Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 22–23

HOS-116419 · Präparat HOS-094447

22  Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone drospirenone AUC ↑ 58%€ When PREZISTA is Ethinylestradiol drospirenone Cmin ND€ co-administered with a (3 mg/0.02 mg once drospirenone Cmax ↑ 15%€ drospirenone-containing product, daily) ethinylestradiol AUC  30%€ clinical monitoring is recommended due to the potential ethinylestradiol Cmin ND€ for hyperkalaemia. ethinylestradiol Cmax  14%€ € with darunavir/cobicistat Alternative or additional contraceptive measures are Ethinylestradiol ethinylestradiol AUC ↓ 44%β recommended when Norethindrone ethinylestradiol Cmin ↓ 62%β oestrogen-based contraceptives are 35 g/1 mg once daily ethinylestradiol Cmax ↓ 32%β co-administered with boosted norethindrone AUC ↓ 14%β PREZISTA. Patients using norethindrone Cmin ↓ 30%β oestrogens as hormone norethindrone Cmax ↔β replacement therapy should be β with darunavir/ritonavir clinically monitored for signs of oestrogen deficiency. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted PREZISTA and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of In an interaction study #, a comparable The combination of avanafil and erectile dysfunction systemic exposure to sildenafil was boosted PREZISTA is Avanafil observed for a single intake of 100 mg contraindicated (see section 4.3). Sildenafil sildenafil alone and a single intake of Concomitant use of other PDE-5 Tadalafil 25 mg sildenafil co-administered with inhibitors for the treatment of Vardenafil PREZISTA and low dose ritonavir. erectile dysfunction with boosted PREZISTA should be done with caution. If concomitant use of boosted PREZISTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tadalafil (HOS-086316) oxycodone (HOS-109487) cobicistat (HOS-088111) avanafil (HOS-086161) drospirenone (HOS-116422) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) fentanyl (HOS-086196) ritonavir (HOS-084521) vardenafil (HOS-086163) tramadol (HOS-112871)

Wechselwirkungen · Prezista

PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 64–65

HOS-116530 · Präparat HOS-094447

64  Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the 8/2 mg–16/4 mg once buprenorphine Cmin ↔ increase in norbuprenorphine daily buprenorphine Cmax ↓ 8% pharmacokinetic parameters has norbuprenorphine AUC ↑ 46% not been established. Dose norbuprenorphine Cmin ↑ 71% adjustment for buprenorphine may norbuprenorphine Cmax ↑ 36% not be necessary when naloxone AUC ↔ co-administered with PREZISTA/ritonavir but a careful naloxone Cmin ND clinical monitoring for signs of naloxone Cmax ↔ opiate toxicity is recommended. Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone Not studied with darunavir/ritonavir. When PREZISTA is co- Ethinylestradiol administered with a drospirenone- (3 mg/0.02 mg once containing product, clinical daily) monitoring is recommended due to the potential for hyperkalaemia.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): oxycodone (HOS-109487) buprenorphine (HOS-086193) drospirenone (HOS-116422) naloxone (HOS-109490) fentanyl (HOS-086196) ritonavir (HOS-084521) tramadol (HOS-112871)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 104–105

