Rowalief 500 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Rowa Pharmaceuticals Limited

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2012-12-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROWALIEF
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, pharmacist or nurse has
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 effects, talk to your doctor, pharmacist or nurse.
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 Rowalief is and what it is used for
2.
What you need to know before you take Rowalief
3.
How to take Rowalief
4.
Possible side effects
5.
How to store Rowalief
6.
Contents of the pack and other information
1.
WHAT ROWALIEF IS AND WHAT IT IS USED FOR
ROWALIEF CONTAINS PARACETAMOL.
Paracetamol is a pain relieving, fever reducing medicinal product
(analgesic and antipyretic).
Paracetamol is used for symptomatic treatment of mild to moderate pain
and/or fever.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROWALIEF
DO NOT TAKE ROWALIEF:
-
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in section 6)
-
if you are taking any other paracetamol containing products.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Rowalief if
-
you have kidney or liver disease
-
you regularly consume excess amounts of alcohol
-
you suffer from a condition known as Gilbert’s syndrome
-
you are in a poor nutritional state e.g. due to eating disorders,
cystic fibrosis, HIV infection,
starvation
-
you have severe haemolytic anaemia (abnormal breakdown of red blood
cells).
Never take more paracetamol than recommended. A higher dose does not
increase pain relief; instead it
can caus

Summary of Product characteristics

Health Products Regulatory Authority
21 April 2023
CRN00CY3K
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowalief 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, caplet shaped, film-coated tablets with ‘P’, a bisect
breakline and ‘500’ on one side and plain on the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly)_
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.
The maximum daily dose must 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.
Maximum daily dose must 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 a suitable dosage
should be used. Information on the age of children
within each weight group given below is for guidance only.
Care must be taken not to exceed the maximum number of doses in a 24
hour period i.e. not more than 4 doses in a 24 hour
period. Paracetamol should only be administered when clearly necessary
and at the lowest efficacious dose.
_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)_
The usual dose