Package leaflet: Information for the user Moclobemide 150 mg film-coated tablets Moclobemide 300 mg film-coated tablets Moclobemide Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Moclobemide is and what it is used for 2. What you need to know before you take Moclobemide 3. How to take Moclobemide 4. Possible side effects 5. How to store Moclobemide 6. Contents of the pack and other information 1. What Moclobemide is and what it is used for Moclobemide film-coated tablets contain the active substance moclobemide. This active substance should make your symptoms better. Moclobemide belongs to a group of medicines known as ‘reversible monoamine oxidase A inhibitors’. These increase the levels of some of the chemical messengers in the brain, for example serotonin and dopamine. This should help to improve your depression (feeling sad, low, worthless or incapable). Medicines which have this effect are called antidepressants. Moclobemide is used to treat major bouts of depression (feeling very low or sad) 2. What you need to know before you take Moclobemide DO NOT take Moclobemide if you are allergic to moclobemide or any of the other ingredients of this medicine (listed in section 6). if you have sudden severe confusion if you have a cancer (tumour) of the small glands on the tops of your kidneys (adrenal glands) called a phaeochromocytoma. if you are under 18 years old if you are also taking the following medicines: - selegiline (used to treat Parkinson’s disease) - serotonin re-uptake inhibitors (SSRI antidepressants) - other antidepressants including tricyclic antidepressants - dextromethorphan (used to treat cough) - pethidine (a pain killer) - tramadol (a pain killer) - linezolid (an antibiotic) - bupropion (an antidepressant) - triptans (used to treat migraine) Warnings and precautions Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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. Excitation and nervousness (agitation) If the main symptoms of your depression are excitation or nervousness (agitation) you should either: not take Moclobemide at all or only take Moclobemide together with a sedative and not for longer than 2 to 3 weeks. Talk about this with your doctor or a pharmacist if you are not sure what to do. Bipolar disorder Bipolar disorder is a condition that causes you to have abnormally good moods (mania/hypomania), often followed by times when you have very low mood (depressive episodes). You should take care if you have bipolar disorder as Moclobemide may cause bouts of abnormally elevated mood (mania/hypomania). Symptoms of mania/hypomania include: being overexcited being overactive a feeling of elation an excessive feeling of well-being and self-importance agitation increased speed of thought and speech If you think you may be having a bout of mania you should stop taking Moclobemide and go to see your doctor or go to a hospital. If you have bipolar disorder, you should talk to your doctor or pharmacist before you take any Moclobemide. Schizophrenia and similar mental disorders You should not take Moclobemide unless you also take medication to treat your schizophrenia. This medication is called neuroleptic medication. Ask your doctor or pharmacist about this if you are not sure what to do. Tyramine rich food Tyramine is a chemical found naturally in food, especially fermented foods such as: mature cheese red wine You should avoid eating large amounts of food that are known to contain tyramine. High blood pressure If you suffer from high blood pressure (hypertension) your doctor will monitor your blood pressure closely during treatment with Moclobemide. Cough and cold medicines You should not take any cough and cold remedies containing medicines called sympathomimetics. These include: ephedrine pseudoephedrine phenylpropanolamine Surgery If you need to have an operation you should tell a nurse, the surgeon or the anaesthetist that you are taking Moclobemide. The anaesthetist is the person who will make sure you are asleep and unable to feel pain during the operation. Serotonin Syndrome This is a group of symptoms that can occur during treatment for depression. The symptoms develop if there is too much of a chemical messenger called serotonin in the brain. Symptoms of serotonin syndrome include: rise in body temperature confusion stiffness (rigidity) being easily angered or annoyed (irritability) increased heartbeat (tachycardia) rise in blood pressure shaking (tremors) Serotonin syndrome can occur if Moclobemide and other medicines are taken together. These medicines include: clomipramine (an antidepressant) antidepressants such as selective serotonin re-uptake inhibitors (SSRIs) You must not take Moclobemide together with these medicines (see section 2, “DO NOT take Moclobemide). If you stop taking SSRIs, you must wait for some time before starting to take Moclobemide. This is to avoid Serotonin syndrome. Your doctor will tell you how long you should wait. If you have an abnormality of the heart rhythm (QT-prolongation) or have had other heart problems (including conduction defect, cardiac arrhythmia) you should talk to your doctor or pharmacist before taking Moclobemide. Do not take Moclobemide together with dextromethorphan (a drug used in many cough medicines). Take special care if you are taking products containing the herbal remedy commonly known as St John’s wort (Hypericum perforatum) as this may increase the likelihood of side effects. Children and adolescents Children must not take Moclobemide Liver disease If you have liver disease your doctor should give you a low dose of Moclobemide. Other medicines and Moclobemide Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do NOT take Moclobemide together with: opiate medicines such as pethidine (a pain killer), dextromethorphan (a drug used in many cough medicines). In a few cases, severe reactions have affected the nervous system when dextromethorphan is taken with Moclobemide. tramadol (a pain killer) triptans (used to treat migraine). This combination of treatment can cause high blood pressure and chest pain (angina). other tricyclic antidepressants (e.g. clomipramine) selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g. fluoxetine and fluvoxamine) This combination of treatment can cause the development of serotonin syndrome which can be life-threatening. If you stop treatment with selective serotonin reuptake inhibitors SSRIs, you must wait for some time before starting to take Moclobemide. This is to avoid serotonin syndrome. Your doctor will tell you how long you must wait. Once you start Moclobemide treatment you should not take more than 300 mg per day for the first week. selegiline (used to treat Parkinson’s disease) linezolid (an antibiotic) You should not take Moclobemide together with: buspirone (used to treat anxiety) alcohol other medicinal products which are known to cause a abnormality of your heart rhythm (QT- prolongation) products containing the herbal remedy commonly known as St John’s wort (Hypericum perforatum) sibutramine (used to reduce appetite) Your doctor may need to adjust the dose if you are to take Moclobemide together with the following medicines: morphine (a pain killer) fentanyl (a pain killer) codeine (used to treat cough) cimetidine (used to treat stomach ulcers) adrenaline noradrenaline omeprazole (for acid reflux, indigestion or ulcers) trimipramine (used to treat depression) maprotiline (used to treat depression) dextropropoxyphene (a pain killer) If you stop treatment with: tricyclic antidepressants antidepressants called monoamine oxidase inhibitors (MAOIs), or other antidepressants You can start Moclobemide therapy straight away provided your doctor monitors you carefully. If you develop symptoms of serotonin syndrome your doctor will treat them. Moclobemide with food, drink and alcohol You should swallow your