Ibuprofen Actavis 400mg 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 400 mg

Pharmaceutical form:

COATED TABLET

Composition:

IBUPROFEN 400 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Withdrawn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 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 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 to provide relief from mild to moderate pain
such as headache, including
migraine headache, dental pain, period pain and fever. If you are over
12 years of age your doctor
may also prescribe this or higher doses 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 ul

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Actavis 400 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg ibuprofen.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
400 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
Mild to moderate pain, such as headache including migraine headache,
dental pain.
Primary dysmenorrhoea.
Fever.
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).
If a child or adolescent requires this medicinal product for more than
3 days, or if symptoms worsen,
a doctor should be consulted.
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.
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_MILD TO MODERATE PAIN AND FEVER _
_Adults and adolescents older than 12 years (≥40 kg): _
200-400 mg given as a single dose or 3-4 times a day with an interval
of 4 to 6 hours. The dosage in
migraine headache should be: 400 mg given as a single dose, if
necessary 400 mg with intervals of 4
to 6 hours.
The maximum daily dose should not exceed 1200 mg.
_Children 6-12 years (>20 kg):_
Children 6-9 years (20-29 kg): 200 mg 1-3 times a day with intervals
of 4 to 6 hours as required.
The maximum daily dose should not exceed 600 mg.
Children 10-12 years (30-40 kg): 200 mg 1-4 times a day with intervals
of 4 to