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MOCLOBEMIDE 300 MG FILM-COATED TABLETS

Active substance(s): MOCLOBEMIDE

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Patient Information Leaflet

Manerix® 300 mg film-coated tablets
(moclobemide)
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.
• The name of your medicine is Manerix 300 mg film-coated tablets, but
will be referred to as Manerix throughout the remainder of this leaflet.
• Manerix is also available in other strengths.
In this leaflet:
1) What Manerix is and what it is used for
2) Before you take Manerix
3) How to take Manerix
4) Possible side effects
5) How to store Manerix
6) Further information
7) 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 called 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).
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 - three 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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines Manerix can cause side effects, although not everyone
will get them.
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).
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 at:
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 MANERIX
• Keep out of the sight and reach of children.
• Store in the original package.
• Do not use Manerix after the expiry date which is stated on the
blister/carton. The expiry date refers to the last day of that month.
• Manerix tablets do not need any special storage conditions.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6) FURTHER INFORMATION
What Manerix contains
Each tablet contains 300 mg moclobemide.
The other ingredients are:
Lactose, maize starch, povidone, sodium starch glycollate, magnesium
stearate, ethylcellulose, macrogol 6000, hypromellose, talc and titanium
dioxide (E171).
What Manerix looks like and contents of the pack
Manerix 300 mg tablets are oval and white to off-white in colour. They
have a score line on one side and are marked 300 on the other.
Manerix tablets come in packs of 30 tablets.
Manufacturer
CENEXI SAS, Rue Marcel et Jacques Gaucher, 52, Fontenay Sous Bois,
France.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0657

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.
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 dated 8th April 2016
Leaflet coded XXXXXXXXXX
Manerix® is a registered trademark of Meda AB.

Patient Information Leaflet

Moclobemide 300 mg film-coated tablets
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.
• The name of your medicine is Moclobemide 300 mg film-coated
tablets, but will be referred to as Moclobemide throughout the
remainder of this leaflet.
• Moclobemide is also available in other strengths.
In this leaflet:
1) What Moclobemide is and what it is used for
2) Before you take Moclobemide
3) How to take Moclobemide
4) Possible side effects
5) How to store Moclobemide
6) Further information
7) 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 called 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).
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 - three 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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines Moclobemide can cause side effects, although not
everyone will get them.
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).
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 at:
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 out of the sight and reach of children.
• Store in the original package.
• Do not use Moclobemide after the expiry date which is stated on the
blister/carton. The expiry date refers to the last day of that month.
• Moclobemide tablets do not need any special storage conditions.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6) FURTHER INFORMATION
What Moclobemide contains
Each tablet contains 300 mg moclobemide.
The other ingredients are:
Lactose, maize starch, povidone, sodium starch glycollate, magnesium
stearate, ethylcellulose, macrogol 6000, hypromellose, talc and titanium
dioxide (E171).
What Moclobemide looks like and contents of the pack
Moclobemide 300 mg tablets are oval and white to off-white in colour.
They have a score line on one side and are marked 300 on the other.
Moclobemide tablets come in packs of 30 tablets.
Manufacturer
CENEXI SAS, Rue Marcel et Jacques Gaucher, 52, Fontenay Sous Bois,
France.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0657

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.
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 dated 8th April 2016
Leaflet coded XXXXXXXXXX

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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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