12 August

Vesicare - instructions for use , indications, dosage

Vesicare - a drug that reduces the tone of smooth muscles of the urinary tract, is used for the treatment of urological diseases.

release form and composition

dosage form - tablets, film-coated: round, convex on both sides, light yellow (tablets 5 mg) or light pink (tablets 10 mg) colors with the company logo and labeled "150"(5 mg tablets) or" 151 "(10 mg tablets) on one side (10 pcs. in a blister pack in a cardboard blister 1 or 3).

active substance of Vesicare: solifenacin succinate in the tablet 1 - 5 or 10 mg.

Valium Valium 3 mPa × s, corn starch, magnesium stearate, lactose monohydrate.Composition

coating film 5 mg tablets: Opadry Yellow 03F12967 (macrogol 8000, talc, Hypromellose 6 mPa × sec, titanium dioxide and iron oxide yellow).Composition

film coating of 10 mg tablets: Opadry pink 03F14895 (macrogol 8000, talc, Hypromellose 6 mPa × sec, titanium dioxide and red iron oxide).


Vesicare is used to treat an imperative (Urge), urinary incontinence, imperative (urg

ent) urge to urinate and frequent urination - features characteristic syndrome overactive bladder.

Contraindications Absolute:

  • Severe hepatic impairment;
  • moderate hepatic impairment, if necessary, the simultaneous application of inhibitors of CYP3A4 (eg, ketoconazole);
  • Severe gastrointestinal diseases (including toxic megacolon);
  • Urinary retention;
  • -closure glaucoma;
  • severe renal insufficiency;
  • hemodialysis;
  • Myasthenia gravis;
  • rare hereditary disorders of galactose tolerance, Lapp lactase deficiency (Sami), glucose-galactose malabsorption;
  • the age of 18;
  • Lactation;
  • hypersensitivity to the drug.

Relative (use of the drug is possible, but with extreme caution because of the risk of complications):

  • Clinically significant obstruction of the bladder outlet, fraught with the development of urinary retention;
  • Gastrointestinal obstructive disorders (including food stagnation in the stomach);
  • downside motility of the gastrointestinal tract;
  • Severe renal (creatinine clearance ≤30 mL / min) and moderate hepatic (7-9 points on a scale Child-Pugh) failure (for these patients the dose of Vesicare should not exceed 5 mg);
  • simultaneous use of a potent inhibitor of the isoenzyme CYP3A4 (eg, ketoconazole);
  • Hiatal hernia, gastroesophageal reflux disease;
  • Concomitant use of drugs that can cause or exacerbate esophagitis (such as bisphosphonates);
  • autonomic neuropathy;
  • presence of risk factors such as hypokalemia, or long QT syndrome interval;
  • Pregnancy.

Dosage and Administration

Vesicare should be taken orally, swallowing pills entirely and drinking plenty of fluids, regardless of meals.

At the beginning of the treatment of adult patients administered 5 mg 1 time per day.If necessary to increase the dose of 10 mg 1 time per day.

Side effects

  • digestive system: often (& gt; 1/100, & lt; 1/10) - dyspepsia, nausea, abdominal pain, constipation;infrequently (& gt; 1/1000, & lt; 1/100) - dry throat, gastroesophageal reflux disease;rare (& gt; 1/10 000, & lt; 1/1000) - coprostasia, intestinal obstruction;very rare (& lt; 1/10 000, including isolated cases) - decreased appetite *, vomiting *, increased liver enzymes * * hyperkalemia;
  • Urinary system: rare - difficulty urinating, urinary tract infection;rarely - acute urinary retention;very rarely - renal failure *;
  • Central nervous system: rarely - a violation of taste (dysgeusia), drowsiness, rarely - headache and dizziness * *;
  • Psychiatric disorders: very rarely - drowsiness, * confusion *, * delirium, hallucinations *;
  • Authority of view often - accommodation disturbance (blurred vision);Infrequent - dry eye;
  • Respiratory system: Infrequent - dry mucous membranes of the nasal cavity;
  • Cardiovascular system: lengthening of the interval QT *, tachycardia for "pirouette" type *;
  • Skin and subcutaneous tissue: rare - dryness of the skin;very rare - rash *, pruritus *, rash *, exfoliative dermatitis *, erythema multiforme *, angioedema *;
  • Allergic reactions: anaphylactic reactions *;
  • Other: rarely - swelling of the lower limbs, fatigue.

* - these side effects have been observed in the post-registration period of the drug.of these data were obtained by spontaneous reports, and therefore the determination of frequency and the causal relationship of these reactions with taking Vesicare difficult.


Vesicare Before the appointment the patient must undergo a full medical examination to determine if there are any other causes urination disorders, such as kidney disease or heart failure.In the case of diagnosis of urinary tract infection prescribe appropriate antimicrobial therapy.

solifenacin, like other m-holinoblokatory can cause blurred vision, fatigue and drowsiness.For this reason, the period of treatment should be particularly careful when driving and occupation of potentially hazardous activities that require speed psychophysical reactions and the high concentration of attention.

Drug Interactions

Vesicare reduces the effectiveness of drugs that stimulate the motility of the gastrointestinal tract (eg, metoclopramide and cisapride).

In case of simultaneous use of ketoconazole in a daily dose of 200 mg solifenacin total concentration in the blood plasma increases by 2 times, when receiving ketoconazole in a daily dose of 400 mg - 3 times.If necessary, use Vesicare concurrently with ketoconazole or other inhibitors of CYP3A4 (such as nelfinavir, ritonavir, itraconazole) the dose should not exceed 5 mg / day.This combination is contraindicated in patients with moderate hepatic impairment and severe renal insufficiency.Given that solifenacin metabolized by CYP3A4, can not be excluded and pharmacokinetic interactions with other CYP3A4 substrates with higher affinity (diltiazem, verapamil), as well as inducers of CYP3A4 (phenytoin, rifampin, carbamazepine).

should be borne in mind that the Vesicare, like all drugs with m-anticholinergic properties may affect the validity of any simultaneously used drugs, including the severity of their side effects.Before starting treatment with another M-anticholinergics, after taking solifenacin should be done a week break.

therapeutic effect of Vesicare can reduce M-cholinomimetics.

Terms and conditions of storage

Store at temperatures up to 25 ° C out of reach of children.

Shelf life - 3 years.

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