VESOMNI Modified release tablets Ref.[10456] Active ingredients: Solifenacin Tamsulosin

Adult males, including older people

One Vesomni tablet (6 mg/0.4 mg) once daily taken orally with or without food. The maximum daily dose is one Vesomni tablet (6 mg/0.4 mg).

The tablet must be swallowed whole, intact without biting or chewing. Do not crush the tablet.

Patients with renal impairment

The effect of renal impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances is well known (see section 5.2). Vesomni can be used in patients with mild to moderate renal impairment (creatinine clearance >30 mL/min). Patients with severe renal impairment (creatinine clearance ≤30 mL/min) should be treated with caution and the maximum daily dose in these patients is one Vesomni tablet (6 mg/0.4 mg) (see section 4.4).

Patients with hepatic impairment

The effect of hepatic impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances is well known (see section 5.2). Vesomni can be used in patients with mild hepatic impairment (Child-Pugh score ≤7). Patients with moderate hepatic impairment (Child-Pugh score 7-9) should be treated with caution and the maximum daily dose in these patients is one Vesomni tablet (6 mg/0.4 mg). In patients with severe hepatic impairment (Child-Pugh score >9), the use of Vesomni is contraindicated (see section 4.3).

Moderate and strong inhibitors of cytochrome P450 3A4

The maximum daily dose of Vesomni should be limited to one tablet (6 mg/0.4 mg). Vesomni should be used with caution in patients treated simultaneously with moderate or strong CYP3A4 inhibitors, e.g. verapamil, ketoconazole, ritonavir, nelfinavir, itraconazole (see section 4.5).

Paediatric population

There is no relevant indication for use of Vesomni in children and adolescents.

Symptoms

Overdosage with the combination of solifenacin and tamsulosin can potentially result in severe anticholinergic effects plus acute hypotension. The highest dose taken accidentally during a clinical study corresponded to 126 mg of solifenacin succinate and 5.6 mg of tamsulosin hydrochloride. This dose was well-tolerated, with mild dry mouth for 16 days as the only reported adverse event.

Treatment

In the event of overdose with solifenacin and tamsulosin, the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced.

As for other anticholinergics, symptoms of overdose due to the solifenacin component can be treated as follows:

• Severe central anticholinergic effects such as hallucinations or pronounced excitation: treat with physostigmine or carbachol.
• Convulsions or pronounced excitation: treat with benzodiazepines.
• Respiratory insufficiency: treat with artificial respiration.
• Tachycardia: treat symptomatically if needed. Beta-blockers should be used with caution, since the concomitant overdose with tamsulosin could potentially induce severe hypotension.
• Urinary retention: treat with catheterisation.

As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with a known risk for QT-prolongation (i.e., hypokalaemia, bradycardia and concurrent administration of medicinal products known to prolong QT-interval) and relevant pre-existing cardiac diseases (i.e., myocardial ischaemia, arrhythmia, congestive heart failure).

Acute hypotension, which can occur after overdosage due to the tamsulosin component, should be treated symptomatically. Hemodialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins.

3 years.

The medicinal product does not require any special storage conditions.

Aluminium blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.