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ACTAVIS PARACETAMOL 500MG CAPLETS

Active substance(s): PARACETAMOL

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Read all of this leaflet carefully 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. 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 Paracetamol Caplets are and what they are used for
2. Before you take Paracetamol Caplets
3. How to take Paracetamol Caplets
4. Possible side effects
5. How to store Paracetamol Caplets
6. Further information

1. WHAT PARACETAMOL CAPLETS ARE AND
WHAT THEY ARE USED FOR
Paracetamol Caplets 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 CAPLETS
DO NOT take Paracetamol Caplets 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.

Take special care with Paracetamol Caplets
Consult your doctor before taking these caplets 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 Caplets’)
• 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).
Taking Paracetamol Caplets with food and drink
Avoid alcoholic drinks whilst taking these caplets.
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 Caplets are not expected to affect your ability to drive or
operate machinery.

3. HOW TO TAKE PARACETAMOL CAPLETS
Always take Paracetamol Caplets exactly as your doctor has told
you. Swallow each caplet with a drink of water.
Adults, the elderly and children over 12 years:
Take one or two caplets every 4 to 6 hours, up to a maximum of 8
caplets in any 24 hour period.
Children (6-12 years):
Take half to one caplet every 4 to 6 hours, up to a maximum of 4
caplets in any 24 hour period.
Do not give this medicine to children under 6 years of age,
except on medical advice.
The dose should not be repeated more frequently than 4 hourly
intervals. You should not take Paracetamol Caplets for longer than 3
days.
WARNING: DO NOT EXCEED THE STATED DOSE
Contains paracetamol. Do not take with other
paracetamol containing products.
Do not exceed the treatment for more than 3 days and if
symptoms persist seek medical advice before continuing
treatment.
If symptoms persist for more than 3 days, speak to your doctor.
If you take more Paracetamol Caplets 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.
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.
If you forget to take Paracetamol Caplets
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.

Like all medicines, Paracetamol Caplets can cause side effects,
although not everybody gets them.
You may suffer an allergic reaction, symptoms of which include
skin rashes, hives. If this happens to you, stop taking the caplets
immediately and seek urgent medical help.
There have been few reports of blood abnormalities 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.
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 effect directly via the Yellow Card Scheme (Tel:
Freephone 0808 100 3352 or website: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 CAPLETS
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use Paracetamol Caplets 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 Caplets contain
The active substance is paracetamol 500mg.
The other ingredients are povidone, lactose, starch (maize), magnesium stearate, sodium starch glycollate, colloidal anhydrous silica
(see also end of Section 2 on ‘Important information about some of
the ingredients of Paracetamol Caplets’).
What Paracetamol Caplets look like and contents of the pack
Paracetamol Caplets are white capsule shaped caplets with
break-line. They are supplied in child-resistant blister packs of 16s,
24s, 32s, 48s, 96s and 100s (not all pack sizes may be marketed).
Marketing Authorisation Holder: Fourrts (UK) Pharmacare Ltd.,
First Floor, No. 2, Victoria Road,Harpenden, Hertfordshire, AL5 4EA
Marketing Authorisation Number: PL 39484/0038
This leaflet was last revised in August 2014.

Item code

34 mm

PARACETAMOL 500mg CAPLETS

4. POSSIBLE SIDE EFFECTS

Pharma
code

PACKAGE LEAFLET: INFORMATION FOR THE USER

Important information about some of the ingredients of
Paracetamol Caplets
Lactose – if you know you have an intolerance to some sugars,
inform your doctor before use.

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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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