CITALOPRAM 20MG TABLETS
Active substance: CITALOPRAM HYDROBROMIDE
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CITALOPRAM 10mg, 20mg AND 40mg TABLETS
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. IN THIS LEAFLET 1. What citalopram is and what it is used for 2. Before you take citalopram 3. How to take citalopram 4. Possible side effects 5. Storing citalopram 6. More information
If you have any further questions about this you should speak to your doctor.
Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before taking any medicine. Do not take this medicine if you are pregnant unless you have discussed the risks and benefits involved. If you take this group of medicines (antidepressants) during the last few months of your pregnancy and until the date of birth, you should be aware that the following effects have been seen in newborns: 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. 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 new born (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. You should not breastfeed your baby while taking Citalopram as small amounts of the medicine can pass into the breast milk. 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 yet. Driving and using machines Most people do not find their ability to carry out normal daily activities affected. However, make sure your abilities are not affected before you drive or operate machinery. Taking other medicines DO NOT take the following medicines while on citalopram: Other antidepressants: - Monoamine Oxidase Inhibitors (MAOIs), or in the two weeks after they have been stopped. If your doctor asks you to take a MAOI you will be asked to stop taking this medicine at least seven days before starting the MAOI. - If you are or were taking a RIMA (Reversible MAOI), e.g. moclobemide, consult your doctor and/or pharmacist on how long you must wait after stopping therapy before starting citalopram. Medicines for heart rhythm problems or medicines that may affect the hearts rhythm, such as: - Class IA and III antiarrhythmics - Antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol) - Tricyclic antidepressants - Certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malaria treatment particularly halofantrine)
1.
WHAT CITALOPRAM IS AND WHAT IT IS USED FOR
How does Citalopram work? Citalopram is a SSRI (Selective Serotonin Reuptake Inhibitor) and belongs to a group of medicines called antidepressants. Depression is linked to a shortage of substances which carry messages in the brain (including serotonin and noradrenaline). Citalopram helps to relieve the shortage of these brain messages. Common signs of depression include feelings of worthlessness or deep sadness; difficulty with everyday tasks; sleeping too much or not being able to sleep; feeling anxious; and changes in appetite. What is Citalopram used for? Citalopram tablets are used to treat the symptoms of depression and, when you are feeling better, to help prevent these symptoms recurring. Citalopram tablets are also beneficial in relieving symptoms in patients prone to panic attacks. Treatment for depression is usually continued for at least six months and for panic disorder for at least three months. It may take a while before you start to feel better. It is important to take citalopram every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms may come back.
Take special care with citalopram: If you have or have had: Liver disease Kidney disease Low blood levels of sodium ECT (electroconvulsive therapy) Heart problems or a heart attack A low resting heart-rate Mania or panic disorder Salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets) A fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate Diabetes (you may need an adjustment of your antidiabetic therapy) Epilepsy or a history of seizures or fits A bleeding disorder or have ever suffered from bleeding in the stomach or intestine Problem with your eyes, such as certain kinds of glaucoma Some patients with manic-depressive illness may enter into a manic phase. This is characterised by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor. Symptoms of restlessness or difficulty sitting or standing can also occur during the first few weeks of treatment. Tell your doctor immediately if you experience these symptoms. Alcohol As with all antidepressants, it is advisable to avoid drinking any alcohol. Use in children and adolescents under 18 years of age: Citalopram Tablets should normally not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal
Take care when taking any of the following medicines: Lithium or tryptophan drugs for depression or mania attacks Drugs to prevent blood clotting (Anticoagulants) e.g. warfarin Antiplatelet agents e.g. aspirin Drugs for pain relief e.g. Non-steroidal anti-inflammatory drugs (NSAIDs), tramadol Drugs for migraine e.g. Sumatriptan Medicines for depression (antidepressants) e.g. Imipramine, desipramine Antimalarial drugs e.g. artemether with lumefantrine, Mefloquin Buproprion A drug used to help you stop smoking Medicines for mental health problems (Antipsychotics) e.g. Phenothiazine Beta-blockers e.g. Metoprolol The herbal remedy St. Johns Wort (Hypericum perforatum). If you already take a St. Johns Wort preparation stop taking the St Johns Wort and mention it to your doctor at your next visit. Drugs that decrease the amount of acid produced in the stomach e.g. omeprazole, cimetidine. Neuroleptics (used in the treatment of schizophrenia) Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. Taking Citalopram with food and drink Citalopram can be taken with or without food (see section 3 How to take citalopram)
3.
