DROVELIS

Posology and method of administration How to take Drovelis Oral use. One tablet is to be taken daily for 28 consecutive days. The tablets must be taken every day at about the same time, if necessary, with a little liquid, in the order shown on the blister pack.

Each pack starts with 24 pink active tablets, followed by 4 white placebo tablets. Each subsequent pack is started the day after the last tablet of the previous pack. Stickers marked with the 7 days of the week are provided, and the relevant weekday sticker should be stuck on the tablet blister as an indicator of when the first tablet has been taken.

Withdrawal bleeding usually starts on day 2-3 after starting the white placebo tablets and may not have finished before the next pack is started. See ‘Cycle control’ in section

4%). Tabulated list of adverse reactions Adverse reactions that have been identified are listed below (see table 3). Adverse reactions are listed according to the MedDRA system organ class and ranked under frequency groupings using the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000).

4. 4 Special warning and precautions for use: - Venous thromboembolic disorders; - Arterial thromboembolic disorders; - Hypertension; - Liver tumours; - Occurrence or deterioration of conditions for which association with CHC use is not conclusive: Crohn’s disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice; - Chloasma; - Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal.

- Exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema. The frequency of diagnosis of breast cancer is very slightly increased among CHC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer.

Causation with CHC use is unknown. 4. 5). Paediatric population In a phase 3 study including 105 adolescents aged 12 to-17 years, Drovelis was well- tolerated for 6 cycles of use and no safety concerns were raised during the study. 9%).

Other adverse events were reported in ≤ 1% of the study population. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued […]

4. , the first day of her menstrual bleeding, and when doing so, no additional contraceptive measures are necessary. If the first tablet is taken on days 2 to 5 of the woman’s menstruation, this medicinal product will not be effective until after the first 7 consecutive days of pink active tablet-taking.

A reliable barrier method of contraception such as a condom must therefore be used additionally during these first 7 days. The possibility of pregnancy should be considered before starting Drovelis. • Changing from a CHC (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start with Drovelis preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.

In case a vaginal ring or transdermal patch has been used the woman should start using Drovelis preferably on the day of removal, but at the latest when the next application would have been due. • Changing from a progestogen-only-method (progestogen-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but should in all of these cases be advised to additionally use a barrier method for the first 7 consecutive days of tablet-taking.

• Following first-trimester abortion The woman may start immediately. When doing so, she needs not take additional contraceptive measures. • Following delivery or second-trimester abortion Women should be advised to start between day 21 and 28 after delivery or second- trimester abortion.

When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of CHC use or the woman has to wait for her first menstrual period.

For breast-feeding women see section

As no epidemiological data are yet available for estetrol-containing CHCs, the contraindications for ethinylestradiol-containing CHCs are considered applicable to the use of Drovelis. CHCs should not be used in the following conditions.

Should any of the conditions appear for the first time during Drovelis use, the medicinal product should be stopped immediately. , deep venous thrombosis [DVT] or pulmonary embolism [PE]). - Known hereditary or acquired predisposition for venous thromboembolism, such as activated protein C (APC)-resistance (including factor V Leiden), antithrombin- III-deficiency, protein C deficiency, protein S deficiency.

4). 4). , angina pectoris). , transient ischaemic attack [TIA]). - Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin- antibodies, lupus anticoagulant).

- History of migraine with focal neurological symptoms. 4) or to the presence of one serious risk factor such as: - diabetes mellitus with vascular symptoms; - severe hypertension; - severe dyslipoproteinaemia. - Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

- Severe renal insufficiency or acute renal failure. - Presence or history of liver tumours (benign or malignant). , of the genital organs or the breasts). - Undiagnosed vaginal bleeding. 1.