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MANERIX 150MG FILM-COATED TABLETS

Active substance: MOCLOBEMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MANERIX® 150MG FILM-COATED TABLETS
(moclobemide)
Manerix film-coated tablets come in two strengths: 150mg and
300mg. Manerix 150mg film-coated tablets will be referred to as
Manerix throughout this leaflet.

Please read all of this leaflet carefully before
you start taking this medicine.

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. Do not pass it on
to others. It may harm them even if their symptoms are the
same as yours.
If any of the side effects become serious or troublesome, or
if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.
7.

What Manerix is and what it is used for
Before you take Manerix
How to take Manerix
Possible side effects
How to store Manerix
Further information
More information about your condition

1. What Manerix is and what it is used for
Manerix contains a medicine called moclobemide. This belongs to
a group of medicines called antidepressants.
Manerix is used to treat depression and social phobia. For further
information about these conditions, see Section 7.
Manerix works by increasing the levels of important chemical
messengers in your brain. This increase can help your depression
or social phobia.

2. Before you take Manerix
Do not take Manerix if:

You are allergic (hypersensitive) to moclobemide or any of
the other ingredients of Manerix (listed in Section 6: Further
information).
You have a severe mental problem which may make you
confused, lose contact with reality or become unable to think
and judge clearly.
You have a growth on one of your adrenal glands
(phaeochromocytoma).
You are taking or have recently stopped taking any other
medicines to treat your depression or anxiety, such as
fluoxetine, paroxetine or clomipramine. See the section
‘Taking other medicines’.

You are taking dextromethorphan, which is found in many
cough medicines. See the section ‘Taking other medicines’.
You are taking pethidine (for pain relief). See the section
‘Taking other medicines’.
You are taking selegiline (for Parkinson’s disease). See the
section ‘Taking other medicines’.
Manerix is not suitable for children or adolescents
Do not take Manerix if any of the above applies to you. If you are
not sure, talk to your doctor or pharmacist before taking Manerix.

Take special care with Manerix

Check with your doctor or pharmacist before taking Manerix if:
You have a ‘bi-polar disorder’, sometimes call manic
depression.
You have ever thought about, or tried to harm or kill
yourself.
You have an overactive thyroid.
You have serious liver disease.
If any of the above apply to you, or if you are not sure, talk to
your doctor or pharmacist before you take Manerix.

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.
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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
that you buy without a prescription and herbal medicines. This is
because Manerix can affect the way some medicines work.
Also some other medicines can affect the way Manerix works.
Do not take Manerix, and tell your doctor or pharmacist, if you are
taking the following:
Other medicines for your depression or anxiety, such as
fluoxetine, paroxetine or clomipramine.
Dextromethorphan, which is found in many cough
medicines.
Pethidine (for pain relief).
Selegiline (for Parkinson’s disease).

Page 1 of 2

Tell your doctor or pharmacist if you are taking any of the
following medicines:
Cimetidine (used to treat stomach ulcers and acid
indigestion or reflux).
Ephedrine, pseudoephedrine and phenylpropanolamine,
found in many cough and cold medicines.
Morphine or fentanyl (for pain relief).

Taking Manerix with food and drink

Do not eat large quantities of foods containing tyramine when you
are taking Manerix. These include:
Mature cheese
Yeast extract
Fermented soya bean products.
If you are not sure about this talk to your doctor or pharmacist
before you take Manerix.

Pregnancy and breast-feeding

Do not take Manerix if you are pregnant, trying to get pregnant or
are breast-feeding, unless your doctor has told you to.

Driving and using machines

Manerix is not likely to affect your ability to drive or use any tools
or machines. Talk to your doctor if you notice any effects that
might affect driving, or using tools or machines, particularly when
you start taking Manerix.

Important information about some of the
ingredients of Manerix

This medicine contains lactose, which is a type of sugar. If you
have been told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars), talk to your
doctor before taking this medicine.

