Brufen 200 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:

200 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:

2013-05-17

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUFEN
200 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.

You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
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 200 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 200 mg of ibuprofen.
This medicine is used:

to relieve pain in conditions such as toothache, period pain and
headache

to reduce fever (high temperature) and pain when you have the common
cold.
It can be used in adults and children over 30 kg in body weight (over
8 years old).
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
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 or
shortness of breath

you have (or have had two or more episodes of) a stomach ulcer or
bleeding of the
stomach


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 200 mg Effervescent Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains 200 mg ibuprofen.
Each sachet contains 1111 mg sucrose and 66 mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent granules.
White granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of mild to moderate pain, such as headache,
period pain, dental pain, and fever and pain in the
common cold.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_FOR ORAL USE AND SHORT-TERM USE ONLY._
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 400mg of ibuprofen. More than 400mg at a time does
not give a better analgesic effect.
The adult patient should consult a doctor if symptoms persist or
worsen, or if Brufen Effervescent Granules is required for more
than 3 days in case of fever and 5 days in case of pain.
Suitable for adults and children over 30 kg (over 8 years old).
_Adults and adolescents ≥ 40 kg:_
Initial dose, 200 mg or 400 mg ibuprofen. If necessary additional
doses of 1 or 2 sachets (200 mg to 400 mg ibuprofen) can be
taken.
Leave at least 4 hours between doses. A total dose of 1,200 mg
ibuprofen should not be exceeded in any 24-hour period.
BODY WEIGHT
SINGLE DOSE IN NUMBER OF SACHETS
MAXIMUM DAILY DOSE IN NUMBER OF
SACHETS
≥40kg
Adolescents, adults and the elderly
1 or 2 sachets (equivalent to
200 mg or 400 mg ibuprofen)
6 sachets (equivalent to 1,200 mg ibuprofen)
If in adolescents this medicinal product is required for more than 3
days or if symptoms worse, a doctor should be consulted.
_Children ≥30 kg (OVER 8 YEARS OLD)_:
Health Products Regulatory Authority
19 No