Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 12/2013 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:TANATRIL Tablets 10 Active ingredient:Imidapril hydrochloride Dosage form:white tablet, diameter: 6.5 mm, thickness: 2.6 mm Imprint or print on wrapping:タナトリル 10 mg, Tanatril10, TA136 Effects of this medicine This medicine inhibits angiotensin converting enzyme (ACE)-activity to suppress production of angiotensin II which elevates blood pressure, and decrease blood pressure. It is usually used to treat hypertension and renal parenchymal hypertension. The following patients may need to be careful when 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 or foods. ・If you have a history of angioedema, or you are on a blood purification therapy with extracorporeal circulation (hemodialysis). ・If you are pregnant, possibly 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)) ・In general, for adults, take 5 to 10 mg of the active ingredient once a day. The dosage may be adjusted according to the disease, age, or symptoms. However, for patients with severe hypertension or with hypertension accompanying renal disorder, the initial dose may be started with 2.5 mg once a day. This preparation contains 10 mg of the active ingredient in a tablet. Strictly follow the instructions. ・If you missed a dose, take the dose as soon as possible. However, if it is almost time for the next 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 ・Dizziness and light headedness may occur due to antihypertensive effect. Pay attention to performing dangerous operations such as working in high places or driving a car. Possible adverse reactions to this medicine The most commonly reported adverse reactions include dry cough, hypotension, dizziness, light headedness, headache, discomfort or strange feeling in throat, gastric distress, palpitation, rash and itch. 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. ・respiratory distress, swelling of face/tongue/throat, hives [angioedema] ・nose bleeding, gum bleeding, bruise on limbs [decreased platelets] ・decreased urine output, edema, dull [acute renal failure, exacerbation of renal dysfunction] ・numbness in limbs or lips, muscle weakness, paralysis of limbs [hyperkalemia] ・high fever over 38 degrees celcius, rash on skin mucosa/blister/extensive skin reddening, red eyes or lip sore [erythroderma (exfoliative dermatitis), Stevens-Johnson syndrome (oculomucocutaneous syndrome), pemphigus-like symptoms] 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 1/2 ・Keep out of reach of children. Store away from direct sunlight, heat and moisture. ・Discard the remainder. Do not store them. For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 2/2

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