Do not take Citalopram Film-Coated Tablets
- if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
- if you are currently taking MAO (monoamine oxidase) inhibitors (medicines used for treatment of depression or Parkinson’s disease). The MAO-inhibitor selegiline may be used in combination with citalopram, albeit not more than 10 mg per day.
- if you have recently taken MAO-inhibitors. Depending on the type of MAO-inhibitor you were using, you may have to wait for up to 14 days after stopping the MAO-inhibitor before starting with citalopram (see also “Other medicines and Citalopram Film-Coated Tablets”). If you stop taking Citalopram and want to start using MAO-inhibitors, you have to wait for at least 7 days.
- if you are taking a medicine called linezolid (used to treat infections). If your doctor decides that you can take Citalopram Tablets at the same time as taking linezolid, they will have to check your blood pressure regularly.
- if 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).
- if you take medicines for heart rhythm problems or that may affect the heart’s rhythm (see also “Other Medicines and Citalopram Film-Coated Tablets”).
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Warning and precautions
Talk to your doctor before taking Citalopram Tablets if any of the following apply to you:
- if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.
- if you are a diabetic. Citalopram may alter blood sugar control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
- if you suffer or have suffered from heart problems or have recently had a heart attack.
- if you have a low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
- if you suffer from epilepsy or have a history of seizures or fits. Treatment with citalopram should be stopped if seizures occur or if there is an increase in the seizures frequency.
- if you suffer or have suffered from a bleeding disorder which includes tendency to bleed including the occurrence of bruises without an apparent cause (ecchymosis), gastrointestinal bleeding, bleeding under the skin, abnormal periods in females or if you use medicines which possibly increase tendency to bleed, such as warfarin (see section “Other Medicines and Citalopram Film-Coated Tablets”).
- if you are having electro-convulsive therapy (ECT).
- if you have a history of overactive behaviour or thoughts (mania) . If a new manic episode occurs, your doctor may ask you to stop taking citalopram.
- if you suffer from hallucinations or delusions (psychosis). Treatment with citalopram may increase these symptoms.
- if you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) or have a history of glaucoma.
Check with your doctor:
- if you start to develop fever, muscle stiffness or tremor and extreme agitation; you may suffer from the so called serotonin syndrome. Although this syndrome occurs rarely it may result in potentially life threatening conditions. Contact your doctor immediately. The use of Citalopram might need to be discontinued.
- if you start feeling sick and unwell with weak muscles or confused while being treated with citalopram. You may have a decreased level of sodium in the blood.
- if you experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
- if you experience sleeplessness and agitation at the beginning of the treatment. Your doctor may adjust your dosage.
Other important information you should know before taking this medicine
Thoughts of suicide and worsening of your depression
If you are depressed you can sometimes have thoughts of harming or killingyourself. These may be increased when first startingantidepressants 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 behaviour in young adultsaged less than 25 yearswith 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 friendthat you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, of if they are worried about changes in your behaviour.
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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 attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interest. 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 symptoms listed above develop or worsen when patients under 18 are taking citalopram. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of citalopram in this age group have not yet been demonstrated.
Restlessness/difficulty to sit or stand still (acathisia)
Symptoms such as restlessness or difficulty to sit or stand still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Withdrawal symptoms seen on discontinuation
Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation of Citalopram is abrupt. The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including
paraesthesia), sleep disturbances (including insomnia and | intense dreams), agitation or anxiety, nausea |
and/or vomiting, tremor, confusion, sweating, headache, | diarrhoea, palpitations, emotional instability, |
irritability, and visual disturbances are the most commonly reported reactions. Generally these symptoms are |
mild to moderate; however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in someindividuals they may be prolonged (23- months or more). It is therefore advised that Citalopram should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to your needs.
If intolerable symptoms occur following a decrease in the dose upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, your doctor may continue decreasing the dose, but at a more gradual rate.
Other medicines and Citalopram Film-Coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might have take any other medicines.
DO NOT TAKE CITALOPRAM FILM-COATED TABLETS
- 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. phenothiazine derviatives, pimozide, haloperidol), tricyclic antidepressants , certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
- if you take irreversible non-selective “monoamine oxidase inhibitors” (MAOIs) (e.g. phenelzine, iproniazid, isocarboxazid or tranylcypromine). You should not start taking citalopram for 14 days after finishing treatment with your previous medicine.
- if you take “Reversible, selective MAO-A inhibitors” (e.g. moclobemide used to treat depression). You may have to wait for one or more days before you can start using citalopram.
- if you take more than 10 mg per day of the “Irreversible MAO-B inhibitor” selegiline (used to treat Parkinson’s disease).
Tell your doctor if you are taking any of the following medicines:
- Sumatriptan and similar medicines (used to treat migraine).
- Tramadol (used against severe pain).
- Tryptophan or oxitriptan (substances that may increase serotonin levels).
- St John's Wort (hypericum perforatum) - a herbal remedy used for depression.
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- Lithium (used in the treatment of manic-depressive disorder).
Concomitant use of citalopram and the medicines mentioned above may increase the risk of severe side effects like the so-called serotonin-syndrome (see section 4 “Possible side effects”).
- Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant).
- Warfarin, dypiridamol and ticlopedine (medicines used to thin the blood, so called anti-coagulants).
- Atypical antipsychotics such as risperidone, clozapine, olanzapine, quetiapine and paliperidone.
- Phenohiazines such as chlorpromazine, thioridazine, promazine, levomepromazine, fluphenazine and prochlorperazine (medicines used to treat psychosis).
- Tricyclic antidepressants such as clomipramine, nortriptyline and amitryptiline.
Concomitant use of citalopram and the medicines mentioned above may increase the risk of bleeding.
- Metoprolol (used in cardio-vascular diseases).
- Haloperidol (antipsychotic).
- Imipramine and desipramine (to treat depression).
- Cimetidine (used to treat stomach ulcers).
Your doctor may need to adjust the dosage when citalopram is used together with the above mentioned medicines.
- Neuroleptics (medicines to treat schizophrenia, psychosis).
Citalopram Film-Coated Tablets with food, drink and alcohol
These tablets should be swallowed with water and can be taken with or without food. Do not crush or chew your tablets.
The effect of alcohol is unknown and should be avoided while you are taking these tablets.
Pregnancy, breast-feeding 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
Do not take citalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
You should not discontinue treatment with Citalopram Tablets abruptly.
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.
When used during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may also be seen in your newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
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If you are breast-feeding, ask your doctor for advice.
You should not breastfeed when taking citalopram because small amounts of the medicine can pass into the breast milk.
Fertility
Citalopram has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Citalopram may cause side effects which may affect your ability to make judgments or react to emergencies. If you suffer from any of these side effects, do NOT drive, operate machinery or perform tasks that require you to be alert.