国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC DIETHYLAMINE
UNIMED SDN BHD
DICLOFENAC DIETHYLAMINE
30 ml
Troikaa Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DICLOTROY (DICLOFENAC DIETHYLAMINE TOPICAL SOLUTION 4.64% W/V) Diclofenac Diethylamine (46.40mg) WHAT IS IN THIS LEAFLET 1. What Diclotroy is used for 2. How Diclotroy works 3. Before you use Diclotroy 4. How to use Diclotroy 5. While you are using it 6. Side effects 7. Storage and Disposal of Diclotroy 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DICLOTROY IS USED FOR Diclotroy is used to relieve pain and swelling in a number of painful conditions such as low back pain or pain following sprain, strain and blunt trauma to tendons, ligaments, muscles and joints. HOW DICLOTROY WORKS Diclotroy contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti- inflammatory drugs. It acts by inhibiting the prostaglandin synthesis responsible for pain. BEFORE YOU USE DICLOTROY - _When you must not use it _ _ _ Do not use Diclotroy: • If you are allergic (hypersensitive) to diclofenac or other medicine used to relieve pain and inflammation such as ibuprofen or acetylsalicylic acid. • In the last trimester of pregnancy • If you are below 14 years of age - _Before you start use it _ _ _ Tell your pharmacist or doctor if you are using any other painkillers. PREGNANCY You must tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant. Do not use Diclotroy if you are pregnant especially during the last 3 months of pregnancy as it could harm unborn child or cause problems at delivery. Diclotroy should be used with caution and only if clearly necessary during the first 6 months of pregnancy. LACTATION Tell your doctor if you are breast-feeding or about to start breast-feeding. Do not use it if you are breast-feeding. Ask your doctor, health-care provider or pharmacist for advice before taking any medicine. - _Taking other medicines _ Please tell a doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines o 阅读完整的文件
FRONT DICLOTROY Prescribing Information Diclofenac Diethylamine Topical Solution 4.64% w/v INDICATIONS: Use in pediatric population is not recommended as data related to safety and efficacy is not available. Geriatric Use: DOSAGE AND ADMINISTRATION: Pediatric Use: No overall difference in effectiveness or safety is expected between elderly and younger patients, but greater sensitivity to the effect of NSAIDs in some older individuals cannot be ruled • Low backache, sprain and strain DESCRIPTION: DICLOTROY is indicated for the symptomatic relief of mild to moderate pain and inflammation associated with: DICLOTROY (Diclofenac Diethylamine Solution 4 % w/v) is Clear, Colourless to Topical .64 yellow coloured solution filled in 30 ml frosted cobalt blue moulded vial USP type-I and sealed with spray pump crimp on covered with pump ring and actuator. Each pump strokes contains 0.1 ml which is equivalent to 4 mg of diclofenac sodium • blunt trauma of the tendons, ligaments, muscles and joints The treatment may be discontinued when the symptoms (pain and/or swelling) have subsided. Patient should be advised to ensure that the site of application is clean and dry before applying DICLOTROY. Before using DICLOTROY for the first time, prime the pump by spraying it into the air 2-3 times. On the affected area, 4 pump strokes (0.4 ml equivalent to 16 mg of diclofenac sodium) should be applied 4 times a day at regular intervals. Number of the pump strokes to be applied may be higher or lower depending on the area to be treated. The maximum single dose of 7 pump strokes and the maximum daily dose of 30 pump strokes (120 mg of diclofenac sodium) should not be exceeded. It should be sprayed from a distance of 6-8 inches from the site of application. DICLOTROY is a non-aqueous solution, hence the spray pattern will not be like the spray pattern of aqueous solutions or aerosol sprays. The prime purpose of the spray system is to ensure accurate dosing with each metered dose spray, which delivers 0.1 ml of solution. After applying 阅读完整的文件