HOW TO TAKE CITALOPRAM
The tablets should be taken regularly according to your doctors instructions. The dispensing label on the pack will tell you how many to take and when to take them. Adults Depression: The usual dose is 20mg per day. This may be increased by your doctor to a maximum of 40mg per day. Panic disorder: 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. Elderly patients The starting dose should be decreased to half of the recommended dose, e.g. 10-20mg per day. Elderly patients should not usually receive more than 20mg per day. Patients with liver problems Patients with liver problems should not receive more than 20mg per day.
2.
BEFORE YOU TAKE CITALOPRAM
Important information about some of the ingredients of citalopram: Citalopram tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
CP.CIP.JNT.T.V8P1
Customer: IS/ID
Originated by: Kent Pharm
Colours
Product: Citalopram 10mg 20mg and 40mg Tablets Dimensions: 190mm x 510mm Item Code: CP.CIP.JNT.T.V8P1 Proof No and Date: 1 08/03/13 Revision: ARTWORK FOR SUBMISSION Supersedes: n/a
Pantone Blue 280 C
Pharmacode
PATIENT INFORMATION LEAFLET
Do not take citalopram: If you are allergic (hypersensitive) to citalopram or any of the other ingredients of Citalopram Tablets (see Section 6, More information). If you are also taking a medicine containing pimozide. Talk to your doctor. If you are also taking medications known as monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinsons disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking your Citalopram tablets. One day must elapse after you have finished taking moclobemide. After stopping citalopram you must allow 1 week before taking any MAOI. For information on medicines that should not be taken with citalopram, see section on Taking other medicines. If you were 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 hearts rhythm. Also refer to the section Taking other medicines below.
thoughts and hostility (predominantly aggression, defiant behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed this medicine 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 above develop or worsen when patients under 18 are taking this medicine. The long-term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine in this age group have not yet been demonstrated.
- Certain antihistamines (astemizole, mizolastine) - Linezolid, used in the treatment of skin infections or pneumonia - Medicines containing selegiline (used to treat Parkinsons disease)
Pharmacode
Citalopram can be taken any time of the day with or without food. The tablets should be swallowed whole without chewing and with plenty of fluid. This medicine is not recommended for use in children or adolescents (under the age of 18). This medicine can be taken by elderly patients. Patients with kidney or liver problems may be given a lower dose of Citalopram, between 20 and 40mg per day. It may take several weeks before you feel any benefit from these tablets. This is normal for this type of medicine. The duration of treatment is individual, usually at least 6 months. Continue to take your tablets for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. Never change the dose of your medicine without talking to your doctor first. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return. If you take more citalopram than you should Call a doctor straight away or go immediately to the nearest casualty department, taking the remaining tablets with you. The most likely signs of overdose are convulsions, tiredness, unconsciousness, coma, feeling or being sick, tremor, enlarged eye pupils, dizziness, changes in blood pressure, hyperventilation, increased heart rate, agitation, sweating and/or turning blue. If you forget to take citalopram Do not take a double dose to make up for forgotten individual doses. Just skip that dose and take your next one at the normal time. Effects when treatment with citalopram is stopped Do not suddenly stop taking citalopram even if your depression has lifted. If you stop suddenly, you may experience dizziness, tingling in hands and feet, anxiety, numbness, nausea and headaches, feeling or being sick, sleep disturbances (vivid dreams, nightmares, inability to sleep), sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). It is possible that some of your symptoms may come back. Once you are feeling better, talk to your doctor who will tell you how to reduce the dose gradually.
