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PARAMAX 500MG/5MG TABLETS

Active substance(s): METOCLOPRAMIDE / METOCLOPRAMIDE HYDROCHLORIDE / PARACETAMOL

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Assessed against the UK PIL dated January 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
®

PARAMAX 500MG/5MG TABLETS

(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.
2.
3.
4.
5.
6.

What Paramax Tablets are and what they are used for
What you need to know before you take Paramax Tablets
How to take Paramax Tablets
Possible side effects
How to store Paramax Tablets
Contents of the pack and other information

1. What Paramax Tablets are and what they
are used for
The name of your medicine is Paramax 500mg/5mg Tablets
(called Paramax Tablets in this leaflet).

What Paramax Tablets contain

Paramax Tablets contain 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)

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 Tablets are used for

Paramax Tablets are 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 Tablets
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 ‘Other medicines and Paramax
Tablets’)

Children

Paramax Tablets 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 Tablets.

Warnings and precautions
Take special care with Paramax Tablets
Check with your doctor or pharmacist before taking
your medicine if:

By hussainal at 2:20 pm, May 19, 2016

Pregnancy and breast-feeding

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Paramax Tablets.

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 Tablets 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 Tablets. 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.

Other medicines and Paramax Tablets

Driving and using machines





You have severe kidney problems
You have severe liver problems caused by alcohol
You are elderly (65 years of age or older)

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 Tablets can affect the way some
other medicines work. Also some medicines can affect the
way Paramax Tablets work.

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.

While taking Paramax Tablets you should not take
any other medicines which contain paracetamol.

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

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

3. How to take Paramax Tablets

Taking this medicine





Tell your doctor if you are taking any of the
following:
Paramax Tablets 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 Tablets 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 Tablets:

Domperidone (a similar medicine to metoclopramide) - used
to stop you feeling sick (nausea) or being sick (vomiting)

The following medicines can make Paramax Tablets
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 Tablets with alcohol

You should not drink alcohol while you are taking these
tablets. Drinking alcohol while taking Paramax Tablets may
make you feel very sleepy.

Page 1 of 2

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.

If you take more Paramax Tablets 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, bleeding in your stomach and gut, 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 Tablets 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 Tablets. 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 cases 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

6. Contents of the pack and other
information
What Paramax Tablets contain

Each tablet contains 500mg paracetamol and 5mg
metoclopramide hydrochloride (as anhydrous) as the active
ingredients.
The other ingredients are: gelatin, colloidal silicon dioxide,
magnesium stearate and microcrystalline cellulose.

What Paramax Tablets look like and contents of the
pack

Paramax Tablets are white, round, biconvex tablets, engraved
'PARAMAX' on one side and a break-line on the reverse.
Paramax Tablets come in blister packs containing 14 or 42
tablets.

Manufacturer

Manufactured by:
Sanofi-Aventis Sp. z o.o., ul. Lubelska 52,
35-233 Rzeszów, Poland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0387

POM

Leaflet issue and revision date (Ref): 30.03.16
Paramax® is a registered trademark of Lorex Synthelabo
Limited.

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 Tablets











KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Paramax Tablets 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 from light.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any signs of
deterioration, you should seek the advice of your
pharmacist who will tell you what to do.
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.
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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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