10 mg, 20 mg and 40 mg film-coated tablets 
citalopram

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Citalopram Teva is and what it is used for 
2. What you need to know before you use Citalopram Teva 
3. How to use Citalopram Teva 
4. Possible side effects 
5. How to store Citalopram Teva 
6. Contents of the pack and other information 

What Citalopram Teva is and what it is used for

Citalopram Teva belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ).

Citalopram Teva is used for treating depression (actual depression episode).

Citalopram contained in Citalopram Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Citalopram Teva

DO NOT use Citalopram Teva

  • if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
  • if you are also taking antidepressant medication of the monoamine oxidase inhibitor type (so-called MAO inhibitors ), e.g. selegiline or moclobemide, or have taken them at any time during the last two weeks.
  • if you are being treated with linezolid (an antibiotic ) unless you are being closely monitored and your blood pressure is being monitored.
  • if you were born with or have had an episode of abnormal heart rhythm (seen on ECG , a test to see how the heart works).
  • if you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm. See also section “Other medicines and Citalopram Teva” below.

Warnings and cautions

Talk to your doctor or pharmacist before using Citalopram Teva if you:

  • Suffering from diabetes , treatment with Citalopram Teva can affect the control of your blood sugar.
  • suffer from epilepsy or have seizures because there is a possible risk of seizures when taking antidepressant drugs.
  • receiving electroconvulsive therapy.
  • previously had mania/hypomania, Citalopram Teva should be used with caution and you should discontinue the drug when entering a manic phase
  • have kidney or liver problems. Citalopram Teva is not recommended for use in patients with severe kidney problems.
  • Suffering from any form of bleeding disorder, Citalopram Teva may cause bleeding.
  • take medicines that affect the coagulation of the blood (see section “Other medicines and Citalopram Teva”).
  • have stomach ulcers or have previously had bleeding in the stomach or intestines.
  • have low levels of potassium or magnesium in the blood.
  • is psychotic with depressive episodes.
  • experiencing a so-called serotonergic syndrome. A combination of symptoms, e.g. Anxiety, tremors, muscle contractions and elevated body temperature may indicate the development of this condition. Treatment with Citalopram Teva should be stopped immediately.
  • if you have or have had heart problems or have recently had a heart attack.
  • if you have a slow heartbeat at rest and / or if you know you may have a salt deficiency due to prolonged severe diarrhea and vomiting or the use of diuretics ( diuretics ).
  • if you experience rapid or irregular heartbeat, fainting, collapse or dizziness when standing up. This may indicate an abnormal function of the heart rhythm.
  • if you have eye problems, such as certain types of glaucoma .
  • Symptoms such as restlessness and an inability to sit or stand still may occur during the first weeks of treatment in patients taking antidepressants. In patients who experience these symptoms, a dose increase may be harmful.
  • treatment with Citalopram Teva should be discontinued in patients who experience seizures ( epilepsy ) or if the seizures occur at more frequent intervals. Citalopram Teva should not be used in patients with unstable (uncontrolled) epilepsy . Patients with controlled epilepsy should be closely monitored.
  • Citalopram Teva should not be used concomitantly with medicines that have a serotonergic effect, including painkillers and medicines used to treat migraines(see section “Other medicines and Citalopram Teva”).
  • Citalopram Teva should be used with caution in patients with low blood sodiumlevels.

Drugs such as Citalopram Teva (so-called SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

You should not suddenly stop taking Citalopram Teva as withdrawal symptoms may occur (see section 3).

If you start to feel worse and have thoughts of harming yourself 
You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • If you have previously had thoughts of harming yourself or committing suicide.
  • If you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It can be helpful to tell a relative or close friend that you are depressed. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior has changed.

Children and young people

Citalopram Teva should not normally be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, defiance and anger) is greater in patients under 18 years of age, when taking drugs of this type. Despite this, Citalopram Teva can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you were given this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse. 
The long-term effects on growth, maturity and cognitive and behavioral development has not yet been established for children and adolescents under 18 years of age

Other medicines and Citalopram Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

DO NOT use Citalopram Teva

  • If you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, e.g. antiarrhythmics of Class IA and III (drug for irregular cardiac activity), antipsychotics (such as phenothiazines, pimozide, haloperidol ), tricyclic antidepressants (depression), certain antimicrobial drugs (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine , anti- malarialdrugs, especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.
  • If you are taking monoamine oxidase inhibitors ( MAOIs ), e.g. phenelzine, isocarboxazide and tranylcypromine. Do not take Citalopram Teva for fourteen days after stopping treatment with a so-called irreversible MAOI . Do not take Citalopram Teva for the specified time after discontinuation of a reversible MAOI(eg moclobemide), as indicated in the package leaflet of a reversible MAOI . Do not take MAOIs for seven days after stopping treatment with Citalopram Teva. Do not use Citalopram Teva if you are taking more than 10 mg / dayselegilin .
  • If you are taking pimozide (an antipsychotic medicine). Citalopram Teva should not be used with pimozide because of the effect this combination has on heart function.

