Šalis: Malta
kalba: anglų
Šaltinis: Malta Medicines Authority
CHOLINE SALICYLATE, CETALKONIUM CHLORIDE
Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom
N02BA03
CETALKONIUM CHLORIDE 0.01 % (W/W) CHOLINE SALICYLATE 8.714 % (W/W)
OROMUCOSAL GEL
CETALKONIUM CHLORIDE 0.01 % (W/W) CHOLINE SALICYLATE 8.714 % (W/W)
OTC
ANALGESICS
Authorised
2006-04-24
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SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bonjela 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient %w/w Specification Choline salicylate* 8.7 14 Reckitt Benckiser Cetalkonium chloride 0.0 10 Reckitt Benckiser *Added as choline salicylate solution prepared from: Choline bicarbonate solution Reckitt Benckiser Salicylic acid Ph.Eur 3. PHARMACEUTICAL FORM Gel. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the relief of pain, discomfort and inflammation caused by common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots due to orthodontic devices. To help to fight minor mouth infection and aid healing of sore spots and ulcers due to dentures and orthodontic devices. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION By topical application of the oral mucosa Adults and children over the age of 16: Using a clean finger message approximately half an an inch of the gel onto the sore area, not more than once every 3 hours. There is no indication that dosage need be modified in the elderly. Denture irritation: Apply and leave at least 30 minutes before reinsertion of the dentures. Do not apply this product directly to the dentures. 4.3. CONTRAINDICATIONS Not to be used in children and adolescents under the age of 16. This is because there is Page 2 of 4 possible association between salicylates and Reye’s syndrome when given to children. Reye ‘syndrome is a very rare disease which affects the brain and liver and can be fatal. Not to be used in patients suffering from active peptic ulceration or known to be allergic to salicylates. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Label warnings: Do not exceed the stated dose. If symptoms persist for more than seven days consult your doctor or dentist. Keep out of the reach of children. Contains ethanol. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Salicylates may enhance the effect of anticoagulants and inhibit the action of uricosurics. 4.6. PREGNANCY AND LACTA Perskaitykite visą dokumentą