COTAREG

Treatment of essential arterial hypertension in adults.

The combination of valsartan/hydrochlorothiazide, a fixed-dose combination, is indicated in patients whose blood pressure is not sufficiently controlled by valsartan or hydrochlorothiazide monotherapy.

Pregnancy

Valsartan

The use of ARBs is not recommended during the 1st trimester of pregnancy (see section 4.4). The use of ARBs is contraindicated during the 2nd and 3rd trimesters of pregnancy (see sections 4.3 and 4.4).

Available epidemiological data regarding 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 regarding the risk with angiotensin II receptor blockers (ARBs), however a risk may exist for this class. Unless treatment with ARBs is considered essential, antihypertensive treatment should be modified in patients planning pregnancy to another medication having an established safety profile during pregnancy.

In case of diagnosis of pregnancy, treatment with ARBs 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 fetal toxicity (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 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 ARBs must be monitored closely for blood pressure (see sections 4.3 and 4.4).

Hydrochlorothiazide

Data concerning the use of hydrochlorothiazide during pregnancy, notably 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 trimester of pregnancy may decrease fetal-placental perfusion and lead to fetal 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 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 the valsartan/hydrochlorothiazide combination on the ability to drive vehicles and use machines. Particular caution should be observed in drivers of vehicles and users of machines, due to the occasional risk of dizziness and fatigue.