Nurofen 200mg

Land: Malta

Taal: Engels

Bron: Malta Medicines Authority

Werkstoffen:

IBUPROFEN

Beschikbaar vanaf:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC-code:

M01AE01

INN (Algemene Internationale Benaming):

IBUPROFEN

farmaceutische vorm:

COATED TABLET

Samenstelling:

IBUPROFEN 200 milligram(s)

Prescription-type:

OTC

Therapeutisch gebied:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Autorisatie-status:

Authorised

Autorisatie datum:

2008-07-09

Bijsluiter

Reckitt Benckiser
0008 385 article 31 ibup
1.3.1 Package Leaflet
Ibuprofen 200mg Tablets PL00063-0385
Page 1

Productkenmerken

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen 200 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg
Excipient(s)
with
known
effect:
Sucrose
Sodium
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated Tablet
A white to off-white, biconvex, round, sugar coated tablet printed
‘Nurofen’ in
black on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of migraine-headaches, backache, dental pain, neuralgia
and
period pains as well as rheumatic and muscular pains, and pain of
non-serious
arthritic conditions.
Nurofen relieves pain and reduces inflammation and temperature as well
as
relieving headaches and other types of pain. It also relieves cold and
flu
symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
During short-term use, if symptoms persist or worsen the patient
should be
advised to consult a doctor.
Adults and children and adolescents between 12 and 18
years:
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
If in children and adolescents this medicinal product is required for
more than
3 days, or if symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the
symptoms
worsen the patient should consult a doctor.
Page 2 of 12
CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS: Take 1 or 2 tablets
with water, up to three times a day as required.
ADULTS: Take 1 or 2 tablets with water, up to three times a day as
required.
Leave at least four hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Not for use by children under 12 years of age.
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma,
rhinitis, angioedema, or urticaria) in response to aspirin or other
non-steroi