Brufen 400 mg effervescent Granules

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Ibuprofen

Prieinama:

Mylan IRE Healthcare Limited

ATC kodas:

M01AE; M01AE01

INN (Tarptautinis Pavadinimas):

Ibuprofen

Dozė:

400 milligram(s)

Vaisto forma:

Effervescent granules

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

Propionic acid derivatives; ibuprofen

Autorizacija statusas:

Not marketed

Leidimo data:

2013-01-18

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN 400 MG EFFERVESCENT GRANULES
ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days with
fever and 5 days with pain.
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 and above)

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


Prekės savybės

Health Products Regulatory Authority
19 November 2020
CRN00C1GJ
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brufen 400 mg effervescent Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 PHARMACEUTICAL FORM
Effervescent granules.
White granules, with orange flavour.
4 CLINICAL PARTICULARS
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
_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_
Brufen400 mg effervescent Granules are not suitable for use in
children under 12 years. Other more appropriate ibuprofen
formulations are available for this population.
Health Products Regulatory Authority
19 November 2020
CRN00C1GJ
Page 2 of 13
_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