PARAMAX 500MG/5MG EFFERVESCENT POWDER

Active substance: METOCLOPRAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET:
-INFORMATION FOR THE USER

Paramax 500mg/5mg
Effervescent Powder

Paracetamol
Metoclopramide hydrochloride
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 500mg/5mg,
Effervescent Powder (called Paramax in this leaflet).

 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

Paramax contains sodium:
Sodium: There is 387.7 mg of sodium per sachet. This may
be harmful to people on a low sodium or low salt diet.

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 other
medicines can affect the way Paramax works.

Always take Paramax exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

3. How to take Paramax

While 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.
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 Paramax can make the following medicine work less
well:
is relieved
Digoxin - used for heart problems. Your doctor may
What Paramax is used for
change your dose of digoxin
Paramax is used to treat the signs of migraine, such as
headache, feeling sick (nausea) or being sick (vomiting) The following medicine can increase the effects of
in adults 18 years and over.
Paramax:
Domperidone (a similar medicine to metoclopramide) 2. What you need to know before you take
used to stop you feeling sick (nausea) or being sick
(vomiting)
Paramax

The following medicines can make Paramax work
less well:
• 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
sachets. 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
Children
because small amounts may pass into mothers’ milk.
Paramax must not be given to patients under
Ask your doctor or pharmacist for advice before taking
18 years of age.
Do not take this medicine if any of the above apply to any medicine if you are pregnant or breast-feeding.
you. If you are not sure, talk to your doctor or pharmacist
before taking Paramax.
Driving and using machines
Warnings and precautions
You may feel sleepy after taking this medicine. This is
Take special care with Paramax
more likely if you have drunk alcohol or taken other
Check with your doctor or pharmacist before medicines that cause drowsiness. If this happens, do not
taking your medicine if:
drive or use any tools or machines.
 You have severe kidney problems
Turn
 You have a liver problems including alcoholic liver
Over
disease

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’)

Taking this medicine
• Take this medicine by mouth
• Pour the contents of the sachet into about a quarter
of a glass of water mix well and drink straight away
• 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 sachets 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 sachets in any 24 hour
period
Use in children and adults under 18
Do not take if you are under 18 years of age.
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 sachets 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 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
difficulty 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 causes have
been reported.
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.

5. How to store Paramax
Keep this medicine out of the sight and reach of children.
Do not use Paramax after the expiry date which is stated
on the sachet and carton after EXP. The expiry date refers
to the last day of that month.
Store below 25°C. Keep the sachets in the outer carton.
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.

6. Contents of the pack and other information
What Paramax contains
• The active substances are metoclopramide
hydrochloride and paracetamol. Each sachet
contains 500mg paracetamol and 5mg
metoclopramide hydrochloride (as anhydrous) as the
active ingredients
• The other ingredients are gelatin, sodium carbonate,
saccharin sodium, sodium dihydrogen citrate
(anhydrous), sodium bicarbonate and lemon flavour
What Paramax looks like and contents of the pack
A white, soluble effervescent powder for oral solution.
Cartons containing 6, 30 or 42 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-Aventis Sp. z o.o.
ul. Lubelska 52
35-233 Rzeszów, Poland
This leaflet was last revised in March 2014.
© Zentiva 2014

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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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