VESICARE

Posology Overactive bladder Adults, including elderly:

The recommended dose is 5 mg (5 ml) solifenacin succinate once daily. If needed, the dose may be increased to 10 mg (10 ml) solifenacin succinate once daily.

Paediatric population:

The efficacy of Vesicare in children and adolescents with overactive bladder has not been established. Therefore, Vesicare should not be used for treatment of overactive bladder in children and adolescents under 18 years of age. 2.

Neurogenic detrusor overactivity Paediatric population (age 2 to 18 years):

The recommended dose of Vesicare oral suspension is determined based on patient weight. Treatment should be initiated at the recommended starting dose. Thereafter, the dose may be increased to the lowest effective dose. The maximum dose should not be exceeded.

During long-term therapy, patients should be periodically evaluated for treatment continuation and for potential dose adjustment, at least annually or more frequently if indicated. The doses according to the patient's body weight are found in the table below.

Weight range (kg) Starting dose (ml) §1 Maximum dose (ml) §2 9 to 15 2 4 >15 to 30 3 5 >30 to 45 3 6 >45 to 60 4 8 >60 5 10 § The oral suspension formulation of Vesicare has a concentration of 1 mg/ml. 1 Equivalent to steady-state exposure after a 5 mg daily dose in adults 2 Equivalent to steady-state exposure after a 10 mg daily dose in adults Vesicare oral suspension should be taken once daily by mouth.

Vesicare oral suspension should not be used in children below age of 2 years. 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 Vesicare oral suspension should be taken orally followed by a glass of water. It should not be ingested together with food and/or other drinks. This ingestion with food and/or drinks may cause a release of solifenacin in the mouth resulting in a bitter taste and a feeling of numbness in the mouth.

), 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, 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 in adults 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 tract infection Cystitis Immune system disorders Anaphylactic reaction* Metabolism and nutrition disorders Decreased appetite* Hyperkalaemia* Psychiatric disorders Hallucinations* Confusional state* Delirium* Nervous system disorders Somnolence Dysgeusia Dizziness*, Headache* Eye disorders Blurred vision Dry eyes Glaucoma* Cardiac disorders Torsade de Pointes* Electrocardiogram QT prolonged* Atrial fibrillation* Palpitations* Tachycardia* Respiratory, thoracic and mediastinal disorders Nasal dryness Dysphonia* Gastrointestinal disorders Dry mouth Constipation Nausea Dyspepsia Abdominal pain Gastro- oesophageal reflux diseases Dry throat Colonic obstruction Faecal impaction, Vomiting* Ileus* Abdominal discomfort* Hepatobiliary disorders Liver disorder* Liver function test abnormal* Skin and subcutaneous tissue disorders Dry skin Pruritus*, Rash*, Erythema multiforme* , Urticaria* Angioedema* Exfoliative dermatitis* Musculoskeletal and connective tissue disorders Muscular weakness* Renal and urinary disorders Difficulty in micturition Urinary retention Renal impairment* 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) General disorders and administration site conditions Fatigue Peripheral oedema *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 in the absence of clean intermittent catheterization because of the risk of urinary retention.

- gastrointestinal obstructive disorders. - risk of decreased gastrointestinal motility. 2). 2). g. 5). - hiatus hernia/gastro-oesophageal 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 pre-existing long QT syndrome and hypokalaemia. Angioedema with airway obstruction has been reported in some patients on solifenacin.

If angioedema occurs, solifenacin should be discontinued and appropriate therapy and/or measures should be taken. Anaphylactic reaction has been reported in some patients treated with solifenacin. In patients who develop anaphylactic reactions, solifenacin 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. Vesicare oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. This may cause allergic reactions (possibly delayed). Vesicare oral suspension contains small amounts of ethanol (alcohol), less than 100 mg per maximum daily dose (10 ml Vesicare oral suspension).

Vesicare Oral Suspension contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’. 15 mg/10 ml. Vesicare Oral Suspension contains 20 mg propylene glycol in each ml which is equivalent to 200 mg/10 ml.

When used for treatment of overactive bladder solifenacin is contraindicated in patients with urinary retention. When used for treatment of overactive bladder or neurogenic detrusor overactivity solifenacin is contraindicated in - Patients with severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions.

1. 2). 2). g. 5).