3. How to take Manerix
Always take Manerix exactly as your doctor has told you. You
should check with your doctor if you are not sure.
Manerix is not suitable for children or adolescents.
Take your tablets at the end of a meal.
Swallow each tablet with a drink of water.

Depression:

The usual starting dose is 300 mg a day, split into two
doses.
Your doctor will adjust the dose up or down to find the right
dose for you.
The maximum dose is 600 mg a day.

Social phobia:

The usual starting dose is 150 mg twice a day for three
days.
Your doctor will increase the dose to 300 mg twice a day.

People with severe liver disease:

Your doctor will decide the right dose for you. This will usually be
lower than the doses stated above.

If you take more Manerix than you should

If you take more Manerix than you should or someone else takes
your medicine by mistake, talk to a doctor or go to a hospital
straight away. Take the medicine pack with you.

If you forget to take Manerix

If you forget to take a dose, take it as soon as you
remember.
If it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Manerix

Even when you start to feel better, you should keep taking your
tablets for as long as your doctor tells you to. Do not stop
taking this medicine without talking to your doctor first.

5. How to store Manerix
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in the original package.
Do not store above 30ºC.
Do not use Manerix after the expiry date printed on the
pack.
If your doctor decides to stop your treatment, take any
leftover tablets back to the pharmacy.
If your tablets appear discoloured, or show any other signs
of deterioration, take them to your pharmacist who will
advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. This will help to
protect the environment.

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

6. Further information

4. Possible side effects

What Manerix contains

Like all medicines Manerix can cause side effects, although not
everyone will get them.

Each film-coated tablet contains 150mg of moclobemide.

Allergic reactions:

If you have an allergic reaction, stop taking Manerix and see a
doctor straight away. The signs may include:
Swelling of your throat, face, lips and mouth. This may
make it difficult to breathe or swallow.
Sudden swelling of your hands, feet or ankles.
A raised, itchy skin rash (hives), itchy skin or flushing.

Other possible side effects:

Trouble sleeping.
Feeling nervous, twitchy (restless), anxious or bad-tempered
(irritable).
Feeling confused and lost (disorientated).
Pins and needles or numbness of your hands and feet.
Feeling dizzy.
Headache.
Dry mouth.
Changes to your eyesight (vision).
Feeling sick or being sick.
Diarrhoea or constipation.
Not enough sodium in your blood. Signs of this may be
feeling sleepy, confused or having fits (seizures).
Changes to your liver (shown up in a blood test).

If any of the side effects become serious or troublesome, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

The active substance is moclobemide.

Other ingredients are: lactose, maize starch, povidone, sodium
starch glycollate, magnesium stearate, ethylcellulose, macrogol,
hypromellose, talc, titanium dioxide (E171) and yellow iron oxide
(E172).

What Manerix looks like and contents of the pack

Manerix are oval, pale yellow tablets with a score line on one side
and a marking ‘ROCHE 150’ on the other.
Manerix is supplied in blister packs containing 30 and 100 tablets.

Manufacturer

Manufactured by: MEDA Pharma GmbH & Co. KG, Benzstrasse 1,
61352 Bad Homburg, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0529

POM

7. More information about your condition
What is depression?

The signs of this problem (condition) can include extreme feelings
of sadness, low mood, tearfulness, worry, changes in sleep
pattern (such as difficulty sleeping) or difficulty enjoying life as
you used to. If these feelings affect your everyday life or last for a
long time it is important to get help from your doctor. Depression
is a common medical problem affecting around one in four women
and one in ten men at some time in their lives.

Page 2 of 2

What is social phobia?

Social phobia is a common medical problem that can affect both
men and women. The signs of this condition are an extreme fear
of being seen doing something embarrassing or humiliating. This
can cause problems even when taking part in simple social
activities such as eating, drinking, speaking, meeting people and
going to parties. People with this condition will be too afraid to
take part in social occasions.
Leaflet issue and revision date: 27.11.12
Manerix® is a registered trademark of Roche Products Limited.

