Drug Information Sheet ("Kusuri-no-Shiori") 620003654 Revised: 05/2007 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: RIVOTRIL Tablet 0.5mg Active ingredient: Clonazepam Dosage form: white tablet (φ: approx. 8.0mm, thickness: approx. 2.3mm) Printings on wrapping: リボトリール 0.5mg Effects of this medicine This medicine works on benzodiazepine receptor in the brain in order to control seizure (convulsion, loss of consciousness, etc.). It is usually used to treat minor (motor) seizure, psychomotor seizure, and autonomic seizure. Before using this medicine, tell your doctor/pharmacist ・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with glaucoma, myasthenia gravis, cardiac/hepatic/renal/brain disorder, or decreased respiratory function. If you are debilitated. ・ 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 and children: Take the initial dose of 0.5-1mg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 2-6mg in 1-3 divided doses a day. For babies and toddlers: Take the initial dose of 0.025mg/kg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 0.1mg/kg in 1-3 divided doses a day. It should be adjusted according to the patient's disease, age and symptoms in either case. 1 tablet contains 0.5mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist. ・ Missed dose: Take the missed dose as soon as possible. However, after taking the missed dose, you have to wait about 4 hours before your next dose. 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 ・ Alcohol causes this medicine to act excessively. Avoid taking alcohol while taking this medicine. ・ This medicine may cause sleepiness or lightheadedness. Do not drive a car, work at heights, or operate dangerous machinery. Continued on next page. RIVOTRIL Tablet 0.5mg Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: sleepiness, lightheadedness, wheezing, symptom of irritation, rash. 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. ・ compulsive drug use, symptoms showing when suspending use of medicine (convulsion, consciousness disorder, shaky hands and legs, sleeplessness, anxiety, hallucination, delusion) [dependence] ・ shallow and fast breathing turning into breathlessness, increase in breathing, fast breathing while sleeping[respiratory depression, tachypnea while sleeping] ・ abnormally excited and restless mind, impaired judgment, inability to have normal thoughts [irritable excitation, confusion] ・ yellowness in the skin and/or the white of the eye, lassitude[hepatic function disorder, jaundice] 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 light and moisture. ・ Discard the remainder. Do not store them. Ask the pharmacist how to discard. 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") 620003655 Revised: 05/2007 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: RIVOTRIL Tablet 1mg Active ingredient: Clonazepam Dosage form: white tablet (φ: approx. 8.0mm, thickness: approx. 2.3mm) Printings on wrapping: リボトリール 1mg Effects of this medicine This medicine works on benzodiazepine receptor in the brain in order to control seizure (convulsion, loss of conscious, etc.). It is usually used to treat minor (motor) seizure, psychomotor seizure, and autonomic seizure. Before using this medicine, tell your doctor/pharmacist ・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with glaucoma, myasthenia gravis, cardiac/hepatic/renal/brain disorder, or decreased respiratory function. If you are debilitated. ・ 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 and children: Take the initial dose of 0.5-1mg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 2-6mg in 1-3 divided doses a day. For babies and toddlers: Take the initial dose of 0.025mg/kg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 0.1mg/kg in 1-3 divided doses a day. It should be adjusted according to the patient's disease, age and symptoms in either case. 1 tablet contains 1mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist. ・ Missed dose: Take the missed dose as soon as possible. However, after taking the missed dose, you have to wait about 4 hours before your next dose. 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 ・ Alcohol causes this medicine to act excessively. Avoid drinking alcohol while taking this medicine. ・ This medicine may cause sleepiness or lightheadedness. Do not drive a car, work at heights, or operate dangerous machinery. Continued on next page. RIVOTRIL Tablet 1mg Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: sleepiness, lightheadedness, wheezing, symptom of irritation, rash. 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. ・ compulsive drug use, symptoms showing when suspending use of medicine (convulsion, consciousness disorder, shaky hands and legs, sleeplessness, anxiety, hallucination, delusion) [dependence] ・ shallow and fast breathing turning into breathlessness, increase in breathing, fast breathing while sleeping[respiratory depression, tachypnea while sleeping] ・ abnormally excited and restless mind, impaired judgment, inability to have normal thoughts [irritable excitation, confusion] ・ yellowness in the skin and/or the white of the eye, lassitude[hepatic function disorder, jaundice] 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 light and moisture. ・ Discard the remainder. Do not store them. Ask the pharmacist how to discard. 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") 620003656 Revised: 05/2007 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: RIVOTRIL Tablet 2mg Active ingredient: Clonazepam Dosage form: pale orange tablet (φ: approx. 8.0mm, thickness: approx. 2.3mm) Printings on wrapping: リボトリール 2mg Effects of this medicine This medicine works on benzodiazepine receptor in the brain in order to control seizure (convulsion, loss of conscious, etc.). It is usually used to treat minor (motor) seizure, psychomotor seizure, and autonomic seizure. Before using this medicine, tell your doctor/pharmacist ・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with glaucoma, myasthenia gravis, cardiac/hepatic/renal/brain disorder, or decreased respiratory function. If you are debilitated. ・ 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 and children: Take the initial dose of 0.5-1mg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 2-6mg in 1-3 divided doses a day. For babies and toddlers: Take the initial dose of 0.025mg/kg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 0.1mg/kg in 1-3 divided doses a day. It should be adjusted according to the patient's disease, age and symptoms in either case. 1 tablet contains 2mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist. ・ Missed dose: Take the missed dose as soon as possible. However, after taking the missed dose, you have to wait about 4 hours before your next dose. 