Drug Information Sheet ("Kusuri-no-Shiori") 612140557 Revised: 08/2008 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit (effects) it will do. The patient's cooperation is indispensable here. Brand name INHIBACE Tablet 0.25 Active ingredient Cilazapril hydrate Dosage form white tablet ( : approx. 5.1mm, thickness: approx. 1.9mm) Printings on wrapping 0.25mg Effects of this medicine This medicine lowers blood pressure by suppressing hypertensive substance of angiotensin II. It is usually used to treat hypertension. Before using this medicine, tell your doctor/pharmacist If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you ever had angioedema. If you are receiving hemodialysis therapy, or the treatment to clear extra blood cholesterol from the blood (apheresis). If you are a patient with cirrhosis, renal function disorder, hyperkalemia, or diabetes. If you are limited your intake of salt. If you are pregnant or breastfeeding. If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosage regimen (proper use of this medicine) Your dosage regimen is: :order of your doctor General dosage regimen: For adults, start with 2 tablets (0.5mg of the active ingredient in terms of anhydride) once a day and increase the dosage little by little. The maximum dosage is 8 tablets (2mg of the active ingredient in terms of anhydride) once a day. However, if you have serious hypertension or you also have renal disorder, start with 1 tablet (0.25mg of the active ingredient in terms of anhydride) once a day. It should be adjusted according to your age and symptoms. Strictly follow the instructions of your doctor/pharmacist. Missed dose: Take the missed dose 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 of this medicine (more than ordered), check with your doctor/pharmacist. Others: Do not stop taking this medicine without the instructions of your doctor. Precautions while using this medicine This medicine may cause dizziness/lightheadedness with decreased blood pressure. Exercise caution to drive a car, operate dangerous machinery, or work at heights. Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: cough, dizziness/vertigo, hypotension, headache, stiff shoulder, discomfort in the throat, rash, pruritus. Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately. breathlessness, swollen face/tongue/throat angioedema decreased urinary volume, bloody urine, swollen body/legs/eyes acute renal failure bad abdominal pain, back/lower-back pain, fever, nausea, vomiting, loss of appetite pancreatitis Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. Storage and other information Keep out of the reach of children. Store at room temperature (1-30 ), away from direct sunlight and moisture. Discard the remainder. Do not store them. Ask the pharmacist how to discard. Continued on next page.
INHIBACE Tablet 0.25 For doctor use only: Day Month Year For further information, ask your doctor/pharmacist. Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.
Drug Information Sheet ("Kusuri-no-Shiori") 612140558 Revised: 08/2008 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit (effects) it will do. The patient's cooperation is indispensable here. Brand name INHIBACE Tablet 0.5 Active ingredient Cilazapril hydrate Dosage form white tablet ( : approx. 6.1mm, thickness: approx. 2.7mm) Printings on wrapping 0.5mg Effects of this medicine This medicine lowers blood pressure by suppressing hypertensive substance of angiotensin II. It is usually used to treat hypertension. Before using this medicine, tell your doctor/pharmacist If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you ever had angioedema. If you are receiving hemodialysis therapy, or the treatment to clear extra blood cholesterol from the blood (apheresis). If you are a patient with cirrhosis, renal function disorder, hyperkalemia, or diabetes. If you are limited your intake of salt. If you are pregnant or breastfeeding. If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosage regimen (proper use of this medicine) Your dosage regimen is: :order of your doctor General dosage regimen: For adults, start with 0.5mg of the active ingredient in terms of anhydride once a day and increase the dosage little by little. The maximum dosage is 2mg of the active ingredient in terms of anhydride once a day. However, if you have serious hypertension or you also have renal disorder, start with 0.25mg once a day. It should be adjusted according to your age and symptoms. 1 tablet contains 0.5mg of the active ingredient in terms of anhydride. Strictly follow the instructions of your doctor/pharmacist. Missed dose: Take the missed dose as soon as possible. If it 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 of this medicine (more than ordered), check with your doctor/pharmacist. Others: Do not stop taking this medicine without the instructions of your doctor. Precautions while using this medicine This medicine may cause dizziness/lightheadedness with decreased blood pressure. Exercise caution to drive a car, operate dangerous machinery, or work at heights. Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: cough, dizziness/vertigo, hypotension, headache, stiff shoulder, discomfort in the throat, rash, pruritus. Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately. breathlessness, swollen face/tongue/throat angioedema decreased urinary volume, bloody urine, swollen body/legs/eyes acute renal failure bad abdominal pain, back/lower-back pain, fever, nausea, vomiting, loss of appetite pancreatitis Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. Storage and other information Keep out of the reach of children. Store at room temperature (1-30 ), away from direct sunlight and moisture. Discard the remainder. Do not store them. Ask the pharmacist how to discard. Continued on next page.
INHIBACE Tablet 0.5 For doctor use only: Day Month Year For further information, ask your doctor/pharmacist. Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.
Drug Information Sheet ("Kusuri-no-Shiori") 612140559 Revised: 08/2008 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit (effects) it will do. The patient's cooperation is indispensable here. Brand name INHIBACE Tablet 1 Active ingredient Cilazapril hydrate Dosage form white tablet ( : approx. 7.1mm, thickness: approx. 3.1mm) Printings on wrapping 1mg Effects of this medicine This medicine lowers blood pressure by suppressing hypertensive substance of angiotensin II. It is usually used to treat hypertension. Before using this medicine, tell your doctor/pharmacist If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you ever had angioedema. If you are receiving hemodialysis therapy, or the treatment to clear extra blood cholesterol from the blood (apheresis). If you are a patient with cirrhosis, renal function disorder, hyperkalemia, or diabetes. If you are limited your intake of salt. If you are pregnant or breastfeeding. If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosage regimen (proper use of this medicine) Your dosage regimen is: :order of your doctor General dosage regimen: For adults, start with 0.5mg of the active ingredient in terms of anhydride once a day and increase the dosage little by little. The maximum dosage is 2mg of the active ingredient in terms of anhydride once a day. However, if you have serious hypertension or you also have renal disorder, start with 0.25mg once a day. It should be adjusted according to your age and symptoms. 1 tablet contains 1mg of the active ingredient in terms of anhydride. Strictly follow the instructions of your doctor/pharmacist. Missed dose: Take the missed dose as soon as possible. If it 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 of this medicine (more than ordered), check with your doctor/pharmacist. Others: Do not stop taking this medicine without the instructions of your doctor. Precautions while using this medicine This medicine may cause dizziness/lightheadedness with decreased blood pressure. Exercise caution to drive a car, operate dangerous machinery, or work at heights. Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: cough, dizziness/vertigo, hypotension, headache, stiff shoulder, discomfort in the throat, rash, pruritus. Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately. breathlessness, swollen face/tongue/throat angioedema decreased urinary volume, bloody urine, swollen body/legs/eyes acute renal failure bad abdominal pain, back/lower-back pain, fever, nausea, vomiting, loss of appetite pancreatitis Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. Storage and other information Keep out of the reach of children. Store at room temperature (1-30 ), away from direct sunlight and moisture. Discard the remainder. Do not store them. Ask the pharmacist how to discard. Continued on next page.
INHIBACE Tablet 1 For doctor use only: Day Month Year For further information, ask your doctor/pharmacist. Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.