MIGRAMAX 900MG/10MG POWDER FOR ORAL SOLUTION

Active substance: METOCLOPRAMIDE HYDROCHLORIDE

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(1,1) -1- 523899_NPI MIGRAMAX GB-D.indd 24/09/13 10:23

RG2 / RG3 / RG5 / RG6 /
RG10 / RG21

MigraMax 900mg/10mg,
Powder for oral solution
Acetylsalicylic acid
(as DL-lysine acetylsalicylate)
Metoclopramide hydrochloride

PACKAGING TEAM

523899

Product type:
Product name:

FOLDED LEAFLET
MIGRAMAX

Country:

GB

Plant:

For Sanofi-Aventis use only

ID number:
Version and Date:
Previous ID number:

AMILLY PHARMA

V3 - 24/09/2013
256661

Technical Data

Format: FOLDED - 144 x 448 mm - Pli de 32mm
Number of colors: 1
■ PMS Process Black U

Minimum point size of text: 9 pt
Space between lines: 10 pt
Narrowed: 100 %
Fonts: Ocean Sans Pro SAN - C39P24N

Modifications

Native file: In Design CS5
Layout of cutting: AY_NPI_144 x 448_A_3
V1 - 26/06/2013: New regulatory text
V2 - 15/07/2013: Text modifications
V3 - 24/09/2013: Corrections.

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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What MigraMax is and what it is used for
2. Before you take MigraMax
3. How to take MigraMax
4. Possible side effects
5. How to store MigraMax
6. Further information

1. What MigraMax is and what it
is used for
The name of your medicine is MigraMax
900mg/10mg Powder for oral solution (called
MigraMax in this leaflet).
What MigraMax contains
MigraMax contains two different medicines.
These are called:
• Metoclopramide hydrochloride: This
belongs to a group of medicines called antiemetics. It works on muscles in the upper part
of the digestive system causing your stomach
to empty. It also works on a part of your brain
that prevents you from feeling sick (nausea) or
being sick (vomiting).
• DL-lysine acetylsalicylate: This belongs
to a group of medicines called painkillers
(analgesics). DL-lysine acetylsalicylate
is broken down in your body to aspirin
(acetylsalicylic acid). This works by blocking
a substance that naturally occurs in your
body called cyclo-oxygenase. Cyclo-oxygenase
makes some of the chemicals that cause pain.
If it is blocked, pain is relieved.
What MigraMax is used for
MigraMax is used to treat the signs of migraine,
such as headache, feeling sick (nausea) or being
sick (vomiting) in adults 18 years and over.

2. Before you take MigraMax
Do not take this medicine and tell your
doctor if:
You are allergic (hypersensitive) to:
- Metoclopramide hydrochloride
- DL-lysine acetylsalicylate (aspirin)
- Other salicylates or non-steroidal antiinflammatory medicines (NSAIDs)
- Any of the other ingredients of MigraMax
(listed in Section 6 below)
Signs of an allergic reaction can include:
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
You have a condition called mastocytosis as
the use of aspirin may cause severe allergic
reactions such as skin flushing, low blood
pressure, a fast heartbeat and vomiting
You are under the age of 18
You have haemophilia or any other blood
clotting or bleeding problems
You have a blockage or bleeding in your
stomach or intestine
You have an ulcer in your stomach or gut.
Signs include burning or aching pain in your
stomach, with an empty feeling and hunger
You have had an operation on your stomach
or intestine (gut). Do not take during the first
3 to 4 days after your operation.
You have a tumour on the adrenal gland
(called phaeochromocytoma)
You are pregnant. This is especially important
during the third trimester (week 26 to
delivery). See Pregnancy and breast feeding
section below.
You are breast feeding (see Pregnancy and
breast feeding section below)
Do not take this medicine if any of the above
applies to you. If you are not sure, talk to your
doctor or pharmacist before taking MigraMax.
Take special care with MigraMax.
Check with your doctor or pharmacist
before taking your medicine if:
▲You have ever had an ulcer in your stomach
or gut. Signs include burning or aching pain
in your stomach with an empty feeling and
hunger
▲You have asthma