Talk to your doctor or pharmacist if you are using, or have ever used, any of the following:

  • other drugs with serotonergic effects such as sumatriptan, other triptans or tryptophan (see section “Warnings and precautions”).
  • anticoagulants (inhibits the ability of the blood to clot), e.g. warfarin , acetylsalicylic acid , dipyridamole or ticlopidine.
  • drugs that lower the seizure threshold, ie neuroleptics , mefloquine or bupropion.
  • natural remedy containing St. John’s wort ( Hypericum perforatum )
  • painkillers or anti-inflammatory drugs called non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen , ketoprofen or diclofenac .
  • painkillers such as tramadol (see section “Warnings and precautions”).
  • drugs used to treat depression, e.g. fluoxetine , fluvoxamine, paroxetine , sertraline , venlafaxine .
  • medicines used to treat migraines , e.g. sumatriptan and other triptans (see section “Warnings and Precautions”).
  • drugs used to treat heart failure , e.g. metoprolol .
  • drugs for mental illness, e.g. lithium, risperidone or chlorpromazine.
  • medicines for stomach ulcers , e.g. omeprazole, esomeprazole, lansoprazole or cimetidine.
  • fluconazole (used to treat fungal infections) 
  • drugs that lower blood levels of potassium or magnesium , as these conditions increase the risk of life-threatening heart rhythm disorders ( QT prolongation, Torsades de Pointes ).
  • linezolid (an antibiotic ).

Citalopram Teva with food, drink and alcohol

You should not drink alcohol while you are being treated with Citalopram Teva. Citalopram Teva can be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy 
There is only limited experience with the use of Citalopram Teva during pregnancy. Do not use Citalopram Teva if you are pregnant or planning to become pregnant, unless your doctor considers it absolutely necessary.

Tell your midwife or doctor that you are taking Citalopram Teva. When drugs such as Citalopram Teva are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonaryhypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

You should not suddenly stop taking Citalopram Teva. If you are taking CitalopramTeva during the last three months of pregnancy, tell your doctor, as your baby may show some symptoms at birth. These symptoms usually occur during the first 24 hours after birth. They include difficulty sleeping or eating properly, difficulty breathing, bluish skin or difficulty regulating body temperature, nausea, persistent crying, tense or slack muscles, increased sleepiness, tremors, tremors or seizures. If your baby has any of these symptoms at birth, talk to your doctor who will be able to advise you.

Breast-feeding 
Citalopram passes into breast milk in small amounts. It is possible that a breastfed baby may be affected. If you are taking Citalopram Teva, talk to your doctor before starting breast-feeding.

Fertility 
In animal studies, citalopram has been shown toreduce sperm quality. In theory, this could affect fertility , but no such degrading effect of citalopram on fertility has yet been demonstrated in humans.

Driving and using machines

Citalopram Teva may affect your ability to drive or use machines. Do not drive or use machines until you know how Citalopram Teva affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Citalopram Teva contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie it is essentially ‘sodium-free’.

How to use Citalopram Teva

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Citalopram Teva should be taken once daily, either in the morning or in the evening. The tablets can be taken with or without food. The tablets should be swallowed with a little water or other liquid.

Citalopram Teva does not start working immediately.

An antidepressant effect can usually not be expected until at the earliest after 2 weeks. Treatment should be continued until you have been asymptomatic for 4-6 months. Citalopram Teva should be discontinued slowly and it is recommended that the dose be gradually reduced over 1-2 weeks. Do not stop taking Citalopram Teva unless your doctor tells you to, even if you start to feel better. Never change your dose without first consulting your doctor.

40 mg tablets: If the prescribed amount cannot be obtained with this product, there are other medicines that contain citalopram .

The recommended dose is:

Adults

The recommended dose is 20 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day.

Elderly patients (> 65 years)

The starting dose should be reduced to half of the recommended dose , e.g. 10-20 mg per day. Elderly patients should usually not receive more than 20 mg per day.

Liver problems 
In patients with mild to moderate hepatic impairment, treatment is started with 10 mg daily. Patients who have liver problems should not receive more than 20 mg per day. These patients should be supervised by healthcare professionals. Caution and extra careful dosing are recommended in patients with severe hepatic impairment.

Kidney 
problems Dose adjustment is not required in patients with mild to moderate kidney disease. The use of Citalopram Teva in patients with severe kidney disease is not recommended as information is lacking in this patient group.

Discontinuation of treatment discontinuation of treatment 
Rapid discontinuation of treatment should be avoided. When treatment with Citalopram Teva is discontinued, the dose should be gradually reduced over a period of 1-2 weeks to reduce the risk of withdrawal symptoms (see sections “If you stop using Citalopram Teva” and “Possible side effects”). If unacceptable symptoms occur with a dose reduction during treatment discontinuation, a return to the previously used dose may be considered. Thereafter, your doctor may continue to gradually reduce dose one.

Use for children and adolescents

Citalopram Teva should not be used in the treatment of children and adolescents under 18 years of age (see section “Warnings and precautions”).

Symptoms of overdose: 
Drowsiness, a state of near unconsciousness with obvious mental inactivity and decreased ability to respond to stimuli (comatose stupor ), coma , seizures, ECGchanges (eg prolonged QT interval ), irregular heartbeat, nausea, vomiting , bluish discoloration of the skin, sweating, rapid breathing (hyperventilation). Symptoms of serotonergic syndrome may occur (see section “Possible side effects”), especially when combined with other medicines.

If you forget to use Citalopram Teva

Do not take double dose to make up for forgotten dose .

If you stop using Citalopram Teva

Do not stop using Citalopram Teva unless your doctor tells you to. 
As withdrawal symptoms may occur, dose one should be gradually reduced at intervals of 1-2 weeks. 
Withdrawal symptoms include: dizziness, tingling or numbness, feeling of electric shock, numbness, difficulty sleeping, vivid dreams, anxiety / restlessness, anxiety, malaise or nausea, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability and irritability. . Most withdrawal symptoms are mild and transient but may be severe in some patients.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

A few people can get severe allergic reactions. These are very rare but serious side effects . Stop taking Citalopram Teva and contact a doctor immediately or go to the nearest emergency department if you experience any of the following symptoms:

  • swelling of the face, tongue or throat ( allergic reaction ) leading to severe difficulty swallowing or breathing
  • shock (sharply decreased blood pressure , pallor, anxiety, weak and fast pulse , moist and sticky skin, decreased level of consciousness) caused by severe vasodilation due to severe hypersensitivity to certain substances (anaphylactic reactions).
  • rapid, irregular heartbeat, fainting which may be a symptom of a life-threatening condition called Torsades de Pointes .

Serotonergic syndrome has been reported in patients treated with this type of antidepressant ( SSRI ). Tell your doctor if you experience high fever, tremors, muscle twitching and anxiety, as these symptoms may indicate the development of this condition. Treatment with Citalopram Teva should be stopped immediately.

Cases of suicidal ideation or behavior have been reported during treatment with Citalopram Teva or immediately after stopping treatment (see section 2 “Warnings and precautions”). Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

An increased risk of bone fractures has been seen in patients taking this type of drug.

The following side effects have been reported with the approximate frequencies shown:

Very common (may affect more than 1 user in 10):

  • insomnia, difficulty sleeping
  • headache
  • feel the heart beat
  • nausea, dry mouth
  • increased sweating
  • feeling of weakness ( asthenia )

Common (may affect up to 1 in 10 people):

  • weight loss, decreased appetite
  • agitation (restlessness), difficulty concentrating, abnormal dreams (unusual and vivid dreams), memory loss, anxiety, decreased sex drive, indifference, confusion, nervousness
  • tingling and numbness or numbness
  • tremors, dizziness, ringing in the ears ( tinnitus ), pain in muscles and joints
  • runny nose and itching in the nose, sinusitis (pain and pressure in the face, which worsens when leaning forward, stuffy nose, sore throat and cough, headache, fever, earache, toothache or pain in the upper jaw)
  • indigestion / heartburn, vomiting, abdominal pain, gas in the stomach, increased saliva production, diarrhea, constipation
  • problems with urination (eg control urination)
  • inability for women to achieve orgasm, impotence (inability to get or maintain an erection ), inability to ejaculate
  • itching
  • fatigue, yawning

