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Active substance: Darifenacin

ATX Code

G04BD10 Darifenacin

Pharmacological group

Antispasmodics [Spazmolitiki myotropic]

The nosological classification (ICD-10)

F98.0 Enuresis inorganic nature

Urinary incontinence., Urinary incontinence etiology nonhormonal, Urinary incontinence inorganic etiology, Functional enuresis in children, Children's enuresis

N31.1 Reflex neuropathic bladder, not elsewhere classified

hyperreflexia, Overactive Bladder, detrusor hyperreflexia, detrusor hyperreflexia

N39.3 Involuntary urination

Urinary incontinence in women, Anishuriya, Urinary incontinence

N39.4 Other specified types of urinary incontinence

Urinary incontinence, Bed-wetting, Frequent nocturnal urination, Urinary incontinence in women, Anishuriya, Primary nocturnal enuresis, Primary nocturnal enuresis in children

R32 Urinary incontinence unspecified

daytime enuresis, Idiopathic bladder instability, Urinary incontinence, nocturia, The disorder of the bladder sphincter function, Spontaneous urination, Mixed forms of urinary incontinence, Functional disorders of micturition, Functional micturition disorders, Functional enuresis in children, Enuresis

R39.1 Other difficulties with micturition

Frequent urination, urinary retention, strangury, Obstructed flow of urine, Violation of urination, Violation of urination, Violation of bladder emptying, Violation of the outflow of urine, Frequent urination, Abnormalities of urination

Sustained-release tablets, film-coated Table 1.

darifenacin hydrobromide 8.929 mg

17.858 mg

(Corresponds to 7.5 mg darifenacin or 15 bases)

excipients: calcium dihydrogen phosphate; Valium; magnesium stearate

coated tablets: hypromellose 2910; polyethylene glycol 4000; talc; titanium dioxide (E171); for tablets, sustained-release, film-coated, 15 mg (optional) - Iron oxide yellow (E172); iron oxide red (E172)

in blister 7 or 14 pcs .; In the paper cartons 1, 2 (7 pcs.) or 1, 2, 4, 7 (14 pcs.) blisters.

pharmachologic effect

antispasmodic, myotropic.

Dosing and Administration

Inside, swallowed whole, without chewing, not sharing or crush.

The drug should be one time per day, with some liquid, regardless of the meal.

For adult patients, the recommended initial dose - 7.5 mg / day.

With insufficient therapeutic effect of the dose can be increased to 15 mg / day. Dose escalation should be performed 2 weeks after initiation of therapy based on the patient's individual response to treatment.

Elderly patients. Elderly patients correction dose is not required.

Use in impaired renal function. In patients with impaired renal function dose adjustment is required.

Application for violations of liver function. In patients with moderate liver function impairment (class B on a scale Child-Pough) should not exceed a daily dose of 7.5 mg Enableks.

Conditions of supply of pharmacies

On prescription.

Storage conditions

In the dark place at a temperature no higher than 30 C.

Keep out of the reach of children.

The shelf

3 years.

Do not use beyond the expiration date printed on the package.

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