DESOGESTREL - ETHINYLESTRADIOL MYLAN

Oral contraception.

The decision to prescribe VARNOLINE must be made taking into account the patient's risk factors, in particular her risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with VARNOLINE in comparison to other CHCs (Combined Hormonal Contraceptives) (see sections 4.3 and 4.4).

Pregnancy

VARNOLINE is not indicated during pregnancy. If pregnancy occurs during the use of VARNOLINE, the intake of VARNOLINE must immediately be interrupted.

Many epidemiological studies have not revealed an increase in the risk of congenital anomalies in children born to women who used an oral contraceptive before pregnancy.

No teratogenic effect has been observed when a combined oral contraceptive was taken by mistake at the beginning of pregnancy.

The increased risk of TEV in the postpartum period must be taken into account when resuming VARNOLINE (see sections 4.2 and 4.4).

Breastfeeding

In case of breastfeeding, the use of this medicine is not recommended due to the passage of estroprogestogens into breast milk.

If the woman wishes to breastfeed, another method of contraception must be offered.

VARNOLINE has no effect on the ability to drive vehicles and use machines.

Description of certain particular adverse effects

An increase in the risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism, has been observed in women using CHCs; this is addressed in more detail in section 4.4.

Possibly related adverse effects reported in users of VARNOLINE or CHCs in general are listed in the table below 1:

1 The most appropriate MeDRA (version 11.0) terms to describe certain reactions have been used. Synonyms and related conditions are not mentioned but should also be taken into account.

A number of adverse effects reported in users of combined oral contraceptives are detailed in section 4.4. :

§ arterial hypertension,

§ hepatic tumours,

§ appearance or aggravation of conditions whose association with CHCs is not certain: Crohn's disease, hemorrhagic colitis, epilepsy, migraine, uterine fibroid, porphyria, systemic lupus erythematosus, herpes gravidarum, Sydenham's chorea, haemolytic uraemic syndrome, cholestatic jaundice,

§ chloasma,

§ chronic or severe disturbances of hepatic function which may necessitate discontinuation of a CHC until normalization of hepatic function tests,

§ occurrence or aggravation of angioedema symptoms by oestrogens in women with hereditary and acquired angioedema.

Interactions

Metrorrhagia and/or contraceptive failure may be the result of interactions between other medicines (enzyme inducers) and oral contraceptives (see section 4.5).

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization is important. It allows for continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres. Website: www.signalement-sante.gouv.fr.