Ibuprofen Galpharm Max 400mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Galpharm Healthcare Limited

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Not marketed

Authorization date:

2013-11-29

Patient Information leaflet

1.3
PRODUCT INFORMATION.
1.3.1
SPC, LABELLING AND PACKAGE LEAFLET.
IBUPROFEN 400MG FILM-COATED TABLETS / MODULE 1.3.1 / FEBRUARY 2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS
For adults and adolescents weighing from 40kg body weight (12 years
and above)
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 has 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 contact a doctor if you do not feel better or if you feel
worse after 3 days with fever and
4 days with pain.
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.
WHAT IS IN THIS LEAFLET
_ _
1.
WHAT IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS IS AND WHAT IT
IS USED FOR.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN GALPHARM MAX 400MG
FILM-COATED
TABLETS.
3.
HOW TO TAKE IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS.
4.
POSSIBLE SIDE EFFECTS.
5.
HOW TO STORE IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS.
6.
CONTENTS OF THE PACK AND OTHER INFORMATION.
1. WHAT IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS IS AND WHAT
IT IS
USED FOR.
Ibuprofen Galpharm Max 400mg Film-coated Tablets contain ibuprofen,
which belongs to a group of
medicines

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2018
CRN008L6Z
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Galpharm Max 400mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg Ibuprofen.
Excipients with known effect: 80mg Lactose monohydrate per film-coated
tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
White, capsule-shaped, biconvex, film-coated tablets with no markings.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For short term symptomatic treatment of mild to moderate pain such as
headache,
dysmenorrhoea (period pain), dental pain, and fever and pain in the
common cold.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration 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).
Adults:
400mg, up to three times a day as required.
Leave at least six hours between doses and do not take more than
1200mg in any 24
hour period.
If this medicinal is required for more than 3 days in the case of
fever or for more than
4 day for the treatment of pain, or if the symptoms do not improve or
worsen the
patient is advised to consult a doctor
Adolescents ≥ 40 kg (12 years of age and above):
400mg, up to three times a day as required.
Leave at least six hours between doses and do not take more than
1200mg in any 24
hour period.
Health Products Regulatory Authority
09 November 2018
CRN008L6Z
Page 2 of 17
If this medicinal product is required for more than 3 days or if
symptoms worsen a
doctor should be consulted.
It is recommended that patients with a sensitive stomach take
Ibuprofen Galpharm
Max 400mg Film-coated Tablets with food.
Special patient groups
_Paediatric Population:_
Not recommended for adolescents weighing under 40 kg or children under
12 years
of age.
_Elderly:_
The elderly are at increased risk of serious consequences of adverse
reactions.