Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 6–7

HOS-117273 · Präparat HOS-094561

6 Tabulated list of adverse reactions The table below gives the frequency of treatment emergent adverse reactions from placebo-controlled clinical trials and from post-marketing experience. The adverse reactions are reported in this table with the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000).

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-117274 · Präparat HOS-094561

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-117275 · Präparat HOS-094561

System organ class Very common Common Uncommon Rare Infections and Urinary tract infestations infection

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-117276 · Präparat HOS-094561

Psychiatric disorders Insomnia Confusional state Nervous system Dizziness; Dysgeusia; disorders Headache Somnolence Eye disorders Dry eye Blurred vision Ear and labyrinth Vertigo disorders Cardiac disorders Tachycardia; Palpitations Respiratory, thoracic Dry throat Pharyngolaryng and mediastinal eal pain; Cough; disorders Nasal dryness Gastrointestinal Dry mouth Abdominal pain; Abdominal Hypoaesthesia disorders Diarrhoea; discomfort; oral Dyspepsia; Flatulence, Constipation; Gastroesophage Nausea al reflux Hepatobiliary disorders ALT increased; GGT increased Skin and subcutaneous Rash; Dry skin; Angioedema; tissue disorders Pruritus Urticaria Renal and urinary Dysuria Urinary disorders retention (including feeling of residual urine; micturition disorder); Urinary hesitation General disorders and Fatigue administration site conditions

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-117277 · Präparat HOS-094561

Description of selected adverse reactions In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group. The relation to fesoterodine treatment is unclear.

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-117278 · Präparat HOS-094561

Electrocardiograms were obtained from 782 patients treated with 4 mg, 785 treated with 8 mg, 222 treated with 12 mg fesoterodine and 780 with placebo. The heart rate corrected QT interval in fesoterodine treated patients did not differ from that seen in placebo treated patients. The incidence rates of QTc  500 ms post baseline or QTc increase of  60 ms is 1.9%, 1.3%, 1.4% and 1.5%, for

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 7–8

HOS-117279 · Präparat HOS-094561

7 fesoterodine 4 mg, 8 mg, 12 mg and placebo, respectively. The clinical relevance of these findings will depend on individual patient risk factors and susceptibilities present (see section 4.4).

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-117280 · Präparat HOS-094561

Post-marketing cases of urinary retention requiring catheterisation have been described, generally within the first week of treatment with fesoterodine. They have mainly involved elderly (≥ 65 years) male patients with a history consistent with benign prostatic hyperplasia (see section 4.4).

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

Nebenwirkungen · Toviaz

TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-117281 · Präparat HOS-094561

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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

Gegenanzeigen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.3 · PDF-Seite 4–5

HOS-132835 · Präparat HOS-097310

4  o colchicine in patients with renal impairment due to an increased risk of severe adverse reactions; o irinotecan due to an alteration of the metabolism of this medicinal product; o everolimus, sirolimus (also known as rapamycin) due to an increase of the plasma concentrations of these medicinal products; o vardenafil in men older than 75-years due to increased risk of adverse reactions; o paritaprevir/ombitasvir (ritonavir) due to increased risk of adverse reactions; o fesoterodine and solifenacin in patients with renal impairment; o tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion”.

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): solifenacin (HOS-116433) tolvaptan (HOS-109429) ombitasvir (HOS-110300) colchicine (HOS-086147) everolimus (HOS-086310) fesoterodine (HOS-116432) sirolimus (HOS-085172) ritonavir (HOS-084521) paritaprevir (HOS-110301) irinotecan (HOS-112102) vardenafil (HOS-086163)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132842 · Präparat HOS-097310

o CYP3A4 metabolised HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin and lovastatin) due to an increased risk of skeletal muscle toxicity including rhabdomyolysis; o eplerenone due to an increased risk of hyperkalemia and hypotension; o substances that may have their plasma concentrations increased and have QT prolonging potential : methadone, disopyramide, quinidine, dronedarone, pimozide, sertindole, saquinavir (saquinavir/ritonavir 1000/100 mg bid), ranolazine, mizolastine, halofantrine; o dabigatran due to an increased bleeding risk; o triazolam, oral midazolam and alprazolam due to potential for prolonged or increased sedation and respiratory depression; o ergot alkaloids (eg dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) due to an increased risk of ergotism and other serious vasospastic adverse reactionsevents o lurasidone; o quetiapine due to an increased risk of toxicity; o telithromycin and clarithromycin in patients with severe renal impairment due to an increased risk of hepatotoxicity and QT interval prolongation; o felodipine, nisoldipine due to an increased risk of oedema and congestive heart failure; o colchicine in patients with renal impairment due to an increased risk of severe adverse reactions; o irinotecan due to an alteration of the metabolism of this medicinal product; o everolimus, sirolimus (also known as rapamycin) due to an increase of the plasma concentrations of these medicinal products; o vardenafil in men older than 75-years due to increased risk of adverse reactions o paritaprevir/ombitasvir (ritonavir) due to increased risk of adverse reactions; o fesoterodine and solifenacin in patients with renal impairment; o tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion”.

