Do not take < Invented Name >:
- If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of < Invented Name > (see section 6 "Further information").
- If you take other medicines which belongs to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson´s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic).
- 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 section 2 “Taking other medicines”)
Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:
- If you have epilepsy. Treatment with < Invented Name > should be stopped if seizures occur or if there is an increase in the seizure frequency (see also section 4 "Possible side effects").
- If you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.
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- If you have diabetes. Treatment with < Invented Name > may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
- If you have a decreased level of sodium in the blood.
- If you have a tendency to easily develop bleedings or bruises.
- If you are receiving electroconvulsive treatment.
- If you have a coronary heart disease.
- 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 experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up, which may indicate abnormal functioning of the heart rate
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.
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.
Children and adolescents under 18 years of age:
< Invented Name > 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 < Invented Name > for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed < Invented Name > 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 < Invented Name >. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of < Invented Name > in this age group have not yet been demonstrated.
Other medicines and < Invented Name >:
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Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Tell your doctor if you taking any of the following medicines:
- "Non-selective monoamine oxidase inhibitors (MAOIs)", containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines you will need to wait 14 days before you start taking < Invented Name >. After stopping < Invented Name > you must allow 7 days before taking any of these medicines.
- "Reversible, selective MAO-A inhibitors", containing moclobemide (used to treat depression).
- "Irreversible MAO-B inhibitors", containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects.
- The antibiotic linezolid
- Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
- Imipramine and desipramine (both used to treat depression).
- Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These increase the risk of side effects.
- Cimetidine and omeprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
- St. John's Wort (Hypericum perforatum) - a herbal remedy used for depression.
- Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anticoagulants). These may increase bleeding-tendency.
- Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anticoagulants). Your doctor will probably check the coagulation time of your blood when starting and discontinuing < Invented Name > in order to verify that your dose of anticoagulant is still adequate.
- Mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures.
- Neuroleptics (medicines to treat schizophrenia, psychosis) due to a possible risk of a lowered threshold for seizures, and antidepressants.
- Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of < Invented Name > may need to be adjusted.
- Medicinal products which may cause low blood levels of potassium or magnesium (in particular diuretics (water tablets)). Please ask your doctor or pharmacist if the medicinal product(s) you are taking/using concomitantly with < Invented Name > belong(s) to this group.
DO NOT TAKE < Invented Name > if you take medicines for heart rhythm problems or medicines that may affect the heart’s 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-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
- Invented Name > with food, drink and alcohol:
- Invented Name > can be taken with or without food (see section 3 "How to take < Invented Name > "). As with many medicines, combining < Invented Name > with alcohol is not advisable, although < Invented Name > is not expected to interact with alcohol.
Pregnancy, breast-feeding and fertility:
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Inform your doctor if you are pregnant or planning to become pregnant. Do not take < Invented Name > if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved. It is expected that <invented name> will be excreted in human milk. Consequently, breast-feeding is not recommended during treatment.
If you take < Invented Name > during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.
Make sure your midwife and/or doctor know you are on < Invented Name >. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like < Invented Name > 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.
If used during pregnancy < Invented Name > should never be stopped abruptly.
Citalopram, a medicine like escitalopram, 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
You are advised not to drive a car or operate machinery until you know how < Invented Name > affects you.
< Invented Name > contains ethanol:
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose. Each drop contains 4.7 mg ethanol.
