SOLIFENACIN SUCCINATE HEC PHARM

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. Other formulations containing 5 mg slolifenacin are available.

Paediatric population The safety and efficacy of solifenacin in children have not yet been established. Therefore, Solifenacin succinate HEC Pharm 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). This medicinal product is therefore not recommended for patients with severe renal impairment. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. 2). This medicinal product is therefore not recommended for patients with moderate hepatic impairment.

g. 5). This medicinal product is therefore not recommended when patients are concomitantly treated with potent CYP3Y4-inhibitors. Method of administration Solifenacin succinate HEC Pharm should be taken orally and should be swallowed whole with liquids.

It can be taken with or without food.

Summary of the safety profile Due to the pharmacological effect of solifenacin, Solifenacin succinate HEC Pharm 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 Very Commo n Uncommo n Rare Very rare Not known (cannot be estimated from the available system organ class common ≥1/10 ≥1/100, <1/10 ≥1/1,000, <1/100 ≥ 1/10,000, <1/1,000 <1/10,000 data) Infections and infestations Urinary tract infection Cystitis Immune system disorders Anaphylactic reaction* Metabolism and nutrition Decreased appetite* Hyperkalaemia MedDRA Very Commo n Uncommo n Rare Very rare Not known (cannot be estimated from the available system organ class common ≥1/10 ≥1/100, <1/10 ≥1/1,000, <1/100 ≥ 1/10,000, <1/1,000 <1/10,000 data) disorders * Psychiatric disorders Hallucination s* Confusional state* Delirium* Nervous system disorders Somnolenc e Dysgeusia Dizziness* , Headache* Eye disorders Blurred vision Dry eyes Glaucoma* Cardiac disorders Torsade de Pointes* Electrocardiog ram QT prolonged* Atrial fibrillation* Palpitations* Tachycardia* Respiratory, thoracic and mediastinal disorders Nasal dryness Dysphonia* Gastrointest i-nal disorders Dry mouth Constipat ion Nausea Dyspepsi a Abdomin al pain Gastro- oesophagea l reflux diseases Dry throat Colonic obstruction Faecal impaction, Vomiting* Ileus* Abdominal discomfort* Hepatobiliar y disorders Liver disorder* Liver function test abnormal* Skin and subcutaneou s tissue disorders Dry skin Pruritus*, Rash* Erythema multiforme*, Urticaria*, Angioedema * Exfoliative dermatitis* MedDRA Very Commo n Uncommo n Rare Very rare Not known (cannot be estimated from the available system organ class common ≥1/10 ≥1/100, <1/10 ≥1/1,000, <1/100 ≥ 1/10,000, <1/1,000 <1/10,000 data) Musculoske letal and connective tissue disorders Muscular weakness* Renal and urinary disorders Difficulty in micturition Urinary retention Renal impairment* General disorders and administrati on 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 succinate HEC Pharm. If urinary tract infection is present, an appropriate antibacterial therapy should be started.

Solifenacin succinate HEC Pharm 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-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. 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, total lactase deficiency or glucose-galactose malabsorption should not take this medicine 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 succinate HEC Pharm can be determined after 4 weeks at the earliest.

Solifenacin is contraindicated in patients with urinary retention, 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).