Ibuprofen Actavis 600mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 600 mg

Pharmaceutical form:

COATED TABLET

Composition:

IBUPROFEN 600 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2009-06-24

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUPROFEN ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you take Ibuprofen Actavis
3.
How to take Ibuprofen Actavis
4.
Possible side effects
5.
How to store Ibuprofen Actavis
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN ACTAVIS IS AND WHAT IT IS USED FOR
Ibuprofen Actavis belongs to a group of medicines called NSAID
(non-steroidal anti-inflammatory
drugs) which work by reducing pain, inflammation and fever.
Ibuprofen
Actavis
is
used
for
the
treatment
of
rheumatoid
arthritis,
osteoarthritis
or
other
inflammatory or painful joint conditions, as well as for inflammatory
and painful conditions of soft
tissues such as muscles.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN ACTAVIS
DO NOT TAKE IBUPROFEN ACTAVIS:
-
if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section
6).
-
if you have had allergic reactions such as asthma, runny nose, itchy
skin rash or swelling of the
lips, face, tongue, or throat after you have taken medicines
containing acetylsalicylic acid or
other drugs for pain and inflammation (NSAIDs).
-
if you have suffered from an ulcer or bleeding in the stomach or small
intestine (duodenum)
related to previous use of drugs for pain and inflammation (NSAIDs)
-
if you are suffering from an ulcer or bleeding in the stomach or small
intestine (

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Actavis 600 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg ibuprofen.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
600 mg tablet:
White, oval, biconvex film-coated tablets with a score on one face.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatic
conditions
such
as
arthritic
diseases
(e.g.
rheumatoid
arthritis
including
juvenile
rheumatoid arthritis), degenerative arthritic conditions (e.g.
osteoarthritis), non-articular rheumatic
conditions, other muscular and joint disorders, and soft tissue
injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
The ibuprofen dose depends on the patient’s age and body weight. The
maximum single daily dose
for adults should not exceed 800 mg of ibuprofen.
The tablet should be swallowed with a glass of water during or after a
meal.
_RHEUMATIC DISEASES _
_Adults:_
The usual dose is 400-600 mg 3 times a day. Maintenance doses of 600
mg-1200 mg daily may be
effective in some patients. In acute and severe conditions the dose
may be increased to a maximum
of 2400 mg in 3 or 4 divided doses.
_Adolescents over 12 years of age (>40 kg): _
The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight
daily in 3 to 4 divided
doses.
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There are other dosage forms which may be more suitable to attain the
required posology in this age
and body weight group.
_Elderly _
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse
events and are at increased risk of potentially fatal gastrointestinal
haemorrhage, ulceration or
perforation (see section 4.4). If treatment is considered necessary,
the lowest dose for the shortest
duration necessary to