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

  • weight gain, increased appetite, loss of appetite
  • optimism, cheerfulness and well-being ( euphoria ), aggression, decreased emotions, indifference, hallucinations, mania, general feeling of discomfort or anxiety
  • fainting
  • slower heart rate, fast heart rate
  • cough
  • hives , hair loss, skin rash, bruising, sensitivity to sunlight, dilation of the pupil of the eye
  • problems urinating
  • swelling in arms and legs
  • abnormally heavy and prolonged menstruation

Rare (may affect up to 1 in 1,000 people):

  • bleeding e.g. from the vagina , stomach, skin and mucous membranes (the surface that covers the oral cavity, the respiratory tract of the nose, vagina and urethra)
  • cramps, involuntary movements, taste changes
  • unintentional and meaningless movements
  • inflammation of the liver ( hepatitis )
  • decreased sodium levels in the blood, mainly in the elderly (causing hallucinations, confusion, cramps, weakness and muscle cramps or muscle weakness)
  • fever

Has been reported (occurs in unknown number of users):

  • low levels of platelets in the blood ( thrombocytopenia ) which can lead to increased bleeding or bruising
  • panic attacks, gnashing of teeth, restlessness, disturbed ADH – secretion(characterized by excessive production of urine)
  • seizures, deterioration of voluntary movements, ie. tremors, tics , changes in muscle tension, slowness of movements, involuntary and / or irregular muscle movements occurring in the face, restlessness in arms and legs ( akathisia )
  • visual disturbances
  • dizziness when suddenly standing up
  • changes in electrical measurement of the heart ( QT interval et extended at ECG )
  • nosebleed
  • bleeding in the stomach or intestines
  • bleeding disorder that includes bleeding into the skin and mucous membranes ( ecchymosis )
  • sudden swelling of the skin and mucous membranes
  • abnormal results from liver function tests
  • abnormal milk secretion from the breast ( galactorrhea )
  • irregular menstruation
  • painful erection er in men
  • low potassium levels in the blood

As withdrawal symptoms may occur at the end of treatment, the dose should be gradually reduced at intervals of 1-2 weeks. 
Withdrawal symptoms include: dizziness, tingling or numbness, feeling of electric shock, numbness, difficulty sleeping, vivid dreams, anxiety / restlessness, anxiety, nausea or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and instability. . Most withdrawal symptoms are mild and transient.

All possible side effects that occur usually disappear after a few days.

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. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Citalopram Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

10 mg / 20 mg

HDPE jar

Shelf life after the first opening of the jar is 100 days.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is citalopram .
  • 10 mg 
    Each film-coated tablet contains 10 mg of citalopram (as hydrobromide).
  • 20 mg 
    Each film-coated tablet contains 20 mg of citalopram (as hydrobromide).
  • 40 mg 
    Each film-coated tablet contains 40 mg of citalopram (as hydrobromide).
  • Other ingredients are:
  • Tablet core: copovidone, croscarmellose sodium (E466), glycerol (E422), lactose monohydrate , magnesium stearate (E470b), corn starch, microcrystalline cellulose (E460i).
  • Tablet coating: hypromellose (E464), microcrystalline cellulose (E460i), macrogol stearate 40 (E431) and titanium dioxide (E171).

What the medicine looks like and contents of the pack

  • Citalopram Teva 10 mg film-coated tablet: white, round, film-coated tablet, 6 mm in diameter.
  • Citalopram Teva 20 mg film-coated tablet: white, oval, film-coated tablet with a notch on one side and a diameter of 8 mm. The tablet can be divided into two equal parts.
  • Citalopram Teva 40 mg film-coated tablet: white, oval, film-coated tablet with a score line on one side and a diameter of 11 mm. The tablet can be divided into two equal parts.
  • Pack sizes:

Blister

10 mg: 10, 14, 20, 28, 30, 50, 56, 98 and 100 film-coated tablets in PVC / PVDC / AL blisters. 50×1 film-coated tablets in PVC / PVDC / AL perforated unit dose blister.

20 mg: 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 120 film-coated tablets iPVC / PVDC / AL blister. 50×1 film-coated tablets in perforated PVC / PVDC / AL single-dose blisters.

40 mg: 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 120 film-coated tablets iPVC / PVDC / AL blister. 50×1 film-coated tablets in PVC / PVDC / AL single-dose blisters.

HDPE jars with child-resistant PP lids and desiccant inserts

10 mg and 20 mg Citalopram Teva:

100 and 250 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder: 
Teva AB, Box 1070, 251 10 Helsingborg,

Manufacturer: 
TEVA Pharmaceutical Works Private Limited Company, Debrecen, Hungary

Teva UK Limited, Eastbourne, BN22 9AG, UK

Muhammad Nadeem

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