COIRBESAR SUN /

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 (AIIRAs):

The available epidemiological data regarding 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 regarding the use of AIIRAs during the 1st trimester of pregnancy, however a risk similar to ACE inhibitors could exist for this class. Unless treatment with an AIIRA is considered essential, it is recommended to change the antihypertensive treatment in patients who are planning a pregnancy to a medicine with an established safety profile during pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately and, if necessary, an alternative treatment should be started.

Exposure to AIIRAs during the 2nd and 3rd trimesters of pregnancy is known to induce foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

In case of exposure to AIIRAs from the 2nd trimester of pregnancy, it is recommended to perform a foetal ultrasound to check renal function and the skull vault bones.

Newborns of mothers treated with an AIIRA must be monitored for blood pressure (see sections 4.3 and 4.4).

Hydrochlorothiazide:

Data regarding 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 cause foetal and neonatal effects such as jaundice, electrolyte imbalance and thrombocytopenia.

Hydrochlorothiazide should not be used to treat gestational oedema, gestational hypertension or pre-eclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without beneficial effect on the course of the disease.

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

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

Breastfeeding

Angiotensin II receptor antagonists (AIIRAs):

As no information is available regarding the use of IRBESARTAN/ HYDROCHLOROTHIAZIDE SANDOZ during breastfeeding, IRBESARTAN/ HYDROCHLOROTHIAZIDE SANDOZ is not recommended. Alternative treatments with a better established safety profile during breastfeeding are advised, especially when breastfeeding newborns or preterm infants.

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

Hydrochlorothiazide:

Hydrochlorothiazide is excreted in human milk in small amounts. Thiazide derivatives at high doses causing intense diuresis can inhibit lactation. The use of IRBESARTAN/HYDROCHLOROTHIAZIDE SANDOZ during breastfeeding is not recommended. If IRBESARTAN/HYDROCHLOROTHIAZIDE SANDOZ is used during breastfeeding, doses should be kept as low as possible.

Fertility

Irbesartan had no effect on the fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3).

Based on its pharmacodynamic properties, it is unlikely that IRBESARTAN/ HYDROCHLOROTHIAZIDE SANDOZ affects the ability to drive or use machines. When driving vehicles or using machines, it should be taken into account that dizziness or fatigue may occur during treatment.