Ibuprofen 400mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 400 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IBUPROFEN 400 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2016-07-14

Patient Information leaflet

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

Summary of Product characteristics

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of
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S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Ibuprofen 400 mg film-coated tablets
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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.
P
HARMACEUTICAL
F
ORM
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.
C
LINICAL
P
ARTICULARS
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.
The lowest effective dose should be used for the shortest duration
necessary to relieve 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
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less than 40 kg, use of a different strength or a liquid formulation
of ibuprofen should be considered to
aid accurate dosing.
_Short term symptomati