IBUPROFEN 200 MG/CODEINE PHOSPHATE 12.8 MG TABLETS 200/12.8 Milligram Tablets
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
31-05-2024
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Viambatanisho vya kazi:
IBUPROFEN CODEINE PHOSPHATE HEMIHYDRATE
Inapatikana kutoka:
Crookes Healthcare Ltd
INN (Jina la Kimataifa):
IBUPROFEN CODEINE PHOSPHATE HEMIHYDRATE
Kipimo:
200/12.8 Milligram
Dawa fomu:
Tablets
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
2007-08-07
Tabia za bidhaa
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200 mg / Codeine Phosphate 12.8 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200 mg and Codeine Phosphate 12.8 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
A white, capsule-shaped tablet embossed with the logo ‘N +’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arthritic pain
Short to medium term use in acute and chronic painful arthroses and rheumatoid ‘flare’, including relief from severe
pain in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and sero-negative arthropathies.
Other inflammatory disorders
Short term relief from severe pain associated with inflammatory disorders such as bursitis, capsulitis of the shoulder,
tendinitis, tenosynovitis.
Cancer pain
For use in patients where the pain may be controlled by this combination prior to the administration of morphine.
Dysmenorrhoea
Short term treatment of severe pain associated with dysmenorrhoea.
Severe pain in other clinical conditions
Short term treatment of severe pain in clinical conditions such as dental extraction, post-operative pain (including post-
episiotomy), migraine, sprains, strains and low back pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
Oral.
Adults
One or two tablets every four to six hours.
Children under 12 years
Not recommended.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/11/2006_
_CRN 2030023_
_page number: 1_
Elderly
No special dosage recommendations are required for elderly patients unless renal or hepatic function is impaired, in
which case dosage should be assessed individually. NSAIDs (non steroidal anti-infl
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