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Dosage form: & nbsppills
Composition:

Active components: dihydroergocryptin αMesylate - 4,00 mg, caffeine - 40,00 mg; Excipients: lactose monohydrate 94.1 mg, microcrystalline cellulose (Avicel PH102) 60.0 mg, magnesium stearate 1.5 mg, anhydrous silicon dioxide colloid (Aerosil 200) 0.4 mg.

Description:

Practically white, round, flat with beveled edge tablets with a risk on one and a stamp "VASOBRAL" on the other side.

Pharmacotherapeutic group:Vasodilator
ATX: & nbsp
  • Ergoloid mesylate in combination with other drugs
  • Pharmacodynamics:

    Combined drug. α-Dihydroergocryptine is a dihydrogenated ergot alkaloid derivative, blocks α1 - and α2-adrenoceptors. It acts dopaminergic, serotonergic, reduces aggregation of platelets and erythrocytes, reduces the permeability of the vascular wall, increases the number of functioning capillaries, improves blood circulation and metabolic processes in the brain, increases the resistance of brain tissue to hypoxia.

    Caffeine has a psychostimulating and analeptic effect, enhances the processes of excitation in the cerebral cortex - increases mental and physical performance, reduces fatigue and drowsiness, increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, and has a diuretic effect.

    Pharmacokinetics:

    When ingested, the absorption of dihydroergocryptin is accelerated in the presence of caffeine (the time to reach the maximum concentration (Tmax) - 0.5 hours).

    After oral administration of 8 mg of a-dihydroergocryptin, the maximum concentration (Cmax) is 227 pg / ml, and the elimination half-life (t1 / 2) is less than 2 hours.

    Indications:
    • Cerebrovascular insufficiency (including due to cerebral atherosclerosis).
    • Consequences of cerebral circulation disorders.
    • Vestibular and labyrinthine disorders (dizziness, tinnitus, hypoacusia) ischemic origin.
    • Ménière's disease.
    Contraindications:Increased individual sensitivity to the components of the drug. Contraindications for long-term use: signs of the presence of heart valve flaws, revealed in echocardiography performed prior to the use of the drug.
    Carefully:
    Pregnancy and lactation:

    There are no clinical data on the use of Vasobral during pregnancy. Use during pregnancy is not recommended.

    The use of the drug in the period of breastfeeding can lead to a decrease in lactation. Application in the period of breastfeeding is not recommended.
    Dosing and Administration:

    Inside (during meals, with a small amount of liquid) 1 / 2-1 tablet 2 times a day. The duration of the course of treatment is 2-3 months, if necessary, treatment courses can be carried out 1-2 times a year.

    Side effects:

    Frequency of occurrence of undesirable phenomena / adverse reactions (A / N) when taking the drug is presented in accordance with the following gradation (classification of the World Health Organization): very often 10 %; often ≥1% and <10%; infrequently ≥0.1% and <1%; rarely ≥0.01% and <0.1%; very rarely <0.01%.

    Disorders from the gastrointestinal tract

    Possible nausea (especially when taking the drug on an empty stomach), gastralgia, dyspepsia, with these manifestations, the drug is not required to be withdrawn.

    Heart Disease

    Rarely: tachycardia, lowering of arterial pressure, heart defects (including defects with blood regurgitation) and associated conditions (pericarditis, effusion into the pericardial cavity).

    Disturbances from the nervous system

    Rarely: dizziness, agitation, headache.

    Immune system disorders

    Rarely: allergic reactions.

    Overdose:

    Overdose can cause vomiting.

    Symptoms of overdose - increased severity of side effects.

    Treatment is symptomatic.

    Interaction:

    With the simultaneous administration of Vasobral and antihypertensive drugs, an additional reduction in blood pressure is possible.

    Caffeine weakens the effect of hypnotics.

    Special instructions:

    Vasobrail has a vasodilating effect, without affecting the systemic blood pressure. The appointment of Vasobral to patients with hypertension does not exclude the need for antihypertensive drugs.

    Contained in the preparation caffeine can cause sleep disturbance, tachycardia.

    It should avoid taking the drug on an empty stomach.

    In patients taking dihydroergocryptine, especially at high doses and for a long time, sometimes the development of effusion into the pericardial cavity and the pleural cavity was reported, as well as the development of pleural and pulmonary fibrosis and constrictive pericarditis. Patients with unexplained pleuropulmonary disorders should be examined and the issue of discontinuing treatment with dihydroergocryptine should be considered.

    There have been reports of rare cases of retroperitoneal fibrosis, especially when high doses are used and with prolonged treatment with dihydroergocryptin. In order to diagnose retroperitoneal fibrosis at a reversible stage, such patients should be regularly observed for clinical signs of retroperitoneal fibrosis (back pain, edema of the lower extremities, renal failure). When diagnosing or suspected fibrotic changes in the retroperitoneal space, treatment with dihydroergocryptin should be discontinued.

    Athletes should be warned that this drug contains a substance that can cause a positive reaction in tests conducted during doping control.

    Effect on the ability to drive transp. cf. and fur:

    The drug in rare cases can cause a decrease in blood pressure, dizziness. If these side effects occur, driving or other potentially hazardous activities is contraindicated.

    Form release / dosage:

    Pills.

    Packaging:For 10 tablets in a blister of PVC / PVDC / aluminum. For 1 or 3 blisters together with instructions for use in a cardboard box.
    Storage conditions:

    At a temperature 15-25 ° C, out of the reach of children.

    Shelf life:

    4 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014499 / 02
    Date of registration:09.12.2009 / 20.05.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Chiesi Pharmaceuticals Ltd.Chiesi Pharmaceuticals Ltd.
    Manufacturer: & nbsp
    Representation: & nbspChiesi Pharmaceuticals Ltd.Chiesi Pharmaceuticals Ltd.
    Information update date: & nbsp10.01.2017
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