If you notice any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped: You start having fits for the first time or fits that you have suffered from in the past become more frequent Your behaviour changes because you feel elated or over excited You experience high fever, agitation, confusion, trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium or potassium
Dizziness Ringing in the ears (tinnitus) Diarrhoea, vomiting, constipation Rash, itching Muscle or joint pain For men, problems with ejaculation and erection Uncommon (likely to affect up to 1 in every 100 people) Increase in appetite, weight gain Aggression, hallucination Mania Depersonalisation (having out of body experiences) Reduced emotions, indifference Feeling faint or light headed Fast heart rate Slow heart rate Large pupils (the dark centre of the eye) Rash Hair loss Sensitivity to sunlight Vaginal bleeding Difficulty passing urine Heavy menstrual periods Swelling of the arms and legs Rare (likely to affect up to 1 in every 1000 people) Taste disturbances Convulsions Hepatitis Bleeding Fever Difficulty in controlling voluntary movements, i.e. walking and increased involuntary movements An increased risk of bone fractures has been observed in patients taking this type of medicines Frequency not known A reduction in blood platelets which increase the risk of bleeding or bruising Thoughts of harming or killing themselves Panic attacks, restlessness, grinding of teeth or clenching of jaws Abnormal movements or jerky movements, inability to sit still Disturbed vision A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting Nosebleeds Rash (hypersensitivity) Unusual bleeding from the stomach and back passage Bleeding between menstrual periods Bruising/skin discolouration due to bleeding (ruptured blood vessels), skin swelling In men, painful erection Secretion of breast milk in men or women who are not breast feeding
Abnormal liver function tests Low potassium levels in the blood (hypokalaemia) If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. 6.
STORING 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 behaviour 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 behaviour. The following side effects are often mild and usually disappear after a few days treatment. Very Common (likely to affect more than 1 in 10 people) Feeling sick (nausea) Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often than usual) Increased sweating Sleepiness Difficulty in sleeping Common (likely to affect up to 1 in 10 people) Lack of appetite, loss of weight Tremor Anxiety, nervousness, problems with concentration, confusion, agitation Abnormal dreams Tiredness, constantly yawning, exhaustion Reduced libido (decreased sex drive) For women, problems with reaching orgasm Listlessness and shakiness Tingling (pins and needles)
Do not use after the expiry date stated on the foil and carton KEEP OUT OF THE SIGHT AND REACH OF CHILDREN This product does not require any special storage conditions. If your doctor tells you to stop treatment, return any left over to the pharmacist MORE INFORMATION
Citalopram 10mg Tablets are supplied as white, round, biconvex, embossed 10 on one side and plain on the other side, film-coated tablets. Citalopram 20mg Tablets are supplied as white, oval, biconvex, embossed 20 on one side with a break-line on the other side, film-coated tablets. Citalopram 40mg Tablets are supplied as white, oval, biconvex, embossed 40 on one side with a break-line on the other side, film-coated tablets. Citalopram 10mg, 20mg, 40mg Tablets. Each tablet contains 10, 20 or 40mg of the active ingredient citalopram as citalopram hydrobromide Other ingredients are maize starch, lactose monohydrate, copovidone, magnesium stearate, glycerol, microcrystalline cellulose, croscarmellose sodium, hydroxypropylmethylcellulose, polyethylene stearate, and titanium dioxide (E-171). Marketing Authorisation Holder Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland. Company responsible for release of this medicine Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K. Kent Pharmaceuticals Limited, Repton Road, Measham, DE12, 7DT, U.K. Distributor Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, UK This leaflet was revised: February 2013.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, citalopram can have side effects. Patients who are prone to panic attacks may actually experience a temporary period of heightened anxiety after starting treatment. This generally resolves during the first 1-2 weeks. STOP taking Citalopram tablets and seek medical advice immediately if you have any of the following symptoms: Difficulty in breathing Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing Severe itching of the skin (with raised lumps) Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes Hepatitis (inflammation of the liver) may cause yellowing of the skin and whites of the eyes
CP.CIP.JNT.T.V8P1
Customer: IS/ID
Originated by: Kent Pharm
Colours
Product: Citalopram 10mg 20mg and 40mg Tablets Dimensions: 190mm x 510mm Item Code: CP.CIP.JNT.T.V8P1 Proof No and Date: 1 08/03/13 Revision: ARTWORK FOR SUBMISSION Supersedes: n/a
Pantone Blue 280 C
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. IN THIS LEAFLET 1. What citalopram is and what it is used for 2. Before you take citalopram 3. How to take citalopram 4. Possible side effects 5. Storing citalopram 6. More information
If you have any further questions about this you should speak to your doctor.
Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before taking any medicine. Do not take this medicine if you are pregnant unless you have discussed the risks and benefits involved. If you take this group of medicines (antidepressants) during the last few months of your pregnancy and until the date of birth, you should be aware that the following effects have been seen in newborns: 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. 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 new born (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. You should not breastfeed your baby while taking Citalopram as small amounts of the medicine can pass into the breast milk. 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 yet. Driving and using machines Most people do not find their ability to carry out normal daily activities affected. However, make sure your abilities are not affected before you drive or operate machinery. Taking other medicines DO NOT take the following medicines while on citalopram: Other antidepressants: - Monoamine Oxidase Inhibitors (MAOIs), or in the two weeks after they have been stopped. If your doctor asks you to take a MAOI you will be asked to stop taking this medicine at least seven days before starting the MAOI. - If you are or were taking a RIMA (Reversible MAOI), e.g. moclobemide, consult your doctor and/or pharmacist on how long you must wait after stopping therapy before starting citalopram. Medicines for heart rhythm problems or medicines that may affect the hearts rhythm, such as: - Class IA and III antiarrhythmics - Antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol) - Tricyclic antidepressants - Certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malaria treatment particularly halofantrine)
1.
WHAT CITALOPRAM IS AND WHAT IT IS USED FOR
How does Citalopram work? Citalopram is a SSRI (Selective Serotonin Reuptake Inhibitor) and belongs to a group of medicines called antidepressants. Depression is linked to a shortage of substances which carry messages in the brain (including serotonin and noradrenaline). Citalopram helps to relieve the shortage of these brain messages. Common signs of depression include feelings of worthlessness or deep sadness; difficulty with everyday tasks; sleeping too much or not being able to sleep; feeling anxious; and changes in appetite. What is Citalopram used for? Citalopram tablets are used to treat the symptoms of depression and, when you are feeling better, to help prevent these symptoms recurring. Citalopram tablets are also beneficial in relieving symptoms in patients prone to panic attacks. Treatment for depression is usually continued for at least six months and for panic disorder for at least three months. It may take a while before you start to feel better. It is important to take citalopram every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms may come back.
Take special care with citalopram: If you have or have had: Liver disease Kidney disease Low blood levels of sodium ECT (electroconvulsive therapy) Heart problems or a heart attack A low resting heart-rate Mania or panic disorder Salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets) A fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate Diabetes (you may need an adjustment of your antidiabetic therapy) Epilepsy or a history of seizures or fits A bleeding disorder or have ever suffered from bleeding in the stomach or intestine Problem with your eyes, such as certain kinds of glaucoma Some patients with manic-depressive illness may enter into a manic phase. This is characterised by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor. Symptoms of restlessness or difficulty sitting or standing can also occur during the first few weeks of treatment. Tell your doctor immediately if you experience these symptoms. Alcohol As with all antidepressants, it is advisable to avoid drinking any alcohol. Use in children and adolescents under 18 years of age: Citalopram Tablets should normally not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal
Take care when taking any of the following medicines: Lithium or tryptophan drugs for depression or mania attacks Drugs to prevent blood clotting (Anticoagulants) e.g. warfarin Antiplatelet agents e.g. aspirin Drugs for pain relief e.g. Non-steroidal anti-inflammatory drugs (NSAIDs), tramadol Drugs for migraine e.g. Sumatriptan Medicines for depression (antidepressants) e.g. Imipramine, desipramine Antimalarial drugs e.g. artemether with lumefantrine, Mefloquin Buproprion A drug used to help you stop smoking Medicines for mental health problems (Antipsychotics) e.g. Phenothiazine Beta-blockers e.g. Metoprolol The herbal remedy St. Johns Wort (Hypericum perforatum). If you already take a St. Johns Wort preparation stop taking the St Johns Wort and mention it to your doctor at your next visit. Drugs that decrease the amount of acid produced in the stomach e.g. omeprazole, cimetidine. Neuroleptics (used in the treatment of schizophrenia) Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. Taking Citalopram with food and drink Citalopram can be taken with or without food (see section 3 How to take citalopram)
3.
