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Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 03/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name:Vasolan Tablets 40mg Active ingredient:Verapamil hydrochloride Dosage form:yellowish green tablet, diameter: 7.2 mm, thickness: 4.0 mm Print on wrapping:(Face) ワソラン 40mg, E213 (Back) ワソラン, 40mg, E213, Vasolan Effects of this medicine This medicine has calcium antagonistic action to inhibit calcium influx of extracellular fluid into cells, and delays the excitation-conduction of the heart to correct irregular heart beats due to tachyarrhythmia. It also dilates the coronary arteries to increase the blood flow to the heart and the peripheral vessels to reduce the work load of the heart. It consequently suppresses the symptoms such as chest pain due to myocardial ischemia. It is usually used for treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, angina, myocardial infarction or other ischemic heart diseases. Before using this medicine, be sure to tell your doctor and pharmacist ・If you have previously experienced any allergic reactions (itch, rach, etc.) to any medicines. If you have congestive heart failure, atrioventricular block, sinoatrial block, hypotension, cardiomyopathy, valvular disease, hypertensive heart disease, hepatic failure, renal failure or muscular dystrophy. ・If you are pregnant, possibility 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>> ・For treatment of atrial fibrillation, atrial flutter or paroxysmal supraventricular tachycardia: In general, for adults, take one or two tablets (40 to 80 mg as active ingredient) at a time, 3 times a day, to be reduced depending on the disease, severity of the symptoms or age. Strictly follow the instructions. For treatment of angina, myocardial infarction or other ischemic heart diseases: In general, for adults, take one or two tablets (40 to 80 mg as active ingredient) at a time, 3 times a day, to be adjusted depending on the disease, severity of the symptoms or age. Strictly follow the instructions. For children's tachyarrhythmia (atrial fibrillation, atrial flutter or paroxysmal supraventricular tachycardia): In general, for children, take 3 to 6 mg/kg of the active ingredient daily in 3 divided doses, however, the maximum daily dose should be 240 mg. The dosage may be decreased according to the disease, age or symptoms. 1 tablet contains 40 mg of the active ingredient. Strictly follow the instructions. ・If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time. ・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. ・Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine ・Grapefruit juice may potentiate the effect and adverse reactions of this medicine. Do not take this medicine with grapefruit juice. Possible adverse reactions to this medicine The most commonly reported adverse reactions include rash, gum hypertrophy, constipation, headache, decrease in blood pressure, dizziness, nausea and vomiting. 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 reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. ・difficulty in breathing, dizziness, loss of consciousness [heart failure, sinus arrest, atrioventricular block, bradycardia, unconsciousness] 1/2 ・fever, widespread flat reddish patches, bloodshot eyes, stomatitis [mucocutaneous ocular syndrome, erythema exsudativum multiforme, psoriasiform eruption] 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 ・Keep this medicine out of the reach of children and away from light, heat and moisture. ・If you have leftover medicines, dispose of them appropriately and do not keep any unused medicine. For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 2/2