APO-Moclobemide

Moclobemide

Consumer Medicine Information

This leaflet answers some common questions about moclobemide. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

Moclobemide is used to treat depression. It belongs to a group of antidepressant medicines called reversible inhibitors of monoamine oxidase A (RIMA).

Antidepressants are used to treat depression and work on the central nervous system. They are thought to work by their action on brain chemicals called amines, which are involved in controlling mood.

Depression is longer lasting and/or more severe than the “low moods” everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.

Moclobemide helps to correct this chemical imbalance and may help relieve the symptoms of depression.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed moclobemide for another reason.

This medicine is available only with a doctor’s prescription.

This medicine is not addictive.

There is not enough information to recommend the use of this medicine in children under 18 years of age.

Do not take this medicine if youhave an allergy to:

moclobemide

any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

cough, shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue, throat or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms.

Do not take this medicine if you are taking other medications known as selective serotonin reuptake inhibitors, tricyclic antidepressants, or selegiline, bupropion, triptans, pethidine, tramadol, dextromethorphan or linezolid.

A serious reaction called serotonin syndrome may occur if you take moclobemide with the above medicines. This can cause a sudden increase in body temperature, high blood pressure and convulsions (fits).

Do not take this medicine if you are suffering from or have had recent episodes of severe confusion.

Do not take this medicine after the expiry date has passed or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

any mental illness including bipolar disorder, schizophrenia, agitation and excitation

history or family history of suicide, bipolar disorder or depression

liver disease

high blood pressure

thyrotoxicosis (excessive amount of thyroid hormone)

phaeochromocytoma (a rare tumour of the adrenal gland).

Tell your doctor if you arepregnant or plan to become pregnant.

Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

Tell your doctor if you are breastfeeding.

A small amount of moclobemide passes into breast milk and may affect your baby. Your doctor will discuss with you the risks and benefits involved.

Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic.

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

You MUST NOT take moclobemide with:

clomipramine

selegiline

selective serotonin reuptake inhibitors, such as fluoxetine, paroxetine, sertraline

tricyclic antidepressants, such as amitriptyline or nortriptyline

dextromethorphan, a cough suppressant (ingredient in some cold & flu preparations)

a class of medicines called triptans, used for treating migraine for example sumatriptan

pethidine, a pain reliever

bupropion, an antidepressant

tramadol

linezolid.

Taking these medicines may increase the chance of you developing serotonin syndrome.

Some medicines and moclobemide may interfere with each other. These include:

cimetidine, an anti-ulcer drug

opiate pain killers, such as dextropropoxyphene, morphine, fentanyl and codeine

other types mood disorder therapies called MAOIs, venlafaxine or St John’s wort

omeprazole, used for stomach acid reduction

metoprolol, used for treating certain heart problems, angina, or high blood pressure.

These medicines may be affected by moclobemide or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor may have more information on medicines to be careful with or avoid while taking moclobemide.

Other interactions not listed above may also occur.

In addition, do not eat large quantities of tyramine-containing food (mature cheese, yeast extract, fermented soya bean products) while you are taking moclobemide, especially if you have high blood pressure.

Follow all directions given to you by your doctor carefully.

They may differ to the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines. If you have liver problems your doctor may prescribe a lower dose.

The usual dose is between 300 mg and 600 mg per day, but you usually start on a lower dose.

If you are changing from one antidepressant to another, follow your doctor’s instructions carefully and report any unexpected effects.

Swallow the tablets whole with a glass of water.

Moclobemide is usually taken twice a day (e.g. morning and evening), at the end of a meal.

Take this medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Continue taking your medicine for as long as your doctor tells you.

The length of treatment with an antidepressant will depend on how quickly your symptoms improve.Most antidepressants take time to work, so don’t be discouraged if you don’t feel better right away. Some of your symptoms may improve in 1-2 weeks, but it can take up to 4-6 weeks to feel any real improvement.

Even when you feel well, you will usually have to take your medicine for several months or even longer to make sure the benefits will last.

Make sure you have enough to last over weekends and holidays.

Occasionally the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide. It is possible that these symptoms may continue or increase until the full anti-depressant effect of your medicine becomes apparent (i.e. one to two months).

You or anyone close to you or caring for you should watch for these symptoms and tell your doctor immediately or go to the nearest hospital if you have any distressing thoughts or experiences during this initial period or at any other time.

Contact your doctor if you experience any worsening of your depression or other symptoms at any time during your treatment.

If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of unwanted side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much moclobemide, you may get nausea, vomiting, drowsiness, disorientation, memory loss, slurred speech, reduced reflexes, agitation, high blood pressure and/or convulsions (fits).