HOW TO TAKE CITALOPRAM
The tablets should be taken regularly according to your doctors instructions. The dispensing label on the pack will tell you how many to take and when to take them. Adults Depression: The usual dose is 20mg per day. This may be increased by your doctor to a maximum of 40mg per day. Panic disorder: 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. Elderly patients The starting dose should be decreased to half of the recommended dose, e.g. 10-20mg per day. Elderly patients should not usually receive more than 20mg per day. Patients with liver problems Patients with liver problems should not receive more than 20mg per day.
2.
BEFORE YOU TAKE CITALOPRAM
Important information about some of the ingredients of citalopram: Citalopram tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
CP.CIP.JNT.T.V8P1
Customer: IS/ID
Originated by: Kent Pharm
Colours
Product: Citalopram 10mg 20mg and 40mg Tablets Dimensions: 190mm x 510mm Item Code: CP.CIP.JNT.T.V8P1 Proof No and Date: 1 08/03/13 Revision: ARTWORK FOR SUBMISSION Supersedes: n/a
Pantone Blue 280 C
Pharmacode
PATIENT INFORMATION LEAFLET
Do not take citalopram: If you are allergic (hypersensitive) to citalopram or any of the other ingredients of Citalopram Tablets (see Section 6, More information). If you are also taking a medicine containing pimozide. Talk to your doctor. If you are also taking medications known as monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinsons disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking your Citalopram tablets. One day must elapse after you have finished taking moclobemide. After stopping citalopram you must allow 1 week before taking any MAOI. For information on medicines that should not be taken with citalopram, see section on Taking other medicines. If you were 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 hearts rhythm. Also refer to the section Taking other medicines below.
thoughts and hostility (predominantly aggression, defiant behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed this medicine 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 above develop or worsen when patients under 18 are taking this medicine. The long-term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine in this age group have not yet been demonstrated.
- Certain antihistamines (astemizole, mizolastine) - Linezolid, used in the treatment of skin infections or pneumonia - Medicines containing selegiline (used to treat Parkinsons disease)
Pharmacode
Citalopram can be taken any time of the day with or without food. The tablets should be swallowed whole without chewing and with plenty of fluid. This medicine is not recommended for use in children or adolescents (under the age of 18). This medicine can be taken by elderly patients. Patients with kidney or liver problems may be given a lower dose of Citalopram, between 20 and 40mg per day. It may take several weeks before you feel any benefit from these tablets. This is normal for this type of medicine. The duration of treatment is individual, usually at least 6 months. Continue to take your tablets for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. Never change the dose of your medicine without talking to your doctor first. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return. If you take more citalopram than you should Call a doctor straight away or go immediately to the nearest casualty department, taking the remaining tablets with you. The most likely signs of overdose are convulsions, tiredness, unconsciousness, coma, feeling or being sick, tremor, enlarged eye pupils, dizziness, changes in blood pressure, hyperventilation, increased heart rate, agitation, sweating and/or turning blue. If you forget to take citalopram Do not take a double dose to make up for forgotten individual doses. Just skip that dose and take your next one at the normal time. Effects when treatment with citalopram is stopped Do not suddenly stop taking citalopram even if your depression has lifted. If you stop suddenly, you may experience dizziness, tingling in hands and feet, anxiety, numbness, nausea and headaches, feeling or being sick, sleep disturbances (vivid dreams, nightmares, inability to sleep), sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). It is possible that some of your symptoms may come back. Once you are feeling better, talk to your doctor who will tell you how to reduce the dose gradually.
