Drug Information Sheet ("Kusuri-no-Shiori") Revised:9/2006 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. Brand Name:Depas Fine Granules 1% Nonproprietary (Generic) Name:Etizolam DESCRIPTION Dosage Form:fine granules Color:white Printings on wrapping:デパス細粒 1%, DEPAS FINE GRANULES 1%, Y-DP This medicine acts on benzodiazepine receptors to relieve anxiety and tension. THIS MEDICINE WORKS FOR It also relieves muscle tone. Usually, it is used to improve anxiety, tension, depressive symptom and sleep disorder in neurosis, depression, psychosomatic diseases (hypertension, gastroduodenal ulcer). It is also used to improve muscle stiffness in cervical vertebral disease, low back pain and muscle contraction headache. ・Tell your Doctor: - If you ever had any unusual or allergic reaction to any medicines. - Patients with glaucoma, myasthenia gravis. BEFORE USING THIS MEDICINE - 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 with neurosis/depression): Take 100 mg (1 mg of the active ingredient) at a time three times a day ・General dosage regimen (for adults with psychosomatic disease/cervical vertebral disease/low back pain/muscle contraction headache): Take 50 mg (0.5 mg of the active ingredient) at a time three times a day. ・General dosage regimen (for adults with sleep disorder): Take 100-300 mg (1-3 mg of the active ingredient) at a time once a day at bedtime. ・In any of the above indications, 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. Continued on next page Depas Fine Granules 1% ・Overdose: If you took too much Depas Fine Granules 1%, check with your doctor/pharmacist immediately. ・Do not stop your medication without the instructions of your doctor. ・This medicine may cause drowsiness, lack of attentiveness, concentration or ability of reflexive motion. Avoid driving a car or operating machinery PRECAUTIONS WHILE USING THIS MEDICINE requiring alertness. ・Do not drink alcoholic beverage because it may cause this medicine to work excessively. ・Storage: Keep out of the reach of children. Store away from heat, humidity and light. ・Others: If any medicine is left, do not store them. You must discard the remainder. ・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. Drowsiness, light-headedness, fatigue, weakness, hypersensitivity (itching, hives, rash). SIDE EFFECT(s) OF THIS MEDICINE ・In rare cases, symptoms may be the sign of side effects indicated in brackets [ ]. Stop taking your medicine and check with your doctor immediately if any of the following side effects occur: ・Convulsion, insomnia, expression of anxiety, unbearable suffering without this medicine [drug dependency] ・General fatigue, loss of appetite, yellowing of the skin or the whites of the eyes [hepatic function disorder, jaundice] ・Fever with body temperature above 38℃, muscle stiffness, tremor of limbs [malignant syndrome] ・Muscle pain, numbness of the limbs, weakness, urine like red wine [rhabdomyolysis] ・Fever dry cough, respiratory distress [intestinal pneumonia] Other side effects not listed above may also occur in some patients. Check with your doctor/pharmacist if anything is bothersome to you. COMMENT Contact No. of your Doctor Contact No. of your Pharmacist For more detailed information about this medicine, ask your doctor or pharmacist.