HOS-116620 · Präparat HOS-094447

104  Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone drospirenone AUC ↑ 58%€ When PREZISTA is co- Ethinylestradiol drospirenone Cmin ND€ administered with a drospirenone- (3 mg/0.02 mg once drospirenone Cmax ↑ 15%€ containing product, clinical daily) ethinylestradiol AUC  30%€ monitoring is recommended due to the potential for hyperkalaemia. ethinylestradiol Cmin ND€ ethinylestradiol Cmax  14%€ Alternative or additional € with darunavir/cobicistat contraceptive measures are recommended when Ethinylestradiol ethinylestradiol AUC ↓ 44%β oestrogen-based contraceptives are Norethindrone ethinylestradiol Cmin ↓ 62%β co-administered with boosted 35 g/1 mg once daily ethinylestradiol Cmax ↓ 32%β PREZISTA. Patients using norethindrone AUC ↓ 14%β oestrogens as hormone norethindrone Cmin ↓ 30%β replacement therapy should be norethindrone Cmax ↔β clinically monitored for signs of β with darunavir/ritonavir oestrogen deficiency. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted PREZISTA and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of In an interaction study #, a comparable The combination of avanafil and erectile dysfunction systemic exposure to sildenafil was boosted PREZISTA is Avanafil observed for a single intake of 100 mg contraindicated (see section 4.3). Sildenafil sildenafil alone and a single intake of Concomitant use of other PDE-5 Tadalafil 25 mg sildenafil co-administered with inhibitors for the treatment of Vardenafil PREZISTA and low dose ritonavir. erectile dysfunction with boosted PREZISTA should be done with caution. If concomitant use of boosted PREZISTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended. For the treatment of Not studied. Concomitant use of A safe and effective dose of pulmonary arterial sildenafil or tadalafil for the treatment of sildenafil for the treatment of hypertension pulmonary arterial hypertension and pulmonary arterial hypertension Sildenafil boosted PREZISTA may increase plasma co-administered with boosted Tadalafil concentrations of sildenafil or tadalafil. PREZISTA has not been (CYP3A inhibition) established. There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope). Therefore, co-administration of boosted PREZISTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3). Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with boosted PREZISTA is not recommended.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tadalafil (HOS-086316) oxycodone (HOS-109487) cobicistat (HOS-088111) avanafil (HOS-086161) drospirenone (HOS-116422) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) fentanyl (HOS-086196) ritonavir (HOS-084521) vardenafil (HOS-086163) tramadol (HOS-112871)

Wechselwirkungen · Genvoya

Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Genvoya 90 mg/90 mg/120 mg/6 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16

HOS-133994 · Präparat HOS-097520

Elvitegravir: AUC: ↔ Cmin: ↔ Cmax: ↔ ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol Interaction not studied with Plasma concentrations of (3 mg/0.02 mg single dose)/ Genvoya. drospirenone may be increased Cobicistat (150 mg once daily) when co-administered with Expected cobicistat-containing products. Drospirenone: Clinical monitoring is recommended AUC: ↑ due to the potential for hyperkalaemia. Norgestimate Norelgestromin: (0.180/0.215/0.250 mg once daily)/ AUC: ↔ Caution should be exercised when Ethinyloestradiol (0.025 mg once Cmin: ↔ co-administering Genvoya and a daily)/ Emtricitabine/Tenofovir Cmax: ↔ hormonal contraceptive. The alafenamide (200/25 mg once hormonal contraceptive should daily)6 Norgestrel: contain at least 30 µg AUC: ↔ ethinyloestradiol and contain Cmin: ↔ drospirenone or norgestimate as the Cmax: ↔ progestogen or patients should use an alternative reliable method of Ethinyloestradiol: contraception (see sections 4.4 and AUC: ↔ 4.6). Cmin: ↔ Cmax: ↔ The long-term effects of substantial increases in progestogen exposure are unknown. Norgestimate (0.180/0.215 mg Norgestimate: once daily)/ Ethinyloestradiol AUC: ↑ 126% (0.025 mg once daily)/ Elvitegravir Cmin: ↑ 167% (150 mg once daily)/ Cobicistat Cmax: ↑ 108% (150 mg once daily)4 Ethinyloestradiol: AUC: ↓ 25% Cmin: ↓ 44% Cmax: ↔

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) norgestimate (HOS-110544) norelgestromin (HOS-110295) drospirenone (HOS-116422) norgestrel (HOS-090613)

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 75 mg film-coated tablets Darunavir Viatris 150 mg film-coated tablets Darunavir Viatris 300 mg film-coated tablets Darunavir Viatris 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 20–21

