Rowalief Max 1000 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:

1000 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Not marketed

Authorization date:

2012-12-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROWALIEF MAX
1000 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, nurse or pharmacist 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 Max is and what it is used for
2.
What you need to know before you take Rowalief Max
3.
How to take Rowalief Max
4.
Possible side effects
5.
How to store Rowalief Max
6.
Contents of the pack and other information
1.
WHAT ROWALIEF MAX IS AND WHAT IT IS USED FOR
ROWALIEF MAX 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROWALIEF MAX
DO NOT TAKE ROWALIEF MAX
-
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 Max 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 cause serious liver damage. The symptoms of liver

Summary of Product characteristics

Health Products Regulatory Authority
21 April 2023
CRN00CY3K
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowalief Max 1000 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, caplet-shaped, biconvex, film-coated tablets that have a break
line on one side and are 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_
Rowalief Max 1000 mg Film-coated tablets are not suitable for children
under 12 years of age as the dosage strength is not
suitable for this age group. However, there are appropriate dosage
strengths and/or formulations available for this age.
_Hepatic and Renal impairment_
In patients with impaired hepatic or renal function or Gilbert’s
syndrome, the dose must be reduced or the dosing interval
prolonged (see section 4.4).
In patients with renal insufficiency, the dose should be reduced:
Glomerular filtration
Dose
10‑50 ml/min
500 mg every 6 hours
<10 ml/min
500 mg every 8 hours
These doses should not be repeated more frequently than every 4 hours
and not more than 4 doses should be given in any
24 hour period.
Maximum duration of continued use without medical advice: 3 days
The lowest effective dose should be used for the shortest duration
necessary.
Health Products Regulatory Authority
21 April 2023
CRN00CY3K
Page 2 of 7
Method of administration
For oral use.
The tablet should be swallowed with a glass of water.
4.3 CONTRAINDICATIONS
Hyper