SOLIFENACIN

Posology Adults, including the elderly The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily. Paediatric population The safety and efficacy of Solifenacin in children have not yet been established.

Therefore, Solifenacin should not be used in children. Patients with renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). 2). Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment.

2). g. 5). Method of administration Solifenacin should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.

), the ability to drive and use machines may be negatively affected. 8 Undesirable effects Summary of the safety profile Due to the pharmacological effect of solifenacin, Solifenacin 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 Solifenacin 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 Solifenacin completed the full study period of 12 weeks treatment.

Tabulated list of adverse reactions:

MedDRA system organ class Very common ≥1/10 Common >1/100, <1/10 Uncommon >1/1000, <1/100 Rare > 1/10000, <1/1000 Very rare <1/10,000, not known (cannot be estimated from the available data) Infections and infestations Urinary trac infection Cystitis Immune system disorders Anaphylactic reaction* Metabolism and nutrition disorders Decreased appetite* Hyperkalaemi Psychiatric disorders Hallucinations* Confusional state* Delirium* Nervous system disorders Somnolence Dysgeusia Dizziness* Headache* Eye disorders Blurred vision Dry eyes Glaucoma* Cardiac disorders Torsades de Pointes* Electrocardiog am QT prolonged* Atrial fibrillation* Palpitations* Tachycardia* Respiratory, Nasal Dysphonia* thoracic and dryness mediastinal disorders Gastrointestina Dry Constipation Gastro- Colonic Ileus* disorders mouth Nausea oesophageal obstruction Abdominal Dyspepsia reflux Faecal discomfort* Abdominal diseases impaction pain Dry throat Vomiting* Hepatobiliary disorders Liver disorder Liver function test abnormal * Skin and Dry skin Rash*, Erythema Exfoliating subcutaneous Pruritus* multiforma*, dermatitis* tissue disorders Urticaria*, Angioedema* Musculoskeleta and connective tissue disorders Muscular weakness* Renal and urinary disorde Difficulty in micturition Urinary retention Renal impairment* 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.

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solifenacin should be used with caution in patients with: - clinically significant bladder outflow obstruction at risk of urinary retention.

- gastrointestinal obstructive disorders. - risk of decreased gastrointestinal motility. 2) and doses should not exceed 5 mg for these patients. 2) and doses should not exceed 5 mg for these patients. g. 5). - hiatus hernia/gastro-oesophagal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.

- autonomic neuropathy. QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as preexisting long QT syndrome and hypokalaemia. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Angioedema with airway obstruction has been reported in some patients on solifenacin succinate.

If angioedema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

The maximum effect of Solifenacin can be determined after 4 weeks at the earliest.

Solifenacin is contraindicated in patients with urinary retention, severe gastrointestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions. 1. 2). 2). g. 5).