Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Due to the pharmacological effect of solifenacin, Vesicare may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related.
The most commonly reported adverse reaction with Vesicare was dry mouth. It occurred in 11% of patients treated with 5 mg once daily, in 22% of patients treated with 10 mg once daily and in 4% of placebo-treated patients. The severity of dry mouth was generally mild and did only occasionally lead to discontinuation of treatment. In general, medicinal product compliance was very high (approximately 99%) and approximately 90% of the patients treated with Vesicare completed the full study period of 12 weeks treatment.

Tabulated list of adverse reactions



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MedDRA            Very      Common         Uncommon           Rare        Very rare     Not known system organ     commo       ≥1/100,         ≥1/1000,      ≥ 1/10000,    <1/10,000,     (cannot be class            n ≥1/10      <1/10           <1/100        <1/1000                      estimated form the available data)
Infections and                             Urinary tract infestations                               infection
Cystitis
Immune                                                                            Anaphylactic system                                                                           reaction* disorders
Metabolism                                                                           Decreased and nutrition                                                                         appetite* disorders                                                                           Hyperkalaemia *
Psychiatric                                                             Hallucinations Delirium* disorders                                                               * Confusional state*
Nervous                                    Somnolence Dizziness* system                                     Dysgeusia  ,
disorders                                             Headache
*
Eye disorders              Blurred         Dry eyes                                   Glaucoma* vision
Cardiac                                                                               Torsade de disorders                                                                             Pointes* Electrocardiogr am QT prolonged*
Atrial fibrillation*
Palpitation*
Tachycardia*
Respiratory,                               Nasal                                      Dysphonia* thoracic and                               dryness mediastinal disorders
Gastrointestina Dry        Constipatio     Gastro-         Colonic                    Ileus* l disorders     mouth      n               oesophagea      obstructio                 Abdominal Nausea          l reflux        n                          discomfort* Dyspepsia       diseases        Faecal
Abdominal       Dry throat      impaction pain                            Vomiting*
Hepatobiliary                                                                         Liver disorder* disorders                                                                             Liver function test abnormal*


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Skin and                                      Dry skin        Pruritus*,   Erythema       Exfoliative subcutaneous                                                  Rash*,       multiforme*,   dermatitis* tissue                                                                     Urticaria* disorders                                                                  Angioedema* Musculoskeleta                                                                            Muscular l and                                                                                     weakness* connective tissue disorders
Renal and                                     Difficulty in   Urinary                     Renal urinary                                       micturition     retention                   impairment* disorders
General                                       Fatigue disorders and                                 Peripheral administration                                oedema site conditions
* observed post-marketing

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.

Any suspected adverse events should be reported to the Ministry of Health according to the national regulation by using an online form https://sideeffects.health.gov.il/