Brufen 400mg film-coated tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Ibuprofen

Disponibbli minn:

Viatris Healthcare Limited

Kodiċi ATC:

M01AE; M01AE01

INN (Isem Internazzjonali):

Ibuprofen

Għamla farmaċewtika:

Film-coated tablet

Żona terapewtika:

Propionic acid derivatives; ibuprofen

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1975-04-14

Fuljett ta 'informazzjoni

Package leaflet: Information for the user
BRUFEN
® 400 MG FILM-COATED 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 and 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 400MG FILM-COATED TABLETS. In
this leaflet, the
shorter name Brufen is used.
1. WHAT BRUFEN IS AND WHAT IT IS USED FOR
Brufen belong to a group of medicines called anti-inflammatory pain
killers.
The active ingredient in Brufen is ibuprofen and each tablet contains
400mg of
ibuprofen.
They 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
•
if you are allergic to ibuprofen or any of the other ingredients of
this medicine
(listed in section 6)
•
if you previously experienced stomach bleeding or perforation after
taking
ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
•
if you currently have a peptic ulcer (ulce

Karatteristiċi tal-prodott

Health Products Regulatory Authority
17 January 2024
CRN00F259
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brufen 400mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Brufen tablet contains 400 mg of ibuprofen.
Excipient(s) with known effect: each tablet contains 26.7mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
A white, pillow-shaped, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brufen is indicated in the symptomatic management of various arthroses
such as rheumatoid arthritis (including juvenile
rheumatoid arthritis or Still’s disease) and osteoarthritis,
fibrositis, ankylosing spondylitis and other muscular syndromes, such
as low back pain, soft tissue trauma and various inflammations of
tendon, joint capsules and ligaments.
Brufen is also used as an analgesic in the relief of mild to moderate
pain.
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 OLDER THAN 12 YEARS (≥ 40KG)
The recommended dosage of Brufen is 1200-1800 mg daily in divided
doses. Some patients can be maintained on 600-1200
mg daily. The total daily dose should not exceed 2400 mg.
PAEDIATRIC POPULATION
Brufen 400mg film-coated tablets are not suitable for use in children
under 12 years.
ELDERLY
No specific dosage modifications are required for elderly patients,
unless renal or hepatic function is impaired, in which case,
dosage should be assessed individually.
NSAIDs (Nonsteroidal anti-inflammatories) should be used with
particular caution in elderly patients who are more prone to
adverse events. The lowest dose compatible with adequate safe clinical
control should be employed (see section 4.4).
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
RENAL IMPAIRMENT
No dose reduction is requi