Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Hexylresorcinol
Reckitt Benckiser Ireland Ltd
R02AA12
Hexylresorcinol
2.4 milligram(s)
Lozenge
Product not subject to medical prescription
hexylresorcinol
Marketed
2005-06-10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON) 1. NAME OF THE MEDICINAL PRODUCT Strepsils Extra Blackcurrant Lozenges 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each lozenge contains the active ingredient: Hexylresorcinol Ph Eur 2.4mg. 3. LIST OF EXCIPIENTS Strepsils Extra Blackcurrant Lozenges contain: Glucose & Sucrose: 1.121 g glucose and 1.408 g sucrose per lozenge. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Wheat Starch: This medicine contains only very low levels of gluten (from wheat starch). It is regarded as ‘gluten free’ and very unlikely to cause problems if you have coeliac disease. One lozenge contains no more than 22.42 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine. Propylene glycol: This medicine contains 10.8 mg propylene glycol per lozenge. Sodium: Contains less than 1 mmol sodium (23 mg) per lozenge, that is to say essentially ‘sodium-free’. Sulphur Dioxide (E220) which may rarely cause severe hypersensitivity reactions and bronchospasm. Contains fragrances with d-Limonene and linalool which may cause allergic reactions. Azo colouring agent Carmoisine (E122) may cause allergic reactions. Also contains Levomenthol. 4. PHARMACEUTICAL FORM AND CONTENTS Lozenge 24 lozenges Strepsils Extra Blackcurrant Lozenges are formulated to bring effective relief from painful sore throats. The active ingredient in Strepsils Extra Blackcurrant is an antiseptic which combats the bacteria which can cause sore throat conditions and also has a local anaesthetic action which brings relief from pain and discomfort. 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. 6. SPECIAL WARNING: THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNINGS: IF NECESSARY Remember young children Pročitajte cijeli dokument
Health Products Regulatory Authority 13 August 2021 CRN00C5NR Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Extra Blackcurrant Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains hexylresorcinol 2.4 mg. Excipients with known effects: Each lozenge contains Glucose 1.121 g, Sucrose 1.408 g, Propylene Glycol 10.8 mg, Wheat Starch 22.42 µg, Sulphur Dioxide (E220) 0.143 ppm and Carmoisine (E122) 0.130 ppm. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge Circular purple lozenge. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS: One lozenge every three hours or as required. Do not take more than 12 lozenges in 24 hours. Duration of therapy should be limited to a maximum of 3 days. PAEDIATRIC POPULATION: Children of 6 years and over: Same as for adults. Not to be given to children under 6 years. ELDERLY POPULATION: No dosage adjustment is considered necessary in the elderly. METHOD OF ADMINISTRATION For oral administration. Allow the lozenge to dissolve slowly in the mouth. 4.3 CONTRAINDICATIONS Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms do not improve or worsen within 3 days, consult a healthcare professional. This medicine contains only very low levels of gluten (from wheat starch). It is regarded as 'gluten-free' and is very unlikely to cause problems if you have coeliac disease. One lozenge contains no more than 22.42 micrograms of gluten. If you have a wheat allergy (different from coeliac disease) you should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'. This medicine also contains 1.121 g glucose and 1.408 g sucrose per lozenge. This should be taken into account in patients with diabetes Pročitajte cijeli dokument