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MILORA HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help to control high blood pressure. Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall, which stops the blood vessels from tightening. Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”. Hydrochlorothiazide increases urine output, which also lowers blood pressure. As a result of all three mechanisms, the blood vessels relax and blood pressure is lowered. MILORA HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances. How to use Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This will help you get the best results and lower the risk of side effects. The usual dose of MILORA HCT is one tablet per day It is best to take the tablet at the same time each day. Morning is the best time. Swallow the tablet whole with a glass of water. You can take MILORA HCT with or without food. Do not take MILORA HCT with grapefruit or grapefruit juice. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Do not exceed the prescribed dose. Warnings and precautions Do not take Melora HCT in the following cases: If you are more than 3 months pregnant. If you are allergic to amlodipine or to any other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived medicines If you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the buildup of bile in the liver (cholestasis). If you have severe kidney problems or if you are having dialysis. If you are unable to produce urine (anuria). If the level of potassium or sodium in your blood is too low despite treatment to increase the potassium or sodium levels in your blood. If the level of calcium in your blood is too high despite treatment to reduce the calcium levels in your blood. If you have gout (uric acid crystals in the joints). If you have severe low blood pressure (hypotension). Warning and precautions Talk to your doctor or pharmacist before taking MILORA HCT 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). If you have a low level of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions). 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). 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. If you have liver problems. If you have or have had heart failure or coronary artery disease. If you have experienced a heart attack. Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. As for any combination containing three active substances, side effects associated with each individual component cannot be excluded. The side effects reported with MILORA HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur with the use of MILORA HCT. Some side effects can be serious and need immediate medical attention. Consult a doctor immediately if you experience any of the following serious side effects after taking this medicine: Common (may affect up to 1 in 10 people): Dizziness Low blood pressure (feeling of faintness, lightheadedness, sudden loss of consciousness) Other side effects may include: Very common (may affect more than 1 in 10 people): Low level of potassium in the blood Increase of lipids in the blood Storage Information Store below 30 C. Drug Interactions Do not take together with: lithium (a medicine used to treat some types of depression); medicines or substances that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassiumsparing medicines and heparin; ACE inhibitors or aliskiren. Ingredients MILORA HCT (25/10/160) contains Valsartan 160mg, Amlodipine 10mg and Hydrochlorothiazide 25 mg The other ingredients are: Microcrystalline cellulose, Crospovidone, Colloidal Silicon Dioxide, Magnesium Stearate, Opadry Specifications MILORA HCT 25/10/160 mg is Brownish yellow oval shaped biconvex film coated tablet embossed with SJ531 in one side
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