PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ91005LT01A

Moclobemide 150mg film-coated tablets Moclobemide 300mg 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 of the 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

SANDOZ

What Moclobemide is and what it is used for

Moclobemide is an antidepressant belonging to the group of monoamine-oxidase (MAO) inhibitors.

If you require surgery, you should inform the anaesthesiologist about taking moclobemide.

After the end of therapy, withdrawal symptoms commonly occur, particularly if Moclobemide is discontinued abruptly (see section 3 under “If you stop taking Moclobemide”).

Moclobemide is used to treat major depressive episodes.

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 (listed in section 6),

•    if you have attacks of sudden confusion,

•    if you suffer from phaeochromocytoma, a special hormone producing tumour of the adrenal marrow,

•    if you are taking medicines containing selegiline (to treat Parkinson's Disease), linezolid (antimicrobial agent), other antidepressants (including so-called selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants), dextromethorphan (cough and cold medicaments may contain this substance), pethidine or tramadol (pain killer), triptans (medicinal products against migraine), bupropion (antidepressant).

Moclobemide must not be given to children and

adolescents under the age of 18.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Moclobemide:

•    if you have schizophrenia or schizoaffective disorders. You should not be treated with moclobemide without additional neuroleptic medication.

•    if you suffer from thyroid overactivity, as moclobemide may provoke an increase in blood pressure.

•    if you have a liver disease, as your doctor will possibly reduce the daily dose of Moclobemide

•    if you have depression and your main symptoms include excitation or restlessness (agitation), your doctor will decide not to treat you with Moclobemide, or you should be co-medicated with a sedative but only for at most of 2-3 weeks. The treatment of depressive episode in bipolar disorders may provoke episodes of overactive behavior and thoughts. In such cases treatment with moclobemide should be stopped.

•    In patients receiving moclobemide, caution should be exercised when co administering active substances that enhance serotonin in order to prevent onset of serotonergic syndrome, which may be fatal. This is particularly true for tricyclic antidepressants (e.g. clomipramine), selective serotonin re-uptake inhibitors (SSRI), other antidepressants or opiates (see “Do not take Moclobemide” and “Other medicines and Moclobemide”). Symptoms of serotonergic syndrome may be high fever, muscle cramps, confusion and anxiety.

•    Caution should be exercised in patients with congenital deviation of heart rhythm (long QT syndrome) or with a history of heart disorders (including disturbances of conduction, arrhythmia). Simultaneous administration of QT prolonging medicinal products should be avoided (see section “Other medicines and Moclobemide”).

Other medicines and Moclobemide

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take Moclobemide concurrent with the following medicinal products:

•    Tricyclic antidepressants (e.g. clomipramine), SSRI antidepressants (e.g. citalopram, fluoxetine, fluvoxamine, paroxetine) or other antidepressants (e.g. bupropion), selegilin (medicinal product to treat Parkinson's Disease), linezolid (antimicrobial agent) because of development of serotonin syndrome with severe central nervous system adverse reactions. Switching from another antidepressant to moclobemide a wash-out period is necessary. After discontinuing treatment with other antidepressants before starting with moclobemide please ask your doctor.

•    Opiates such as pethidine and tramadol (pain killer) and dextromethorphan (in cough and cold medicines) due to the risk of serotonin syndrome.

•    Medicines against migraine (like triptans), due to the risk of high blood pressure or narrowing of coronary vessels.

Moclobemide should be used with caution concurrent with:

•    Cimetidine (a stomach ulcer medicine) can inhibit the metabolization of moclobemide. The usual dose of Moclobemide might therefore be reduced by your doctor.

•    Morphine, fentanyl and codeine (strong pain-killer). Adjustment of the dose for these medicinal products may be necessary.

•    Epinephrine and norepinephrine (active substances with vessel-narrowing effect, contained, e.g., in local anaesthetics). A dosage adjustment may be necessary.

•    Buspirone (medicine against anxiety). Simultaneous administration could lead to rise of blood pressure.

•    Herbal remedy St. John’s Wort (Hypericum perforatum). Regular monitoring is recommended due to onset of serotonin syndrome.

•    The combination with other medicinal products that are known to lead to deviation of heart rhythm (prolongation of QT- interval) should be avoided. Moclobemide should not be given with class Ia and III antiarrhythmics, cisapride, macrolide antibiotics, anti-histaminics, medicinal products, known to cause hypokalemia (e.g. certain diuretics) or can inhibit the hepatic degradation of moclobemide (e.g. cimetidine, fluoxetine).

•    Proton pump inhibitors (e.g. omeprazole), sibutramine, dextropropoxyphene, trimipramine and maprotiline.

•    Sympathomimetic agents, such as ephedrine, pseudoephedrine and phenylpropanolamine (contained in many proprietary cough medicinal products) should be avoided.

Thoughts of suicide and worsening of your depression

If you are depressed you can sometimes have thoughts of harming or killing themselves. 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 young adults (less than 25 years old) 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, 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.

Moclobemide with food and drink

The tablets must be swallowed whole with water after meals.

During treatment with Moclobemide you should avoid high amounts of tyramine containing food and drinks (e.g. mature cheese, yeast extract, soya bean products and 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 or pharmacist for advice before taking this medicine.

Pregnancy

There are only limited experiences from the use of moclobemide, the active substance of Moclobemide, in pregnant women. The benefits of treatment during pregnancy should be carefully weighed against possible risks to the unborn child. Do not take Moclobemide if you are pregnant or planning to become pregnant unless specifically directed by your doctor.

Continued on the next page >>

co

co

o

3; oo

"sT

C\J C\j O t-CO ..

