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ARBITEN PLUS Film Coated Tablets contain two active substances called Valsartan and Hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension). Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”).Hydrochlorothiazide increases urine output, which also lowers blood pressure. ARBITEN PLUS is used to treat high blood pressure which is not adequately controlled by a single substance alone. High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders. How to use The usual dose of ARBITEN PLUS is one Film Coated Tablet per day. Do not change the dose or stop taking the tablets without consulting your doctor. The medicine should be taken at the same time each day, usually in the morning. You can take ARBITEN PLUS with or without food. Swallow the Film Coated Tablets with a glass of water. Warnings and precautions Do not take ARBITEN PLUS: If you are allergic (hypersensitive) to Valsartan, Hydrochlorothiazide, sulphonamide derivatives (substances chemically related to Hydrochlorothiazide) or to any of the other ingredients of ARBITEN PLUS. If you are more than 3 months pregnant. If you have severe 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 disease. If you are unable to produce urine (anuria). If you are treated with an artificial kidney. If the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal despite treatment. If you have gout. If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine called aliskiren. If any of the above applies to you, do not take this medicine and speak to your doctor. Take special care with ARBITEN PLUS: If you have low levels of potassium in your blood. If you have diarrhoea or severe vomiting. If you are taking high doses of water tablets (diuretics). If you have severe heart disease. If you are suffering from heart failure or have experienced a heart attack. If you suffer from a narrowing of the kidney artery. If you have recently received a new kidney. If you suffer from hyperaldosteronism. If you have liver or kidney disease. Side Effects Some side effects can be serious and need immediate medical attention: You should see your doctor immediately if you experience symptoms of angioedema, such as: Swollen face, tongue or pharynx Difficulty in swallowing Hives and difficulties in breathing Other side effects include: Uncommon: Cough. Low blood pressure. Light-headedness. Dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored urine, dry skin). Muscle pain. Tiredness. Tingling or numbness. Blurred vision. Noises (e.G. Hissing, buzzing) in ears. Storage Information Store below 30°C Drug Interactions The effect of the treatment can be influenced if ARBITEN PLUS is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This especially applies to the following medicines: Lithium, a medicine used to treat some types of psychiatric diseases. Medicines or substances that may increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. Medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G. Some antibiotics (rifamycin group), a drug used to protect against transplant rejection (ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of ARBITEN PLUS. Medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics. Medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics. Medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone. Therapeutic vitamin D and calcium supplements. Medicines for the treatment of diabetes (oral agents such as metformin or insulins). Other medicines to lower your blood pressure including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren. Ingredients ARBITEN PLUS 160/12.5 contains 160mg of Valsartan and 12.5mg of Hydrochlorothiazide. The other ingredients are: Microcrystalline Cellulose, Povidone, Crospovidone, Sodium Lauryl Sulphate, Silicified Microcrystalline Cellulose, Talc, Magnesium Stearate, Hydroxy Propyl Methyl Cellulose, (Hydroxy Propyl Methyl Cellulose & Yellow Iron Oxide).
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