Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland
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
bonjela Oromucosal Gel Choline salicylate 8.714% Cetalkonium chloride 0.010% PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Bonjela carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 7 days. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Bonjela is and what it is used for 2. Before you use Bonjela 3. How to use Bonjela 4. Possible side effects 5. How to store Bonjela 6. Further information 1. WHAT BONJELA IS AND WHAT IT IS USED FOR Bonjela is a clear gel, which is applied to the inside of the mouth or gums. It contains choline salicylate (a pain killer and anti-inflammatory) which soothes the sore areas in the mouth, and antiseptic called cetalkonium chloride, which kills bacteria and helps prevent infection. Bonjela can be used to relieve pain and reduce inflammation and help fight infection in infant teething, mouth ulcers, cold sores, and sore spots due to dentures in adults and orthodontic devices in children. 2. BEFORE YOU USE BONJELA DO NOT USE BONJELA: − if you are allergic (hypersensitive) to the active ingredients or any of the ingredients listed in section 6. − if you are currently taking aspirin or other salicylate, except under direction of a doctor − in children under 4 months − if you have active or a history of recurrent stomach ulcer − if you are currently suffering from chicken pox or flu particularly in children and adolescents under 16 years of age TAKE SPECIAL CARE WITH BONJELA − if you are pregnant or breastfeeding, please consult your doctor before use − if there is no improvement after 7 days, consult your doctor − especially i Đọc toàn bộ tài liệu
Page 1 of 5 Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Bonjela Oromucosal GelCholine Salicylate 8.714%Cetalkonium Chloride 0.010% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances % w/w Choline salicylate Cetalkonium chloride 8.714 0.010 Excipient(s) with known effect: Ethanol Present at a level of 33.45 % w/w d-Limonene, anisyl alcohol and linalool (contained in trace amounts in fragrances of star anise oil) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal gel Clear, colourless gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of pain and discomfort of common mouth ulcers, cold sores, denture sore spots, infant teething and mouth ulcers, and sore spots due to orthodontic devises in children. To aid healing of sore spots and ulcers due to dentures in adults and orthodontic devices in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Using a clean finger, massage approximately one centimetre of the gel onto the sore area, not more than once every 3 hours. Children (from four months): Using a clean finger, massage a pea size amount of gel onto the sore area, not more than once every 3 hours. Do not apply more than six doses in any 24 hour period. Not suitable for infants under four months. Orthodontic devices: Apply to the sore area as described above, not more than once every 3 hours. Denture irritation: Apply and leave at least 30 minutes before re-insertion of the dentures. Do not apply this product directly to the dentures. Do not exceed the stated dose. If symptoms do not improve after 7 days seek medical advice (see section 4.4). Older people: There is no indication that dosage need be modified in the elderly. Page 2 of 5 By topical application to the oral mucosa. 4.3 CONTRAINDICATIONS Not to be used in patients with hypersensitivity to salicylates, aspirin or other NSAIDs, to cetylpyridium chloride or to any of the excipients. Not to be used in infants under four months. Hypersensitivity to choline salicylate, Đọc toàn bộ tài liệu