Brufen 400 mg bruisgranulaat

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

IBUPROFEN

Beschikbaar vanaf:

Mylan Healthcare B.V.

ATC-code:

M01AE01

INN (Algemene Internationale Benaming):

IBUPROFEN

farmaceutische vorm:

Bruisgranulaat

Samenstelling:

APPELZUUR, (DL)(+-)(E 296) ; CARMELLOSE (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MALTODEXTRINE ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POVIDON K 30 (E 1201) ; SACCHAROIDE NATRIUM X-WATER (E 954) ; SACCHAROSE ; SINAASAPPELSMAAKSTOF,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ibuprofen

Product samenvatting:

Hulpstoffen: APPELZUUR, (DL)(+-)(E 296); CARMELLOSE (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); MALTODEXTRINE; NATRIUMCARBONAAT 0-WATER (E 500 (I)); NATRIUMLAURILSULFAAT (E 487); NATRIUMWATERSTOFCARBONAAT (E 500 (II)); POVIDON K 30 (E 1201); SACCHAROIDE NATRIUM 0-WATER (E 954); SACCHAROSE; SINAASAPPELSMAAKSTOF;

Autorisatie datum:

2012-12-20

Bijsluiter

IA/024
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN 400 MG
BRUISGRANULAAT
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 belongs to a group of medicines called ‘non-steroidal
anti-inflammatory drugs’ or NSAIDs.
One sachet of medicine contains 400 mg of ibuprofen.
This medicine is for short-term use in adults and adolescents over 12
years (>40 kg)

to relieve mild to moderate pain such as headache and toothache ,

to relieve period pain

to reduce fever (high temperature)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN
DO NOT GIVE/TAKE BRUFEN:

to children younger than 12 years of age

if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section
6)

if you have ever had an allergic reaction to ibuprofen,
acetylsalicylic acid or other NSAIDs -
the signs include a reddening or rash of the skin, swollen face or
lips, runny nose, wheezing or
shortness of breath

if you have (or have had two or more episodes of) a stomach/duodenal
ulcer (peptic ulcer) or
bleeding

if you have ever had bleeding or a tear in your stomach or gut when
taking NSAIDs

if you have severe liver or kidney problems

if you have severe heart failure or coronary heart disease
IA/024

if you ar

Productkenmerken

II/016 - 1 of 14
S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Brufen 400 mg bruisgranulaat
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
One sachet contains 400 mg ibuprofen.
Excipients with known effect
One sachet also contains 2222 mg sucrose and 131 mg sodium.
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Effervescent granules.
White granules, with orange flavour.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and adolescents over 12 years (> 40 kg)

Acute mild to moderate pain, such as headache and dental pain.

Primary dysmenorrhoea.

Fever.
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).
The ibuprofen dose depends on the patient’s age and body weight. The
maximum single daily dose
for adults and adolescents should not exceed 400 mg of ibuprofen.
_ADULTS AND ADOLESCENTS OLDER THAN 12 YEARS (≥ 40 KG) _
400 mg given as a single dose or up to 3 times a day with an interval
of 4 to 6 hours.
More than 400 mg at a time does not give a better analgesic effect.
The maximum daily dose should not exceed 1200 mg.
_ADOLESCENTS _
If in adolescents this medicinal product is required for more than 3
days or if symptoms worsen a
doctor should be consulted.
II/016 - 2 of 14
_ADULTS _
The patient should consult a doctor if symptoms worsen, or persist for
more than 3 days in case of
fever and 5 days in case of pain.
_ _
_PAEDIATRIC POPULATION _
Brufen 400 mg Effervescent Granules are not suitable for use in
children under 12 years. Other more
appropriate ibuprofen formulations are available for this population.
_ELDERLY POPULATION _
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse
events (see sections 4.4 and 4.8). If treatment is considered
necessary, the lowest dose for the
shortest duration necessary to control symptoms should be used.
Treatment s