Mechanism Of Action Of Valsartan, Amlodipine & Hydrochlorothiazide Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to constrict. As a result, Valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart. Amlodipine inhibits calcium ion influx across cell membranes, with a greater effect on vascular smooth muscle cells. This causes vasodilation and a reduction in peripheral vascular resistance, thus lowering blood pressure. Hydrochlorothiazide inhibits sodium chloride transport in the distal convoluted tubule. More sodium is then excreted in the kidney with accompanying fluid. Thus it increases urine excretion, which by turn decreases blood volume and finally blood pressure. On long-term usage, thiazide diuretic (TZD)-mediated chronic reduction of arterial pressure is thought to occur through decreased total peripheral vascular resistance. Therapeutic Indications Of Exforge HCT 10/320/25 Tablets Treating high blood pressure (hypertension) in adult patients when monotherapy with amlodipine, valsartan, or hydrochlorothiazide is not sufficient. High blood pressure is a common condition in which the long-term force of the blood against your artery walls is high enough that it may eventually cause health problems, such as heart disease. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Method Of Administration Of Exforge HCT 10/320/25 Tablets Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at about the same time each day. You must continue to take the drug until your doctor tells you otherwise. Do not break the tablet in half You can take the tablet with or without food. The usual dose of Amlodipine/Valsartan/Hydrochlorothiazide is one tablet per day Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Do not exceed the prescribed dose. Doses may be changed in special conditions so always follow your doctor's or pharmacist's instructions. If you take more than you should, talk to a doctor or go to the hospital straight away. If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do not take a double dose (two doses at the same time) to make up for the forgotten dose. Undesirable Side Effects Of Exforge HCT 10/320/25 Tablets Dizziness Low blood pressure (feeling of faintness, light-headedness, sudden loss of consciousness) Sleepiness Palpitations (awareness of your heartbeat) Flushing Ankle swelling (edema) Abdominal pain Stomach discomfort after a meal Tiredness Headache Frequent urination Low level of potassium in the blood High level of uric acid in the blood Low level of magnesium in the blood Low level of sodium in the blood Reduced appetite Nausea and vomiting Itchy rash and other types of rash Inability to achieve or maintain an erection Pregnancy & Breastfeeding Precautions While Taking Exforge HCT 10/320/25 Tablets If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Non-Pharmacological Treatments & Advice To Reduce Blood Pressure • To measure blood pressure correctly: 1. Don’t eat or drink anything 30 minutes before you take your blood pressure. 2. Empty your bladder before your reading. 3. Sit in a comfortable chair with your back supported for at least 5 minutes before your reading. 4. Put both feet flat on the ground and keep your legs uncrossed. 5. Rest your arm with the cuff on a table at chest height. 6. Make sure the blood pressure cuff is snug but not too tight. The cuff should be against your bare skin, not over clothing. 7. Do not talk while your blood pressure is being measured. • You will also find the following Non-Pharmacological treatments effective in blood pressure reduction: 1. Lose extra pounds and watch your waistline 2. Exercise regularly 3. Eat a healthy diet 4. Reduce sodium in your diet 5. Quit smoking 6. Reduce caffeine 7. Reduce your stress 8. Monitor your blood pressure at home using for example Beurer, Blood Pressure Monitor or Omron Blood Pressure Measuring Device 9. See your doctor regularly Warnings & Special Precautions While Taking Exforge HCT 10/320/25 Tablets • Talk to your doctor or pharmacist before taking Amlodipine/Valsartan/Hydrochlorothiazide: 1. If you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm). 2. If you have a low level of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twisting, convulsions). 3. If you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and twitching). 4. If you have kidney problems, have had a kidney transplant, or if you had been told that you have a narrowing of your kidney arteries. 5. If you have liver problems. 6. if you have or have had heart failure or coronary artery disease, particularly if you are prescribed the maximum dose of Amlodipine/valsartan/Hydrochlorothiazide (10 mg/320 mg/25 mg). 7. If you have experienced a heart attack. Follow your doctor’s instructions for the starting dose carefully. Your doctor may also check your kidney function. 8. If your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertropic cardiomyopathy”). 