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PARACETAMOL TABLETS 500MG
Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL
500 mg Tablets
148 x 210 mm
Final Preparation Date For Submission: 17/06/2017
Packing Site Technical Approval:
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL 500 mg
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
- 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.
WHAT IS IN THIS LEAFLET
1. What Paracetamol is and what it is
2. What you need to know before you
3. How to take Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Contents of the pack and other
1. WHAT PARACETAMOL IS AND
WHAT IT IS USED FOR
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
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.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE PARACETAMOL
Do not take Paracetamol if you:
are allergic to paracetamol or any of the other
ingredients of this medicine (listed in section 6 of
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
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
You should 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
3. HOW TO TAKE PARACETAMOL
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
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.
4. POSSIBLE SIDE EFFECTS
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
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 PARACETAMOL
Keep this medicine out of the sight and reach of
This medicinal product does not require any special
temperature storage conditions. Store in the original
package. Keep blister in the outer carton in order to
protect from moisture and light.
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.
6. CONTENTS OF THE PACK AND
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 K30,
pregelatinised starch (starch 1500), magnesium
stearate and stearic acid.
What Paracetamol tablets look like and contents
of the pack
Paracetamol tablets are capsule shaped, white,
scored tablets, which come in blister packs of 28 and
32 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 07/2017.
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.