Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
CETALKONIUM CHLORIDE; CHOLINE SALICYLATE
RAFA LABORATORIES LTD
N02BA03
GEL
CETALKONIUM CHLORIDE 0.01 %W/W; CHOLINE SALICYLATE 8.7 %W/W
LOCAL ORAL
Not required
RAFA LABORATORIES LTD, JERUSALEM
CHOLINE SALICYLATE
CHOLINE SALICYLATE
As an antiseptic and local pain reliever for mouth ulcers, teething pain, denture irritation, and cold sores.
2020-05-31
1 PATIENT LEALFET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) -1986 This medicine is sold without a doctor's prescription TEEJEL ® GEL ACTIVE INGREDIENTS: Choline salicylate 8.7% Cetalkonium chloride 0.01% For the list of the additional ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. Read this entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. Use this medicine according to the instructions in the dosage section in this leaflet. Consult the pharmacist if you require additional information. If the symptoms worsen or do not improve after 3 days, consult your doctor. 1. WHAT IS THE MEDICINE INTENDED FOR? Antiseptic and pain relieving gel for the mouth. The medicine is intended for the relief of teething pains, mouth ulcers, denture irritation and cold sores. THERAPEUTIC GROUP: Choline salicylate – pain reliever Cetalkonium chloride - antiseptic 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredients or to any of the additional ingredients the medicine contains (for a list of the additional ingredients, see section 6). • You are sensitive (allergic) to salicylates, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) or to cetylpyrdinium. • You are taking aspirin or other salicylates (unless instructed so by the doctor). • Do not use in infants under 4 months of age. • You suffer from an active stomach ulcer, or you have a history of recurrent stomach ulcer. • Do not use in cases of viral illnesses, such as influenza or chickenpox, particularly in children and adolescents under 16 years of age for fear of Reye’s syndrome. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: • If there is no improvement after 3 days, consult your doctor. • Do not use this medicine frequently or for a long period without consulting your Perskaitykite visą dokumentą
Teejel-DL-Nov 2023-02 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teejel Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENTS Choline salicylate 8.7% Cetalkonium chloride 0.01% EXCIPIENT Ethanol 38% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear, colorless oromucosal gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic and local pain reliever for mouth ulcers, teething pain, denture irritation, and cold sores. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION By topical application to the oral mucosa. Adults: Using a clean finger, massage approximately 1-1.5 cm of the gel onto the sore area, not more than once every 3-4 hours. Do not apply more than six doses in any 24 hour period. Children (from four months to 16 years old): Using a clean finger, massage approximately 0.5 cm (a pea size amount) of gel onto the sore area, not more than once every 3-4 hours. Do not apply more than six doses in any 24 hour period. Not suitable for infants under four months. Do not exceed the stated dose. If symptoms do not improve after 3 days seek medical advice (see section 4.4). Older people: There is no indication that dosage need be modified in the elderly. 4.3 CONTRAINDICATIONS Not to be used in infants under four months. Hypersensitivity to choline salicylate, cetalkonium chloride or to any of the excipients in the product listed in section 6.1. Not to be used in patients with hypersensitivity to salicylates, aspirin or other NSAIDs, to cetylpyrdinium or to any of the excipients. 2 Not to be used in patients with active or a history of recurrent peptic ulceration. Do not use in patients currently suffering from viral illnesses such as varicella (chicken pox) or influenza infection particularly in children and adolescents under 16 years of age due to the risk of precipitating Reye’s syndrome in this patient populatio n. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The recommended dose and frequency should not be exceeded especially in children Perskaitykite visą dokumentą