PACKAGE LEAFLET: INFORMATION FOR THE USER

MOCLOBEMIDE 150MG FILM-COATED TABLETS
Moclobemide film-coated tablets come in two strengths: 150mg
and 300mg. Moclobemide 150mg film-coated tablets will be
referred to as Moclobemide throughout this leaflet.

Please read all of this leaflet carefully before
you start taking this medicine.

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. Do not pass it on
to others. It may harm them even if their symptoms are the
same as yours.
If any of the side effects become serious or troublesome, or
if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.
7.

What Moclobemide is and what it is used for
Before you take Moclobemide
How to take Moclobemide
Possible side effects
How to store Moclobemide
Further information
More information about your condition

1. What Moclobemide is and what it is used
for
Moclobemide contains a medicine called moclobemide. This
belongs to a group of medicines called antidepressants.
Moclobemide is used to treat depression and social phobia. For
further information about these conditions, see Section 7.
Moclobemide works by increasing the levels of important chemical
messengers in your brain. This increase can help your depression
or social phobia.

2. Before you take Moclobemide
Do not take Moclobemide if:

You are allergic (hypersensitive) to moclobemide or any of
the other ingredients of Moclobemide (listed in Section 6:
Further information).
You have a severe mental problem which may make you
confused, lose contact with reality or become unable to think
and judge clearly.
You have a growth on one of your adrenal glands
(phaeochromocytoma).
You are taking or have recently stopped taking any other
medicines to treat your depression or anxiety, such as
fluoxetine, paroxetine or clomipramine. See the section
‘Taking other medicines’.

You are taking dextromethorphan, which is found in many
cough medicines. See the section ‘Taking other medicines’.
You are taking pethidine (for pain relief). See the section
‘Taking other medicines’.
You are taking selegiline (for Parkinson’s disease). See the
section ‘Taking other medicines’.
Moclobemide is not suitable for children or adolescents
Do not take Moclobemide if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist before taking
Moclobemide.

Take special care with Moclobemide

Check with your doctor or pharmacist before taking Moclobemide
if:
You have a ‘bi-polar disorder’, sometimes call manic
depression.
You have ever thought about, or tried to harm or kill
yourself.
You have an overactive thyroid.
You have serious liver disease.
If any of the above apply to you, or if you are not sure, talk to
your doctor or pharmacist before you take 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.
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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
that you buy without a prescription and herbal medicines. This is
because Moclobemide can affect the way some medicines work.
Also some other medicines can affect the way Moclobemide works.
Do not take Moclobemide, and tell your doctor or pharmacist, if
you are taking the following:
Other medicines for your depression or anxiety, such as
fluoxetine, paroxetine or clomipramine.
Dextromethorphan, which is found in many cough
medicines.
Pethidine (for pain relief).
Selegiline (for Parkinson’s disease).
Page 1 of 2

Tell your doctor or pharmacist if you are taking any of the
following medicines:
Cimetidine (used to treat stomach ulcers and acid
indigestion or reflux).
Ephedrine, pseudoephedrine and phenylpropanolamine,
found in many cough and cold medicines.
Morphine or fentanyl (for pain relief).

Taking Moclobemide with food and drink

Do not eat large quantities of foods containing tyramine when you
are taking Moclobemide. These include:
Mature cheese
Yeast extract
Fermented soya bean products.
If you are not sure about this talk to your doctor or pharmacist
before you take Moclobemide.

Pregnancy and breast-feeding

Do not take Moclobemide if you are pregnant, trying to get
pregnant or are breast-feeding, unless your doctor has told you
to.

Driving and using machines

Moclobemide is not likely to affect your ability to drive or use any
tools or machines. Talk to your doctor if you notice any effects
that might affect driving, or using tools or machines, particularly
when you start taking Moclobemide.

Important information about some of the
ingredients of Moclobemide

This medicine contains lactose, which is a type of sugar. If you
have been told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars), talk to your
doctor before taking this medicine.

