Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Esflurbiprofen
HOE PHARMACEUTICALS SDN. BHD.
Esflurbiprofen
7 patches x 10 pouches (70 patches) Units
Tokuhon Corporation
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LOCOA ® 40MG TRANSDERMAL PATCH Esflurbiprofen (40mg) WHAT IS IN THIS LEAFLET 1. What LOCOA ® is used for 2. How LOCOA ® works 3. Before you use LOCOA ® 4. How to use LOCOA ® 5. While you are using LOCOA ® 6. Side effects 7. Storage and Disposal of LOCOA ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT LOCOA ® IS USED FOR LOCOA ® is used to relieve pain and inflammation caused by osteoarthritis (wear and tear arthritis) in which the joints become painful and stiff. HOW LOCOA ® WORKS LOCOA ® suppresses production of prostaglandin, a cause of pain and inflammation, to relieve pain and inflammation. BEFORE YOU USE LOCOA ® _ _ - _When you must not use it _ Do not use LOCOA ® : Patients with stomach ulcer, severe blood disorder, bleeding or any type of blood clotting disorder, severe liver and kidney disease, severe heart disease, or extremely high blood pressure. _ _ Patients with a history of allergic to the components of LOCOA ® or flurbiprofen. _ _ Patients with current or previous aspirin-induced asthma (asthmatic attacks induced by nonsteroidal anti-inflammatory analgesics and other relevant drugs). _ _ Patients who are taking medicines for infections (antibiotics) of the quinolone group such as enoxacin hydrate, lomefloxacin, norfloxacin, or prulifloxacin. _ _ Women in the last 3 months (third trimester) of pregnancy. _ _ Pregnancy and breast-feeding: In the first 6 months of pregnancy, breast-feeding or if you want to become pregnant, LOCOA ® should be used only after talking to your doctor. Taking LOCOA ® at 20 weeks of pregnancy or later may harm your unborn baby. Kidney impairment and decreased urine output in the unborn baby as well as low amount of fluid in the womb have been reported in pregnant women after use of other non-steroidal anti- inflammatory drugs (NSAIDs). Your doctor may need to monitor the amount of fluid in your womb around your Baca dokumen lengkap
1 1. NAME OF THE MEDICINAL PRODUCT LOCOA 40mg transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 × 14 cm patch contains 40mg of esflurbiprofen. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Transdermal Patch The patch consists of a colorless to light yellow transparent adhesive plaster base and has characteristic aroma, in which the adhesive plaster base is spread on a backing layer, and the surface of the adhesive plaster base is covered with a liner. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of pain and inflammation associated with osteoarthritis_ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology LOCOA should be applied to the affected area once daily in adults. Do not use more than 2 patches at once. Do not use more than 2 patches per day, since LOCOA is a topical patch with improved transdermal absorption and enhanced penetration of esflurbiprofen, the active ingredient, into the affected tissue. Also, the safety of LOCOA has been examined for up to 2 patches per day in clinical studies. The use of LOCOA with any other anti-inflammatory agent with expected systemic effects should be avoided wherever possible. If such use is deemed necessary, it should be limited to a minimal level and the condition of the patient should be carefully monitored. _ELDERLY _ Since elderly patients are more susceptible to adverse reactions, their condition should be carefully monitored during use of LOCOA. _ _ _PAEDIATRIC POPULATION _ Safety has not been established in low-birth-weight babies, neonates, nursing infants, infants and children. [Clinical studies have only been performed in adults and there is no experience in the use for the above patients.] _ _ Method of administration LOCOA is administered topically by attaching the patch to the skin of the affected area. LOCOA cannot be applied to the skin wounds, open injuries, mucous membrane or to the area of eczema or rash. If 2 patches are used at a time, the entire sticky side needs to be in direct contact with Baca dokumen lengkap