PARAMAX 500 MG/5 MG TABLETS

Active substance: METOCLOPRAMIDE HYDROCHLORIDE

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503991/PL1d

®

Paramax 500 mg/5 mg Tablets

(paracetamol / metoclopramide hydrochloride)
Patient Information Leaflet
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 only. 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.
What is in this leaflet:
®
1) What Paramax is and what it is used for
®
2) What you need to know before you take Paramax
®
3) How to take Paramax
4) Possible side effects
®
5) How to store Paramax
6) Contents of the pack and other information
®

1) WHAT PARAMAX IS AND WHAT IT IS USED FOR
®
The name of your medicine is Paramax 500 mg/5 mg Tablets
®
(called Paramax in this leaflet).

Do not take this medicine, and tell your doctor, if you are
taking:
• Levodopa - used for Parkinson’s disease
Tell your doctor if you are taking any of the following:
®

Paramax 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)
• Some medicines used for depression such as
mirtazapine or trazodone
• Chloramphenicol – an antibiotic used for infections
• Medicines to prevent blood clotting (anti-coagulants)
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
• Some medicines for moderate to severe pain
(morphine products) such as codeine, dihydrocodeine
or dextropropoxyphene
• Medicines that can make you sleepy that are used for
hay fever, rashes or other allergies called sedative
antihistamines
such
as
chlorphenamine
or
promethazine
®

®

What Paramax contains
®
Paramax contains two different medicines. These are called:
• Metoclopramide hydrochloride: this belongs to a
group of medicines called anti-emetics. 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)
• Paracetamol: this belongs to a group of medicines
called painkillers (analgesics). It works by stopping
substances that naturally occur in your body called
prostaglandins from being made. Prostaglandins cause
pain. If they are blocked, pain is relieved
®

What Paramax is used for
®
Paramax 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) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
®
PARAMAX
Do not take this medicine and tell your doctor if:
• You are allergic to the active substances or any of the
other ingredients (listed in section 6)
Signs of an allergic reaction include: rash, swallowing
or breathing problems, swelling of your lips, face,
throat or tongue
• You have a blockage or bleeding in your stomach or
intestine (gut)
• You have had movements that you cannot control,
mainly of the tongue, mouth, jaw, arms and legs after
taking metoclopramide or medicines used to calm
emotional and mental problems
• You have epilepsy
• 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 taking a medicine called levodopa used to
treat Parkinson’s disease (see ‘Taking other
medicines’)
Children
®
Paramax must not be given to patients under 18 years of
age.
Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
®
taking Paramax .
Warnings and precautions
®
Take special care with Paramax
Check with your doctor or pharmacist before taking your
medicine if:
• You have severe kidney problems
• You have a severe liver problem caused by alcohol
• You are elderly (65 years of age or older)
If you are not sure if any of the above apply to you, talk
®
to your doctor or pharmacist before taking Paramax
®

Other medicines and Paramax
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines.
®
This is because Paramax can affect the way some other
medicines work. Also some medicines can affect the way
®
Paramax works.

Paramax can make the following medicine work less
well:
Digoxin - used for heart problems. Your doctor may change
your dose of digoxin
The following medicine can increase the effects of
®
Paramax :
Domperidone (a similar medicine to metoclopramide) - used
to stop you feeling sick (nausea) or being sick (vomiting)
®

The following medicines can make Paramax work less
well:
• The oral contraceptive pill
• Colestyramine - for lowering blood cholesterol levels
• 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
®

Paramax with alcohol
You should not drink alcohol while you are taking these
®
tablets. Drinking alcohol while taking Paramax may make
you feel very sleepy.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if:
• You are pregnant, think you may be pregnant or plan
®
to get pregnant. You must not take Paramax during
the first six months of pregnancy
• You are breast-feeding or planning to breast feed. Do
®
not breast-feed if you are taking Paramax . This is
because small amounts may pass into mothers’ milk.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel sleepy after taking this medicine. This is more
likely if you have drunk alcohol or taken other medicines that
cause drowsiness. If this happens, do not drive or use any
tools or machines.
®

