Drovelis · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-099533 · has-adverse-reaction-information · PDF-Seite 14

Summary of the safety profile The most commonly reported adverse reactions with Drovelis are metrorrhagia (4.3%), headache (3.2%), acne (3.2%), vaginal haemorrhage (2.7%) and dysmenorrhoea (2.4%). 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 (≥ 1/1000 to < 1/100) and rare (≥ 1/10 000 to < 1/1000). Table 3: List of adverse reactions System organ Common Uncommon Rare class Infections and Fungal infection Mastitis infestations Vaginal infection Urinary tract infection 14 System organ Common Uncommon Rare class Neoplasms Fibroadenoma of breast benign, malignant and unspecified (including cysts and polyps) Immune system Hypersensitivity disorders Metabolism and Appetite disorder Hyperkalaemia nutrition disorders Fluid retention Psychiatric Mood disorders and Depression(2) Nervousness disorders disturbances(1) Anxiety disorder(3) Libido disorder Insomnia Emotional disorder(4) Stress Nervous system Headache Migraine Amnesia disorders Dizziness Paraesthesia Somnolence Eye disorders Visual impairment Vision blurred Dry eye Ear and labyrinth Vertigo disorders Vascular Hot flush Hypertension disorders Venous thrombosis

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099529 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 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. - Presence or risk of venous thromboembolism (VTE) - VTE - current VTE (on anticoagulants) or history of VTE (e.g. 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. - Major surgery with prolonged immobilisation (see section 4.4). - A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4). - Presence or risk of arterial thromboembolism (ATE) 5  - ATE - current ATE, history of ATE (e.g. myocardial infarction [MI]) or prodromal condition (e.g. angina pectoris). - Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. 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. - A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) 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). - Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts). - Undiagnosed vaginal bl

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099528 · has-indication-information · PDF-Seite 2

Oral contraception. The decision to prescribe Drovelis should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Drovelis compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).

HOS-099531 · has-interaction-information · PDF-Seite 12

Pharmacokinetic interactions Effects of other medicinal products on Drovelis Interactions can occur with medicinal products that induce microsomal enzymes, resulting in increased clearance of sex hormones, which may lead to breakthrough bleeding and/or contraceptive failure. - Management Enzyme induction can already be observed after a few days of treatment. Maximum enzyme induction is generally observed within a few weeks. After the cessation of medicinal product therapy, enzyme induction may be sustained for about 4 weeks. - Short-term treatment Women on treatment with enzyme-inducing medicinal products should temporarily use a barrier method or another method of contraception in addition to the CHC. The barrier method must be used during the whole time of the concomitant medicinal product therapy and for 28 days after its discontinuation. If the medicinal product therapy runs beyond the end of the pink active tablets in the CHC pack, the white placebo tablets must be discarded and the next CHC pack should be started right away. - Long-term treatment In women on long-term treatment with hepatic enzyme-inducing active substances, another reliable, non-hormonal, method of contraception is recommended. The following interactions have been reported in the literature. Medicinal products increasing the clearance of CHCs (enzyme-induction) Barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin and HIV medicinal products (e.g., ritonavir, nevirapine and efavirenz) and possibly also felbamate, griseofulvin, oxcarbazepine, topiramate and herbal preparationscontaining St. John's wort (Hypericum perforatum). Medicinal products with variable effects on the clearance of CHCs 12 When co-administered with CHCs, many combinations of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors, including combinations with HCV inhibitors can increase or decrease plasma concentrations of oestrogens and progestogens. The effect of these changes may be clinically relevant in some cases. Therefore, the prescribing information of concomitant HIV/HCV medicinal products should be consulted to identify potential interactions and any related recommendations. In case of any doubt, an additional barrier method of contraception should be used by women on protease inhibitor or non- nucleoside reverse transcriptase inhibitor therapy. Medicinal products decreasing the clearance of C

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099532 · has-pregnancy-information · PDF-Seite 14

Pregnancy Drovelis is not indicated during pregnancy. If pregnancy occurs while taking Drovelis, further intake must be stopped. There is limited amount of data from the use of Drovelis in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Based on animal experience, harmful effects due to hormonal action of the active substances cannot be excluded. The increased risk of VTE during the postpartum period should be considered when re-starting Drovelis (see sections 4.2 and 4.4). Breast-feeding Small amounts of the contraceptive steroids and metabolites may be excreted in human milk and might affect the newborns/infants. Breast-feeding may be influenced by CHCs as they may reduce the quantity and change the composition of human milk. Therefore, the use of CHCs should not be recommended until the breast-feeding mother has completely weaned her child and an alternative method of contraception should be proposed to women wishing to breastfeed. Fertility Drovelis is indicated for oral contraception. For information on return to fertility, see section 5.1.

HOS-099530 · has-warning-information · PDF-Seite 6

If any of the conditions or risk factors mentioned below is present, the suitability of Drovelis should be discussed with the woman before she decides to start using it. In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of Drovelis should be discontinued. All data presented below are based upon epidemiological data obtained with CHCs containing ethinylestradiol. It contains estetrol. As no epidemiological data are yet available with estetrol containing-CHCs, the warnings are considered applicable to the use of Drovelis. In case of suspected or confirmed VTE or ATE, CHC use must be discontinued. In case anticoagulant therapy is started, adequate alternative non-hormonal contraception should be initiated because of the teratogenicity of anticoagulant therapy (coumarins). Circulatory disorders Risk of VTE The use of any CHC increases the risk of VTE compared with no use. Products that contain low dose ethinylestradiol (< 50 mcg ethinylestradiol) combined with levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. It is not yet known how the risk with Drovelis compares with these lower risk products. The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. In women who do not use a CHC and are not pregnant about 2 out of 10 000 will develop a VTE over the period of one year. However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). Epidemiological studies in women who use low dose (< 50 mcg ethinylestradiol) combined hormonal contraceptives have found that out of 10 000 women between about 6 and 12 will develop a VTE in one year. 6 It is estimated1 that out of 10 000 women who use a CHC containing ethinylestradiol and drospirenone, between 9 and 12 women will develop a VTE in one year; this compares with about 6 2 in 10 000 women who use a levonorgestrel-containing CHC. It is not yet known how the risk of VTE with CHC containin

Auszug; vollständigen Abschnitt im Original lesen.