CO-APROVEL

Treatment of essential arterial hypertension.

This fixed-dose combination is indicated in adult patients whose blood pressure is insufficiently controlled by irbesartan alone or hydrochlorothiazide alone (see section 5.1).

Pregnancy

Angiotensin II receptor antagonists (ARAII)

The use of ARAII is not recommended during the 1st trimester of pregnancy (see section 4.4). The use of ARAII is contraindicated in 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 ARAII in the 1st trimester of pregnancy; however, a risk similar to ACE inhibitors could exist for this class. Unless treatment with ARAII is considered essential, it is recommended to modify antihypertensive treatment in patients planning a pregnancy to a medication with an established safety profile during pregnancy. In case of diagnosis of pregnancy, treatment with an ARAII must be stopped immediately and, if necessary, an alternative treatment will be started.

Exposure to ARAII during the 2nd and 3rd trimesters of pregnancy is known to cause foetotoxicity (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 a mother treated with an angiotensin II receptor inhibitor 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 foeto-placental perfusion and lead to foetal 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 rare cases where no other treatment is possible.

As IRBESARTAN/HYDROCHLOROTHIAZIDE VIATRIS contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy. A change to a suitable alternative treatment should be made before considering a pregnancy.

Breastfeeding

Angiotensin II receptor antagonists (ARAII)

As no information is available regarding the use of IRBESARTAN/HYDROCHLOROTHIAZIDE VIATRIS during breastfeeding, IRBESARTAN/HYDROCHLOROTHIAZIDE VIATRIS is not recommended. It is advised to use alternative treatments with a better established safety profile during breastfeeding, particularly for the breastfeeding of newborns and premature infants.

It is unknown whether irbesartan and its metabolites are excreted in human milk. Pharmacodynamic and toxicological data available in rats have shown that irbesartan and its metabolites are excreted in milk (see section 5.3).

Hydrochlorothiazide

Hydrochlorothiazide is excreted in small quantities in breast milk. High-dose thiazides cause intense diuresis and may inhibit milk production. The use of IRBESARTAN/HYDROCHLOROTHIAZIDE VIATRIS during breastfeeding is not recommended. If IRBESARTAN/HYDROCHLOROTHIAZIDE VIATRIS is used during breastfeeding, the doses should be as low as possible.

Fertility

Irbesartan has shown no effects on the fertility of treated rats and their offspring up to doses causing the first signs of toxicity (see section 5.3).

No study has been conducted on the effects of irbésartan/hydrochlorothiazide on the ability to drive vehicles and use machines. Based on its pharmacodynamic properties, it is unlikely that IRBESARTAN/HYDROCHLOROTHIAZIDE VIATRIS will affect the ability to drive vehicles and use machines. When driving vehicles or using machines, it should be taken into account that dizziness or fatigue may occur during treatment.