LOSARTAN PHARMA 5

· 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 mellitus 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 inappropriate due to incompatibility, in particular cough, or contraindication. Patients with heart failure who are stabilized with an ACE inhibitor should not be switched to losartan. 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 adult hypertensive 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).

Available epidemiological data concerning 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 concerning 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 an angiotensin II receptor antagonist is considered essential, in patients planning a pregnancy, it is recommended to modify the antihypertensive treatment to a medication having an established safety profile during pregnancy. In case of diagnosis of pregnancy, losartan treatment must be stopped immediately and, if necessary, an alternative treatment must be started.

Exposure to angiotensin II antagonist treatment during the 2nd and 3rd trimesters of pregnancy is known to cause fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of skull bones) and toxicity in the newborn (renal failure, hypotension, hyperkalemia) (see also section 5.3).

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

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 available information on the use of losartan during breastfeeding, losartan is not recommended. It is preferable to use other treatments having a well established safety profile during breastfeeding, particularly in the newborn and the premature infant.