If you notice any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped: You start having fits for the first time or fits that you have suffered from in the past become more frequent Your behaviour changes because you feel elated or over excited You experience high fever, agitation, confusion, trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium or potassium
Dizziness Ringing in the ears (tinnitus) Diarrhoea, vomiting, constipation Rash, itching Muscle or joint pain For men, problems with ejaculation and erection Uncommon (likely to affect up to 1 in every 100 people) Increase in appetite, weight gain Aggression, hallucination Mania Depersonalisation (having out of body experiences) Reduced emotions, indifference Feeling faint or light headed Fast heart rate Slow heart rate Large pupils (the dark centre of the eye) Rash Hair loss Sensitivity to sunlight Vaginal bleeding Difficulty passing urine Heavy menstrual periods Swelling of the arms and legs Rare (likely to affect up to 1 in every 1000 people) Taste disturbances Convulsions Hepatitis Bleeding Fever Difficulty in controlling voluntary movements, i.e. walking and increased involuntary movements An increased risk of bone fractures has been observed in patients taking this type of medicines Frequency not known A reduction in blood platelets which increase the risk of bleeding or bruising Thoughts of harming or killing themselves Panic attacks, restlessness, grinding of teeth or clenching of jaws Abnormal movements or jerky movements, inability to sit still Disturbed vision A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting Nosebleeds Rash (hypersensitivity) Unusual bleeding from the stomach and back passage Bleeding between menstrual periods Bruising/skin discolouration due to bleeding (ruptured blood vessels), skin swelling In men, painful erection Secretion of breast milk in men or women who are not breast feeding
Abnormal liver function tests Low potassium levels in the blood (hypokalaemia) If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. 6.
STORING 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 behaviour 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 behaviour. The following side effects are often mild and usually disappear after a few days treatment. Very Common (likely to affect more than 1 in 10 people) Feeling sick (nausea) Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often than usual) Increased sweating Sleepiness Difficulty in sleeping Common (likely to affect up to 1 in 10 people) Lack of appetite, loss of weight Tremor Anxiety, nervousness, problems with concentration, confusion, agitation Abnormal dreams Tiredness, constantly yawning, exhaustion Reduced libido (decreased sex drive) For women, problems with reaching orgasm Listlessness and shakiness Tingling (pins and needles)
Do not use after the expiry date stated on the foil and carton KEEP OUT OF THE SIGHT AND REACH OF CHILDREN This product does not require any special storage conditions. If your doctor tells you to stop treatment, return any left over to the pharmacist MORE INFORMATION
Citalopram 10mg Tablets are supplied as white, round, biconvex, embossed 10 on one side and plain on the other side, film-coated tablets. Citalopram 20mg Tablets are supplied as white, oval, biconvex, embossed 20 on one side with a break-line on the other side, film-coated tablets. Citalopram 40mg Tablets are supplied as white, oval, biconvex, embossed 40 on one side with a break-line on the other side, film-coated tablets. Citalopram 10mg, 20mg, 40mg Tablets. Each tablet contains 10, 20 or 40mg of the active ingredient citalopram as citalopram hydrobromide Other ingredients are maize starch, lactose monohydrate, copovidone, magnesium stearate, glycerol, microcrystalline cellulose, croscarmellose sodium, hydroxypropylmethylcellulose, polyethylene stearate, and titanium dioxide (E-171). Marketing Authorisation Holder Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland. Company responsible for release of this medicine Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K. Kent Pharmaceuticals Limited, Repton Road, Measham, DE12, 7DT, U.K. Distributor Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, UK This leaflet was revised: February 2013.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, citalopram can have side effects. Patients who are prone to panic attacks may actually experience a temporary period of heightened anxiety after starting treatment. This generally resolves during the first 1-2 weeks. STOP taking Citalopram tablets and seek medical advice immediately if you have any of the following symptoms: Difficulty in breathing Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing Severe itching of the skin (with raised lumps) Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes Hepatitis (inflammation of the liver) may cause yellowing of the skin and whites of the eyes
CP.CIP.JNT.T.V8P1
Customer: IS/ID
Originated by: Kent Pharm
Colours
Product: Citalopram 10mg 20mg and 40mg Tablets Dimensions: 190mm x 510mm Item Code: CP.CIP.JNT.T.V8P1 Proof No and Date: 1 08/03/13 Revision: ARTWORK FOR SUBMISSION Supersedes: n/a
Pantone Blue 280 C
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
