Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 14

HOS-113097 · Präparat HOS-093835

Warfarin Standard therapeutic prothrombin time monitoring for warfarin should be continued. The effect of warfarin on prothrombin time was not altered when co-administered with darifenacin.

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): prothrombin (HOS-085093) warfarin (HOS-085950)

Wechselwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 14

HOS-113098 · Präparat HOS-093835

Digoxin Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose. Darifenacin 30 mg once daily (two times greater than the recommended daily dose) co-administered with digoxin at steady state resulted in a small

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): digoxin (HOS-086172)

Wechselwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 14–15

HOS-113099 · Präparat HOS-093835

14 increase in digoxin exposure (AUC: 16% and Cmax: 20%). The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein. Other transporter-related interactions cannot be excluded.

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): digoxin (HOS-086172)

Wechselwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 15

HOS-113100 · Präparat HOS-093835

Antimuscarinic agents As with any other antimuscarinic agents, concomitant use of medicinal products that possess antimuscarinic properties, such as oxybutynin, tolterodine and flavoxate, may result in more pronounced therapeutic and side effects. The potentiation of anticholinergic effects with anti- parkinson agents and tricyclic antidepressants may also occur if antimuscarinic agents are used concurrently with such medicinal products. However, no studies involving the interaction with anti- parkinson agents and tricyclic antidepressants have been performed.

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): tolterodine (HOS-087792) oxybutynin (HOS-087791) flavoxate (HOS-113079)

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 5

HOS-113080 · Präparat HOS-093835

Summary of the safety profile Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo). Anticholinergic effects, in general, are dose-dependent.

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

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 5

HOS-113081 · Präparat HOS-093835

However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0% - 0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).

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

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 5

HOS-113082 · Präparat HOS-093835

Tabulated list of adverse reactions The adverse reactions are ranked under heading of frequency using the following 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), very rare (<1/10,000) and not known (cannot be estimated from the available data). 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 · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 5–6

HOS-113083 · Präparat HOS-093835

5 Table 1: Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets

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

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-113084 · Präparat HOS-093835

Infections and infestations Uncommon Urinary tract infection Psychiatric disorders Uncommon Insomnia, thinking abnormal Not known Confusional state* Not known Depressed mood/mood altered* Not known Hallucination* Nervous system disorders Common Headache Uncommon Dizziness, dysgeusia, somnolence Eye disorders Common Dry eye Uncommon Visual disturbance, including vision blurred Vascular disorders Uncommon Hypertension Respiratory, thoracic and mediastinal disorders Common Nasal dryness Uncommon Dyspnoea, cough, rhinitis Gastrointestinal disorders Very common Constipation, dry mouth Common Abdominal pain, nausea, dyspepsia Uncommon Flatulence, diarrhoea, mouth ulceration Skin and subcutaneous tissue disorders Uncommon Rash, dry skin, pruritus, hyperhidrosis Not known Generalised hypersensitivity reactions including angioedema* Musculoskeletal and connective tissue disorders Not known Muscle spasms* Renal and urinary disorders Uncommon Urinary retention, urinary tract disorder, bladder pain Reproductive system and breast disorders Uncommon Erectile dysfunction, vaginitis General disorders and administration site conditions Uncommon Oedema peripheral, asthenia, face oedema, oedema Investigations Uncommon Aspartate aminotransferase increased, alanine aminotransferase increased Injury, poisoning, and procedural complications Uncommon Injury *observed in post-marketing experience

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

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-113085 · Präparat HOS-093835

Description of selected adverse reactions In the pivotal clinical trials with doses of Emselex 7.5 mg and 15 mg, adverse reactions were reported as presented in the table above. Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.

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

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-113086 · Präparat HOS-093835

Treatment with Emselex may possibly mask symptoms associated with gallbladder disease. However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.

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

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-113087 · Präparat HOS-093835

The incidence of adverse reactions with the doses of Emselex 7.5 mg and 15 mg decreased during the treatment period up to 6 months. A similar trend is also seen for the discontinuation rates.

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

Nebenwirkungen · Emselex

Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 6–7

HOS-113088 · Präparat HOS-093835

6 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.

Nebenwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 15

HOS-113101 · Präparat HOS-093835

Summary of the safety profile Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo). Anticholinergic effects, in general, are dose-dependent.

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

Nebenwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 15

HOS-113102 · Präparat HOS-093835

However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0% - 0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).

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

Nebenwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 15

HOS-113103 · Präparat HOS-093835

Tabulated list of adverse reactions The adverse reactions are ranked under heading of frequency using the following 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), very rare (<1/10,000) and not known (cannot be estimated from the available data). 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 · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 15–16

HOS-113104 · Präparat HOS-093835

15 Table 1: Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets

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

Nebenwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-113105 · Präparat HOS-093835

Infections and infestations Uncommon Urinary tract infection Psychiatric disorders Uncommon Insomnia, thinking abnormal Not known Confusional state* Not known Depressed mood/mood altered* Not known Hallucination* Nervous system disorders Common Headache Uncommon Dizziness, dysgeusia, somnolence Eye disorders Common Dry eye Uncommon Visual disturbance, including vision blurred Vascular disorders Uncommon Hypertension Respiratory, thoracic and mediastinal disorders Common Nasal dryness Uncommon Dyspnoea, cough, rhinitis Gastrointestinal disorders Very common Constipation, dry mouth Common Abdominal pain, nausea, dyspepsia Uncommon Flatulence, diarrhoea, mouth ulceration Skin and subcutaneous tissue disorders Uncommon Rash, dry skin, pruritus, hyperhidrosis Not known Generalised hypersensitivity reactions including angioedema* Musculoskeletal and connective tissue disorders Not known Muscle spasms* Renal and urinary disorders Uncommon Urinary retention, urinary tract disorder, bladder pain Reproductive system and breast disorders Uncommon Erectile dysfunction, vaginitis General disorders and administration site conditions Uncommon Oedema peripheral, asthenia, face oedema, oedema Investigations Uncommon Aspartate aminotransferase increased, alanine aminotransferase increased Injury, poisoning, and procedural complications Uncommon Injury *observed in post-marketing experience

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

Nebenwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-113106 · Präparat HOS-093835

Description of selected adverse reactions In the pivotal clinical trials with doses of Emselex 7.5 mg and 15 mg, adverse reactions were reported as presented in the table above. Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.

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

Nebenwirkungen · Emselex

Emselex 15 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-113107 · Präparat HOS-093835

Treatment with Emselex may possibly mask symptoms associated with gallbladder disease. However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.

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