Solifenacin film-coated tablets 5 mg No. 100

Solifenacin Xanthine tablets are used for the symptomatic treatment of urge incontinence and/or frequent urination, as well as the urge to urinate, typical of patients with overactive bladder syndrome.

Composition

The active substance is solifenacin succinate (one tablet contains 5 mg of solifenacin succinate).

Excipients: lactose monohydrate, corn starch, hypromellose, magnesium stearate; shell composition: Opadry yellow 03F12967 (hypromellose, talc, macrogol 8000, titanium dioxide (E 171), iron oxide yellow (E 172)).

Contraindication

The drug is contraindicated:

Method of application

Adults, including the elderly: The recommended dose is 5 mg once daily. If necessary, the dose may be increased to 10 mg once daily.

"Solifenacin Xanthine" should be taken orally, swallowing the tablets whole with liquid, regardless of meals.

Application features

Pregnant women

There are no clinical data on women who became pregnant while taking solifenacin. Animal studies do not indicate direct adverse effects on fertility, embryonal/fetal development or parturition. The potential risk is unknown. Caution should be exercised when using this drug in pregnant women.

The use of the drug "Solifenacin Xanthine" is not recommended during breastfeeding.

Children

The safety and effectiveness of the drug in children have not been studied, therefore Solifenacin Xanthine should not be prescribed to this category of patients.

Drivers

Due to the fact that solifenacin, like other anticholinergic drugs, can cause blurred vision and rarely drowsiness and increased fatigue, taking the drug may adversely affect the ability to drive a car and other mechanisms.

Overdose

Symptoms

Overdose of solifenacin succinate can lead to severe anticholinergic effects. The highest dose of solifenacin succinate accidentally taken by one patient was 280 mg over 5 hours, and mental status changes were observed that did not require hospitalization.

Treatment

In case of overdose with solifenacin succinate, the patient should be given activated charcoal. Gastric lavage may be useful if given within one hour of ingestion, but vomiting should not be induced.

Side effects

"Solifenacin Xanthine" may cause side effects associated with the anticholinergic effect of solifenacin, which are usually mild or moderate. Their frequency depends on the dose of the drug. The most common side effect is dry mouth, which was observed in 11% of patients receiving a dose of 5 mg per day, in 22% of patients receiving 10 mg per day, in 4% of those receiving placebo. The severity of dry mouth was usually mild and only in rare cases led to discontinuation of treatment. In general, the drug was quite well tolerated (about 99%), and approximately 90% of patients took the drug for the full study period, which lasted 12 weeks.

Storage conditions

The medicine does not require any special storage conditions. Keep out of the reach of children.

Shelf life - 4 years.