▲You have a runny nose, itching, sneezing and
stuffy nose (called rhinitis)
▲You have growths inside your nose causing an
obstruction (called nasal polyps)
▲You have liver problems
▲You have gout
▲You have ever had any bleeding in the
stomach or intestine
▲You have menstrual periods which are heavier
or last longer than usual
▲You use an intrauterine contraceptive device
(IDU)
▲You have epilepsy. This is because MigraMax
may increase the chances of you having a fit
▲You drink a lot of alcohol
▲You have kidney problems
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist
before taking MigraMax
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you
buy without prescription, including herbal
medicines. This is because MigraMax can affect
the way some other medicines work. Also some
medicines can affect the way MigraMax works. In
particular tell your doctor if you are taking any
of the following:
MigraMax may increase the effects of the
following medicines:
• Medicines for mental illness known as
‘antipsychotics’
• Medicines to calm or reduce anxiety
(hypnotics, anxiolytics)
• Medicines to help you sleep (sedatives,
barbiturates)
• Medicines used for epilepsy such as phenytoin
or sodium valproate
• Some medicines used for depression such as
mirtazapine or venlafaxine
• Medicines to prevent blood clotting (anticoagulants) such as warfarin
• Ciclosporin – used to help prevent rejection
of transplants. Your doctor may change your
dose of ciclosporin
• Clonidine – used for high blood pressure,
migraine or hot flushes in the menopause
• Medicines used to treat muscle spasms
(anticholinergics) for irritable bowel syndrome
(IBS) such as mebeverine or hyoscine
• Medicines used to treat incontinence such as
oxybutynin, propiverine or tolterodine
• Some medicines for moderate to severe
pain (morphine products) such as codeine,
dihydrocodeine or dextropropoxyphene
• Oral medicines used for diabetes
(sulphonylureas) such as gliclazide
• Medicines that can make you sleepy that are
used for hay fever, rashes or other allergies
called sedative antihistamines such as
chlorphenamine or promethazine
• Methotrexate – used to treat rheumatoid
arthritis, cancer and some other conditions
• Zafirlukast – used for asthma
MigraMax can make the following medicines
work less well:
• Medicines used to lower the amount of
uric acid in your body (uricosurics) such as
probenecid or sulfinpyrazone
• Digoxin – used for heart problems. Your
doctor may change your dose of digoxin
• Interferon alpha – used to treat certain types
of infections and certain forms of cancer
• Mifepristone – usually given in hospital for
termination of a pregnancy
• Water tablets (diuretics) such as
spironolactone, triamterene or amiloride
The following medicines can increase the
chance of you getting side effects, when
taken with MigraMax:
• Other related painkillers that lower
inflammation (Non-steriodal antiinflammatory medicines – NSAIDs), such as
ibuprofen
• Medicines used to prevent blood clots such as
clopidogrel, ticlopidine or dipyridamole
• Medicines for indigestion and heartburn
(antacids)
• Steroid medicines – used for lots of different
illnesses such as inflammation, allergy or
immune system problems
• Levodopa – used for Parkinson’s disease
Taking MigraMax with food and drink
Drinking alcohol while taking MigraMax may
make you feel sleepy
Pregnancy and breast feeding
Do not take this medicine if:
• You are pregnant, might become pregnant or
think you may be pregnant. This is especially
important during the third trimester, week 26
to delivery
• You are breast feeding or planning to breast
feed. This is because small amounts may pass
1
into mothers’ milk

*523899* *523899*

PACKAGE LEAFLET:
INFORMATION FOR THE USER

(1,1) -2- 523899_NPI MIGRAMAX GB-D.indd 24/09/13 10:23

Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast feeding.

• You have severe pain in your stomach or
intestines
• You are coughing up blood and having
difficulty breathing

Driving and using machines
You may feel sleepy after taking this medicine.
This is more likely if you have drunk alcohol
or are taking other medicines that cause
drowsiness. If this happens do not drive or use
any tools or machines.

Tell a doctor straight away if you notice any
of the following serious side effects:
• Problems controlling certain muscles of the
body or you have muscle spasms or ‘jerks’. The
affected muscles may include your tongue,
mouth, jaw, arms and legs. The spasms may
cause unusual movements of the face, tongue,
eyes, neck and affect speech, expression and/
or lead to unnatural positioning of the head
and shoulders
• Decreased level of consciousness, confusion,
hallucination
• Rigid or stiff muscles, trembling or shaking or
difficulty moving
• You bruise more easily than usual. This
could be because of a blood disorder
(thrombocytopenia)
• You get infections more often and easier than
normal. This could be because you have a low
number of white blood cells (agranulocytosis)
• Shortness of breath, fast heartbeat and chest
pain
• Depression

