Ibuprofen Tablet, film coated 400mg

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

IBUPROFEN

Disponibbli minn:

Accord Healthcare Limited

Kodiċi ATC:

M01AE01

INN (Isem Internazzjonali):

IBUPROFEN

Għamla farmaċewtika:

FILM-COATED TABLET

Kompożizzjoni:

IBUPROFEN 400 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

L-istatus ta 'awtorizzazzjoni:

Authorised

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

Page 1 of 14
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.
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
Page 2 of 14
less than 40 kg, use of a different strength or a liquid formulation
of ibuprofen should be considered to
aid accurate