LO

O

CO

o

c

TO

E

Breast-feeding

Moclobemide passes into breast milk in small amounts. The benefits of continued treatment during breastfeeding should be carefully weighed against possible risks to the child. If you are taking Moclobemide, talk to your doctor before you start breast-feeding.

Driving and using machines

No studies on the effect on the ability to drive and use machines have been performed.

Impairment of performance in activities requiring complete mental alertness (e.g. driving a motor vehicle) is generally not to be expected with Moclobemide. You should monitor your reaction during early treatment.

Moclobemide contains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

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.

The recommended dose for adults is:

In individual cases the dose may be reduced to 150 mg per day, depending on effect.

The dose should not be increased in the first week of treatment.

An effect is to be expected only after 1-3 weeks.

In patients with impaired liver function, the daily dose of Moclobemide should be reduced to one half or one third of the usual standard dose.

Instructions for handling and taking the tablets Please take the tablets unchewed with a big glass of water after meals.

Duration of treatment:

Treatment with moclobemide should be continued for at least 4-6 weeks to be able to judge the efficacy of moclobemide. Treatment with moclobemide should preferably be continued for a symptom free period of 4-6 months. Then treatment should be terminated by gradual reduction of the dose (see “If you stop taking Moclobemide”).

If you take more Moclobemide than you should

Experience with overdose of moclobemide in humans is limited. Overdoses of moclobemide alone induce generally mild and reversible signs of CNS and gastro-intestinal irritation. Signs of unrest, aggressiveness and behavioural changes have been observed. Consult a doctor immediately if overdose is suspected. Although moclobemide alone, even in high doses, seldom leads to fatal reactions, death due to overdose of moclobemide as the only medicinal product has been reported.

If you forget to take Moclobemide

Do not take a double dose to make up for a forgotten dose.

If you stop taking Moclobemide

Do not discontinue the treatment without consulting your doctor.

The treatment should be terminated by gradual reduction of the dose due to reduce the risk of withdrawal symptoms such as feeling dizzy, having sensory disturbances (numbness or ‘pins and needles’), sleep disturbances, diarrhoea, headaches, palpitations of the heart, tremble, sweating, visual disturbances, feeling agitated, anxious or confused.

•    suicidal thoughts.

Rare (may affect up to 1 in 1,000 people):

•    not enough sodium in your blood, signs include feeling sleepy confused or having fits (seizures),

•    suicidal behavior,

•    fixed, irrational idea not shared by others (delusion),

•    if you have some or all of the following symptoms you may have something called serotonin syndrome. The symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat.

The following side effects have also been reported:

Very common (may affect more than 1 in 10 people):

•    Sleep disturbances,

•    nausea,

•    dry mouth,

•    dizziness,

•    headache.

Common (may affect up to 1 in 10 people):

•    Feeling anxious, nervous, twitchy (restless) or bad-tempered (irritable),

•    paraesthesia (sensory disturbances, e.g. prickle),

•    diarrhoea, constipation or vomiting,

•    feeling dizzy (low blood pressure),

•    rash.

Uncommon (may affect up to 1 in 100 people):

•    feeling confused,

•    disturbed sense of taste (dysgeusia),

•    visual disturbances,

•    weakness.

Rare (may affect up to 1 in 1,000 people):

•    Reduced appetite

Very rare (may affect up to 1 in 10,000 people):

•    Galactorrhoea (breast discharge).

Withdrawal symptoms after the end of therapy may occur, particularly if Moclobemide is discontinued abruptly.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). 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 and the blister. The expiry date refers to the last day of that month.

Do not throw 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.

Contents of the pack and other information

What Moclobemide contains

The active substance is moclobemide.

Each film-coated tablet contains 150 mg or 300 mg of moclobemide.

The other ingredients are

Both tablets contain the following: lactose monohydrate, magnesium stearate (Ph.Eur.), maize starch, microcrystalline cellulose, sodium starch glycollate (Type A) (Ph.Eur.), silica colloidal anhydrous, hypromellose, macrogol 4000, titanium dioxide (E171).

Moclobemide 150mg film-coated tablets also contain: copovidone and ferric oxide yellow (E172).

Moclobemide 300mg film-coated tablets also contain: povidone

If you have any further questions on the use of this product, 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 are observed mainly during the first few weeks of treatment and regress subsequently. This is particularly so for some of the side effects that are related to the very nature of the depressive illness such as feelings of anxiety, agitation or irritability, mood switch with mania or delirium.

Stop taking the medicine and tell your doctor immediately or go to your nearest hospital if you experience any of the following serious side effects:

Uncommon (may affect up to 1 in 100 people):

•    Skin reactions including itching, itching skin rash (nettle rash) and flushing,

•    oedema (swelling of the tissue caused by fluid retention),

What Moclobemide film-coated tablets look like and contents of the pack

Moclobemide 150mg film-coated tablets are beige and oblong, with a score notch on both sides and are available in blister packs with 20, 28, 30, 50, 60, 84 and 100 film-coated tablets.

The tablet can be divided into equal halves.

Moclobemide 300mg film-coated tablets are white and oblong, with a score notch on both sides and available in blister packs with 20, 30, 50, 60 and 100 film-coated tablets.

The tablet can be divided into equal halves.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Manufacturer

Salutas Pharma GmbH, Otto-Von-Guericke-Allee 1, 39179 Barleben, Germany.

This leaflet was last revised in 01/2015    ^i⁴™,⁵

CO

CO

o

3; oo

"sT y-

C\J C\j O t-CO ..

LO

O

CO

o

c

TO

E