3. How to take Moclobemide
Always take Moclobemide exactly as your doctor has told you. You
should check with your doctor if you are not sure.
Moclobemide is not suitable for children or adolescents.
Take your tablets at the end of a meal.
Swallow each tablet with a drink of water.

Depression:

The usual starting dose is 300 mg a day, split into two
doses.
Your doctor will adjust the dose up or down to find the right
dose for you.
The maximum dose is 600 mg a day.

Social phobia:

The usual starting dose is 150 mg twice a day for three
days.
Your doctor will increase the dose to 300 mg twice a day.

People with severe liver disease:

Your doctor will decide the right dose for you. This will usually be
lower than the doses stated above.

If you take more Moclobemide than you should

If you take more Moclobemide than you should or someone else
takes your medicine by mistake, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.

If you forget to take Moclobemide

If you forget to take a dose, take it as soon as you
remember.
If it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Moclobemide

Even when you start to feel better, you should keep taking your
tablets for as long as your doctor tells you to. Do not stop
taking this medicine without talking to your doctor first.

5. How to store Moclobemide
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in the original package.
Do not store above 30ºC.
Do not use Moclobemide after the expiry date printed on the
pack.
If your doctor decides to stop your treatment, take any
leftover tablets back to the pharmacy.
If your tablets appear discoloured, or show any other signs
of deterioration, take them to your pharmacist who will
advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. This will help to
protect the environment.

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

6. Further information

4. Possible side effects

What Moclobemide contains

Like all medicines Moclobemide can cause side effects, although
not everyone will get them.

Each film-coated tablet contains 150mg of moclobemide.

Allergic reactions:

If you have an allergic reaction, stop taking Moclobemide and
see a doctor straight away. The signs may include:
Swelling of your throat, face, lips and mouth. This may
make it difficult to breathe or swallow.
Sudden swelling of your hands, feet or ankles.
A raised, itchy skin rash (hives), itchy skin or flushing.

Other possible side effects:

Trouble sleeping.
Feeling nervous, twitchy (restless), anxious or bad-tempered
(irritable).
Feeling confused and lost (disorientated).
Pins and needles or numbness of your hands and feet.
Feeling dizzy.
Headache.
Dry mouth.
Changes to your eyesight (vision).
Feeling sick or being sick.
Diarrhoea or constipation.
Not enough sodium in your blood. Signs of this may be
feeling sleepy, confused or having fits (seizures).
Changes to your liver (shown up in a blood test).

If any of the side effects become serious or troublesome, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

The active substance is moclobemide.

Other ingredients are: lactose, maize starch, povidone, sodium
starch glycollate, magnesium stearate, ethylcellulose, macrogol,
hypromellose, talc, titanium dioxide (E171) and yellow iron oxide
(E172).

What Moclobemide looks like and contents of the
pack

Moclobemide are oval, pale yellow tablets with a score line on one
side and a marking ‘ROCHE 150’ on the other.
Moclobemide is supplied in blister packs containing 30 and 100
tablets.

Manufacturer

Manufactured by: MEDA Pharma GmbH & Co. KG, Benzstrasse 1,
61352 Bad Homburg, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0529

POM

7. More information about your condition
What is depression?

The signs of this problem (condition) can include extreme feelings
of sadness, low mood, tearfulness, worry, changes in sleep
pattern (such as difficulty sleeping) or difficulty enjoying life as
you used to. If these feelings affect your everyday life or last for a
long time it is important to get help from your doctor. Depression
is a common medical problem affecting around one in four women
and one in ten men at some time in their lives.

Page 2 of 2

What is social phobia?

Social phobia is a common medical problem that can affect both
men and women. The signs of this condition are an extreme fear
of being seen doing something embarrassing or humiliating. This
can cause problems even when taking part in simple social
activities such as eating, drinking, speaking, meeting people and
going to parties. People with this condition will be too afraid to
take part in social occasions.
Leaflet issue and revision date: 27.11.12

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.

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