Losartan 50 mg film-coated tablets What Losartan is used for Losartan is used • to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6 - 18 years of age. • to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein). • to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilized with an ACE inhibitor you should not be switched to losartan. • in patients with high blood pressure and a thickening of the left ventricle, Losartan has been shown to decrease the risk of stroke. Do not take Losartan • if you are allergic to losartan or to any of the other ingredients of this medicine, • if you are more than 3 months pregnant, • if your liver function is severely impaired, • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. Warnings and precautions Talk to your doctor or pharmacist before taking Losartan if you: • if you have had a history of angioedema, • if you suffer from excessive vomiting or diarrhea leading to an extreme loss of fluid and/or salt in your body, • if you receive diuretics or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body, • if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently, • if your liver function is impaired, • if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. • if you have problems with your heart valves or heart muscle, • if you suffer from coronary heart disease or from cerebrovascular disease (caused by a reduced blood circulation in the brain), • if you suffer from primary hyperaldosteronism, • if you are taking any of the following medicines used to treat high blood pressure: an ACE-inhibitor, aliskiren. Possible side effects These include dizziness, low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics), dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position, debility, fatigue, too little sugar in the blood (hypoglycemia), too much potassium in the blood (hyperkalemia), changes in kidney function including kidney failure, reduced number of red blood cells (anemia) and increase in blood urea, serum creatinine and serum potassium in patients with heart failure. Other medicines and Losartan Tell your doctor or pharmacist if you are taking: • other blood pressure lowering medicines as they may additionally reduce your blood pressure • non-steroidal anti-inflammatory drugs How to take Losartan Adult patients with High Blood Pressure Treatment usually starts with 50 mg losartan (one tablet Losartan 50 mg) once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients, the dose may later be increased to 100 mg losartan (two tablets Losartan 50 mg) once daily. Use in children and adolescents Children below 6 years of age Losartan is not recommended for use in children under 6 years old, as it has not been shown to work in this age group. Children aged 6 - 18 years old The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day. The doctor may increase the dose if blood pressure is not controlled. 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. It is important that you continue to take Losartan until your doctor tells you otherwise. How to store Losartan Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the carton or the bottle label. The expiry date refers to the last day of that month. • Store Losartan in the original package in order to protect from light and moisture. • Do not open the blister pack until you are ready to take the medicine. • Store Losartan in the original container in order to protect from light. • Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture. • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. A valid prescription should be available upon delivery

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