need to know before you take citalopramDo not take citalopram if:

  • You are allergic (hypersensitive) to citalopram or any of the other ingredients in this medicine (see Section 8: Further Information).
    Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
  • You are taking an MAOI (monoamine oxidase inhibitor) medicine, or have taken them in the last 2 weeks. Examples of MAOIs include: tranylcypromine, phenelzine, and isocarboxazid (for depression) or selegiline (for Parkinson?s disease)
  • You are taking a medicine called moclobemide, or have taken it in the last 24 hours
  • You are taking pimozide (an antipsychotic medicine).
  • You are taking linezolid (an antibiotic medicine used to treat pneumonia and infections in the skin)
  • You are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning)
  • You take medicines for heart rhythm problems or that may affect the heart?s rhythm. Also, refer to the section ?Taking other medicines? below.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking citalopram.

Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

  • If you have previously had thoughts about killing or harming yourself.
  • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Warnings and precautions
Take special care and check with your doctor or pharmacist before taking citalopram if:

  • You have epilepsy or have ever had a fit
  • You have diabetes
  • You have or have ever had a history of overactive behavior or thoughts (mania)
  • You are having ECT (electroconvulsive treatment).
  • You have bleeding disorders or have ever suffered from bleeding in the stomach or intestine or use anticoagulants (for thinning the blood)
  • You are taking this medicine for a panic disorder. You may need to be started on a lower dose.
  • You have problems with your eyes, such as certain kinds of glaucoma or you have in a history of glaucoma.
  • You have liver disease.
  • You have severe kidney disease
  • You suffer or have suffered from heart problems or have recently had a heart attack
  • You have a low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhea and vomiting (being sick) or usage of diuretics (water tablets)
  • You experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may be signs of an abnormal heart rate.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking citalopram.

Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor.

Do not take citalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

Make sure your midwife and/or doctor know you are on citalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like citalopram may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take citalopram during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: trouble with breathing, stiff or lose muscles, jitteriness, a bluish skin or being too hot or cold. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.

Citalopram may get into breast milk in very small amounts and may affect your baby. Talk to your doctor before you start breast-feeding.

Citalopram has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not been observed as yet.

Taking citalopram with other medicines:
 if you take medicines for heart rhythm problems or medicines that may affect the heart?s rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because citalopram can affect the way some other medicines work. Also, some medicines can affect the way citalopram works.

Some medicines should not be taken with citalopram (see Do not take citalopram above).

In particular, tell your doctor if you are taking any of the following:

  • Other medicines for depression (SSRIs, tricyclic antidepressants, such as clomipramine, nortriptyline, imipramine and desipramine, and medicines containing bupropion, oxitriptan, and tryptophan)
  • Some medicines for mental illness (such as perphenazine, risperidone, and lithium)
  • Medicines for epilepsy (such as phenytoin, sodium valproate, phenobarbital or carbamazepine)
  • Painkillers containing acetylsalicylic acid (such as aspirin) or non-steroidal anti-inflammatory medicines (NSAID?s) such as ibuprofen
  • Medicines for migraine such as sumatriptan (triptans)
  • Herbal products containing St John?s Wort
  • Medicines for pain such as tramadol
  • Medicines are known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers and some antipsychotic drugs and tricyclic antidepressants).
  • Metoprolol, a beta-blocker used to treat migraine, some heart conditions, and high blood pressure.
  • Medicines for early-stage Parkinson?s disease such as selegiline
  • Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
  • Medicines used to heal active stomach and duodenal ulcers such as cimetidine
  • Antibiotics such as Linezolid
  • Mefloquine (used to treat malaria)
  • Neuroleptics (used in the treatment of schizophrenia)

Taking citalopram with food, drink, and alcohol:
Citalopram can be taken with or without food. Do not drink alcohol whilst taking citalopram.

Driving and using machines
Citalopram has a minor or moderate influence on the ability to drive and use machines. You should be careful when driving, operating machinery or performing jobs that need you to be alert. Do not drive or use machines if you feel you are affected.

3. How to take citalopram
Always take Citalopram exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how much to take when you first start taking it. Most people start to feel better after 2 to 3 weeks. If you do not feel any better after this time, talk to your doctor. He or she may tell you to take more of the medicine each day.