3. How to take MigraMax
Always take MigraMax exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Pour the contents of one sachet into some
water, mix well and drink straight away
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
How much to take
Adults (18 years and older) and the elderly:
• Take one sachet when you have the first
warning of a migraine attack
• If you do not feel better, you may take a
second sachet 2 hours later
• Do not take more than three sachets in a 24
hour period
Children
Do not take if you are under 18 years old
If you take more MigraMax than you should
If you take more MigraMax than you should, tell
a doctor or go to a hospital casualty department
straight away. Take the medicine pack with you.
This is so the doctor knows what you have taken.
The following effects may happen:
• Being sick (vomiting); feeling thirsty
(dehydration); ringing in the ears (tinnitus);
balance problems, dizziness (vertigo); loss
of hearing (deafness); sweating, feeling of
warmth in the hands, feet or lips with a
strong and forceful pulse; increased or heavy
breathing
• In some cases vomiting blood; very high body
temperature; a sense of nervousness, shaky or
sweaty (hypokalaemia); tiredness or weakness
and muscle cramps (hypokalaemia): you may
also feel that your limbs are swollen (fluid
retention) this is a sign of changes in the way
your kidneys are working
• Extreme shortness of breath or difficulty
breathing and a feeling of suffocating or
drowning. These are signs of something called
non-cardiac pulmonary oedema
• You may also bleed easily or have unusual
bruising or bleeding – these are signs of
blood problems such as thrombocytopenia.
Other effects such as lack of awareness
(disorientation), confusion, loss of
consciousness (coma) and rapid uncontrollable
shaking (convulsion) may also occur
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist

4. Possible side effects
Like all medicines, MigraMax can cause side
effects, although not everybody gets them.
Stop taking MigraMax and see a doctor or go
to a hospital straight away if:
• You have an allergic reaction. Severe allergic
reactions can occur very rarely and usually
happen soon after taking MigraMax. These
can involve difficulty breathing, tightness
in the throat, rapidly spreading rashes,
dizziness, very fast heartbeat or even loss of
consciousness
• You have difficulty breathing, wheezing or
tightness in the chest (called bronchospasm)
• You develop an itchy, lumpy rash sometimes
called hives (urticaria)
• You are short of breath, have bluish skin
colouration, headache, tiredness, dizziness
and loss of consciousness. These could be
signs of a very rare but serious side effect
called methaemoglobinaemia
• You are paler than normal, are sweating,
have a high temperature, fast heartbeat, stiff
muscles, fast breathing and feel confused,
drowsy or agitated. These could be signs of a
serious side effect called neuroleptic malignant
syndrome
• You have a fit
• You notice that you have black tarry stools
(faeces) or blood in the stools
• You notice any blood or dark particles (coffee
ground colour) when you are being sick
• You have a burning, aching pain in your
stomach, with an empty feeling and hunger.
You may have an ulcer in your stomach or gut

Tell your doctor as soon as possible if you
have any of the following side effects:
• Diarrhoea
• You bleed more easily than usual. You may
have something called ‘hypothrombinaemia’
• Feeling tired, faint, dizzy or having pale skin.
These could be signs of anaemia
• You have pain when passing urine with lower
back pain, sometimes radiating to the sides
and/or groin. These could be signs of kidney
stones
• You feel bloated, feel sick (nausea), have
heartburn or are burping (belching) more than
usual
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:
• Abnormal production of breast milk in men
and women
• Breast enlargement in men
• Loss of menstrual periods
• Feeling nervous (anxious), restless or confused
• Difficulty sleeping, feeling drowsy or tired
• Feeling dizzy or having ringing in your ears
(tinnitus)
• Lack or loss of strength (weakness)
• Wind (flatulence)
Talk to your doctor or pharmacist if any of the
side effects get serious or lasts longer than a few
days, or if you notice side effects not listed in this
leaflet

5. How to store MigraMax
Keep this medicine in a safe place where
children cannot see or reach it
Do not use MigraMax after the expiry date which
is stated on the label and carton after EXP. The
expiry date refers to the last day of that month.
Store below 25°C.
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 MigraMax contains
• Each sachet contains 1620mg DL-lysine
acetylsalicylate equivalent to 900mg
acetylsalicylic acid (the same amount that
is in three 300mg aspirin tablets) and 10mg
metoclopramide hydrochloride (as anhydrous)
as the active ingredients
• MigraMax sachets also contain aspartame,
glycine and lemon flavour
What MigraMax looks like and contents of the
pack
MigraMax is a white powder with a lemon odour
and is soluble in water.
MigraMax is available in cartons containing
2, 6 or 20 sachets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Zentiva,
One Onslow Street, Guildford, Surrey,
GU1 4YS, UK.
Manufacturer
Sanofi Winthrop Industrie, 196 avenue du
Maréchal Juin, 45200 Amilly, France
This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor
or pharmacist.
This leaflet was last revised in June 2013.
‘Zentiva’ is a registered trademark

2
523899

Important information about some of the
ingredients of Migramax
This medicine contains aspartame. This is a
source of phenylalanine. It may be harmful for
people with phenylketonuria.

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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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