TANZAAR

· Treatment of essential hypertension in adults and in children and adolescents 6 to 18 years of age.

· Treatment of renal disease in adult patients with type 2 diabetes and hypertension with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment (see sections 4.3, 4.4, 4.5 and 5.1).

· Treatment of chronic heart failure in adult patients, when treatment with Angiotensin Converting Enzyme (ACE) inhibitors is considered unsuitable due to incompatibility (especially cough) or contraindication. Losartan should not be used as a switch treatment in patients with heart failure who are stabilized on an ACE inhibitor. Patients should have a left ventricular ejection fraction ≤ 40 % and should be clinically stable and on an established treatment regimen for chronic heart failure.

· Reduction in the risk of stroke in hypertensive adult patients with left ventricular hypertrophy documented by ECG (see section 5.1: LIFE study, race).

Pregnancy

Losartan must not be used during the 1st trimester of pregnancy (see section 4.4). Losartan is contraindicated during the 2nd and 3rd trimesters of pregnancy (see sections 4.3 and 4.4).

The available epidemiological data regarding the risk of malformation after exposure to ACE inhibitors during the 1st trimester of pregnancy do not allow for a conclusion. However, a small increase in the risk of congenital malformation cannot be excluded. There are no available epidemiological studies regarding the use of angiotensin II receptor antagonists, however a risk similar to that observed with ACE inhibitors could exist with this class. Unless treatment with angiotensin II receptor antagonists is considered essential, in patients who are planning pregnancy, it is recommended to change the antihypertensive treatment to a medicine with an established safety profile during pregnancy. In case of diagnosis of pregnancy, treatment with losartan must be stopped immediately and, if necessary, an alternative treatment should be started.

Exposure to angiotensin II receptor antagonist treatment during the 2nd and 3rd trimesters of pregnancy is known to induce foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also section 5.3).

In case of exposure to losartan from the 2nd trimester of pregnancy, it is recommended to perform a foetal ultrasound to check renal function and skull vault bones.

Newborns of mothers treated with losartan must be monitored for blood pressure (see also sections 4.3 and 4.4).

Breastfeeding

Due to the absence of information available on the use of losartan during breastfeeding, losartan is not recommended. It is preferable to use other treatments with an established safety profile during breastfeeding, particularly in the newborn and preterm infant.