Paracetamol 500 mg film-coated tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

PARACETAMOL

Tillgänglig från:

Accord Healthcare Ireland Ltd.

ATC-kod:

N02BE; N02BE01

INN (International namn):

PARACETAMOL

Dos:

500 milligram(s)

Läkemedelsform:

Film-coated tablet

Terapiområde:

Anilides; paracetamol

Bemyndigande status:

Marketed

Tillstånd datum:

2011-07-15

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG FILM-COATED TABLETS
Paracetamol
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 have
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 effect, 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 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 information
1.
WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
Paracetamol contains paracetamol which belongs to a group of medicines
called analgesics
(painkillers). Paracetamol is used to relieve mild to moderate pain
and reduce fever.
Paracetamol can be used for the relief of headache, toothache, period
pains, muscle pain and fever in
connection with common cold.
PARACETAMOL “CONTAINS PARACETAMOL”
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).
WARNINGS AND PRECAUTIONS
Paracetamol should not be used in combination with alcohol, as it may
severely damage your liver.
The effect of alcohol will not be enhanced by the addition of
paracetamol.
Talk to your doctor before taking Paracetamol:

if you have kidney or liver disease (including Gilbert’s syndrome or
hepatitis);

if you regularly consume large amount of alcohol. You may need lower
doses and to limit the
use for a short period of time, otherwise your liver may be affected;

if you are dehydrated or have i

Produktens egenskaper

Health Products Regulatory Authority
08 August 2019
CRN0094GW
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule-shaped, white film-coated tablet, with break-line on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paracetamol 500 mg film-coated tablets are not intended for children
weighing less than 26 kg.
_POSOLOGY_
_Adults and adolescents (weighing more than 50 kg) _
The usual dose is 500 mg to 1,000 mg every 4 to 6 hours as needed, to
a maximum of 3 g daily. Maximum single dose is
1,000 mg.
Maximal daily dose should not be exceeded due to risk of serious
hepatic damage (see sections 4.4 and 4.9).
_Paediatric population (weighing 20–50 kg)_
The recommended total daily dose of paracetamol is approximately 60
mg/kg divided in 4 or 6 separate doses, or
approximately 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
Maximal daily dose should not be exceeded due to risk of
serious hepatic damage (see sections 4.4 and 4.9).
Paediatric dosage should be based on body weight and suitable dosage
form used. Information on the age of children within
each weight group given below is for guidance only.
Regular administration minimizes pain and fever oscillation. In
children administration should be regular, including night times,
preferably at 6 hours intervals, otherwise at intervals of minimum 4
hours.
_Children and adolescents weighing 43‑50 kg (about 12‑15 years)_
The usual dose is 500 mg every 4 hours as needed, to a maximum of 2.5
g daily.
_Children weighing 34‑43 kg (about 11‑12 years)_
The usual dose is 500 mg every 6 hours as needed, to a maximum of 2 g
daily.
_Children weighing 26‑34 kg (about 8‑11 years