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DOANS 500MG TABLETS

Active substance(s): PARACETAMOL

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180 x180mm - side1

PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500mg TABLETS
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Paracetamol 500mg Tablets carefully to get the best results from
them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 3 days.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Paracetamol 500mg Tablets are and what they are used for
2. Before you take Paracetamol 500mg Tablets
3. How to take Paracetamol 500mg Tablets
4. Possible side effects
5. How to store Paracetamol 500mg Tablets
6. Further information

1. WHAT PARACETAMOL 500mg TABLETS ARE
AND WHAT THEY ARE USED FOR
Paracetamol 500mg Tablets contain the active ingredient paracetamol
and are used for the relief of mild to moderate pain, including:
• rheumatic aches and pains
• neuralgia (severe nerve pain), period pain
• migraine, headache
• sore throat, toothache
• fevers, colds, flu and influenza.

2. BEFORE YOU TAKE

PARACETAMOL 500mg TABLETS

DO NOT take Paracetamol 500mg Tablets if you are:
• allergic (hypersensitive) to Paracetamol, other pain relievers or any
of the other ingredients in the product (see Section 6 and end of
Section 2)
• taking any other Paracetamol-containing medicines, i.e.
over-the-counter cold remedies.
This medicine is NOT recommended for children under 6 years of age.

PL 28444/0085

Paracetamol 500mg Tablets (0116) PIL
Size: 180 x 180mm
Main Heading (page 1)type style: 13pt Helvetica Bold Caps
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Text type style: 9pt Helvetica Light & Bold u&lc

Take special care with Paracetamol 500mg Tablets
Consult your doctor before taking these tablets if you:
• have kidney or liver problems.
• are an alcoholic.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including those obtained without a prescription,
particularly:
• other products containing paracetamol (see ‘DO NOT take
Paracetamol Tablets’).
• warfarin and other drugs which thin the blood.
• cholestyramine (reduces blood cholesterol levels).
• metoclopramide and domperidone (used to treat nausea, vomiting
or other stomach problems).
• chloramphenicol (an antibiotic).
Taking Paracetamol 500mg Tablets with food and drink
Avoid alcoholic drinks whilst taking these tablets.
Pregnancy and Breast Feeding
Ask your doctor or pharmacist for advice before taking any medicine
if you are pregnant, planning to become pregnant or breast-feeding.
Driving and using machines
Paracetamol 500mg Tablets are not expected to affect your ability to
drive or operate machinery.

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Important information about some of the ingredients of
Paracetamol 500mg Tablets
Sodium metabisulphite (E223) – may cause severe hypersensitivity
reactions and bronchospasm (narrowing of airways in the lungs,
causing difficulty in breathing).

3. HOW TO TAKE PARACETAMOL 500mg TABLETS
Always take Paracetamol 500mg Tablets exactly as your doctor has
told you. Swallow each tablet with a drink of water.
Adults, the elderly and children over 12 years:
Take one or two tablets every 4 to 6 hours, up to a maximum of 8
tablets in any 24 hour period.
Children (6-12 years):
Take half to one tablet every 4 to 6 hours, up to a maximum of 4
tablets in any 24 hour period.
This medicine is not recommended for children under 6 years of
age.
The dose should not be repeated more frequently than 4 hourly
intervals. You should not take Paracetamol 500mg Tablets for longer
than 3 days.
WARNING: DO NOT EXCEED THE STATED DOSE
Contains paracetamol. Do not take with other
paracetamol containing products.
If symptoms persist consult your doctor. Do not use for more than
3 days without consulting your doctor.
If you take more Paracetamol 500mg Tablets than you should
It is extremely important to follow the dosage instructions that have
been given to you. Do not change your dose without discussing it
with your doctor first. Symptoms of overdose include pallor (paleness
of skin), nausea, vomiting, anorexia and stomach pain. If you
accidentally take more than the recommended dose, or know
someone who has, contact your doctor or nearest hospital casualty
immediately. Take any remaining medicine and this leaflet with you if
possible.
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.
If you forget to take Paracetamol 500mg Tablets
If you miss a dose, take it as soon as you remember. NEVER take a
double dose to make up for the dose you have forgotten.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol 500mg Tablets can cause side
effects, although not everybody gets them.
You may suffer an allergic reaction, symptoms of which include
skin rashes, hives and itching. If this happens to you, stop taking
the tablets immediately and seek urgent medical help.
There have been few reports of blood abnormalities including
pancreatitis (inflammation of the pancreas) in patients taking paracetamol, but these were not necessarily due to the paracetamol treatment.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE PARACETAMOL TABLETS
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package.
Do not use Paracetamol 500mg Tablets after the expiry date shown on
the pack.
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 Paracetamol 500mg Tablets contain
The active substance is paracetamol 500mg.
The other ingredients are maize starch, povidone K-30, sodium
Metabisulphite (E223), sodium starch glycollate, colloidal anhydrous
silica and magnesium stearate (see also end of Section 2 on ‘Important information about some of the ingredients of Paracetamol
Tablets’).
What Paracetamol 500mg Tablets look like and contents of
the pack
The tablets are white with a breakline on one face and embossed
‘P500’ on the other face. They are supplied in:
sçCARTONSçCONTAININGçBLISTERçSTRIPSçOFççANDççTABLETS
sçBOTTLESçOFççTABLETS
Marketing Authorisation Holder and Batch Release Site:
LPC Medical (UK) Limited, 30 Chaul End Lane, Luton, Bedfordshire LU4 8EZ, U.K.
Marketing Authorisation Number: PL 19348/0116
This leaflet was last revised in May 2009.
Item code

To be confirmed
PL 28444/0085

Paracetamol 500mg Tablets (0116) PIL
Size: 180 x 180mm
Main Heading (page 1)type style: 13pt Helvetica Bold Caps
Sub Heading type style: 11pt Helvetica Bold Caps
Text type style: 9pt Helvetica Light & Bold u&lc

PL 28444/0085

Batch Release Site:
to be confirmed

Activase Pharmaceuticals Limited
11 Boumpoulinas, 3rd Floor
1060 Nicosia, Cyprus

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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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