Skip to Content

MOCLOBEMIDE 150 MG FILM-COATED TABLET

Active substance(s): MOCLOBEMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

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

SZ91005LT01A

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

1

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

What Moclobemide is and what it is
used for

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

Moclobemide is used to treat major depressive episodes.

2

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”).

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.

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. Johnʼs 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.

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.

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.

draft: 44061602, 44061603
laetus code: 12118
mat.no.: 46140151

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

Continued on the next page >>

Artwork Proof Box
Ref: V030: Update QRD + Nat Phase + N001 RFI + New Cutters
Proof no.
002.3

Date prepared:
16/03/2015

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
8pt
Fonts:
Helvetica

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.

• 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.

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.

The following side effects have also been reported:

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

Very common (may affect more than 1 in 10 people):
• Sleep disturbances,
• nausea,
• dry mouth,
• dizziness,
• headache.

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:
The recommended Moclobemide
doses:
150 mg

Moclobemide
300 mg

Dose for the
2-4 tablets
continued treatment divided into 2-3
300-600 mg daily
doses daily

1-2 tablets
divided into 2
doses daily

Starting dose
300 mg daily

2 tablets
divided into 2
doses daily

If necessary the
4 tablets
dose may be
divided into 2-3
increased to 600 mg doses daily
daily

Uncommon (may affect up to 1 in 100 people):
• feeling confused,
• disturbed sense of taste (dysgeusia),
• visual disturbances,
• weakness.

1 tablet
divided into 2
doses daily

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

2 tablets
divided into 2
doses daily

Very rare (may affect up to 1 in 10,000 people):
• Galactorrhoea (breast discharge).

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

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

The dose should not be increased in the first week of
treatment.
An effect is to be expected only after 1-3 weeks.

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.

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.

5

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”).

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.

6

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.

If you forget to take Moclobemide
Do not take a double dose to make up for a forgotten
dose.

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).

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 ʻpins and needlesʼ),
sleep disturbances, diarrhoea, headaches, palpitations
of the heart, tremble, sweating, visual disturbances,
feeling agitated, anxious or confused.

Moclobemide 150mg film-coated tablets also contain:
copovidone and ferric oxide yellow (E172).
Moclobemide 300mg film-coated tablets also contain:
povidone

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.

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

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.

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

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:

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

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),

draft: 44061602, 44061603
laetus code: 12118
mat.no.: 46140151

How to store Moclobemide

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

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.

4

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.

This leaflet was last revised in 01/2015

Artwork Proof Box
Ref: V030: Update QRD + Nat Phase + N001 RFI + New Cutters
Proof no.
002.3

Date prepared:
16/03/2015

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
8pt
Fonts:
Helvetica

46140151
SZ91005LT01A

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide