APROVEL

IRBESARTAN ARROW is indicated in adults for the treatment of essential arterial hypertension.

It is also indicated in the treatment of renal impairment in adult patients with type 2 diabetic hypertension, as part of management with an antihypertensive drug (see sections 4.3, 4.4, 4.5 and 5.1).

Pregnancy

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 concerning the risk of malformation after exposure to ACEs 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 ARBs during the 1st trimester of pregnancy, however a similar risk to ACEs could exist for this class. Unless treatment with an ARB 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, treatment with an ARB 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, hyperkalaemia) (see section 5.3).

In case of exposure to ARBs 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 an ARB must be monitored for blood pressure (see sections 4.3 and 4.4).

Breastfeeding

As no information is available concerning the use of irbesartan during breastfeeding, irbesartan is not recommended. It is advised to use alternative treatments having a better established safety profile during breastfeeding, in particular for the breastfeeding of newborns and premature infants.

It is unknown if irbesartan and its metabolites are excreted in breast milk.

Pharmacodynamic and toxicological data, available in rats, have shown that irbesartan and its metabolites are excreted in milk (see section 5.3).

Fertility

Irbesartan has not shown any 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 irbesartan affects 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.