Contact a doctor immediately orgo to the nearest hospital for treatment, if you or someone you know or care for demonstrates any of the following warning signs of suicide-related behaviour while taking moclobemide:

thoughts or talk of death or suicide

thoughts of talk of self-harm or harm to others

any recent attempts of suicide or self-harm

increase in aggressive behaviour, irritability or agitation

worsening of depression.

All mentions of suicide or violence must be taken seriously.

If you are about to be started on any new medicine, remind your doctor that you are taking this medicine.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

If you become pregnant, tell your doctor immediately.

Tell your doctor if you are going to have surgery or an anaesthetic or are going into hospital.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

When you are being treated for depression, be sure to discuss with your doctor any problems you may have and how you feel.

This will help your doctor to determine the best treatment for you.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not take your medicine to treat any other complaints unless your doctor tells you to.

Do not stop taking your medicine or change the dosage without checking with your doctor.

Be careful driving or operating machinery until you know how this medicine affects you.

Moclobemide generally does not cause any problems with your ability to drive a car or operate machinery. However, moclobemide may cause dizziness or tiredness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Although drinking alcohol is unlikely to affect your response to moclobemide, your doctor may suggest avoiding alcohol while you are being treated for depression.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking moclobemide.

This medicine helps most people with depression, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

In the first week or two you may experience:

sleep disturbances

dizziness

nausea

headache

nervousness

occasionally, the symptoms of depression may include thoughts of suicide or self-harm. These symptoms may continue or get worse during the first one to two months of treatment until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur if you are a young adult under 24 years of age.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

insomnia, disturbed sleep, restlessness, feeling apathetic or tired

dizziness

stomach complaints, such as upset stomach, heartburn or stomach pain, nausea, diarrhoea, decreased appetite, constipation, trapped wind, feeling of fullness

headache or migraine

anxiety or tense feelings

feeling of confusion or being disoriented, forgetfulness

dry mouth, changed taste sensation, problems speaking, sore mouth or gums

blurred vision, red, itchy eyes

mild skin rash

flushing or cold sensation

shaking or twitching

numbness or tingling in the fingers

ringing in the ears

muscle or bone pain

an urge to urinate or defecate

The above list includes the more common side effects and some rarer ones. Mostly, these are mild.

Tell your doctor as soon as possible if you notice any of the following:

change in the colour, frequency or volume of urine

sight problems, seeing flashing lights

troubled breathing

high blood pressure

slow heart beat

hallucinations (seeing, feeling or hearing things that are not there)

swollen veins

dry skin, itchy skin or hives

unusual vaginal bleeding, or prolonged menstruation.

The above list includes serious side effects that may require medical attention.

If any of the following happen, stop taking moclobemide and contact your doctor immediately or go to Accident and Emergency at your nearest hospital:

early signs of mania, such as sense of grandeur, hyperactivity (including increased speech), reckless and impulsive behaviour.

thoughts or talk of death or suicide

thoughts or talk of self-harm or harm to others.

All mentions of suicide or violence must be taken seriously.

any recent attempts of self-harm

increase in aggressive behaviour, irritability or agitation

worsening of depression.

sudden increase in body temperature, agitation, shivering, severe convulsions

fast heartbeat, sweating, muscle spasm, racing thoughts, restlessness

angina or chest pain.

cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, or other parts of the body; rash, itching or hives on the skin; fainting; hayfever-like symptoms (signs of an allergic reaction)

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some patients.

Keep your tablets in the pack until it is time to take them.

If you take them out of the pack, they may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store your medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

150 mg tablets:

Pale yellow, oval, biconvex, film-coated tablets, scored on one side and engraved “APO” over “150” on the other. AUST R 73831.

300 mg tablets:

White, oval, biconvex, film-coated tablets, scored on one side and engraved “APO” over “300” on the other. AUST R 73835.

Available in blister packs of 60 tablets.

Each tablet contains 150 mg or 300 mg of moclobemide as the active ingredient.

The 150 mg tablets also contain the following:

dextrates

croscarmellose sodium

magnesium stearate

colloidal anhydrous silica

hypromellose

polydextrose

macrogol 3350

titanium dioxide

iron oxide yellow

carnauba wax.

The 300 mg tablets also contain the following:

methylcellulose

microcrystalline cellulose

croscarmellose sodium

magnesium stearate

colloidal anhydrous silica

hypromellose

hyprolose

macrogol 8000

titanium dioxide.

This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113.

Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from registered proprietor, Apotex Inc.

This leaflet was updated in October 2018.