Vesomni Modified Release Tablets are indicated for the treatment of moderate to severe bladder filling symptoms (urge to urinate, more frequent urination) and emptying symptoms (obstructive symptoms) associated with benign prostatic hyperplasia (BPH) in men who have monotherapy is ineffective.
Active ingredients: solifenacin succinate, tamsulosin hydrochloride;
* Macrogol 8000, hypromellose (E 464), red iron oxide (E172), purified water (not present in the finished product).
Hypersensitivity to active ingredients or to any of the excipients.
Hemodialysis.
Severe liver failure.
Severe renal failure, in which powerful inhibitors of cytochrome P450 (CYP) 3A4 are used, such as ketoconazole.
Moderate liver dysfunction, in which potent CYP3A4 inhibitors, such as ketoconazole, are also used.
Severe gastrointestinal diseases (including toxic megacolon), myasthenia gravis or glaucoma and the presence of risks of developing these diseases. A history of orthostatic hypotension.
Adult men, including older men.
Take 1 tablet of the drug Vesomni (6 mg / 0.4 mg) orally once a day, regardless of food intake. The maximum daily dose of the drug Vesomni is 1 tablet (6 mg / 0.4 mg). The tablets must be taken whole, not chewed but not crushed.
Pregnant
Vesomni is not indicated for use by women.
Children
Vesomni is not indicated for use in children.
Drivers
Carefully.
Overdose when using a combination of solifenacin and tamsulosin can potentially lead to a severe anticholinergic effect with the development of acute arterial hypotension.
In case of an overdose of the drug solifenacin and tamsulosin, the patient should take activated charcoal. Gastric lavage within the first hour after taking the drug may be helpful, but vomiting should not be induced.
The drug Vesomni can lead to mild to moderate anticholinergic side reactions. The most common adverse reactions were dry mouth (9.5%), constipation (3.2%), and dyspepsia (including abdominal pain, 2.4%). Other adverse reactions were common, such as dizziness (1.4%), blurred vision (1.2%), fatigue (1.2%), and impaired ejaculation (including retrograde ejaculation, 1.5%). The most serious adverse reaction to the drug that was observed during treatment with Vesomni in clinical trials was acute urinary retention (0.3%, infrequently).
The simultaneous use of tamsulosin with other blockers of alpha 1 - adrenergic receptors can lead to hypotensive effects.
Solifenacin can reduce the effects of drugs that stimulate gastrointestinal motility, such as metoclopramide and cisapride.
Store in its original packaging at a temperature not exceeding 30 ° C.
Keep out of the reach of children!
Shelf life is 3 years.
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