Brufen Retard 800mg prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Viatris Healthcare Limited

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

1990-01-03

Patient Information leaflet

Package leaflet: Information for the user
BRUFEN
® RETARD 800MG PROLONGED RELEASE TABLETS
ibuprofen
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, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it 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, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Brufen is what it is used for
2.
What you need to know before you take Brufen
3.
How to take Brufen
4.
Possible side effects
5.
How to store Brufen
6.
Contents of the pack and other information
The full name of your medicine is BRUFEN RETARD 800MG PROLONGED
RELEASE TABLETS. In
this leaflet, the shorter name Brufen is used.
1. WHAT BRUFEN IS AND WHAT IT IS USED FOR
Brufen belongs to a group of medicines called anti-inflammatory pain
killers.
The active ingredient in Brufen is ibuprofen and each tablet contains
800mg of ibuprofen
in a sustained release formulation. This is designed to release
ibuprofen gradually into
your blood stream throughout the day.
It can be used to relieve pain and inflammation in conditions such as
osteoarthritis,
rheumatoid arthritis (including juvenile rheumatoid arthritis or
Still's disease), arthritis of
the spine (ankylosing spondylitis), swollen joints, frozen shoulder,
bursitis, tendonitis,
tenosynovitis, lower back pain, sprains and strains.
Brufen can also be used to treat other painful conditions such as
toothache, pain after
operations, period pain and headache, including migraine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN
DO NOT TAKE BRUFEN TABLETS
•
if you are allergic to ibuprofen or any of the ingredients of this
medicine(listed in
Section 6)
•
if you previously experienced stomach bleed

Summary of Product characteristics

Health Products Regulatory Authority
17 January 2024
CRN00F259
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brufen Retard 800mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg of ibuprofen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
A white, pillow-shaped, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brufen Retard is indicated for its analgesic and anti-inflammatory
effect in the treatment of rheumatoid arthritis (including
juvenile rheumatoid arthritis or Still’s disease), ankylosing
spondylitis, osteoarthritis and other non-rheumatoid (seronegative)
arthropathies.
In the treatment of non-articular rheumatic conditions, Brufen Retard
is indicated in the periarticular conditions such as frozen
shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low
back pain; Brufen Retard can also be used in soft-tissue injuries
such as sprains and strains.
Brufen Retard is also indicated for its analgesic effect in the relief
of mild to moderate pain such as dysmenorrhoea, dental and
post-operative pain and for symptomatic relief of headache, including
migraine headache.
Brufen Retard is not suitable for use in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
ADULTS AND ADOLESCENTS OVER 12 YEARS (≥ 40KG)
Two tablets taken as a single dose, preferably in the early evening
well before retiring to bed. The tablets should be swallowed
whole with plenty of fluid. In severe or acute conditions, total daily
dosage may be increased to three tablets in two divided
doses.
PAEDIATRIC POPULATION
Brufen Retard 800mg prolonged release tablets are not suitable for use
in children under 12 years.
ELDERLY
No special dosage modifications are required, unless renal or hepatic
function is impaired, in which case dosage should be
assessed individu