Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC DIETHYLAMMONIUM
IMEKS PHARMA SDN. BHD.
DICLOFENAC DIETHYLAMMONIUM
20gm mcg/mL
T.O. CHEMICALS (1979) LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ RHUMANOL CREAMAGEL _ _ Diclofenac diethylammonium 1.17g (equivalent to diclofenac sodium 1.00 g) WHAT IS IN THIS LEAFLET 1. What RHUMANOL is used for 2. How it works 3. Before you use it 4. How to use RHUMANOL 5. While you are using it 6. Side effects 7. Storage and Disposal of RHUMANOL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT RHUMANOL IS USED FOR RHUMANOL is used for the treatment of muscle inflammatory conditions such as muscle sprain and strain, tendonitis (inflammation of the tendon) and soft tissue injuries. This preparation is recommended for short term treatment of up to two weeks. HOW RHUMANOL WORKS RHUMANOL contains diclofenac sodium, which belongs to a class of painkillers known as Non-Steroidal Anti-inflammatory Drugs (NSAIDs). It works by blocking the production of some body substances that cause inflammation, pain, and swelling in the muscle and soft tissues. BEFORE YOU USE RHUMANOL _- When you must not use it _ Do not use RHUMANOL: • If you are allergic or hypersensitive to diclofenac, propylene glycol or any of the other ingredients listed at the end of this leaflet. • If you have experienced hypersensitivity reactions such as symptoms of asthma, allergic rhinitis (inflammation of the nasal mucous membrane) or urticaria (itching or hives), to aspirin (medication used to reduce fever, reduce pain and prevent blood clot) or other non-steroidal anti- inflammatory drugs (NSAIDs). Do not use this medicine if any of the above condition applies to you. If you are not sure, get advice from your doctor or pharmacist. _ _ _- Before you start to use it _ Tell your doctor if you: • Have allergies to any other medicines, food, preservatives or dyes. • Have or have had ulceration, bleeding and perforation of the stomach and intestinal • Have heart problems • Have thrombosis (blood clots inside the blood vessels) • Have high blood pressure • Have kidney problems • Have liver problems RHU Baca dokumen lengkap
PLEASE READ CAREFULLY RHUMANOL CREAMAGEL Each 100g RHUMANOL CREAMAGEL contains: Diclofenac diethylammonium 1.17g (equivalent to diclofenac sodium 1.00g) DESCRIPTION A white opaque cream-like gel INDICATIONS Topical symptomatic treatment of the musculoskeletal inflammatory conditions. Muscle sprain and strain, tendinitis and soft tissue injuries. This preparation is recommended for short term treatment of up to two weeks. RECOMMENDED DOSAGE Rub into the affected skin area locally three to four times a day. Wash the hands thoroughly after application. Treatment of more than two weeks is not recommended. Do not apply to the ruptured skin area. After accessing the risk / benefit ration in each individual patient, the lowest effective dose for the shortest possible duration should be used. ROUTE OF ADMINISTRATION For topical use only. CONTRAINDICATIONS • Patients with or without chronic asthma in whom attacks of asthma, urticarial or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non-steroidal anti- inflammatory drugs (NSAIDs) • Hypersensitivity to diclofenac or any of the excipients • Third trimester of pregnancy • The use in children and adolescents aged less than 14 years is contraindicated WARNINGS AND PRECAUTIONS • The possibility of experiencing systemic adverse event (those associated with the use of systemic forms of diclofenac) from application of RHUMANOL CREAMAGEL cannot be excluded if the preparation is used at higher dosage/large amounts over large areas of skin and over a prolonged period. • Concomitant use of systemic NSAIDs should be cautioned since the possibility of an increase in incidence of untoward effects, particularly systemic side effects, cannot be ruled out. • RHUMANOL CREAMAGEL contains propylene glycol which may cause mild, localized skin irritation in some people. • Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administrated to patients suffering from or with a previo Baca dokumen lengkap