Taking citalopram:

  • Take your medicine at the same time every day
  • Swallow the tablets with a glass of water

How much to take:

  • The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of 40mg per day.
  • The exact dose will depend on how your condition responds to treatment
  • You will normally be asked to keep taking this medicine for at least 6 months

Panic disorder (panic attacks):

  • The starting dose is 10mg per day for the first week before increasing the dose to 20-30mg per day. The dose may be increased by your doctor to a maximum of 40mg per day.
  • The exact dose will depend on how your condition responds to treatment.

Older people (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 10-20mg per day. Older people should not usually receive more than 20mg per day.

People with liver problems
Patients with liver complaints should not receive more than 20mg per day.

If you take more citalopram than you should:
If you think that you or anyone else may have taken too many citalopram tablets, contact your doctor or go to the nearest hospital straight away. Do this even if there are no signs of discomfort or poisoning. Signs could include: feeling sick (nausea), being sick (vomiting), dizziness, sweating, fits, being very sleepy, passing out or going into a coma, tremor, having a blue color to the skin, fast short breathing, changes in blood pressure, a staring or fixed look on the face, changes in heart rhythm, a fast or irregular heartbeat, agitation, enlarged eye pupils or serotonin syndrome (see Section 5)

Take the carton and any tablets left with you. This is so that the doctor knows what you have taken.

If you forget to take citalopram:

  • If you forget a tablet and you remember before you go to bed, take it straight away. Carry on, as usual, the next day.
  • If you only remember during the night, or the next day, leave out the missed tablet. You may possibly feel different, but this should go away after you take your next tablet at the usual time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Stopping citalopram
Do not stop taking citalopram until your doctor tells you to.

When stopping citalopram, your doctor will help you to gradually take less of the medicine. This will be over a period of weeks or months. As you take less citalopram you may notice some side effects. If you notice any effects when you are stopping citalopram, tell your doctor. Your doctor may then ask you to start taking it again and reduce the dose more slowly.

Possible effects when stopping: feeling dizzy, feelings like pins and needles, feeling sick (nausea) or vomiting, feeling agitated or being anxious or having headaches, difficulty in falling asleep or staying asleep, vivid dreams, nightmares, tremor, confusion or disorientation, sweating, diarrhea, palpitations, emotional instability, irritability, and visual disturbances.

5. Possible side effects
Like all medicines, citalopram can cause side effects, although not everybody gets them.

Stop taking citalopram and see a doctor or go to a hospital straight away if:

  • Difficulty in breathing
  • You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
    This may mean you are having an allergic reaction to citalopram. This affects less than 1 in every 100 people who take citalopram.
  • You have thoughts of harming or killing yourself
  • You have a fit (seizure). This affects less than 1 in every 1000 people who take citalopram
  • Fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.

Talk to a doctor straightaway if:

  • You have unpleasant or distressing restlessness accompanied by an inability to sit or stand.
  • You feel confused, restless, agitated, sweaty, shaky, shiver, high fever, confusion, see or hear things which are not there (hallucinations), jerking muscles, muscle spasm (which may also affect the jaw and tongue) or a fast heartbeat. You may have something called serotonin syndrome. This happens in only a very few people who take this medicine.
  • You notice changes in the way your heart beats, it may beat much faster or slower than normal
  • You have unusual bruising or bleeding. This affects less than 1 in 1000 people who take citalopram
  • You notice blood in your vomit or stools (motions)
  • You cannot pass water
  • You notice yellowing of your skin or eyes and your urine becomes darker in color. This could be a liver problem, such as jaundice or hepatitis
  • You notice any of the following symptoms: trembling, muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless. This affects less than 1 in every 100 people who take citalopram.
  • You start having fits for the first time or fits that you have suffered from in the past become more frequent
  • Your behavior changes because you feel elated or overexcited
  • You experience tiredness, confusion, and twitching of your muscles. These may be signs of a low blood level of sodium (hyponatremia).

The following side-effects may also occur:
Very common
 (may affect more than 1 in 10 people):

  • Feeling sick (nausea),
  • Being sleepy or drowsy, or finding it difficult to sleep
  • Headaches, dry mouth
  • Feeling weak, dizzy or shaky
  • Sweating more than usual
  • Changes in your sleeping pattern

Common (may affect up to1 in 10 people):