HOS-134517 · Präparat HOS-097580

20 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Geometric mean change Recommendations concerning co- therapeutic areas (%) administration Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the 8/2 mg–16/4 mg once daily buprenorphine Cmin ↔ increase in norbuprenorphine buprenorphine Cmax ↓ 8% pharmacokinetic parameters has not norbuprenorphine AUC ↑ 46% been established. Dose adjustment for buprenorphine may not be norbuprenorphine Cmin ↑ 71% necessary when co- administered norbuprenorphine Cmax ↑ 36% with darunavir/ritonavir but a naloxone AUC ↔ careful clinical monitoring for signs naloxone Cmin ND of opiate toxicity is recommended. naloxone Cmax ↔ Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted darunavir may increase plasma recommended when co- Tramadol concentrations of these analgesics. administering boosted darunavir (CYP2D6 and/or CYP3A inhibition) with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone Not studied with darunavir/ritonavir. When darunavir is coadministered Ethinylestradiol with a drospirenone-containing (3 mg/0.02 mg once daily) product, clinical monitoring is recommended due to the potential Ethinylestradiol ethinylestradiol AUC ↓ 44% β for hyperkalaemia. Norethindrone ethinylestradiol Cmin ↓ 62% β 35 μg/1 mg once daily ethinylestradiol Cmax ↓ 32% β Alternative or additional norethindrone AUC ↓ 14% β contraceptive measures are norethindrone Cmin ↓ 30% β recommended when oestrogen- norethindrone Cmax ↔ β based contraceptives are co- β administered with darunavir and with darunavir/ritonavir low dose ritonavir.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): oxycodone (HOS-109487) buprenorphine (HOS-086193) drospirenone (HOS-116422) naloxone (HOS-109490) norethindrone (HOS-088136) fentanyl (HOS-086196) ritonavir (HOS-084521) tramadol (HOS-112871)

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 400 mg film-coated tablets Darunavir Viatris 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 62–63

HOS-134632 · Präparat HOS-097580

62 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Recommendations concerning co- therapeutic areas Geometric mean change (%) administration Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the increase 8/2 mg–16/4 mg once daily buprenorphine Cmin ↔ in norbuprenorphine pharmacokinetic buprenorphine Cmax ↓ 8% parameters has not been established. norbuprenorphine AUC ↑ 46% Dose adjustment for buprenorphine may not be necessary when co- norbuprenorphine Cmin ↑ 71% administered with boosted darunavir norbuprenorphine Cmax ↑ 36% but a careful clinical monitoring for naloxone AUC ↔ signs of opiate toxicity is naloxone Cmin ND recommended. naloxone Cmax ↔ Fentanyl Based on theoretical considerations Clinical monitoring is recommended Oxycodone boosted darunavir may increase when co-administering boosted Tramadol plasma concentrations of these darunavir with these analgesics. analgesics. (CYP2D6 and/or CYP3A inhibition) OESTROGEN-BASED CONTRACEPTIVES Drospirenone drospirenone AUC ↑ 58%€ When darunavir is coadministered Ethinylestradiol drospirenone Cmin ND€ with a drospirenone-containing (3 mg/0.02 mg once daily) drospirenone Cmax ↑ 15%€ product, clinical monitoring is ethinylestradiol AUC ↓ 30%€ recommended due to the potential for ethinylestradiol Cmin ND € hyperkalaemia. ethinylestradiol Cmax ↓ 14% € € with darunavir/cobicistat Alternative or additional contraceptive measures are recommended when oestrogen-based Ethinylestradiol ethinylestradiol AUC ↓ 44% contraceptives are co- administered Norethindrone ethinylestradiol Cmin ↓ 62% with boosted darunavir. Patients 35 μg/1 mg once daily ethinylestradiol Cmax ↓ 32% using oestrogens as hormone norethindrone AUC ↓ 14% replacement therapy should be norethindrone Cmin ↓ 30% clinically monitored for signs of norethindrone Cmax ↔ β oestrogen deficiency. with darunavir/ritonavir OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted darunavir and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile In an interaction study #, a The combination of avanafil and dysfunction comparable systemic exposure to boosted darunavir is contraindicated Avanafil sildenafil was observed for a single (see section 4.3). Sildenafil intake of 100 mg sildenafil alone Concomitant use of other PDE-5 Tadalafil and a single intake of 25 mg inhibitors for the treatment of erectile Vardenafil sildenafil co-administered with dysfunction with boosted darunavir darunavir and low dose ritonavir. should be done with caution. If concomitant use of boosted darunavir with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tadalafil (HOS-086316) oxycodone (HOS-109487) cobicistat (HOS-088111) avanafil (HOS-086161) buprenorphine (HOS-086193) drospirenone (HOS-116422) naloxegol (HOS-109428) naloxone (HOS-109490) norethindrone (HOS-088136) sildenafil (HOS-086162) fentanyl (HOS-086196) ritonavir (HOS-084521) vardenafil (HOS-086163) tramadol (HOS-112871)