3) HOW TO TAKE PARAMAX
®
Always take Paramax exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Do not take more than the recommended dose
• If you continue being sick (vomiting) after taking this
medicine, tell your doctor
• 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:
• The usual dose is 2 tablets when you have the first
warning of a migraine attack
• Wait at least 4 hours before taking another dose
• Do not take more than 6 tablets in any 24 hour period
Use in children and adults under 18
Do not take if you are under 18 years of age.

®

Whilst taking Paramax you should not take any other
medicines which contain paracetamol.
This includes some painkillers, cough and cold remedies. It
also includes a wide range of other medicines available from
your doctor and more widely in shops.

continued overleaf

®

If you take more Paramax than you should
• Talk to a doctor at once if you take too much of this
medicine even if you feel well. This is because too
much paracetamol can cause delayed, serious liver
damage
• Remember to take any remaining tablets and the pack
with you. This is so the doctor knows what you have
taken.
The following effects may happen:
• Feeling sick (nausea) and being sick (vomiting);
unusually pale complexion; loss of appetite; stomach
pains. Other effects such as drowsiness, rapid
uncontrollable shaking (convulsions), muscle spasms
and ‘jerks’ may also occur
• Severe stomach pain which may reach through to your
back. This could be a sign of pancreatitis
• You may also feel that your limbs are swollen (fluid
retention). This is a sign of changes in the way your
kidneys are working
In some cases an uneven heart beat; increased or heavy
breathing and feeling weak. You may also develop liver
problems that may cause the eyes or skin to go yellow and
in severe cases lack of awareness (disorientation),
confusion, loss of consciousness (coma) and death may
occur.
®

If you forget to take Paramax
If you forget to take a dose at the right time, take it as soon as
you remember. However do not take a double dose to make
up for a forgotten dose. Remember to leave at least 4 hours
between doses.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
®

Stop taking Paramax 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 Paramax . These can involve diffculty
breathing, tightness in the throat, rapidly spreading
rashes, dizziness, very fast heart beat or even loss of
consciousness
• 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
• Shortness of breath, slow heart beat and chest pain
• You have a fit (seizure)
• You get serious skin reactions. Very rare cases have
been reported.

®

5) HOW TO STORE PARAMAX
Keep out of the sight and reach of children.
®

Do not use Paramax after the expiry date which is stated on
the blister and carton after EXP. The expiry date refers to the
last day of that month.
Do not store above 25°C. Store in the original container.
Protect tablets from light.
Do 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.
If you notice any sign of deterioration or discoloration of your
medicine, please consult your pharmacist.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
®
What Paramax contains:
Each tablet contains 500 mg paracetamol and 5 mg of
metoclopramide (as hydrochloride) as the active ingredients.
®
Paramax also contains gelatin, colloidal silicon dioxide,
magnesium stearate and microcrystalline cellulose.
®

What Paramax looks like and contents of the pack
®
Paramax are white, round, scored tablets engraved
‘Paramax’ on one side.
The tablets are supplied in packs of 14 or 42.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James’ House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Sanofi-Aventis Sp. z o.o., ul. Lubelska 52, 35-233 Rzeszów,
Poland.
®

Paramax 500 mg/5 mg Tablets
PL No: 18067/0409

POM

®

Paramax is a registered trademark.
th

This leaflet was last revised on 8 June 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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)
• Depression
Tell your doctor as soon as possible if you have any of
the following side effects:
• Diarrhoea
• Dizziness, lightheadedness and fainting. This could be
because of low blood pressure
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
• Feeling drowsy
• Lack or loss of strength (weakness)
• Skin rash
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.
By reporting side effects, you can help provide more
information on the safety of this medicine.

503991/PL1d

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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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