Brufen 600mg Effervescent Granules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 600 mg

Pharmaceutical form:

EFFERVESCENT GRANULES

Composition:

IBUPROFEN 600 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2019-08-06

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN 600 MG EFFERVESCENT GRANULES
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 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. 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 600 MG EFFERVESCENT GRANULES
. 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 ‘non-steroidal
anti-inflammatory drugs’ or NSAIDs.
Each sachet of medicine contains 600 mg ibuprofen.
This medicine is used:
•
to relieve pain and inflammation in conditions such as osteoarthritis,
rheumatoid arthritis,
arthritis of the spine (ankylosing spondylitis), swollen joints,
frozen shoulder, bursitis,
tendinitis, tenosynovitis, lower back pain, sprains and strains.
•
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)
−
you have ever had an allergic reaction to ibuprofen, acetylsalicylic
acid (e.g. Aspirin) or other
NSAIDs - the signs include a reddening or rash of the skin, swollen
face or lips, shortness of
breath or stuffy and runny nose (rhinitis)
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−
you have ever ha

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Brufen 600 mg Effervescent Granules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains 600 mg ibuprofen.
Excipients with known effect:
Sodium (197 mg/sachet)
Sucrose (3333 mg/sachet)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent granules
Brufen Effervescent Granules are white granules with an orange
flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brufen Effervescent Granules are indicated for their analgesic and
anti-inflammatory effects in the
treatment of rheumatoid arthritis, ankylosing spondylitis,
osteoarthritis and other non-rheumatoid
(seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions Brufen
Effervescent Granules are indicated in
peri-articular conditions such as frozen shoulder (capsulitis),
bursitis, tendinitis, tenosynovitis and
low back pain; Brufen Effervescent Granules can also be used in
soft-tissue injuries such as sprains
and strains.
Brufen Effervescent Granules are also indicated for their analgesic
effect in the relief of moderate
pain such as dysmenorrhoea, dental and post-operative pain and for
symptomatic relief of headache
including migraine headache.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
ADULTS:
The recommended dosage of ibuprofen is 1,200-1,800 mg daily in divided
doses. Some patients can
be maintained on 600-1,200 mg daily. Total daily dose should not
exceed 2,400 mg.
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PAEDIATRIC POPULATION:
Brufen 600 mg Effervescent Granules are not suitable for use in
children and adolescents below the
age of 18 years.
ELDERLY POPULATION:
The elderly are at increased risk of serious consequences of adverse
reactions. If an NSAID is
considered necessary, the lowest effective dose should be used and for
the shortest possible
duration. The patient should be monitored regularly for GI bleeding