Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Loxoprofen sodium hydrate
ZUELLIG PHARMA SDN BHD
Loxoprofen sodium hydrate
5 Pieces; 10 Sachets
Lead Chemical Co., Ltd. Hisagane Plant
LOXOTOP PAP 100MG PATCH Loxoprofen Sodium (100mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _LOXOTOP PAP 100mg Patch _ is used for 2. How _LOXOTOP PAP 100mg_ _Patch_ works 3. Before you use _LOXOTOP PAP _ _100mg Patch_ 4. How to use _LOXOTOP PAP 100mg _ _Patch _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _LOXOTOP _ _PAP 100mg Patch_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT _LOXOTOP PAP 100MG PATCH_ IS USED FOR It is usually used to treat osteoarthritis, muscle pain, swelling/pain after an injury. HOW _LOXOTOP PAP 100MG_ _PATCH_ WORKS This medicine permeates from the skin, suppresses prostaglandin formation that causes inflammation, and acts to ease swelling/pain induced by inflammation. BEFORE YOU USE _LOXOTOP PAP 100MG _ _PATCH _ - _When you must not use it _ _ _ If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have: aspirin-induced asthma or its history. _Pregnancy and lactation _ Do not use _LOXOTOP PAP 100mg _ _Patch_ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not use _LOXOTOP PAP 100mg_ _Patch_ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Taking other medicines _ _ _ Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE _LOXOTOP PAP 100MG _ _PATCH _ - _How much to use _ _ _ In general, apply to the affected area once daily. This preparation contains 100 mg of the active ingredient in one sheet. Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help. - _When to use it _ _ _ Use as directed by your doctor or pharmacist. - _How long Read the complete document
LOXOPROFEN SODIUM HYDRATE _________________________________________ Containing Loxoprofen Sodium Hydrate ( JP ) 113 . 4mg ( 100mg as Anhydride ) LOXOTOP PAP 100MG PATCH FOR EXTERNAL USE ONLY QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION GENERIC NAME Loxoprofen Sodium Hydrate ( JAN ) / Loxoprofen ( INN ) CHEMICAL NAME Monosodium 2 - { 4 - [( 2 - oxocyclopentyl ) methyl ] phenyl} propanoate dihydrate MOLECULAR FORMULA C 15 H 17 NaO 3 2H 2 O MOLECULAR WEIGHT 304 . 31 STRUCTURAL FORMULA DESCRIPTION Loxoprofen sodium hydrate occurs as a white to yellowish white, crystal or crystalline powder . It is very soluble in water and in methanol, freely soluble in ethanol ( 95 ), and practically insoluble in diethyl ether . A solution of loxoprofen sodium hydrate (1 in 20) does not show optical rotation. QUANTITATIVE COMPOSITION LOXOTOP PAP 100MG PATCH A patch containing 113 . 4mg ( 100mg as anhydride ) of loxoprofen sodium hydrate in 10g of ointment ( a sheet of 140 cm 2 ). PHARMACEUTICAL FORM LOXOTOP PAP 100MG PATCH Patch preparation comprising ointment, uniformly spread over a support with the surface of the ointment covered by a liner . The ointment surface is white to pale yellow in color . The ointment has a fragrance of mentha oil . CLINICAL PARTICULARS 1 . THERAPEUTIC INDICATIONS LOXOTOP PAP 100mg Patch is indicated for anti-inflammation and pain relief in the following diseases and symptoms: Osteoarthritis, myalgia, posttraumatic swelling and pain. 2 . POSOLOGY AND METHOD OF ADMINISTRATION LOXOTOP PAP 100mg Patch should be applied once daily to the affected area. 3 . CONTRAINDICATIONS LOXOTOP PAP 100mg Patch is contraindicated in the following patients . • Patients with a history of hypersensitivity to any ingredients of LOXOTOP PAP 100mg Patch • Patients with or with a history of aspirin - induced asthma ( induction of asthmatic attack with nonsteroidal anti - inflammatory - analgesics, etc .) [ May induce an aspirin - induced asthmatic attack .] 4 . SPECIAL WARNINGS AND PRECAUTIONS FOR USE Read the complete document