Brufen 400mg film-coated tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Tilgjengelig fra:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC-kode:

M01AE01

INN (International Name):

IBUPROFEN 400 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

IBUPROFEN 400 mg

Resept typen:

POM

Terapeutisk område:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Autorisasjon status:

Authorised

Autorisasjon dato:

2019-04-10

Informasjon til brukeren

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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 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
1.
WHAT BRUFEN IS AND WHAT IT IS USED FOR
Brufen contains the active substance ibuprofen and belongs to a group
of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs). Brufen reduces fever,
relieves pain and has an anti-
inflammatory effect.
Brufen is used for pain of mild to moderate intensity, fever,
rheumatic conditions (rheumatic arthritis,
arthrosis) and menstrual pain, by adults and adolescents (12-18 years
old, 40 kg and above).
Children 6-12 years (over 20 kg) can be treated with Brufen 200 mg
tablets during acute painful
conditions and fever associated with common cold.
The effect of Brufen is achieved usually within 30 minutes.
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 have stomach ulcer or duodenal ulcer or have had recurrent
ulcer or bleeding in the stomach
or intestine
-
if you have severe liver or kidney disease
-
if you have severe heart failure
-
if you have an increased tendency to bleed
-
if you previously have had bleeding or perforation in your stomach or
intestine when treated with
Brufe

Preparatomtale

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S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Brufen 400 mg film-coated tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
One tablet contains 400 mg ibuprofen
Excipients with known effect: lactose monohydrate 26 mg
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Film-coated tablet
White, oval tablet
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis, arthrosis. Dysmenorrhoea with no organic cause.
Pain of mild to moderate
intensity. Fever in adults and adolescents.
Children 6–12 years (>20 kg): Acute pain and fever associated with
the common cold. The indications
for children apply only to the 200 mg tablets.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should start with the lowest dose anticipated to be
effective, which can subsequently be
adjusted, depending on the therapeutic response and any undesirable
effects. In long-term treatment a
low maintenance dose should be the aim.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_Adults and adolescents older than 12 years (≥ 40 kg): _
_Rheumatic diseases_
One 400 mg tablet three times daily or one 600 mg tablet three times
daily. An interval of at least 4-6
hours should be allowed between doses. For more rapid relief of the
morning stiffness, the first dose
may be given on a fasting stomach. The dose should be reduced in the
event of renal insufficiency.
The maximum dose in a 24-hour period is 2,400 mg.
_ _
_Dysmenorrhoea_
One 400 mg tablet one to three times daily, as needed. An interval of
at least 4-6 hours should be
allowed between doses. Treatment is started at the first sign of
menstruation problems.
_ _
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_Pain of mild to moderate intensity:_
One 200 mg tablet or one 400 mg tablet in a single dose or three to
four times daily. An interval of at least 4-6 hours should be allowed
between doses. Single doses
exceeding 400 mg have not been