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PARAMAX 500MG/5MG EFFERVESCENT POWDER

Active substance: PARACETAMOL

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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
• 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 Paramax is and what it is used for
2. Before you take Paramax
3. How to take Paramax
4. Possible side effects
5. How to store Paramax
6. Further 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).
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. Before you take Paramax
Do not take this medicine and tell your
doctor if:
× You are allergic (hypersensitive) to:
- Metoclopramide hydrochloride
- Paracetamol
- Any of the other ingredients of Paramax (listed in
Section 6 below)
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’)
× The person going to take the sachets is 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.
Take special care with Paramax
Check with your doctor or pharmacist
before taking your medicine if:
 You have severe kidney problems
 You have severe liver problems including alcoholic
liver disease

 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

Taking other medicines
Please 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.
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
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:
• 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
Taking Paramax with food and drink
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
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.
Turn
Over

Important information about some of the
ingredients of Paramax
Sodium: There is 387.7 mg of sodium per sachet. This
may be harmful to people on a low sodium or low salt
diet.

3.How to take Paramax
Always take Paramax 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 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 a any 24 hour
period
Children
Do not take if you are under 18 years of age
If you take more Paramax than you should
• Tell your doctor or go to your nearest hospital
casualty department straight away - even if you feel
well. This is because of the risk of 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, Paramax 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)
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

Scale 100%
PARAMAX Sachets - leaflet UK
148 x 315 mm
code: 395574
Laetus: 61
Fonts: Ocean Sans Pro SAN 8 pt/text
Color: 1/Pantone Reflex Blue
Version nº 3
Plant Rzeszow - Agnieszka Twardochleb
Kamil Giecko
Date: June 2011

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
Talk to your doctor or pharmacist if any of the side
effects gets serious or lasts longer than a few days, or if
you notice side effects not listed in this leaflet.

5. How to store Paramax
Keep this medicine in a safe place where children
cannot see or reach it.
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.
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 Paramax contains
• Each sachet contains 500mg paracetamol and 5mg
metoclopramide hydrochloride (as anhydrous) as
the active ingredients
• Paramax also contains gelatin, sodium carbonate,
saccharin sodium, sodium dihydrogen citrate
(anhydrous), sodium bicarbonate and lemon flavour
What Paramax looks like and contents of the pack
Paramax Sachets contain a white, soluble effervescent
powder for oral solution.
Paramax is presented in 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 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 2011.
© Zentiva 2011

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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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