SOLIFENACIN SUCCINATE

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 Solifenacin succinate in children and adolescents with overactive bladder has not been established. Therefore, Solifenacin succinate 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 Solifenacin succinate 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 Solifenacin succinate 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 Solifenacin succinate oral suspension should be taken once daily by mouth.

Solifenacin succinate 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 Solifenacin succinate 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. 6).

), 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 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* General disorders and administration site conditions Fatigue Peripheral oedema *observed post-marketing Paediatric population Solifenacin oral suspension has been evaluated for safety in 95 paediatric patients aged 2 years to less than 18 years with neurogenic detrusor overactivity in two open- label trials.

Common adverse reactions observed in the paediatric population with NDO include: constipation, dry mouth, abdominal pain, somnolence, urinary tract infection, bacterial test positive, and QT prolonged. The incidence of constipation in patients treated with solifenacin oral suspension was higher in the maximum dose group compared to the starting dose group.

In the paediatric patients with NDO, no severe adverse reactions were reported. The most frequent adverse reaction leading to study discontinuation was QT prolongation. Overall, the safety profile in children and adolescents is similar to that observed in adults.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. This may cause allergic reactions (possibly delayed). This medicine contains 20 mg propylene glycol in each ml which is equivalent to 200 mg/10 ml.

This medicine contains 100 mg xylitol in each ml which is equivalent to 1000 mg/10 ml. Xylitol may have a laxative effect. 4 kcal/g xylitol. 002 mg/10 ml. Benzyl alcohol may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium-free'.

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).