Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FRAMYCETIN SULPHATE; CINCHOCAINE; HYDROCORTISONE; Aesculin
DKSH MALAYSIA SDN BHD
FRAMYCETIN SULPHATE; CINCHOCAINE; HYDROCORTISONE; Aesculin
12Units Units
PT AVENTIS PHARMA
_ Consumer Medication Information Leaflet (RiMUP) _ PROCTOSEDYL ® SUPPOSITORY Cinchocaine Hydrochloride / Hydrocortisone / Framycetin Sulphate / Aesculin (5mg/ 5mg/ 10mg/ 10mg) 1 WHAT IS IN THIS LEAFLET 1. What Proctosedyl Suppository is used for 2. How Proctosedyl Suppository works 3. Before you use Proctosedyl Suppository 4. How to use Proctosedyl Suppository 5. While you are using it 6. Side effects 7. Storage and Disposal of Proctosedyl Suppository 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PROCTOSEDYL SUPPOSITORY IS USED FOR Proctosedyl Suppository can be used for short term relief of: • Pain, irritation, discharge and itching related with enlarged or swollen vessels around your back passage (haemorrhoids) • Pre and post-surgery to remove haemorrhoid. • Postnatal (after given birth) haemorrhoidal conditions. HOW PROCTOSEDYL SUPPOSITORY WORKS Proctosedyl Suppository contains of four different medicines called: Hydrocortisone, Cinchocaine Hydrochloride, Framycetin Sulphate and Aesculin. • Cinchocaine Hydrochloride belongs to a group of medicines called local anaesthetics. It works by causing numbness in the area to which it is applied. This stops you feeling pain in this area and helps lessen the spasm of the back passage. • Hydrocortisone belongs to a group of medicines called corticosteroids. It works by lowering the production of substances that cause inflammation. This helps lower swelling, itching and discharge. • Framycetin Sulphate belongs to a group of medicines called antibiotics. It used to treat local infections. BEFORE YOU USE PROCTOSEDYL SUPPOSITORY _-When you must not use it _ Do not use Proctosedyl Suppository if: • You are allergic (hypersensitive) to Cinchocaine Hydrochloride, hydrocortisone or to any other listed ingredients. - Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue. • You are pregnant • You have any kind of infection Do not use this Read the complete document
Proctosedyl Suppository Cinchocaine Hydrochloride Hydrocortisone Framycetin Sulphate (Soframycin) Aesculin SANOFI Logo Presentation Proctosedyl is available as smooth off‐white suppositories. Each suppository contains the following active ingredients: Cinchocaine Hydrochloride 5mg Hydrocortisone 5mg Framycetin Sulphate (Soframycin) 10mg Aesculin 10mg Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics) Framycetin Sulphate Framycetin Sulphate is administered topically in the treatment of infection of the skin due to susceptible organism such as Staphylococci. Application to the skin have been reported to produce no detectable levels in the blood and urine or sufficient absorption to cause systemic toxicity. However, application to areas of denuded skin (e.g. in serious burns) has resulted in significant absorption and it has been reported to occur from wounds and inflamed skin. Once absorbed, it is rapidly excreted by the kidneys in the active form: 30‐ 50% of a parenteral dose has been detected in the urine. Due to its known toxicological profile contraindicating its parenteral use and its excellent activity, Framycetin is well suited for topical use. Hydrocortisone Hydrocortisone is absorbed through the skin, particularly in denuded areas when applied topically. It acts locally as an anti‐inflammatory agent. When absorbed systematically, it has a biological half‐life of about 100 minutes and is more than 90% bound to plasma proteins. It is metabolized in the liver and most body tissues to hydrogenated and degraded forms which are then excreted in the urine as glucoronides with a small proportion of unchanged Hydrocortisone. Cinchocaine Hydr Read the complete document