Paracetamol Clonmel 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Clonmel Healthcare Ltd

ATC code:

N02BE01

INN (International Name):

Paracetamol

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

paracetamol

Authorization date:

2022-03-04

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL CLONMEL 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.
•
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 only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol Clonmel is and what it is used for
2.
What you need to know before you take Paracetamol Clonmel
3.
How to take Paracetamol Clonmel
4.
Possible side effects
5.
How to store Paracetamol Clonmel
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL CLONMEL IS AND WHAT IT IS USED FOR
Paracetamol Clonmel contains active substance paracetamol which
belongs to a group of medicines
called analgesics (painkillers).
Paracetamol Clonmel are used to relieve pain and help reduce fever.
The tablets can treat over a
short time mild to moderate pain and/or fever.
Paracetamol Clonmel may be used in adults and adolescents but is not
suitable for use in children
below 6 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL CLONMEL
DO NOT TAKE PARACETAMOL CLONMEL
•
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Paracetamol Clonmel.
•
if you are taking other paracetamol containing medicines, as it may
severely damage the liver.
•
if you have kidney or liver disease (including Gilbert’s syndrome or
acute hepatitis).
•
if you have a deficiency of a certain enzyme called
glucose-6-phosphatase.
•
if you have haemolytic anaemia (abnormal breakdown of red blood
cells).
•
if

Summary of Product characteristics

Health Products Regulatory Authority
31 May 2023
CRN00DLK6
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Clonmel 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
Film-coated tablet.
White to off-white coloured, caplet shaped film-coated tablets with
flat-edges debossed with "PARA500" on one side and
score line on the other side. Approximately, the tablet dimensions are
17.5 mm X 7.3 mm.
The tablet can be divided into two equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term symptomatic treatment of mild to moderate pain and/or
fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paracetamol is dosed depending on bodyweight and age, usually with 10
to 15 mg/kg bodyweight as a single dose, up to a
maximum of 60 mg/kg bodyweight as a total daily dose.
Adults and adolescents 15 years and above (> 55 kg bodyweight)
1 to 2 tablets (500-1000 mg) at a time, up to 6 tablets (3000 mg) per
24 hours.
The simultaneous intake of two tablets should be recommended only if
there is insufficient relief with one tablet, or there is
higher requirement due to more intense pain.
Paediatric population (children from 6 years of age (> 22 kg
bodyweight) and adolescents up to 15 years (< 55 kg bodyweight))
AGE GROUP
RECOMMENDED DOSE
NUMBER OF TABLETS
FREQUENCY
6-9 years
(22-30 kg bodyweight)
250 mg
Half tablet
Every 4-6 hours when necessary to a
maximum of 4-6 doses (1000-1500 mg) in
24 hours
9-12 years
(30-40 kg bodyweight)
500 mg
One tablet
Every 4-6 hours when necessary to a
maximum of 4 doses (1500-2000 mg) in 24
hours
12-15 years (40-55 kg bodyweight)
500 mg
One tablet
Every 4-6 hours when necessary to a
maximum of 4-6 doses (2000-3000 mg) in
24 hours
The lower dosing frequency is intended for children in the lower limit
of the relevant weight and / or age group.
Direction for use:

Paracetamol tablet is not suitable