Utocare

Solifenacin succinate.

UTOCARE Tablets 5mg: Light yellow, round, film-coated, engraved "DC" on one side and "150" on the other side.
Each tablet contains solifenacin succinate 5 mg.
UTOCARE Tablets 10mg: Light pink, round, film-coated, engraved "DC" on one side and "151" on the other side.
Each tablet contains solifenacin succinate 10 mg.
Excipients/Inactive Ingredients: UTOCARE Tablets 5mg: Lactose Hydrate, Lactose Hydrate (Flowlac 100), Pregelatinized Starch, Copovidone, Silicon Dioxide, Magnesium Stearate and Opadry Yellow (03B52293).
UTOCARE Tablets 10mg: Lactose Hydrate, Lactose Hydrate (Flowlac 100), Pregelatinized Starch, Copovidone, Silicon Dioxide, Magnesium Stearate and Opadry Pink (03B640016).

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

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.
Paediatric population: The safety and efficacy of Utocare in children have not yet been established. Therefore, Utocare 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). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg once daily.
Patients with hepatic impairment: 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.
Potent inhibitors of cytochrome P450 3A4: The maximum dose of Utocare should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors e.g. ritonavir, nelfinavir, itraconazole.
Method of administration: UTOCARE should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.

Solifenacin is contraindicated in: Patients with urinary retention, severe gastrointestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions; Patients hypersensitive to the active substance or to any of the excipients; Patients undergoing haemodialysis; Patients with severe hepatic impairment; Patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole.

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Utocare. If urinary tract infection is present, an appropriate antibacterial therapy should be started.
UTOCARE 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; severe renal impairment (creatinine clearance ≤ 30 ml/min) (doses should not exceed 5 mg for these patients); moderate hepatic impairment (Child-Pugh score of 7 to 9) (doses should not exceed 5 mg for these patients); concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole; 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, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
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 UTOCARE can be determined after 4 weeks at the earliest.

Store below 25°C.
Shelf-life: 3 years (36 months from the manufacturing date).

Drugs for Bladder & Prostate Disorders

G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.

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