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Document: leaflet MAH GENERIC_PL 11311-0493 change

• leaflet MAH GENERIC_PL 04416-1418
• leaflet MAH GENERIC_PL 11311-0493

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PATIENT INFORMATION LEAFLET

Moclobemide 150mg film-coated tablets Moclobemide 300mg film-coated tablets (moclobemide)

What Moclobemide is and what it is used for

Moclobemide belongs to a group of medicines called antidepressants. Moclobemide is used to treat major depressive episodes.

It is a reversible inhibitor of monoamine oxidase A (RIMA), a type of monoamine oxidase inhibitor (MAOI) and works by increasing the levels of important chemical messengers in your brain. This increase can help your depression.

What you need to know before you take Moclobemide

Do not take Moclobemide

•    If you are allergic (hypersensitive) to Moclobemide or any of the other ingredients of this medicine (See section 6 “Contents of the pack and other information”)

•    If you have sudden attacks of feeling confused

•    If you have a special hormone producing tumour of the adrenal glands (phaeochromocytoma)

•    If you are taking the following medicines: o selegiline, for Parkinson's Disease

o linezolid, used to treat serious infections o bupropion, used as an antidepressant and smoking cessation aid

o any other antidepressants including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (See “Warning and precautions” and “Other medicines and Moclobemide”)

o dextromethorphan, which is found in many cough and cold medicines o pethidine or tramadol, for pain relief o triptans, used to treat migraines o Moclobemide is not suitable for children and adolescents under the age of 18

Warnings and precautions

Talk to your doctor before taking Moclobemide:

•    If you have high blood pressure (hypertension). You should be closely monitored

•    If you have heart problems or a genetic heart condition known as long QT syndrome

•    If you have a mental disorder characterised by seeing, hearing or believing in things that are not real or true (schizophrenia) or you have schizophrenia and mood disorders (schizoaffective disorders)

•    If you have a bipolar disorder and you are being treated for a depressive episode

•    If you have an over active thyroid gland (thyrotoxicosis)

•    If you have liver problems. Your doctor may reduce the dose of Moclobemide

•    If you have depression and your main symptom is feeling excited or agitated. Your doctor will decide either not to treat you with Moclobemide or only in combination with a sedative (e.g. benzodiazepine) for no longer than 2-3 weeks

•    If you are to have surgery, it is important that you tell your doctor or anaesthetist that you are taking Moclobemide.

•    If you feel you are developing the symptoms of mania or hypomania (feeling elated or overexcited, overactive, increased speed of thoughts and speech, agitation) you should stop taking Moclobemide.

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 close friend or relative

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 is getting worse, or if they are worried about changes in your behaviour.

Other medicines and Moclobemide

Tell your doctor or pharmacist if you are taking or have

recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines

Do not take Moclobemide with the following medicines

•    Other antidepressants e.g. clomipramine, fluoxetine, fluvoxamine, venlafaxine, citalopram, escitalopram, paroxetine, sertraline bupropion, phenelzin, tranylcypromine.

If you switch from selective serotonin reuptake inhibitors (SSRIs) to Moclobemide, it is recommended that you have a drug free interval (wash-out period) before starting treatment with Moclobemide (your doctor will tell you how long).

•    Opiates such as pethidine and tramadol (for pain relief) or dextromethorphan (contained in some cough and cold medicines)

•    Triptans, used to treat migraines e.g. sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan and eletriptan. This combination of treatment can cause high blood pressure and chest pain (angina).

If Moclobemide is taken with the medicines above there is a risk of developing an adverse drug reaction known as serotonin syndrome which can be life-threatening (symptoms are: rise in temperature, confusion, stiffness, irritability, faster heart beat, rise in blood pressure and shaking).

•    Selegiline, used to treat Parkinson's Disease

•    Medicines used to treat abnormal heart rhythms (anti-arrhythmics e.g. amiodarone)

•    Cisapride, used to treat heart burn

•    Medicines used to treat certain bacteria (macrolide antibiotics eg. clarithromycin)

•    Medicines used to treat allergic reactions such as hay fever and nettle rash (anti-histamines e.g. chlorphenamine)

•    Medicines known to cause a low the level of potassium in the blood (e.g. certain diuretics such as hydrochlorothiazide)

•    Buspirone, used to relieve anxiety. It may increase blood pressure

•    Sibutramine, used to help weight loss

Moclobemide should be used with caution if taken with the following medicines

•    Cimetidine, omeprazole, used to treat stomach ulcers or indigestion

•    Trimipramine and maprotiline (antidepressants)

•    Morphine, fentanyl, dextropropoxyphene and codeine (strong painkillers)

•    Epinephrine (adrenaline) and norepinephrine (noradrenaline), used in emergency treatment of anaphylaxis and heart failure. Also included in some local anaesthetics

The dose of the medicines listed above or Moclobemide may need to be adjusted if taken together.

•    Herbal remedy St. John's Wort, used to treat depression. Regular monitoring is recommended to avoid the onset of serotonin syndrome

•    Ephedrine, pseudoephedrine and phenylpropanolamine (found in many cough and cold medicines)

Taking Moclobemide with food, drink and alcohol

You should not drink alcohol during treatment with Moclobemide.

You should also avoid eating large amounts of tyramine-rich foods (e.g. mature cheese, yeast extracts and fermented soya bean products or red wine).

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.

Pregnancy:

In animal studies, there is no indication that Moclobemide harms the foetus but the safety during human pregnancy is not known. Your doctor will decide whether the benefits of taking Moclobemide during pregnancy outweigh the possible risks for the unborn baby.

Breast-feeding:

Only a small amount of Moclobemide is excreted into breast milk. However, if you are breast-feeding your doctor will decide whether the benefits of continued treatment outweigh the possible risks to the child.

Driving and using machines

Moclobemide should not affect your ability to drive or operate machinery. However, you should be aware that

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