APROVEL

IRBESARTAN VIATRIS 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 diabetes and hypertension, as part of management with an antihypertensive drug (see sections 4.3, 4.4, 4.5 and 5.1).

Pregnancy

Available epidemiological data concerning the risk of teratogenicity 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 malformations cannot be excluded. There are no available controlled epidemiological studies concerning the use of ARBs during the 1st trimester of pregnancy; however, a risk similar to that of ACEIs could exist for this class. Unless ARB treatment is considered essential, it is recommended that patients planning a pregnancy change their antihypertensive treatment to a medication with a well-established safety profile during pregnancy. In case of diagnosis of pregnancy, ARB treatment must be discontinued 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 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 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 should be monitored to detect any sign of hypotension (see sections 4.3 and 4.4).

Breastfeeding

As no information is available concerning the use of irbesartan during breastfeeding, IRBESARTAN 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.

The excretion of irbesartan and its metabolites in women's milk is unknown. Pharmacodynamic/toxicological data in rats have demonstrated the excretion of irbesartan and its metabolites in milk (for more details, see section 5.3).

Fertility

Irbesartan has no effect on the fertility of rats or their offspring, after receiving doses associated with the first signs of parental toxicity (see section 5.3).

Based on its pharmacodynamic properties, it is unlikely that irbesartan will affect this ability. When driving vehicles or using machines, it should be taken into account that dizziness or fatigue may occur during treatment.