9. If you suffer from aldosteronism. This is a disease in which the adrenal glands make too much of the hormone aldosterone if this applies to you, the use of Amlodipine/Valsartan/Hydrochlorothiazide is not recommended. 10. If you suffer from a disease called systemic lupus erythematosus (also called “lupus” or “SLE”). 11. If you have diabetes (high level of sugar in your blood). 12. If you have high levels of cholesterol or triglycerides in your blood. 13. If you experience skin reactions such as rash after sun exposure. 14. If you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies 15. If you have been sick (vomiting or diarrhea). 16. If you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you get these symptoms, stop taking this medicine and contact your doctor straight away. You should never take this medicine again. 17. If you experience dizziness and/or fainting during treatment with Amlodipine/Valsartan/Hydrochlorothiazide, tell your doctor as soon as possible 18. If you experience a decrease in vision or eye pain 19. If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including vitamins & medications taken without prescription Storage Conditions Of Exforge HCT 10/320/25 Tablets Store below 25°c Don’t refrigerate Keep this medicine out of the sight and reach of children. Store in the original package to protect from moisture. Do not use this medicine after the expiry date which is stated on the box/blisters/label. The expiry date refers to the last day of the month. Normal Ranges Normal: Blood pressure numbers of less than 120/80 mm Hg Elevated: is when readings consistently range from 120-129 systolic and less than 80 mm Hg diastolic. Hypertension Stage 1: is when blood pressure consistently ranges from 130-139 systolic or 80-89 mm Hg diastolic. Hypertension Stage 2: is when blood pressure consistently ranges at 140/90 mm Hg or higher. Hypertensive crisis: This stage of high blood pressure requires medical attention. If your blood pressure readings suddenly exceed 180/120 mm Hg, wait five minutes and then test your blood pressure again. If your readings are still unusually high, contact your doctor immediately. You could be experiencing a hypertensive crisis. For More Information About Valsartan, Amlodipine & Hydrochlorothiazide Ask your physician or pharmacist Visit SFDA website Visit Medscape at Information About Valsartan, Amlodipine & Hydrochlorothiazide Visit Drugs.com at Information About Valsartan, Amlodipine & Hydrochlorothiazide Mechanism Of Action Of Valsartan, Amlodipine & Hydrochlorothiazide Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to constrict. As a result, Valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart. Amlodipine inhibits calcium ion influx across cell membranes, with a greater effect on vascular smooth muscle cells. This causes vasodilation and a reduction in peripheral vascular resistance, thus lowering blood pressure. Hydrochlorothiazide inhibits sodium chloride transport in the distal convoluted tubule. More sodium is then excreted in the kidney with accompanying fluid. Thus it increases urine excretion, which by turn decreases blood volume and finally blood pressure. On long-term usage, thiazide diuretic (TZD)-mediated chronic reduction of arterial pressure is thought to occur through decreased total peripheral vascular resistance. Therapeutic Indications Of Exforge HCT 10/320/25 Tablets Treating high blood pressure (hypertension) in adult patients when monotherapy with amlodipine, valsartan, or hydrochlorothiazide is not sufficient. High blood pressure is a common condition in which the long-term force of the blood against your artery walls is high enough that it may eventually cause health problems, such as heart disease. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Method Of Administration Of Exforge HCT 10/320/25 Tablets Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at about the same time each day. You must continue to take the drug until your doctor tells you otherwise. Do not break the tablet in half You can take the tablet with or without food. The usual dose of Amlodipine/Valsartan/Hydrochlorothiazide is one tablet per day Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Do not exceed the prescribed dose. Doses may be changed in special conditions so always follow your doctor's or pharmacist's instructions. If you take more than you should, talk to a doctor or go to the hospital straight away. If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do not take a double dose (two doses at the same time) to make up for the forgotten dose. Undesirable Side Effects Of Exforge HCT 10/320/25 Tablets Dizziness Low blood pressure (feeling of faintness, light-headedness, sudden loss of consciousness) Sleepiness Palpitations (awareness of your heartbeat) Flushing Ankle swelling (edema) Abdominal pain Stomach discomfort after a meal Tiredness Headache Frequent urination Low level of potassium in the blood High level of uric acid in the blood Low level of magnesium in the blood Low level of sodium in the blood Reduced appetite Nausea and vomiting Itchy rash and other types of rash Inability to achieve or maintain an erection Pregnancy & Breastfeeding Precautions While Taking Exforge HCT 10/320/25 Tablets If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Non-Pharmacological Treatments & Advice To Reduce Blood Pressure • To measure blood pressure correctly: 1. Don’t eat or drink anything 30 minutes before you take your blood pressure. 