Product Details

What you need to know before you take Cipramil Drops

Do not take Cipramil Drops • If you are allergic to citalopram, or any of the other ingredients of this medicine (listed in section 6). Consult your doctor if you think you might be. • At the same time as taking medication 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 Parkinson’s 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 Cipramil. One day must elapse after you have finished taking moclobemide. After stopping Cipramil you must allow 1 week before taking any MAOI. • 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 Other medicines and Cipramil Drops). Warnings and Precautions Please tell your doctor if you have any medical problems, especially if you have: • History of bleeding disorders or have ever suffered from bleeding in the stomach or intestine, or if you are pregnant (see ‘Pregnancy, breast-feeding and fertility’). • Liver disease. • Kidney disease. • Diabetes (you may need an adjustment of your antidiabetic therapy). • Epilepsy or a history of seizures or fits. • Mania or panic disorder. • Low blood levels of sodium. • ECT (electroconvulsive therapy). • Suffered or suffer from heart problems or have recently had a heart attack. • 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). • Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate • If you have or have previously had eye problems, such as certain kinds of glaucoma (increased pressure in the eye). Please consult your doctor, even if these statements were applicable to you at any time in the past. Please note: 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. Medicines like Cipramil (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. Special information relating to your disease As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of Cipramil treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow exactly your doctor’s orders and do not stop the treatment or change the dose without consulting your doctor. 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. Use in children and adolescents under 18 years of age Cipramil 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 attempt, suicidal thoughts and hostility (predominantly 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 interests. If your doctor has prescribed Cipramil 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 Cipramil. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Cipramil in this age group have not yet been demonstrated. Other medicines and Cipramil Drops Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions. Please tell your doctor or pharmacist if you are taking, have taken or might take any other medicines This includes other medicines for depression (see Do not take Cipramil Drops). • The herbal remedy St John’s wort (Hypericum perforatum). This should not be taken at the same time as Cipramil. • Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Cipramil (see Do not take Cipramil Drops). Tell your doctor if you are taking any of the following medicines: • Linezolid (an antibiotic). • Sumatriptan (used to treat migraine) or tramadol and buprenorphine and similar medicines (strong pain killers). Taking these medicines together with Cipramil can lead to serotonin syndrome, a potentially life-threatening condition. The syndrome may be associated with symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms. • Lithium (used to prevent and treat mania) and tryptophan (an antidepressant). • Pimozide (a neuroleptic). This should not be taken at the same time as Cipramil. • Imipramine and desipramine (used to treat depression). • Medicines containing selegiline (used to treat Parkinson’s disease). • Cimetidine, lansoprazole, omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of citalopram. • Mefloquine (used to treat malaria). • Bupropion (used to treat depression). • Medicines 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. The effects of either drug could be increased, decreased or altered. • Neuroleptics (used in the treatment of schizophrenia). Do not take Cipramil 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 derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor. Taking Cipramil with food, drink and alcohol Cipramil can be taken with or without food (see section 3 “How to take Cipramil Drops”). As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Cipramil has not been shown to increase the effects of alcohol. Pregnancy If you take Cipramil near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Cipramil so they can advise you. 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 Cipramil 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 Cipramil. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Cipramil 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 Cipramil 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: 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. Breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Cipramil 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 Cipramil does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off. Important information about some of the ingredients of Cipramil Drops This medicine contains 76 mg of alcohol (ethanol 96%) in each ml which is equivalent to 9.0 % v/v.The amount in 1 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. These drops also contain the preservatives methyl- and propyl parahydroxybenzoate (E218,E216), which may cause allergic reactions (possibly delayed)