Losartan 100 mg coated tablets*

What is Losartan and what is it used for?

Losartan belongs to a group of medicines known as angiotensin II receptor antagonists.

Losartan is used

• For the treatment of high blood pressure in adults, children and adolescents aged 6-18 years.

• To protect the kidneys of type 2 diabetic patients with high blood pressure, laboratory evidence of impaired kidney function, and proteinuria 0.5 grams per day (a condition in which the urine contains an abnormal amount of protein).

• For the treatment of patients with chronic heart failure when treatment with certain medicines called angiotensin-converting enzyme (ACE) inhibitors (ACE inhibitors, medicines used to lower high blood pressure) has not been considered. If your heart failure is stabilized with ACE inhibitors, you should not be switched to losartan.

• For patients with high blood pressure and left ventricular hypertrophy, Cozaar has been shown to reduce the risk of stroke.

Do not take losartan.

• If you are allergic to losartan or any of the other ingredients of this medicine,

• If you are more than 3 months pregnant (it is also best to avoid losartan in early pregnancy),

• If you have severe liver dysfunction,

• If you have diabetes or kidney dysfunction and are being treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking losartan:

• If you have a history of angioedema (swelling of the face, lips, throat and/or tongue),

• If you suffer from excessive vomiting or diarrhea that results in severe loss of fluids and/or salt in your body,

• If you are receiving diuretics (medications that increase the amount of water that leaves the kidneys) or if you are on dietary salt restrictions that result in a significant 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 recently had a kidney transplant,

• If your liver function is weak,

• If you have heart failure with or without kidney failure or concomitant serious, life-threatening heart rhythm disturbances.

• If you have coronary heart disease or cerebrovascular disease,

• If you suffer from primary hyperaldosteronism

• If you are taking any of the following medications used to treat high blood pressure: ACE inhibitors, aliskiren.

Possible side effects of losartan

• Dizziness,

• Low blood pressure,

• Dose-related orthostatic effects such as hypotension that occurs when rising from a supine position,

• Fatigue,

• Hypoglycemia (low blood sugar),

• Increased potassium in the blood (hyperkalemia).

• Changes in kidney function, including kidney failure.

• Increased blood urea, serum creatinine and blood potassium in patients with heart failure.

Other medications and losartan

Take special care if you are taking the following medications while being treated with losartan:

• Other medications to lower blood pressure because they may reduce blood pressure.

• Nonsteroidal anti-inflammatory drugs such as indomethacin, including Cox-2 inhibitors (

How to take losartan

Adult patients with high blood pressure

Treatment usually begins with 50 mg of losartan (one 50 mg losartan tablet) once a day. The maximum blood pressure-lowering effect should be achieved after 3–6 weeks of treatment. In some patients, the dose may be later increased to 100 mg of losartan (two 50 mg losartan tablets) once a day.

children and adolescents

Children under 6 years old

Losartan is not recommended for use in children under 6 years of age, as its effectiveness in this age group has not been proven.

Children from 6 to 18 years old

The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight given once daily. Your 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 to continue taking 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 printed on the carton or bottle label. The expiry date refers to the last day of that month.

• Store losartan in the original package to protect it from light and moisture.

• Do not open the blister pack until you are ready to take the medicine.

• Store losartan in the original container to protect from light.

• Do not store above 25°C. Keep the bottle tightly closed to protect from moisture.

• Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.

* The dosage form and method of administration of Losartan 12.5 mg film-coated tablets, Losartan 25 mg film-coated tablets, Losartan 100 mg film-coated tablets should be prescribed according to the therapeutic indication and severity of the disease for each individual patient.