Roxonin Tape 100 mg 7 sheets

Description

ROXONIN TAPE belongs to a group of medicines called Non-Steroidal Anti- Inflammatory drugs (NSAIDs). ROXONIN TAPE has excellent analgesic, anti-inflammatory properties, particularly in acute inflammations, chronic inflammations and pain. After being absorbed transdermally, loxoprofen sodium hydrate is biotransformed into an active metabolite trans-OH form (SRS coordination) to exert its excellent anti-inflammatory and analgesic effects ROXONIN TAPE is used as anti-inflammation and analgesia in the following diseases and symptoms: Osteoarthritis, myalgia, posttraumatic swelling and pain. How to use Dosage, Methods and routes of administration Always take ROXONIN TAPE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. ROXONIN TAPE should be applied once daily to the affected area. Site of application: Do not apply ROXONIN TAPE onto area of damaged or non-intact skin or mucosal membrane. Do not apply ROXONIN TAPE onto area of eczema and rash. Precautions for Handling After removing the patch from the pouch for use, be sure to close it securely by gently pressing both sides of its zip-lock portion against each other. Use in the Elderly A significant greater incidence of adverse reactions in the elderly patients age ≥ 65 were observed in the post marketing surveillance of ROXONIN TAPE (50mg/100mg). Since the major adverse reactions included dermal symptoms at the application area, ROXONIN TAPE should be used with careful monitoring of dermal condition of application area, in the elderly patients age _ 65. Use during Pregnancy, Delivery or Lactation ROXONIN TAPE should be administered to women who are or are possibly pregnant only when the anticipated therapeutic benefits are considered to outweigh any potential risk. [The safety of ROXONIN TAPE in these populations has not been established.] It has been reported that constriction of the fetal ductus arteriosus is observed when woman in the late stage of pregnancy received other nonsteroidal anti-inflammatory-analgesic drugs for external use. Pediatric Use The safety of ROXONIN TAPE in low birth weight infants, newborn infants, Infants and toddlers, children and adolescents has not been established (because there has been little experience of its use in pediatric patients). Warnings and precautions Do not take ROXONIN TAPE, if you have; A history of hypersensitivity to any ingredients of ROXONIN TAPE. A history of aspirin-induced asthma (induction of asthmatic attack with nonsteroidal anti- inflammatory-analgesics, etc.) (May induce an aspirin-induced asthmatic attack). During third trimester of pregnancy Take special care with ROXONIN TAPE Before taking ROXONIN TAPE, tell your doctor if you Have bronchial asthma (as the disease state may be exacerbated.) Important Precautions It is important to note that treatment with anti-inflammatory-analgesic agents is a symptomatic treatment, not a causal treatment. For treatment of skin inflammation caused by infectious disease, ROXONIN TAPE may cause a risk of masking the signs and symptoms of the infectious disease, therefore, the appropriate antibacterial and/or antifungal drugs must be administered in combination with ROXONIN TAPE to the affected part of the skin, under careful observation and caution. Therapies other than drug treatment must also be considered in using ROXONIN TAPE in the management of chronic diseases (osteoarthritis and others). Side Effects If use of ROXONIN TAPE results in development of any symptom listed below, stop using the patch preparation or take other appropriate remedy depending on the severity of the symptom. Hypersensitivity 0.5% to < 3% - Pruritus, erythema, contact dermatitis, rash < 0.5% - Haemorrhage subcutaneous, skin irritation, pigment precipitation Incidence unknown* - Blister, swelling Gastrointestinal < 0.5% - Stomach discomfort, upper abdominal pain, diarrhea, loose stools Hepatic < 0.5% -Increased AST (GOT), increased ALT (GPT), increased y-GTP Other < 0.5% -Edema *The incidence of adverse reactions is unknown as these adverse reactions are those which have been reported spontaneously. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Storage Information ROXONIN TAPE must be stored in light-proof tightly-sealed container below 25 °C Ingredients Active Ingredient: Loxoprofen sodium hydrate Inactive Ingredients Styrene-isoprene-styrene block copolymer, polyisobutylene, hydrated silicon dioxide, hydrogenated rosin glycerol ester, dibutyl hydroxytoluene, l-menthol, liquid paraffin and Phosphoric acid. Specifications ROXONIN TAPE is packaged in pouches, each containing seven (7) patches, for supply in a package size: 1 pouch (7 patches) per package