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Active substance(s): PARACETAMOL

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Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has
told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more
information or advice.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel
better or if you feel worse after 3 days.

1. What Paracetamol is and what it is
used for
2. What you need to know before you
take Paracetamol
3. How to take Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Contents of the pack and other

Paracetamol belongs to groups of medicines known
as analgesics and antipyretics. It works by relieving
pain and reducing body temperature in cases of fever.
Paracetamol Tablets are used to relieve mild to
moderate pain including headache, migraine,
toothache, backache, period pain and muscle and
rheumatic pain.
They can also be used to relieve the symptoms of
colds and flu (sore throat, fever, aches and pains), as
well as relieve the pain due to mild arthritis.

Do not take Paracetamol if you:
 are allergic to paracetamol or any of the other
ingredients of this medicine (listed in section 6 of
this leaflet)
 are taking other paracetamol-containing products
If you are not sure, check with your doctor or
pharmacist before taking Paracetamol.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Paracetamol if you:
 have kidney problems
 have liver problems, particularly those due to
drinking too much alcohol
 suffer from mild arthritis and need to take
painkillers everyday
Other medicines and Paracetamol
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines bought without a prescription.
This is because Paracetamol can affect the way some
medicines work. Also, some medicines can affect the
way Paracetamol works.
In particular, tell your doctor or pharmacist if you are
taking any of the following:
 medicines to treat epilepsy such as phenobarbital
 doxorubicin, used in the treatment of cancer
 aspirin, used to treat pain, inflammation or fever
 metoclopramide or domperidone, for nausea
(feeling sick) or vomiting (being sick)
 cholestyramine, to reduce blood cholesterol levels
 warfarin and other coumarins, used to thin the
blood and prevent clots from forming
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking
Paracetamol with food and drink
Avoid alcohol whilst taking Paracetamol, as it can
increase the risk of the side effects.
Pregnancy and breast-feeding
Talk to you doctor or pharmacist before taking
Paracetamol if you are pregnant. You can take this
medicine whilst breast-feeding.
Driving and using machines
This medicine should not affect your ability to drive or
operate machines.

Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not
When taking this medicine
 Do not exceed the recommended dose
 Do not take with other paracetamol-containing
 If your symptoms persist for more than three days,
you should consult your doctor
 Swallow the tablets with a drink of water

The recommended dose is:
Adults (including the elderly):
Take 2 tablets up to 4 times a day, as required. Wait at
least 4 hours between doses. Do not take more than 8
tablets in any 24 hour period.
Children aged 10 – 15 years:
One tablet to be taken every 4-6 hours, when
necessary, up to a maximum of 4 tablets in any
24-hour period.
Children under 10 years:
Paracetamol 500 mg Tablets is not recommended for
use in children under 10 years of age. A liquid form of
this medicine may be more suitable for use in children
of this age.
If you take more Paracetamol than you should
Immediate medical advice should be sought in the
event of an overdose, even if you feel well, because of
the risk of delayed, serious liver damage. Symptoms
of an overdose may include paleness, nausea,
vomiting, loss of appetite and abdominal pains.
Consult a doctor or go to the nearest hospital casualty
department straight away. Take this leaflet and the
medicine pack with you, so the doctor knows what has
been taken.
If you forget to take Paracetamol
Take the next dose when needed. Do not take a
double dose (two doses at the same time) to make up
for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
STOP TAKING this medicine and see a doctor or
go to a hospital straight away if you notice any of
the following side effects:
 an allergic reaction, the symptoms of which may
include skin rash, itching, blistering or peeling of
the skin, swelling of the face, lips, tongue or throat,
difficulty in breathing or swallowing, sudden
wheezing or collapse.
If you get any of the following side effects, stop
taking this medicine and talk to your doctor as
soon as possible:
 unexplained bruising or bleeding, red-purple spots
of discolouration on the skin, sore throats or
infections. These may be signs of changes to your
blood cells.
 skin rash or peeling, or mouth ulcers
 breathing problems. This is more likely if you suffer
from asthma and have experienced similar
problems before when taking painkillers such as
aspirin or ibuprofen.

 loss of appetite, abdominal discomfort, dark urine,
or yellowing of the eyes and skin. These may be
signs of changes to your liver.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at By reporting side
effects you can help provide more information on the
safety of this medicine.

Keep this medicine out of the sight and reach of
Do not store above 25°C. Store in the original
Do not use this medicine after the expiry date, which is
stated on the package. The expiry date refers to the
last day of that month.
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.

What Paracetamol tablets contain
The active ingredient in the tablets (the ingredient
which makes this medicine work) is paracetamol.
Each tablet contains 500 mg of paracetamol.
The tablets also contain povidone, starch, magnesium
stearate and stearic acid.
What Paracetamol tablets look like and contents
of the pack
Paracetamol tablets are white capsule-shaped
tablets, scored on one side, which come in containers
or blister packs of 2, 4, 8, 12 and 16 tablets. The score
line is not intended for breaking the tablet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd Floor,
Nicosia, P.C. 1060, Cyprus
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 09/2016.

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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.