2. What you need to know before you take film-coated tablets
Do not take <product name>film-coated tablets
- if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of <product name>film-coated tablets (see section 6 “ Contents of the pack and other information”).
- If you take other medicines that 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 “Other medicines and<product name>”)
Warnings and preacutions
Talk to your doctor or pharmacist before taking<product name>:
- if you have epilepsy. Treatment with <product name>film-coated tablets should be stopped if seizures occur for the first time 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.
- if you have diabetes. Treatment with <product name >film-coated tablets 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 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
- if you have glaucoma (increased eye pressure)
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 to sit or stand 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 yourselves. 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
<product name> film-coated tablets 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 <product name> film-coated tablets for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed <product name> film-coated tablets 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 <product name> film- coated tablets. Also, the long term safety effects concerning growth, maturation and cognitive and
behavioural development of <product name> film-coated tablets in this age group have not yet been demonstrated.
Other medicines and <product name>
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Tell your doctor if you are 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 <product name> film- coated tablets. After stopping <product name> film-coated tablets 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 a rare but potentially serious side effect known as serotonin syndrome..
- Cimetidine and omeprazole esomeprazole, lansoprazole, (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of <product name> film-coated tablets.
- St. John's Wort (hypericum perforatum) - a herbal remedy used for depression.
- Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant). These may increase bleeding-tendency.
- Warfarin, dipyridamole, and acenocumarol, phenprocoumon (medicines used to thin the blood, so called anti-coagulant). Your doctor will probably check the coagulation time of your blood when starting and discontinuing <product name> film-coated tablets in order to verify that your dose of anti-coagulant is still adequate.
- Mefloquin (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/antipsychotics (medicines to treat schizophrenia, psychosis) due to a possible risk of a lowered threshold for seizures, and antidepressants.
- Flecainide, propafenone, and metoprolol (used in cardio-vascular diseases) clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of <product name> film-coated tablets may need to be adjusted.
- Any drug which can decrease levels of potassium (hypokalaemia) or magnesium (hypomagnesaemia) in blood
Do note take <Product name> film-coated tablets 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.
<product name> film-coated tablets with food, drink and alcohol
<product name> film-coated tablets can be taken with or without food (see section 3 “How to take
<product name> film-coated tablets”).
As with many medicines, combining <product name> film-coated tablets with alcohol is not advisable, although <product name> film-coated tablets is not expected to interact with alcohol.
Fertility, pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take <product name> film-coated tablets if you are pregnant or breast-feeding unless you and your doctor have discussed the risks and benefits involved.
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.
If you take <product name> film-coated tablets 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, blue- ish 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 <product name> film-coated tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like <product name> film-coated tablets 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 <product name> film-coated tablets should never be stopped abruptly.
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 <product name> film- coated tablets affects you.