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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg Liquid Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200mg ibuprofen.
Excipient: Also contains 0.606mg ponceau 4R (E124)
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Capsule, soft
A 7.5 minim oval capsule with a translucent red gelatin shell, containing a clear liquid, printed with ‘NUROFEN’ in
white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-inflammatory, analgesic and antipyretic for short term management of mild to moderate pain such as is
associated with headache, dental pain, backache, feverishness, period pain, muscular strain, neuralgia, rheumatic pain
and migraine and for the management of the symptoms of head colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. Do not chew.
Adults and children over 12 years: Initial dose is 400mg taken with water and subsequently if necessary, 200 to 400mg
every four hours with a maximum of 1200mg in any 24 hour period.
Not for use by children under 12 years of age.
Elderly: _See section 4.4 Special Warnings and Special Precautions for Use._
4.3 CONTRAINDICATIONS
Severe heart failure.
Hypersensitivity to any of the constituents, aspirin, or other NSAIDs.
History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy. Active, or history of recurrent
peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding or other gastrointestinal
disorder.
Patients with a history of bronchospasm, asthma, rhinitis, or urticaria associated with aspirin or other anti-inflammatory
IRISH MEDICINES BOARD
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