Composition:

Uromax 5: Each film coated tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin.

Uromax 10: Each film coated tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin.

Each 1 ml oral suspension contains: solifenacin succinate, equivalent to 0.75 mg solifenacin.

Therapeutic indications:

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

Dosage:

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 (age 2 to 18 years):
The recommended dose of solifenacin 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

                         Weight range (kg)                                Starting dose (ml)                             Maximum dose (ml)

                             4                                                           2                                                          9 – 15

                            5                                                            3                                                        > 15 to 30

                           6                                                             3                                                        > 30 to 45

                           8                                                             4                                                        > 45 to 60

                          10                                                            5                                                        > 60

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 solifenacin succinate 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:

Uromax should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.

Presentation:

Uromax 5: A pack of 30 F.C.T.

Uromax 10: A pack of 30 F.C.T.

Glass Bottle contains 100 ml oral suspension.