Drug Information Sheet("Kusuri-no-Shiori") Injection Published: 08/2012 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name:SIGMART Injection 2 mg Active ingredient:Nicorandil Dosage form:injection Print on wrapping: Effects of this medicine This medicine works on coronary dilation and improves such symptoms of angina pectoris as chest pain and chest oppressive feeling. This medicine alleviates the burden of heart by dilating vessels and improves the symptoms of heart failure. It is usually used to treat unstable angina pectoris and acute heart failure. Before using this medicine, be sure to tell your doctor and pharmacist ・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have:hepatic dysfunction, renal dysfunction, cerebral dysfunction, hypotension, cardiogenic shock, Eisenmenger syndrome, primary pulmonary hypertension, right ventricular infarction, symptom of dehydration, neurocirculatory asthenia, glaucoma, left ventricular outflow tract stenosis in acute heart failure, hypertrophic obstructive cardiomyopathy or aortic valve stenosis. ・If you are pregnant or breastfeeding. ・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) ・Your dosing schedule prescribed by your doctor is<< to be written by a healthcare professional>> ・Angina pectoris: In general, inject with intravenous infusion. Heart failure: In general, inject continuously and intravenously. ・The treatment period with this medicine depends on your response to the treatment. Precautions while taking this medicine ・Never take sildenafil citrate (Viagra), vardenafil hydrochloride hydrate (Levitra) or tadalafil (Cialis) while taking this medicine. ・You may feel faint with decreased blood pressure. While you are injected with intravenous infusion and after its completion, you may keep in rest. Possible adverse effects of this medicine The most commonly reported adverse reactions include headache, hepatic dysfunction, decreased blood pressure, ventricular tachycardia, anemia and rash. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. ・yellowness in the skin and the white of the eyes [hepatic dysfunction, jaundice] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 1/3 Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 08/2012 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name:SIGMART Injection 12 mg Active ingredient:Nicorandil Dosage form:injection Print on wrapping: Effects of this medicine This medicine works on coronary dilation and improves such symptoms of angina pectoris as chest pain and chest oppressive feeling. This medicine alleviates the burden of heart by dilating vessels and improves the symptoms of heart failure. It is usually used to treat unstable angina pectoris and acute heart failure. Before using this medicine, be sure to tell your doctor and pharmacist ・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have:hepatic dysfunction, renal dysfunction, cerebral dysfunction, hypotension, cardiogenic shock, Eisenmenger syndrome, primary pulmonary hypertension, right ventricular infarction, symptom of dehydration, neurocirculatory asthenia, glaucoma, left ventricular outflow tract stenosis in acute heart failure, hypertrophic obstructive cardiomyopathy or aortic valve stenosis. ・If you are pregnant or breastfeeding. ・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) ・Your dosing schedule prescribed by your doctor is<< to be written by a healthcare professional>> ・Angina pectoris:In general, inject with intravenous infusion. Heart failure: In general, inject continuously and intravenously. ・The treatment period with this medicine depends on your response to the treatment. Precautions while taking this medicine ・Never take sildenafil citrate (Viagra), vardenafil hydrochloride hydrate (Levitra) or tadalafil (Cialis) while taking this medicine. ・You may feel faint with decreased blood pressure. While you are injected with intravenous infusion and after its completion, you may keep in rest. Possible adverse effects of this medicine The most commonly reported adverse reactions include headache, hepatic dysfunction, decreased blood pressure, ventricular tachycardia, anemia and rash. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. ・yellowness in the skin and the white of the eyes [hepatic dysfunction, jaundice] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 2/3 Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 08/2012 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name:SIGMART Injection 48 mg Active ingredient:Nicorandil Dosage form:injection Print on wrapping: Effects of this medicine This medicine works on coronary dilation and improves such symptoms of angina pectoris as chest pain and chest oppressive feeling. This medicine alleviates the burden of heart by dilating vessels and improves the symptoms of heart failure. It is usually used to treat unstable angina pectoris and acute heart failure. Before using this medicine, be sure to tell your doctor and pharmacist ・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have:hepatic dysfunction, renal dysfunction, cerebral dysfunction, hypotension, cardiogenic shock, Eisenmenger syndrome, primary pulmonary hypertension, right ventricular infarction, symptom of dehydration, neurocirculatory asthenia, glaucoma, left ventricular outflow tract stenosis in acute heart failure, hypertrophic obstructive cardiomyopathy or aortic valve stenosis. ・If you are pregnant or breastfeeding. ・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) ・Your dosing schedule prescribed by your doctor is<< to be written by a healthcare professional>> ・Angina pectoris: In general, inject with intravenous infusion. Heart failure: In general, inject continuously and intravenously. ・The treatment period with this medicine depends on your response to the treatment. Precautions while taking this medicine ・Never take sildenafil citrate (Viagra), vardenafil hydrochloride hydrate (Levitra) or tadalafil (Cialis) while taking this medicine. ・You may feel faint with decreased blood pressure. While you are injected with intravenous infusion and after its completion, you may keep in rest. Possible adverse effects of this medicine The most commonly reported adverse reactions include headache, hepatic dysfunction, decreased blood pressure, ventricular tachycardia, anemia and rash. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. ・yellowness in the skin and the white of the eyes [hepatic dysfunction, jaundice] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 3/3