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MANERIX 150MG FILM-COATED TABLETS

Active substance(s): 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 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. 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 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.
2.
3.
4.
5.
6.
7.

What Manerix is and what it is used for
What you need to know before you take Manerix
How to take Manerix
Possible side effects
How to store Manerix
Contents of the pack and other 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. What you need to know before you take
Manerix
Do not take Manerix if:










You are allergic to moclobemide or any of the other
ingredients of this medicine (listed in Section 6).
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’.

Children


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, bupropion, paroxetine or clomipramine.

Dextromethorphan, which is found in many cough
medicines.

Pethidine (for pain relief).

Selegiline (for Parkinson’s disease).

Triptans (for migraines).

Tramadol (for pain relief).

Linezolid (for the treatment of infections).

St John‘s Wort (for anxiety).
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, Codeine 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

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

Social phobia:



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

Some side effects could be serious. If you have any
of the side effects listed below, stop taking this
medicine and seek urgent medical advice:


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.

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

Other side effects include the following, if they get serious,
please tell your doctor:

The medicine can affect your ability to drive as it may
make you sleepy or dizzy.

Do not drive while taking this medicine until you know
how it affects you.

It is an offence to drive if this medicine affects your
ability to drive.

However, you would not be committing an offence if:

The medicine has been prescribed to treat a
medical or dental problem and

You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and

It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether
it is safe for you to drive while taking this medicine.

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Very common (affects more than 1 in 10 people):






Trouble sleeping
Headache
Feeling dizzy
Dry mouth
Feeling sick

Common (affects 1 in 100 people):







Feeling nervous, twitchy (restless), anxious or badtempered (irritable)
Pins and needles or numbness of your hands and feet
Low blood pressure (hypotension)
Being sick
Diarrhoea
Constipation

Uncommon (affects 1 in 1,000 people):








Thoughts about killing yourself
Feeling confused and lost (disorientated)
Loss of taste in your mouth
Changes to your eyesight (vision)
Swelling (fluid retention)
Feeling weak or tired

Rare (affects 1 in 10,000 people):







Loss of appetite
Not enough sodium in your blood. Signs of this may be
feeling sleepy, confused or having fits (seizures)
Attempting to kill yourself
Delusion
Serotonin syndrome: Signs of this may be High fever,
irregular heartbeat, losing consciousness or having fits
(seizures)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
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 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.

6. Contents of the pack and other
information

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 issue and revision date: 07.12.17
Manerix® is a registered trademark of Roche Products
Limited.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: Manerix
150mg Film-coated Tablets
Reference No: 21828/0529

What Manerix contains

The active substance is moclobemide.
Each film-coated tablet contains 150mg of 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 '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.
Or
CENEXI SAS, Rue Marcel and Jacques Gaucher 52,
Fontenay Sous Bois, France.
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

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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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