Source: Web Search Revision Year: 2021 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street, Limassol, 3011 Cyprus
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily.
The safety and efficacy of solifenacin in children have not yet been established. Therefore, Vezimed should not be used in children.
No dose adjustment is necessary for 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 receive no more than 5 mg once daily (see section 5.2).
No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily (see Section 5.2).
The maximum dose of Vezimed should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors e.g. ritonavir, nelfinavir, itraconazole (see section 4.5).
Vezimed should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects. The highest dose of solifenacin succinate accidentally given to a single patient was 280 mg in a 5 hour period, resulting in mental status changes not requiring hospitalization.
In the event of overdose with solifenacin succinate 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 can be treated as follows:
As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with 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).
2 years.
This medicinal product does not require any special storage conditions.
The tablets are packed in transparent PVC/PVDC-Aluminium blisters and cold forming aluminium/push through aluminium blisters.
The available pack sizes are: 10, 20, 30, 50, 60, 90, 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
