CO VEZAR

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 ACEIs 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 ACEIs could exist for this class. Unless treatment with an ARAII is considered essential, it is recommended to modify antihypertensive treatment in patients planning pregnancy to a medication with an established safety profile during pregnancy. In case of diagnosis of pregnancy, ARAII treatment 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 fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of skull bones) and toxicity in the newborn (renal failure, hypotension, hyperkalemia) (see section 5.3).

In case of exposure to ARAII from the 2nd trimester of pregnancy, fetal ultrasound is recommended 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 fetal-placental perfusion and lead to fetal and neonatal effects such as jaundice, electrolyte imbalance, and thrombocytopenia.

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

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

Breastfeeding

Angiotensin II receptor antagonists (ARAII)

As no information is available regarding the use of IRBÉSARTAN/HYDROCHLOROTHIAZIDE CRISTERS during breastfeeding, IRBÉSARTAN/HYDROCHLOROTHIAZIDE CRISTERS 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 if irbesartan and its metabolites are excreted in women's 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 breast milk in small quantities. High-dose thiazide diuretics causing intense diuresis may inhibit milk production. The use of IRBÉSARTAN/HYDROCHLOROTHIAZIDE CRISTERS during breastfeeding is not recommended. If IRBÉSARTAN/HYDROCHLOROTHIAZIDE CRISTERS is used during breastfeeding, the doses used should be the lowest possible.

Fertility

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

Based on its pharmacodynamic properties, it is unlikely that IRBÉSARTAN/HYDROCHLOROTHIAZIDE CRISTERS 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.