Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Crotamiton
HOE PHARMACEUTICALS SDN. BHD.
Crotamiton
15gm mcg/mL
HOE PHARMACEUTICALS SDN. BHD.
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ A-BITE CREAM Crotamiton (10%w/w) 1 _ _ WHAT IS IN THIS LEAFLET 1. What A-BITE CREAM is used for 2. How A-BITE CREAM works 3. Before you use A-BITE CREAM 4. How to use A-BITE CREAM 5. While you are using A-BITE CREAM 6. Side effects 7. Storage and Disposal of A- BITE CREAM 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision This leaflet answers some common questions about A-BITE CREAM. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you applying A-BITE CREAM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT A-BITE CREAM IS USED FOR A-BITE CREAM is used to relieve the symptoms of itchiness from mosquito bites and other insect bites. HOW A-BITE CREAM WORKS A-BITE CREAM contains the active ingredient crotamiton. It also contains Spent Grain Wax (and) Butyrospermum Parkii (Shea Butter) Extract (and) Argania Spinosa Kernel Oil. Crotamiton helps relieving the itching, it prevents damage to the skin caused by scratching and thus minimizes the risks of secondary infection. BEFORE YOU USE A-BITE CREAM _ _ _-When you must not use it _ DO NOT APPLY A-BITE CREAM IF: • You are allergic (hypersensitive) to crotamiton or any components in this preparation. _-Before you start to use it _ PREGNANCY AND BREAST FEEDING: • Safe use during pregnancy and lactation has not been established. • Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast- feeding. _-Taking other medicines _ Tell your pharmacist or doctor if you are taking any other products (such as over the counter product, prescribed medicine and herbal products). HOW TO USE A-BITE CREAM _-How much to use _ ADULT AND Прочитать полный документ
NAME AND STRENGTH OF ACTIVE SUBSTANCES: Crotamiton 10% w/w. PRODUCT DESCRIPTION: A white opaque, non-greasy, non-perfumed cream with characteristic faint amine-like odour of Crotamiton. Other ingredients: Propyl Paraben, Methyl Paraben, Carbopol 940, Glycerin, Spent Grain Wax (and) Butyrospermum Parkii (Shea Butter) Extract (and) Argania Spinosa Kernel Oil, Cetearyl Alcohol (and) PEG-20 Stearate, Triethanolamine 99 and Purified water. PHARMACODYNAMICS: Crotamiton has antipruritic actions that lasts for 6 to 10 hours. By relieving the itching, it prevents damage to the skin caused by scratching and thus minimizes the risks of secondary infection. INDICATION: For the relief of itch due to mosquitoes and other insects bites. CONTRAINDICATIONS: Known hypersensitivity to Crotamiton or any component in the cream base. ADVERSE EFFECT: Sensitivity to Crotamiton is rare but the drug may produce irritation in the presence of acute vesicular dermatitis. PRECAUTIONS: A-Bite cream should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acute inflamed skin or raw weeping surfaces until the acute inflammation has subsided. Safety for use in pregnancy / lactation has not been established. ROUTE OF ADMINISTRATION: Topical. RECOMMENDED DOSAGE: Apply cream 2 - 3 times daily onto the affected area. Children aged less than 3 years : one application daily. INTERACTIONS WITH OTHER MEDICAMENTS: Unknown. SYMPTOMS AND TREATMENT OF OVERDOSE: There is no specific information on the effect of overtreatment with repeated topical application in humans. There is no specific antidote if taken orally. General measures to eliminate the drug and reduce absorption, combined with symptomatic treatment have been recommended. PACKING: 15g collapsible aluminium tube. STORAGE: Store below 30°C. RECOMMENDED SHELF LIFE: 3 years. Manufactured by: HOE PHARMACEUTICALS SDN. BHD. Lot 10, Jalan Sultan Mohamed 6, Bandar Sultan Suleiman, 42000 Port Klang, Selangor, MALAYSIA. Revision date : May 2022 Прочитать полный документ