Ibuprofen 600mg film-coated Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

IBUPROFEN

Tillgänglig från:

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

ATC-kod:

M01AE01

INN (International namn):

IBUPROFEN 600 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

IBUPROFEN 600 mg

Receptbelagda typ:

POM

Terapiområde:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2016-07-14

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 600 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.
They can be used in symptomatic treatment of pain and inflammation in
rheumatoid arthritis
(including systemic Juvenile Idiopathic Arthritis [sJIA]),
osteoarthritis, seronegative arthropathies and
in painful swelling and inflammation after soft tissue injuries.
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 tendenc
Y
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 allerg

Produktens egenskaper

Page
1
of
14
S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Ibuprofen 600 mg film-coated tablets
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains 600 mg ibuprofen
Excipient with known effect: each tablet contains 70 mg lactose.
For the full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Film-coated tablet
Ibuprofen 600 mg film-coated tablets: pink coloured, oblong shape,
approximately 19 mm in length, 8
mm in width, biconvex, film coated tablets debossed with ‘DL’
separated by break line on one side
and plain on other side. The score line is not intended for breaking
the tablet.
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in rheumatoid arthritis
(including systemic Juvenile
Idiopathic Arthritis [sJIA]), osteoarthritis, seronegative
arthropathies and in painful swelling and
inflammation after soft tissue injuries.
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).
_Adults and adolescents (12 years and older, >40kg): _
_Rheumatic diseases_
One 600 mg tablet three times daily. An interval of at least 4-6 hours
should be allowed between
doses. Some patients can be maintained on 600-1200mg daily. In severe
or acute conditions, it can be
advantageous to increase the dosage until the acute phase is brought
under control, provided that the
total daily dose does not exceed 2400mg in divided doses. This tablet
cannot be halved and in some
instances a different strength or formulation of ibuprofen must be
used.
_Juvenile Rheumatoid Arthritis _
Adolescents over 12 years of age (>40 kg): The recommended dose is
20-30mg/kg body weight daily