Ibuprofen 400 mg Film-coated Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Ibuprofen

Tilgængelig fra:

Accord Healthcare Limited

ATC-kode:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosering:

400 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Propionic acid derivatives; ibuprofen

Autorisation status:

Authorised

Autorisation dato:

2016-10-07

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 400 MG FILM-COATED 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 Ibuprofen tablets is and what it is used for
2.
What you need to know before you take Ibuprofen tablets
3.
How to take Ibuprofen tablets
4.
Possible side effects
5.
How to store Ibuprofen tablets
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN TABLETS IS AND WHAT IT IS USED FOR
Ibuprofen tablets belong to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory
drugs). Ibuprofen tablets reduces fever, relieves pain and has an
anti-inflammatory effect.
In adults and children over 12 years (>40 kg): Short term treatment of
fever and pain of mild to
moderate intensity, including dysmenorrhea.
Long term symptomatic treatment of pain and inflammation in chronic
inflammatory rheumatic
diseases.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS
DO NOT TAKE IBUPROFEN TABLETS:

if you are allergic (hypersensitive) to ibuprofen or any of the other
ingredients of this medicine
(listed in section 6).

if you are in the last three months of pregnancy.

if you have an increased tendency to bleed.

if you have severe liver and kidney disease.

if you have severe heart failure or coronary heart disease.

if you have a stomach ulcer, duodenal ulcer, or if you have had a
stomach ulcer or duodenal
ulcer previously when treated with ibuprofen or a similar product.

if you have experienced allergic reactions (e.g. bre

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 400 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg ibuprofen
Excipient with known effect: each tablet contains 47 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Ibuprofen 400 mg film-coated tablets: pink coloured, round,
approximately 13 mm in diameter, biconvex film coated
tablets debossed with ‘DK’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and children over 12 years (>40 kg): Short term treatment of
fever and pain of mild to moderate intensity,
including dysmenorrhea.
Long term symptomatic treatment of pain and inflammation in chronic
inflammatory rheumatic diseases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should start with the lowest dose anticipated to be
effective, which can subsequently be adjusted,
depending on the therapeutic response and any undesirable effects. In
long-term treatment a low maintenance dose
should be the aim.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
_Rheumatic diseases_
- initial treatment:2x400 mg tablets, three times daily, i.e. 2400 mg
per day
- maintenance treatment : 1x400 mg tablets, three to four times daily,
i.e. 1200 to 1600 mg per day.
An interval of at least 4-6 hours should be allowed between doses. The
total daily dose must not exceed 2400mg in
divided doses. Some patients can be maintained on 600 – 1200mg
daily.
_Juvenile Rheumatoid Arthritis_
For Juvenile Rheumatoid Arthritis, the recommended dose is
20mg-30mg/kg body weight daily in 3 to 4 divided doses
up to a maximum of 40mg/kg body weight daily in severe cases.
In children weighing less than 40 kg, use of a
different strength or a liquid formulation of ibuprofen should be
considered to aid accurate dosing.
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