Country: Malta
Language: English
Source: Medicines Authority
benzalkonium chloride 1.2 mg, hexylresorcinol 2.5 mg
Beecham Group PLC
R02AA12
benzalkonium chloride, hexylresorcinol
lozenge
Authorised
2006-04-13
514'6*41#6 514'6*41#6 514'6*41#6 514'6*41#6 _HEXYLRESORCINOL, BENZALKONIUM CHLORIDE_ _BLACKBERRY FLAVOUR_ _LOZENGES_ PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Beechams Sore Throat Blackberry Flavour Lozenges carefully to get the best results from them. • Keep this leaflet you may need to read it again. • If you have any questions, or if there is anything you do not understand, ask your pharmacist. IN THIS LEAFLET: 1. What Beechams Sore Throat Lozenges do 2. Check before you take Beechams Sore Throat Lozenges 3. How to take Beechams Sore Throat Lozenges 4. Possible side effects 5. How to store Beechams Sore Throat Lozenges 6. Further information 1. WHAT BEECHAMS SORE THROAT LOZENGES DO BEECHAMS SORE THROAT LOZENGES ARE USED FOR THE RELIEF OF THE SYMPTOMS OF SORE THROAT, ITS ASSOCIATED PAIN AND PHARYNGITIS (INFLAMMATION OF THE THROAT). This medicine contains two active ingredients. Hexylresorcinol is an anaesthetic to numb pain in the throat and it is also a mild antibacterial agent which kills bacteria and germs. Benzalkonium chloride is also an antibacterial agent which kills bacteria and germs. 2. CHECK BEFORE YOU TAKE BEECHAMS SORE THROAT LOZENGES DO NOT TAKE BEECHAMS SORE THROAT LOZENGES: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to hexylresorcinol, benzalkonium chloride or any of the other ingredients (listed in Section 6). • if you have SUGAR ABSORPTION PROBLEMS. • IF YOU HAVE BEEN TOLD BY YOUR DOCTOR THAT YOU HAVE AN INTOLERANCE TO SOME SUGARS CONTACT YOUR DOCTOR BEFORE TAKING THIS MEDICINE. • if you are UNDER 7 YEARS. PREGNANCY AND BREAST FEEDING TALK TO YOUR DOCTOR before taking Beechams Sore Throat Lozenges if you are PREGNANT or BREAST FEEDING. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS Each lozenge contains a total amount of GLUCOSE AND SUCROSE OF UP TO 2.5 G. This should be taken into account if y Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Beechams Sore Throat Blackberry Flavour Lozenges. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hexylresorcinol 2.5 mg and Benzalkonium Chloride Solution 1.2 mg 3. PHARMACEUTICAL FORM Lozenge 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of sore throat, the associated pain and pharyngitis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including the elderly) and children over the age of 12:_ One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 8 lozenges in 24 hours. _Children aged 7 to 12 years:_ One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 4 lozenges in 24 hours. Not to be given to children under 7 years. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the active ingredients or excipients. Patients with metabolic disorders relating to glucose/sucrose ingestion or fructose intolerance 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE SPECIAL LABEL WARNINGS Keep out of the reach and sight of children If symptoms persist, consult your doctor. Do not exceed the stated dose. Contains 2.5 g of total glucose and sucrose per lozenge. This should be taken into account in patients with diabetes mellitus. 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION None Page 1 of 3 4.6 PREGNANCY AND LACTATION There is a lack of evidence of safety of the product in human pregnancy and in animals, but both hexylresorcinol and benzalkonium chloride have been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised dur Read the complete document