FORTZAAR

LOSARTAN/HYDROCHLOROTHIAZIDE SANDOZ is indicated in the treatment of essential arterial hypertension in patients whose blood pressure is not sufficiently controlled by losartan or hydrochlorothiazide monotherapy.

Pregnancy

Angiotensin II receptor antagonists (ARAII)

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 of ACE inhibitors could exist with this class. Unless ARAII treatment is considered essential, it is recommended to modify antihypertensive treatment in patients planning pregnancy to a medication having an established safety profile during pregnancy.

In case of diagnosis of pregnancy, ARAII treatment must be stopped immediately and, if necessary, an alternative treatment must be started.

Exposure to ARAII 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, hyperkalaemia) (see section 5.3).

In case of exposure to ARAII from the 2nd trimester of pregnancy, it is recommended to perform a fetal ultrasound to check renal function and the bones of the skull vault. Newborns of mothers treated with ARAII must be monitored for blood pressure (see sections 4.3 and 4.4).

Hydrochlorothiazide

Data concerning the use of hydrochlorothiazide during pregnancy, and particularly during the 1st trimester, are limited. Animal studies are insufficient.

Hydrochlorothiazide crosses the placental barrier. Given the pharmacological mechanism of action of hydrochlorothiazide, its use during the 2nd and 3rd trimesters of pregnancy may decrease fetal-placental perfusion and lead to fetal and neonatal effects such as jaundice, electrolyte imbalance and thrombocytopenia.

Hydrochlorothiazide must not be used to treat gestational oedema, gestational hypertension or pre-eclampsia, due to the risk of decreased blood volume and placental hypoperfusion, without beneficial effect on the progression of the disease.

Hydrochlorothiazide must not be used to treat essential arterial hypertension in pregnant women, except in the rare cases where no other treatment is possible.

Breastfeeding

Angiotensin II receptor antagonists (ARAII)

Losartan

Due to the absence of available information on the use of LOSARTAN/ HYDROCHLOROTHIAZIDE SANDOZ during breastfeeding, this medicine is not recommended. It is preferable to use other treatments having a well established safety profile during breastfeeding, particularly in the newborn or premature infant.

Hydrochlorothiazide

hydrochlorothiazide is excreted in breast milk in small quantities. As thiazide derivatives at high doses lead to intense diuresis, they may inhibit lactation. The use of LOSARTAN/HYDROCHLOROTHIAZIDE SANDOZ during breastfeeding is not recommended. In case of use of LOSARTAN/HYDROCHLOROTHIAZIDE SANDOZ during breastfeeding, doses should remain as low as possible.

Fertility

No human data are available.

The adverse effects below are listed, where appropriate, by organ class and frequency according to the following convention:

Very common: ≥ 1/10.

Common: ≥ 1/100, < 1/10.

Uncommon: ≥ 1/1 000, < 1/100.

Rare: ≥ 1/10 000, < 1/1 000.

Very rare: < 1/10 000.

Not known: cannot be estimated from the available data.

In clinical trials conducted with losartan potassium and hydrochlorothiazide, no adverse effects specific to this combination were observed. The adverse effects were limited to those previously described with losartan potassium and/or hydrochlorothiazide.

In controlled clinical studies conducted in essential hypertension, dizziness was the only drug-related adverse effect reported with a frequency greater than placebo in at least 1 % of patients treated with losartan potassium and hydrochlorothiazide.

In addition to these effects, the adverse effects reported since marketing are as follows:

The adverse effects reported with one of the individual components could be adverse effects observed with the losartan/hydrochlorothiazide combination and are as follows:

Losartan

Hydrochlorothiazide

* based on available data from epidemiological studies, a cumulative dose-dependent association between HCTZ and non-melanoma skin cancer has been observed (see also sections 4.4 and 5.1).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr