COSTARVAL

Treatment of essential arterial hypertension in adults.

VALSARTAN HYDROCHLOROTHIAZIDE BIOGARAN, a fixed-dose combination, is indicated in patients whose blood pressure is not sufficiently controlled by valsartan or hydrochlorothiazide monotherapy.

Pregnancy

Valsartan

Available epidemiological data concerning the risk of malformation after exposure to ACEIs during the 1st trimester of pregnancy do not allow for a conclusion. However, a small increase in risk cannot be excluded. There are no available controlled epidemiological studies concerning the risk with angiotensin II receptor blockers (ARBs); however, a similar risk may exist for this class. Unless treatment with ARBs is considered essential, antihypertensive treatment should be modified in patients planning a pregnancy to a medication having an established safety profile during pregnancy. In case of diagnosis of pregnancy, ARB treatment must be stopped immediately and, if necessary, an alternative treatment will be started.

Exposure to ARBs 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 ARBs 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 ARBs must be closely monitored for blood pressure (see sections 4.3 and 4.4).

Hydrochlorothiazide

Data concerning the use of hydrochlorothiazide during pregnancy, particularly during the 1st trimester, are limited. Animal studies are insufficient. Hydrochlorothiazide crosses the placental barrier. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the 2nd and 3rd trimesters of pregnancy may decrease foeto-placental perfusion and lead to foetal and neonatal effects such as jaundice, electrolyte imbalances and thrombocytopenia.

Breastfeeding

No information is available on the use of valsartan during breastfeeding. Hydrochlorothiazide passes into breast milk. Therefore, the use of VALSARTAN HYDROCHLOROTHIAZIDE BIOGARAN during breastfeeding 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.

No study has been conducted on the effects of VALSARTAN HYDROCHLOROTHIAZIDE BIOGARAN on the ability to drive vehicles and use machines. Particular caution should be observed in vehicle drivers and machine users, due to the occasional risk of dizziness and fatigue.