2. Empty your bladder before your reading. 3. Sit in a comfortable chair with your back supported for at least 5 minutes before your reading. 4. Put both feet flat on the ground and keep your legs uncrossed. 5. Rest your arm with the cuff on a table at chest height. 6. Make sure the blood pressure cuff is snug but not too tight. The cuff should be against your bare skin, not over clothing. 7. Do not talk while your blood pressure is being measured. • You will also find the following Non-Pharmacological treatments effective in blood pressure reduction: 1. Lose extra pounds and watch your waistline 2. Exercise regularly 3. Eat a healthy diet 4. Reduce sodium in your diet 5. Quit smoking 6. Reduce caffeine 7. Reduce your stress 8. Monitor your blood pressure at home using for example Beurer, Blood Pressure Monitor or Omron Blood Pressure Measuring Device 9. See your doctor regularly Warnings & Special Precautions While Taking Exforge HCT 10/320/25 Tablets • Talk to your doctor or pharmacist before taking Amlodipine/Valsartan/Hydrochlorothiazide: 1. If you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm). 2. If you have a low level of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twisting, convulsions). 3. If you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and twitching). 4. If you have kidney problems, have had a kidney transplant, or if you had been told that you have a narrowing of your kidney arteries. 5. If you have liver problems. 6. if you have or have had heart failure or coronary artery disease, particularly if you are prescribed the maximum dose of Amlodipine/valsartan/Hydrochlorothiazide (10 mg/320 mg/25 mg). 7. If you have experienced a heart attack. Follow your doctor’s instructions for the starting dose carefully. Your doctor may also check your kidney function. 8. If your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertropic cardiomyopathy”). 9. If you suffer from aldosteronism. This is a disease in which the adrenal glands make too much of the hormone aldosterone if this applies to you, the use of Amlodipine/Valsartan/Hydrochlorothiazide is not recommended. 10. If you suffer from a disease called systemic lupus erythematosus (also called “lupus” or “SLE”). 11. If you have diabetes (high level of sugar in your blood). 12. If you have high levels of cholesterol or triglycerides in your blood. 13. If you experience skin reactions such as rash after sun exposure. 14. If you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies 15. If you have been sick (vomiting or diarrhea). 16. If you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you get these symptoms, stop taking this medicine and contact your doctor straight away. You should never take this medicine again. 17. If you experience dizziness and/or fainting during treatment with Amlodipine/Valsartan/Hydrochlorothiazide, tell your doctor as soon as possible 18. If you experience a decrease in vision or eye pain 19. If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including vitamins & medications taken without prescription Storage Conditions Of Exforge HCT 10/320/25 Tablets Store below 25°c Don’t refrigerate Keep this medicine out of the sight and reach of children. Store in the original package to protect from moisture. Do not use this medicine after the expiry date which is stated on the box/blisters/label. The expiry date refers to the last day of the month. Normal Ranges Normal: Blood pressure numbers of less than 120/80 mm Hg Elevated: is when readings consistently range from 120-129 systolic and less than 80 mm Hg diastolic. Hypertension Stage 1: is when blood pressure consistently ranges from 130-139 systolic or 80-89 mm Hg diastolic. Hypertension Stage 2: is when blood pressure consistently ranges at 140/90 mm Hg or higher. Hypertensive crisis: This stage of high blood pressure requires medical attention. If your blood pressure readings suddenly exceed 180/120 mm Hg, wait five minutes and then test your blood pressure again. If your readings are still unusually high, contact your doctor immediately. You could be experiencing a hypertensive crisis. For More Information About Valsartan, Amlodipine & Hydrochlorothiazide Ask your physician or pharmacist Visit SFDA website Visit Medscape at Information About Valsartan, Amlodipine & Hydrochlorothiazide Visit Drugs.com at Information About Valsartan, Amlodipine & Hydrochlorothiazide

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