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): sertindole (HOS-085601) quetiapine (HOS-086150) solifenacin (HOS-116433) methylergonovine (HOS-086155) dronedarone (HOS-086144) methadone (HOS-086198) lovastatin (HOS-086157) eplerenone (HOS-089050) atorvastatin (HOS-086304) felodipine (HOS-108908) alprazolam (HOS-086171) halofantrine (HOS-085606) simvastatin (HOS-086158) quinidine (HOS-085593) dabigatran (HOS-112096) tolvaptan (HOS-109429) ergot alkaloids (HOS-108807) disopyramide (HOS-085595) telithromycin (HOS-084523) saquinavir (HOS-084522) ombitasvir (HOS-110300) clarithromycin (HOS-084517) pimozide (HOS-085600) nisoldipine (HOS-114251) colchicine (HOS-086147) everolimus (HOS-086310) fesoterodine (HOS-116432) sirolimus (HOS-085172) ergotamine (HOS-086154) ritonavir (HOS-084521) paritaprevir (HOS-110301) lurasidone (HOS-086148) ranolazine (HOS-086141) irinotecan (HOS-112102) ergonovine (HOS-086153) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167) mizolastine (HOS-085609) vardenafil (HOS-086163)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 13–14

HOS-132872 · Präparat HOS-097310

13 Medicinal product by Expected effect on drug levels Recommendation for co- therapeutic area administration Dexamethasone, Potential ↑in plasma concentrations of Careful monitoring. fluticasone, these drugs Dose adjustment of these medicinal methylprednisolone products may be required. Lipid Lowering Drugs Lovastatin, simvastatin, Potential ↑in plasma concentrations of Contraindicated due to an increased atorvastatin* these drugs risk of skeletal muscle toxicity, including rhabdomyolysis (see section 4.3). Respiratory Drugs Salmeterol Salmeterol Not recommended due to an AUC: ↑ 15-fold increased risk in QT prolongation. Cmax: ↑ 1.4-fold Urological Drugs Fesoterodine Fesoterodine active metabolite: Not recommended due to an Tolterodine AUC: ↑ 2.3-fold increased risk of QT prolongation. Solifenacin Cmax: ↑ 2.0-fold Fesoterodine and solifenacin are contraindicated in patients with renal Solifenacin: impairment (see section 4.3). AUC: ↑ 3.0-fold

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): solifenacin (HOS-116433) tolterodine (HOS-087792) fluticasone (HOS-108914) lovastatin (HOS-086157) atorvastatin (HOS-086304) methylprednisolone (HOS-088374) simvastatin (HOS-086158) salmeterol (HOS-086285) dexamethasone (HOS-084535) fesoterodine (HOS-116432)

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 22–23

HOS-134524 · Präparat HOS-097580

22  INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Geometric mean change Recommendations concerning co- therapeutic areas (%) administration UROLOGICAL DRUGS Fesoterodine Not studied. Use with caution. Monitor for Solifenacin fesoterodine or solifenacin adverse reactions, dose reduction of fesoterodine or solifenacin may be necessary. # Studies have been performed at lower than recommended doses of darunavir or with a different dosing regimen (see section 4.2 Posology). † The efficacy and safety of the use of darunavir with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir and tipranavir) has not been established in HIV patients. According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended. ‡ Study was conducted with tenofovir disoproxil fumarate 300 mg once daily.

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): solifenacin (HOS-116433) protease (HOS-085623) amprenavir (HOS-086183) fesoterodine (HOS-116432) tenofovir disoproxil fumarate (HOS-110471) ritonavir (HOS-084521) tipranavir (HOS-086184)

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 64

HOS-134635 · Präparat HOS-097580

Midazolam (oral) Boosted darunavir with triazolam or Triazolam oral midazolam is contraindicated (see section 4.3) TREATMENT FOR PREMATURE EJACULATION Dapoxetine Not studied. Co-administration of boosted darunavir with dapoxetine is contraindicated. UROLOGICAL DRUGS Fesoterodine Not studied. Use with caution. Monitor for Solifenacin fesoterodine or solifenacin adverse reactions, dose reduction of fesoterodine or solifenacin may be necessary. # Studies have been performed at lower than recommended doses of darunavir or with a different dosing regimen (see section 4.2 Posology).

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): solifenacin (HOS-116433) fesoterodine (HOS-116432) triazolam (HOS-086168) midazolam (HOS-086167)

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 18

HOS-138507 · Präparat HOS-098200

Co-administration of oral Midazolam (oral) midazolam or triazolam and Triazolam Symtuza is contraindicated (see section 4.3). TREATMENT FOR PREMATURE EJACULATION Dapoxetine Not studied. Co-administration of Symtuza with dapoxetine is contraindicated. UROLOGICAL MEDICINAL PRODUCTS Fesoterodine Not studied. Use with caution. Monitor for Solifenacin fesoterodine or solifenacin adverse reactions, dose reduction of fesoterodine or solifenacin may be necessary.

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): solifenacin (HOS-116433) fesoterodine (HOS-116432) triazolam (HOS-086168) midazolam (HOS-086167)