Brufen Retard 800mg prolonged release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 800 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

IBUPROFEN 800 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2019-04-10

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN RETARD 800 MG 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 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 Retard is and what it is used for
2.
What you need to know before you take Brufen Retard
3.
How to take Brufen Retard
4.
Possible side effects
5.
How to store
Brufen Retard
6.
Contents of the pack and other information
1.
WHAT BRUFEN RETARD IS AND WHAT IT IS USED FOR
Brufen Retard contains the active substance ibuprofen and belongs to a
group of medicines called
NSAIDs (non-steroidal anti-inflammatory drugs). Brufen Retard relieves
pain, reduces fever and has
an anti-inflammatory effect.
Brufen Retard is used for symptomatic treatment of pain and
inflammation in rheumatic conditions
(rheumatoid arthritis and osteoarthritis) in adults and adolescents
(12-18 years old, 40 kg and above).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN RETARD
DO NOT TAKE BRUFEN RETARD:
-
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
Brufen Retard or a similar product (other NSAIDs)
-
if you are in the last three months of pregnancy
-
if you have experienced all

Summary of Product characteristics

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S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Brufen Retard 800 mg prolonged-release tablets.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
One tablet contains 800 mg ibuprofen.
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Prolonged-release tablet
White, oval, about 21x10 mm, film-coated tablet.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brufen Retard is indicated in adults and adolescents
Symptomatic treatment of pain and inflammation in rheumatoid arthritis
and osteoarthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should start with the lowest dose anticipated to be
effective, which can subsequently be
adjusted, depending on the therapeutic response and any adverse
reactions. In long-term treatment a
low maintenance dose should be the aim.
The risk of adverse reactions 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): _
2 tablets in the evening. May be increased to maximum 3 tablets daily,
divided between morning and
evening. The maximum dose in a 24-hour period is 2,400 mg.
The tablets should be
_swallowed whole _
with at least half a glass of water.
Patients who have suffered dyspepsia or gastrointestinal bleeding when
taking other oral antiphlogistic
drugs have tolerated ibuprofen well, but should be monitored regularly
the first time they are treated
with Brufen Retard.
PAEDIATRIC POPULATION
Brufen Retard is not recommended for children under the age of 12
years.
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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 during NSAID
therapy. If renal or hepatic
function is impaired, dosage should be assessed individually.
_Renal impairment _
Caution s