ASUMATE

· Oral contraception.

The decision to prescribe ASTERLUNA 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 ASTERLUNA in comparison to other CHCs (Combined Hormonal Contraceptives) (see sections 4.3 and 4.4).

Pregnancy

ASTERLUNA is not indicated during pregnancy.

If pregnancy occurs during the use of ASTERLUNA, treatment must be stopped immediately.

Data from a limited number of exposed pregnancies indicate no adverse effect of levonorgestrel alone on the fetus.

Animal studies have shown reproductive toxicity (see section 5.3).

Adverse hormonal effects on the development of the urogenital system cannot be totally excluded. Nevertheless, most currently available epidemiological studies concerning unintentional exposure of the fetus to progestogen/estrogen combinations have not shown teratogenic or fetotoxic effects.

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

Breastfeeding

Breastfeeding may be influenced by COCs as they may reduce the quantity and modify the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk during COC intake. These amounts may have an effect on the child. In breastfed children, adverse effects such as jaundice and breast swelling have been reported.

If possible, until the breastfeeding mother has completely weaned her child from breast milk, non-hormonal contraception methods should be used.

ASTERLUNA has no effect or a negligible effect on the ability to drive vehicles and use machines.

The use of combined oral contraceptives has been associated with an increased risk of the following:

· Arterial and venous thromboembolic disorders (e.g., venous thrombosis, pulmonary embolism, cerebrovascular accidents [ischaemic and haemorrhagic stroke, transient ischaemic attack], myocardial infarction)

· Benign liver tumours (e.g., focal nodular hyperplasia, hepatic adenoma)

· Cervical intraepithelial neoplasms and cervical carcinoma

· Breast carcinoma

For further information, see section 4.4.

The most frequent adverse effects (≥1/10) related to the use of ASTERLUNA are headache (including migraine), spotting and intermenstrual bleeding.

The following adverse effects have been reported during the use of ethinylestradiol/ levonorgestrel.

* Exogenous oestrogens may induce or exacerbate symptoms of hereditary and acquired angioedema.

** Serum folate levels may be decreased by COC therapy. If pregnancy occurs shortly after stopping the oral contraceptive, the decrease in serum folate levels may be of clinical relevance.

In addition, the following adverse effects have been reported in women using COCs and are described in section 4.4 Special warnings and precautions for use:

· Optic neuritis (which can lead to partial or total loss of vision), retinal vein thrombosis

· Aggravation of varicose veins

· Pancreatitis with concurrent severe hypertriglyceridemia

· Ischemic colitis

· Hepatic injury (e.g., hepatitis, hepatic dysfunction)

· Gallbladder disease, including gallstones (COCs may lead to the development of gallbladder disease or exacerbation of existing gallbladder disease)

· Hemolytic uremic syndrome

· Herpes gestationis

· Otosclerosis

· Exacerbation of systemic lupus erythematosus

· Exacerbation of porphyria

· Exacerbation of chorea minor (Sydenham's chorea)

· Exacerbation of depression

· Chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis)

Interactions

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

Reporting of suspected adverse reactions

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