  • Diarrhoea, constipation
  • Feeling agitated or nervous
  • Feeling anxious
  • Feeling shaky or dizziness
  • Ringing in your ears (Tinnitus)
  • Strange or vivid dreams
  • Finding it hard to concentrate, forgetting things or feeling confused
  • Decreased or loss of appetite (anorexia), or losing weight
  • Becoming less interested or bothered by things
  • Lowered sex drive
  • Migraines
  • Muscles pain
  • Joint pain
  • Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia), ?pins and needles?. These could be signs of paraesthesia
  • Indigestion, being sick (vomiting), stomach ache, passing wind, or having more saliva than usual
  • Problems passing water or passing water more often than usual
  • A runny or itchy nose, blocked or painful sinuses
  • A rash or itching
  • Feeling tired or yawning
  • Painful period cramps
  • Sexual problems including being unable to get an erection, having delayed or no ejaculation, or being unable to have an orgasm, abnormal orgasm (female)
  • Very fast, uneven or forceful heartbeat (palpitations)
  • Loss of memory (amnesia)
  • Loss of weight
  • Tremor

Uncommon (may affect up to 1 in 100 people):

  • Feeling unusually happy (euphoria)
  • Increased appetite, putting on weight
  • Feeling detached from yourself (depersonalization)
  • Seeing or hearing things that aren?t there (hallucinations)
  • Overactive behavior or thoughts (mania)
  • Being more sensitive to sunlight
  • Aggression
  • Fainting
  • Menstrual periods which are heavier or last longer than usual
  • Water retention which may cause swollen arms or legs (Oedema)
  • Large pupils (the dark center of the eye)
  • Severe itching of the skin (with raised lumps)
  • Loss of hair, balding
  • Redness of the skin with blood spots
  • Bruising easily
  • Fast or slow heartbeat
  • Rash
  • Difficulties urinating

Rare (may affect up to 1 in 1000 people):

  • Tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood
  • Increased sex drive
  • Changes in the way things taste
  • Fits or seizure
  • Coughing
  • Fever
  • Bleeding under the skin or mucous membrane
  • Involuntary movements
  • Hepatitis
  • Feeling generally unwell

Not known (frequency cannot be estimated from the available data):

  • Panic attacks
  • Abnormal production of breast milk in men and women
  • Feeling dizzy when you stand up (postural hypotension)
  • Blurred vision
  • Clenching or grinding the teeth (Bruxism)
  • You may bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia)
  • Liver problems shown by blood tests
  • An increased risk of bone fractures has been observed in patients taking this type of medicine.
  • Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ?syndrome of inappropriate antidiuretic hormone secretion? (SIADH). This rare side effect is more likely to happen if you are elderly.
  • Tiredness, confusion, and muscle weakness and muscle cramps. This may be due to low levels of potassium in your body (hypokalaemia)
  • Nose bleed (Epistaxis)
  • Wide spreading of bruising (Ecchymosis)
  • Bleeding between menstrual periods
  • A persistent or painful erection that lasts for several hours (priapism).
  • Rash (hypersensitivity)
  • Restlessness
  • Unusual movements or stiffness
  • Involuntary movements of the muscles (akathisia)
  • Low blood pressure
  • Sudden swelling of skin or mucosa
  • Abnormal heart rhythm

SSRIs can very rarely increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood-stained stools.

Also, let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.

Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Citalopram, please tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine. 

6. Children and adolescents under 18
Use in children and adolescents under 18 years of age

Citalopram should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide and suicidal act when they take this type of medicine. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed citalopram for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed below start or get worse when patients under 18 are taking citalopram.

Among children and teenagers under 18 given citalopram, these side effects are common

  • Increased thoughts about suicide and suicide attempts
  • Being hostile, aggressive or unfriendly
  • Being agitated

7. How to store citalopramKeep out of the sight and reach of children.
Store in the original packaging
Do not use after the expiry date stated on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

8. Contents of the pack and other information

What Citalopram film-coated Tablets contains:

The active substance is: citalopram hydrobromide

Citalopram Tablets contain 10 mg, 20 mg or 40 mg of citalopram (as citalopram hydrobromide).

The other ingredients are mannitol, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. The film-coating contains hypromellose, titanium dioxide (E171) and macrogol 6000.

What Citalopram 10mg, 20mg, and 40mg film-coated Tablets look like and contents of the pack:

This medicine comes in blister packs of 28 film-coated tablets.

  • Citalopram 10 mg tablets are round, biconvex, white film-coated tablets, diameter 6 mm.
  • Citalopram 20 mg tablets are round biconvex, white film-coated tablets, diameter 8 mm, with a score line.
  • Citalopram 40 mg tablets are round biconvex, white film-coated tablets, diameter 10 mm, with a score line.

7. Manufactured In India By:

Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)