Skip to Content

MANERIX 150MG TABLETS

Active substance(s): MOCLOBEMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
56UK1953230-00

Patient Information Leaflet

Manerix®
150 mg and 300 mg
film-coated Tablets
Moclobemide

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. What Manerix is and what it is used for
2. What you need to know before you take
Manerix
3. How to take Manerix
4. Possible side effects
5. How to store Manerix
6. C
 ontents of of the pack and other 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. WHAT YOU NEED TO KNOW
BEFORE YOU 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 m
­ edicines’.
• 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 call
manic depression.
• You have ever thought about, or tried to harm
or kill yourself.
• Y
 ou have an overactive thyroid.
• Y
 ou 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:

0214_GI_Aurorix_56UK1953230-00.indd 1

• Y
 ou 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 m
­ edicines 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.
• M
 orphine, 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
Do not take Manerix if you are pregnant, trying
to get pregnant or are breastfeeding, unless
your doctor has told you to.
Driving and using machines
The medicine can affect your ability to drive
as it may make you sleepy or dizzy.
• D
 o 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.
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.

15.04.15 15:19

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 t­ alking
to your doctor first.
If you have any further questions on the use of
this medicine, ask your d
­ octor or pharmacist.

4. P OSSIBLE 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 breath or swallow.
• sudden swelling of your hands, feet or ankles.
• A raised, itchy skin rash (hives), itchy skin or
flushing.
Other side effects include the following, if they
get serious, please tell your doctor:
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
bad-tempered (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,
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.

• D
 o not throw away 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 Manerix contains
The active substance in Manerix tablets is
­moclobemide. The tablets come in two different
strengths:
• Manerix 150 mg tablets – each tablet contains
150 mg (milligrams) of m
­ oclobemide.
• Manerix 300 mg tablets – each tablet contains
300 mg (milligrams) of m
­ oclobemide.
Other ingredients in both tablets are: lactose,
maize starch, povidone K30, sodium starch glycollate, magnesium stearate, hypromellose,
ethylcellulose, polyethylene glycol 6000, talc
and t­ ita­nium dioxide (E171). The 150 mg tablets
also contain yellow iron oxide (E172).
What Manerix looks like and
contents of the pack
Manerix 150 mg tablets are oval and pale yellow
in colour. They have a score line on one side and
are marked 150 on the other.
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 is supplied in blister packs containing
either 28, 30, 60, 84 or 100 tablets. Not all pack
sizes may be marketed.
The Marketing Authorisation holder is:
MEDA Pharmaceuticals Ltd.
Skyway House, Parsonage Road
Takeley, Bishop’s Stortford
CM22 6PU, United Kingdom
The manufacturer responsible for batch
release is:
MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg, Germany
Cenexi S.A.S.
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

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.
This leaflet was last revised in 04/2015.
Manerix is a registered trade mark.

5. HOW TO STORE MANERIX
• M
 anerix tablets do not need any s­ pecial storage
conditions.
• Keep out of the sight and reach of children.
• Do not use Manerix after the expiry date
printed on the pack.

0214_GI_Aurorix_56UK1953230-00.indd 2

56UK1953230-00

15.04.15 15:19

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