TICALOR

TICAGRELOR EG, in association with acetylsalicylic acid (ASA), is indicated in the prevention of atherothrombotic events in adult patients having:

· an acute coronary syndrome (ACS)

· a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event (see sections 4.2 and 5.1).

Women of childbearing potential

Women of childbearing potential must use an effective method of contraception to avoid pregnancy during treatment with ticagrélor.

Pregnancy

Data on the use of ticagrélor in pregnant women are non-existent or limited. Studies conducted in animals have shown reproductive toxicity (see section 5.3). Ticagrélor is not recommended during pregnancy.

Breastfeeding

Available pharmacodynamic/toxicological data in animals have shown the excretion of ticagrélor and its active metabolites in milk (see section 5.3). A risk to newborns/infants cannot be excluded. A decision must be made either to discontinue breastfeeding or to discontinue/refrain from ticagrélor treatment, taking into account the benefit of breastfeeding for the child versus the benefit of the treatment for the woman.

Fertility

Ticagrélor has no effect on male or female fertility in animals (see section 5.3).

ticagrélor has no effect or a negligible effect on the ability to drive vehicles and use machines. During treatment with ticagrélor, sensations of dizziness and confusion have been reported. Consequently, patients presenting these symptoms should be cautious when driving or using machines.