Drug Information Sheet ("Kusuri-no-Shiori") Revised:6/2007 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. Brand Name:Disopain Tablets 75 Nonproprietary (Generic) Name:Mofezolac DESCRIPTION Dosage Form:tablet (φ7.7mm, thickness 3.9mm) Color:white Printings on wrapping:ジソペイン, Disopain, Y-DS75 This medicine relieves pain/inflammation by inhibiting the production of THIS MEDICINE WORKS FOR prostaglandin, a causative substance of pain/inflammation. Usually, it is used to relieve inflammation/pain of lower back, cervicobrachial syndrome and scapulohumeral periarthritis. It is also used to relieve inflammation/pain after operation, trauma or tooth extraction. ・Tell your Doctor: - If you ever had any unusual or allergic reaction to any medicines. - Patients with: peptic ulcer, abnormality in blood, liver/kidney disease, heart failure, hypertension, asthma. BEFORE USING THIS MEDICINE - If you ever had asthma attack after taking antipyretic/analgesic drug. - If you are using any other prescription or nonprescription (OTC) medicine. It is important to prevent mutual reactions that can worsen your condition. ・Pregnancy/Breast-feeding Make sure your doctor knows if you are already pregnant or are breast -feeding. HOW SHOULD THIS MEDICINE BE USED? ・Dosing Instructions: ・Your dosage regimen: ・General dosage regimen (for adults): Take 1 tablet (75mg of the active ingredient) at a time three times a day after meals. It should be adjusted according to the disease, age and symptom of the patient. Strictly follow the order of your doctor. ・Missed Dose: If you are ordered to use this medicine on regular schedule and you missed a dose, apply as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose. ・Overdose: If you took too much Disopain Tablets 75, check with your doctor/pharmacist immediately. ・Do not stop your medication without the instructions of your doctor. Continued on next page Disopain Tablets 75 PRECAUTIONS WHILE USING THIS MEDICINE ・Along with its needed effects, a medicine may cause some unwanted effects. Some of the commonly reported symptoms are listed below. If they occur, check with your doctor/pharmacist. ・Gastric pain, gastric discomfort, nausea, drowsiness, hypersensitivity (itching, hives, rash), swelling. ・In rare cases, symptoms may be the sign of side effects indicated in brackets [ ]. Stop taking your medicine and check with your doctor SIDE EFFECT(s) OF THIS MEDICINE immediately if any of the following side effects occur: ・Acute respiratory distress, hives, swollen eyes/mouth area [shock, anaphylactoid reaction] ・Respiratory distress, wheezing [asthma attack] ・Stomach/back pain, blood vomiting, black stools [peptic ulcer, gastrointestinal haemorrhage] ・General fatigue, loss of appetite, yellowing of the skin or the whites of the eyes [hepatic function disorder, jaundice] ・Bruises on limbs, bleeding from the nose or gums [thrombocytopenia] Other side effects not listed above may also occur in some patients. Check with your doctor/pharmacist if anything is bothersome to you. Storage: COMMENT Contact No. of your Doctor Keep out of the reach of children. Store away from heat, humidity and direct sunlight. Others: If any medicine is left, do not store them. You must discard the remainder. Ask the pharmacy/hospital how to discard. Contact No. of your Pharmacist For more detailed information about this medicine, ask your doctor or pharmacist.