Wechselwirkungen · Symtuza

Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets Symtuza 675 mg/150 mg/200 mg/10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16–17

HOS-138497 · Präparat HOS-098200

16 OESTROGEN-BASED CONTRACEPTIVES Drospirenone Ethinylestradiol drospirenone AUC ↑ 58% Alternative or additional (3 mg/0.02 mg once daily) drospirenone Cmax ↑ 15% contraceptive measures are drospirenone Cmin ND recommended when oestrogen based contraceptives are Ethinylestradiol ethinylestradiol AUC  30% co-administered with Symtuza. ethinylestradiol Cmax  14% Patients using oestrogens as hormone replacement therapy ethinylestradiol Cmin ND should be clinically monitored for signs of oestrogen deficiency. Norethindrone When Symtuza is co-administered Based on theoretical considerations with a drospirenone-containing DRV/COBI may alter product, clinical monitoring is norethindrone plasma recommended due to the potential concentrations. for hyperkalaemia. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of Symtuza and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile Based on theoretical considerations Concomitant use of PDE-5 dysfunction DRV/COBI is expected to increase inhibitors for the treatment of Sildenafil these PDE-5 inhibitor plasma erectile dysfunction with Symtuza Tadalafil concentrations. should be done with caution. If Vardenafil (CYP3A inhibition) concomitant use of Symtuza with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tadalafil (HOS-086316) drospirenone (HOS-116422) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) vardenafil (HOS-086163)

Wechselwirkungen · Biktarvy

Biktarvy 30 mg/120 mg/15 mg film-coated tablets Biktarvy 50 mg/200 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-139309 · Präparat HOS-098314

Based on drug interaction studies conducted with Biktarvy or the components of Biktarvy, no clinically significant drug interactions are expected with: amlodipine, atorvastatin, buprenorphine, drospirenone, famciclovir, famotidine, fluticasone, methadone, naloxone, norbuprenorphine, omeprazole or rosuvastatin.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): famciclovir (HOS-112681) fluticasone (HOS-108914) methadone (HOS-086198) atorvastatin (HOS-086304) amlodipine (HOS-086287) rosuvastatin (HOS-086307) famotidine (HOS-112087) buprenorphine (HOS-086193) drospirenone (HOS-116422) naloxone (HOS-109490) omeprazole (HOS-085912)

Gegenanzeigen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-146435 · Präparat HOS-099526

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-146436 · Präparat HOS-099526

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-146437 · Präparat HOS-099526

- 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)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): protein S (HOS-110298) protein C (HOS-091603)

Gegenanzeigen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5–6

HOS-146440 · Präparat HOS-099526

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 bleeding.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146441 · Präparat HOS-099526

Pharmacokinetic interactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146442 · Präparat HOS-099526

Effects of other medicinal products on Drovelis

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146443 · Präparat HOS-099526

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lead (HOS-085592)

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146445 · Präparat HOS-099526

- 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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146446 · Präparat HOS-099526

- 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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): placebo (HOS-088378)

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146447 · Präparat HOS-099526

- Long-term treatment In women on long-term treatment with hepatic enzyme-inducing active substances, another reliable, non-hormonal, method of contraception is recommended.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146448 · Präparat HOS-099526

The following interactions have been reported in the literature.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Drovelis

Drovelis 3 mg/14.2 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-146449 · Präparat HOS-099526

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): felbamate (HOS-110308) topiramate (HOS-110310) carbamazepine (HOS-085618) griseofulvin (HOS-091156) efavirenz (HOS-087947) nevirapine (HOS-088064) oxcarbazepine (HOS-110224) ritonavir (HOS-084521) bosentan (HOS-086291) phenytoin (HOS-084531) primidone (HOS-090551)