Paracetamol 500mg Tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

PARACETAMOL

Tilgjengelig fra:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC-kode:

N02BE01

INN (International Name):

PARACETAMOL 500 mg

Legemiddelform:

TABLET

Sammensetning:

PARACETAMOL 500 mg

Resept typen:

OTC

Terapeutisk område:

ANALGESICS

Produkt oppsummering:

Licence number in the source country: NOT APPLICAPABLE

Autorisasjon status:

Authorised

Autorisasjon dato:

2020-04-22

Informasjon til brukeren

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PACKAGE LEAFLET INFORMATION
PARACETAMOL 500MG TABLETS
Please read all of this leaflet carefully before you start taking this
medicine. Keep the leaflet, you may
need to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
In this leaflet
1.
What this medicine is and what it is used for
2.
Before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Further information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED
FOR
Paracetamol is an analgesic (pain killer) and an antipyretic (helps to
reduce body temperature when
you have a fever).
This medicine is used for the relief of headache, migraine, neuralgia
and rheumatic aches and pains.
Also for the relief of symptoms of colds and influenza
2.
BEFORE USING THIS MEDICINE
DO NOT TAKE THESE TABLETS IF
:
•
you are allergic to paracetamol or any of the other ingredients (see
section 6).
DO NOT TAKE
anything else containing paracetamol while taking this medicine.
CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS IF:
•
you suffer from any liver or kidney problems
•
you suffer from alcohol dependence
TAKING OTHER MEDICINES:
Check with your doctor or pharmacist before taking these Tablets if
you are taking other medicines,
including any that you can buy without a prescription. This is
especially important if you are taking:
•
anticoagulants to thin the blood e.g. warfarin
•
colestyramine (to lower cholesterol levels)
•
metoclopramide or domperidone (for feeling sick or being sick)
•
flucloxacillin (antibiotic), due to a serious risk of blood and fluid
abnormality (high anion gap
metabolic acidosis) that must have urgent treatment and which may
occur particularly in case of
severe renal impairment, sepsis (when bacteria and their toxins
circulate in the blood leading to
organ damage), malnutrition, chronic alcoholism, and if the maximum
daily doses of paracetamol
are used.
PREGNANCY AND BREAST FEEDING
Check with your doctor before taking if you a

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500.00 mg of Paracetamol BP
3
PHARMACEUTICAL FORM
White, capsule shaped tablets, plain on one side and with a breakline
on the other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol is indicated for the relief of headaches, migraine,
neuralgia, rheumatic aches and pains.
For the relief of colds and influenza.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise directed by the doctor:
Posology
Adults, the elderly and children 16 years and over: One or two tablets
every 4 – 6 hours when
necessary to a maximum of 4 doses in 24 hours.
Paediatric population
Children 12 to15 years: One to one and a half tablets every 4 – 6
hours when necessary to a maximum
of 4 doses in 24 hours.
Children 10 to 12 years: One tablet every 4 – 6 hours when necessary
to a maximum of 4 doses in 24
hours.
Children 6 to 10 years: Half a tablet every 4 – 6 hours when
necessary to a maximum of 4 doses in
24 hours.
Not recommended for children under 6 years.
Method of administration
For oral use. To be swallowed with some water.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol and/or other constituents.
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4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care is advised in the administration of paracetamol to patients with
severe renal or severe hepatic
impairment. The hazards of overdose are greater in those with
non-cirrhotic alcoholic liver disease.
Do not exceed the recommended dose.
If symptoms persist, consult your doctor.
Keep out of the reach and sight of children.
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.
Do not take with any other paracetamol-containing products.
Caution is advised if paracetamol is administered concomitantly with
flucloxacillin due to increased
risk of high ani