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 ・ Alcohol causes this medicine to act excessively. Avoid drinking alcohol while taking this medicine. ・ This medicine may cause sleepiness or lightheadedness. Do not drive a car, work at heights, or operate dangerous machinery. Continued on next page. RIVOTRIL Tablet 2mg Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: sleepiness, lightheadedness, wheezing, symptom of irritation, rash. 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. ・ compulsive drug use, symptoms showing when suspending use of medicine (convulsion, consciousness disorder, shaky hands and legs, sleeplessness, anxiety, hallucination, delusion) [dependence] ・ shallow and fast breathing turning into breathlessness, increase in breathing, fast breathing while sleeping[respiratory depression, tachypnea while sleeping] ・ abnormally excited and restless mind, impaired judgment, inability to have normal thoughts [irritable excitation, confusion] ・ yellowness in the skin and/or the white of the eye, lassitude[hepatic function disorder, jaundice] 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 light and moisture. ・ Discard the remainder. Do not store them. Ask the pharmacist how to discard. 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") 620003652 Revised: 05/2007 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: RIVOTRIL Fine Granule 0.1% Active ingredient: Clonazepam Dosage form: white fine granule Printings on wrapping: Effects of this medicine This medicine works on benzodiazepine receptor in the brain in order to control seizure (convulsion, loss of conscious, etc.). It is usually used to treat minor (motor) seizure, psychomotor seizure, and autonomic seizure. Before using this medicine, tell your doctor/pharmacist ・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with glaucoma, myasthenia gravis, cardiac/hepatic/renal/brain disorder, or decreased respiratory function. If you are debilitated. ・ 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 and children: Take the initial dose of 0.5-1mg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 2-6mg in 1-3 divided doses a day. For babies and toddlers: Take the initial dose of 0.025mg/kg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 0.1mg/kg in 1-3 divided doses a day. It should be adjusted according to the patient's disease, age and symptoms in either case. 1g of this medicine contains 1mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist. ・ Missed dose: Take the missed dose as soon as possible. However, after taking the missed dose, you have to wait about 4 hours before your next dose. 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 ・ Alcohol causes this medicine to act excessively. Avoid drinking alcohol while taking this medicine. ・ This medicine may cause sleepiness or lightheadedness. Do not drive a car, work at heights, or operate dangerous machinery. Continued on next page. RIVOTRIL Fine Granule 0.1% Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: sleepiness, lightheadedness, wheezing, symptom of irritation, rash. 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. ・ compulsive drug use, symptoms showing when suspending use of medicine (convulsion, consciousness disorder, shaky hands and legs, sleeplessness, anxiety, hallucination, delusion) [dependence] ・ shallow and fast breathing turning into breathlessness, increase in breathing, fast breathing while sleeping[respiratory depression, tachypnea while sleeping] ・ abnormally excited and restless mind, impaired judgment, inability to have normal thoughts [irritable excitation, confusion] ・ yellowness in the skin and/or the white of the eye, lassitude[hepatic function disorder, jaundice] 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 light and moisture. ・ Discard the remainder. Do not store them. Ask the pharmacist how to discard. 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") 620003653 Revised: 05/2007 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: RIVOTRIL Fine Granule 0.5% Active ingredient: Clonazepam Dosage form: pale orange fine granule Printings on wrapping: Effects of this medicine This medicine works on benzodiazepine receptor in the brain in order to control seizure (convulsion, loss of conscious, etc.). It is usually used to treat minor (motor) seizure, psychomotor seizure, and autonomic seizure. Before using this medicine, tell your doctor/pharmacist ・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with glaucoma, myasthenia gravis, cardiac/hepatic/renal/brain disorder, or decreased respiratory function. If you are debilitated. ・ 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 and children: Take the initial dose of 0.5-1mg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 2-6mg in 1-3 divided doses a day. For babies and toddlers: Take the initial dose of 0.025mg/kg of the active ingredient in 1-3 divided doses a day. After that it will be increased gradually according to patient's symptom until he/she gets optimal effectiveness. Generally, the maintenance dosage is 0.1mg/kg in 1-3 divided doses a day. It should be adjusted according to the patient's disease, age and symptoms in either case. 1g of this medicine contains 5mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist. ・ Missed dose: Take the missed dose as soon as possible. However, after taking the missed dose, you have to wait about 4 hours before your next dose. 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 ・ Alcohol causes this medicine to act excessively. Avoid drinking alcohol while taking this medicine. ・ This medicine may cause sleepiness or lightheadedness. Do not drive a car, work at heights, or operate dangerous machinery. Continued on next page. RIVOTRIL Fine Granule 0.5% Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: sleepiness, lightheadedness, wheezing, symptom of irritation, rash. 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. ・ compulsive drug use, symptoms showing when suspending use of medicine (convulsion, consciousness disorder, shaky hands and legs, sleeplessness, anxiety, hallucination, delusion) [dependence] ・ shallow and fast breathing turning into breathlessness, increase in breathing, fast breathing while sleeping[respiratory depression, tachypnea while sleeping] ・ abnormally excited and restless mind, impaired judgment, inability to have normal thoughts [irritable excitation, confusion] ・ yellowness in the skin and/or the white of the eye, lassitude[hepatic function disorder, jaundice] 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 light and moisture. ・ Discard the remainder. Do not store them. Ask the pharmacist how to discard. 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.