Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
FLURBIPROFEN
Crookes Healthcare Ltd
FLURBIPROFEN
8.75mg Milligram
Lozenges
Withdrawn
2007-12-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stresils Intensive Sugar Free Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient flurbiprofen BP 8.75 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Lozenge 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strepsils Intensive Sugar Free Lozenges are indicated for the symptomatic relief of sore throat. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over the age of 12 years: One lozenge sucked/dissolved slowly in the mouth every 3 - 6 hours as required. Maximum 5 lozenges in a 24 hour period. It is recommended that this product should be used for a maximum of three days. Children: Not indicated for children under 12 years. Elderly: No dose modification is required. As with all lozenges, to avoid local irritation, Strepsils Intensive Sugar Free Orange Lozenges should be moved around the mouth whilst sucking. 4.3 CONTRAINDICATIONS Hypersensitivity to flurbiprofen, aspirin, other non-steroidal anti-inflammatory drug (NSAIDs) or other lozenge ingredients. Existing or history of peptic ulceration. History of bronchospasm, rhinitis, or urticaria associated with aspirin or other NSAIDs. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma. Strepsils Intensive Sugar Free Lozenges should be used with caution in these patients. NSAID’s have been reported to cause nephrotoxicity in various forms including interstitial nephritis, nephrotic syndrome and renal failure. In patients with renal, cardiac or hepatic impairment, caution is required since the use of the NSAID’s may result in the deterioration of renal function. Caution is required in patients with hypertension. Flurbiprofen Lugege kogu dokumenti