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 A inhibitors’. These increase the levels of some of the chemical messengers in the brain, for example and . This should help to improve your depression (feeling sad, low, worthless or incapable). Medicines which have this effect are called .

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: - (used to treat Parkinson’s disease) - serotonin re-uptake inhibitors (SSRI antidepressants) - other antidepressants including antidepressants - (used to treat cough) - (a pain killer) - tramadol (a pain killer) - (an antibiotic) - (an ) - triptans (used to treat )

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 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 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 () 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:   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 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:  (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 () as this may increase the likelihood of side effects.

Children and adolescents Children must not take Moclobemide

Liver disease If you have 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 inhibitor (SSRI) antidepressants (e.g. and ) 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:  (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)  (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)  (used to treat stomach ulcers)   noradrenaline  omeprazole (for acid reflux, indigestion or ulcers)  (used to treat depression)  (used to treat depression)  (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 tablets whole with water. You should take your Moclobemide tablets after a meal. Do not drink any alcohol during treatment with Moclobemide.

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 or pharmacist for advice before taking this medicine.

Pregnancy This medicine may harm your unborn child. If you are planning to become pregnant or are already pregnant:  you should only use Moclobemide tablets if your doctor tells you to. Your doctor will decide if you should take Moclobemide tablets after carefully considering: - the possible benefits of treatment - the possible risks of treatment

Breast-feeding  A small amount of moclobemide may pass through your breast-milk to your infant. Your doctor will decide if you should breast-feed after carefully considering: - the possible benefits of treatment - the possible risks of treatment

Driving and using machines When taking Moclobemide, you may feel dizzy, particularly in the first weeks of treatment. If you do feel dizzy, you must not drive or use machines.

Moclobemide tablets contain lactose and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Moclobemide

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and older people: You should swallow your tablets whole with water. You should take your Moclobemide tablets after meals.

The recommended starting dose is 300 mg per day. You should take this as:  150 mg in the morning after a meal and 150 mg in the evening after a meal.

You should not take an increased dose during the first week of treatment. You may not feel the effect of your medicine straight away. This may take between 1 and 3 weeks.

After the first week of treatment your doctor may increase your dose to:  600 mg per day.

Depending on how well you respond to treatment, your dose may be gradually reduced to:  150 mg per day.

Duration of treatment Your doctor will tell you how long you need to keep on taking Moclobemide. You should take Moclobemide for at least 4 to 6 weeks so that your doctor can judge how well it is working.

Ideally you should take Moclobemide until you have had no symptoms of depression for 4-6 months. Your doctor will then gradually reduce and stop your treatment.

Use in children and adolescents Children must not take Moclobemide.

If you have problems You can still take the normal dose of Moclobemide.

If you have liver problems Your doctor will check your liver function. If you do have liver disease, your doctor will reduce your dose.

If you take more Moclobemide than you should If you have taken more tablets than your doctor told you to, contact your doctor or go to your nearest emergency department immediately!

Remember to take the pack and any remaining tablets with you.

Your doctor will treat the symptoms of Moclobemide overdose. Symptoms may include:  nervousness (agitation)  aggressiveness  changes in behaviour

You may suffer more serious effects, especially if you have taken other medicines. For example, other medicines that affect the nervous system.

Overdose with Moclobemide can, in some cases, be life-threatening. Your doctor may admit you to hospital so that you can be given the best treatment.

If you forget to take Moclobemide Do not take a double dose to make up for a forgotten dose. Just take the usual dose when it is due.

If you stop taking Moclobemide Do not stop taking your Moclobemide unless your doctor tells you to. If you stop taking your tablets suddenly this can make your symptoms worse or cause other symptoms including dizziness, sweating, feeling sick (nausea) and confusion. Your doctor will tell you how to reduce and then stop this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects occur mainly during the first few weeks of treatment. Side effects tend to become less common as your depression improves, especially those related to your depression, such as:  feelings of anxiety  severe nervousness (agitation)  irritability  mood changes with mental excitement (mania) or severe mental delusions (delirium)

Very common (may affect more than 1 in 10 people):  sleep disturbances  dizziness  headache  dry mouth  feeling sick (nausea)

Common (may affect up to 1 in 10 people):  feelings of anxiety  severe nervousness (agitation)  restlessness  tingling or numbness (paraesthesia)  low blood pressure (hypotension)  being sick ()  loose stool (diarrhoea)  difficult, incomplete, or infrequent stool (constipation)  rash  irritability

Uncommon (may affect up to 1 in 100 people):  skin reactions including: - itching (pruritus) - hives (urticaria) - sudden reddening of the face (flushing)  suicidal thoughts, either during treatment or shortly after stopping treatment with Moclobemide  confusion. This disappears quickly after stopping treatment.  disturbance of the sense of taste (dysgeusia)  visual disturbances  swelling caused by excess fluid in body tissues, mostly under the skin (oedema)  feeling of weakness (asthenia)

Rare (may affect up to 1 in 1,000 people):  decreased appetite  low blood levels of sodium which can cause tiredness, muscle twitching, fits and coma (hyponatraemia)  suicidal behaviour  false beliefs (delusions)  a reaction which may cause feelings of great happiness, drowsiness, clumsiness, feeling of being drunk, fever, sweating or rigid muscles (serotonin syndrome)  changes to your liver shown up in a blood test (raised liver enzymes)

Very rare (may affect up to 1 in 10,000 people):  sudden or excessive production of breast milk, regardless of whether you are breast-feeding (galactorrhoea)

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moclobemide

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Moclobemide contains The active substance is moclobemide. One 150 mg Moclobemide tablet contains 150 mg moclobemide. One 300 mg Moclobemide tablet contains 300 mg moclobemide.

The other ingredients in the tablet core are:  anhydrous lactose  maize starch  sodium starch glycolate (type A)  povidone  magnesium stearate

The other ingredients in the 150 mg tablet film coat are:  lactose monohydrate  hypromellose  titanium dioxide (E171)  glyceryl triacetate  ferric oxide yellow (E172)

The other ingredients in the 300 mg tablet film coat are:  hyprolose  hypromellose  titanium dioxide (E171)  macrogol 400

What Moclobemide 150 mg and 300 mg film-coated tablets look like and contents of the pack  Moclobemide 150 mg film-coated tablets are yellow, oval and biconvex in shape with a white core. They are scored on one side and imprinted “P” logo “150” on the other side.

 Moclobemide 300 mg film-coated tablets are white, oval and biconvex in shape with a white core. They are scored on one side and imprinted “P” logo “300” on the other side.

The tablets can be divided into equal halves, along the score lines. You should only do this if your doctor has told you to take half tablets, to reduce your dose.

Moclobemide film-coated tablets are packaged in:  a plastic (HDPE) bottle, or  PVC/Aluminium blister packs

Packs of Moclobemide 150 mg tablets contain 10, 20, 28, 30, 40, 50, 60, 84, 90, 100, 250, 500 (10 x 50 as hospital pack only), 1000 film-coated tablets.

Packs of Moclobemide 300 mg tablets contain 10, 16, 20, 30, 40, 50, 60, 90, 100, 250, 500 (10 x 50 as hospital pack only), 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names: Germany: Moclobemid AL 150 mg <300 mg> Filmtabletten Denmark: Moclostad 150 mg <300 mg>

This leaflet was last revised in November 2019.