Vibrocil - instructions for use, dose, side effects, contraindications

Active substanceDimethinden + PhenylephrineDimethinden + Phenylephrine

Similar drugsTo uncover

Vibrocil®

gel nazal.

GlaxoSmithKline Helsker, ZAO Russia

Vibrocil®

drops nazal.

GlaxoSmithKline Helsker, ZAO Russia

Vibrocil®

spray nazal.

GlaxoSmithKline Helsker, ZAO Russia

Dosage form: & nbspnasal drops

Composition:

Active substances: phenylephrine 2.5 mg, dimethindene maleate 0.25 mg.

Excipients: benzalkonium chloride 50% solution (in terms of benzalkonium chloride) 0.2 mg (0.1 mg), citric acid monohydrate 2.6 mg, sodium hydrophosphate 4.4 mg, sorbitol 35 mg, lavender oil 0.2 mg, water up to 1 ml.

Description:Transparent solution from colorless to slightly yellow with a faint smell of lavender.

Pharmacotherapeutic group:Antiallergic combination drug (H1-histamine receptor blocker + alpha-adrenomimetic)

ATX: & nbsp

A.01.B.A.53 Phenylephrine in combination with other drugs

Pharmacodynamics:

Vibrocil® is a combined preparation containing phenylephrine and dimethindene. Phenylephrine - sympathomimetic agent, with local application has a moderate vasoconstrictive effect (due to the stimulation of alpha1-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminates the edema of the nasal mucosa and its adnexal sinuses.

Dimethinden is an antiallergic agent, an antagonist of histamine H1 receptors; does not reduce the activity of the ciliated epithelium of the nasal mucosa.

Pharmacokinetics:

Vibrocil® is for topical use, and its activity does not depend on the concentration of active substances in the blood plasma.

Indications:Acute rhinitis (including, runny nose with colds); allergic rhinitis (including hay fever); vasomotor rhinitis; chronic rhinitis; acute and chronic sinusitis; acute otitis media (as an auxiliary method of treatment). Preparation for surgical interventions in the nose area and elimination of swelling of the nasal mucosa and accessory sinuses after surgical interventions in this area.

Contraindications:Hypersensitivity to phenylephrine, dimethindene maleate or other components of the drug. Atrophic rhinitis (including, with fetid detachable - ozena). Acceptance of MAO inhibitors (simultaneously or in the previous 14 days). Closed-angle glaucoma. Children up to 1 year.

Carefully:Cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, obstruction neck of the bladder (for example, due to hypertrophy of the prostate glands), epilepsy.

As with any local vasoconstrictor, caution should be exercised when prescribing Vibrocil® to patients with pronounced reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmias, or increase in blood pressure.

Pregnancy and lactation:

Given the potential systemic vasoconstrictor effect of phenylephrine, Vibrotsil® not recommended for use during pregnancy and lactation.

Dosing and Administration:

Children under the age of 1 year: it is contraindicated.

Children aged 1 to 6 years (under adults): 1-2 drops in each nasal passage 3-4 times a day.

Children aged 6 to 12 years (under supervision of adults): 3-4 drops in each nasal passage 3-4 times a day.

Adolescents over the age of 12 and adults: 3-4 drops in each bow stroke 3-4 times a day.

Before use, it is recommended carefully clean the nasal passages; buried in the nose, threw back his head. This position of the head is kept for a few minutes.

The drug should not be used continuously for more than 7 days. If symptoms persist, consult a physician.

Side effects:

Frequency classification side effects (WHO):

very often> 1/10; often from> 1/100 to <1/10; infrequently from> 1/1000 to <1/100; rarely from> 1/10000 to <1/1000; rarely from <1/10000, including individual message.

From the respiratory system:

Rarely: discomfort in the nose, dry nose, nosebleeds.

Local reactions:

Rarely: burning in the area of application.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:Overdose with Vibrocil® can cause sympathomimetic effects, for example, heart palpitations, premature contraction of the ventricles of the heart, headache in the neck, tremor, fatigue, increased blood pressure, emotional arousal, insomnia, pale skin. The drug can also cause mild sedation, dizziness, a feeling of pain in the stomach, nausea, vomiting.

Treatment: the use of activated carbon, laxatives in children younger age; in adults and children older than 6 years - reception of a large amount of liquid. There is no specific antidote.
Increased arterial pressure caused by phenylephrine, can be eliminated by the use of alpha-blockers.

Interaction:

Phenylephrine (as well as others vasoconstrictor) contraindicated in patients receiving MAO inhibitors at this time or received them within 2 previous weeks. Do not prescribe a drug simultaneously with tri- and tetracyclic antidepressants, beta-adrenoblockers.

Special instructions:

Vibrocil® should not be used continuously for more than 7 days without consulting your doctor. Prolonged or excessive use of the drug may cause tachyphylaxis and effect "rebound" associated with a second development of nasal congestion (drug rhinitis), lead to development of systemic vasoconstrictive action.

Do not exceed recommended doses of Vibrocil®! Otherwise In case of possible development of manifestations systemic effects of the drug, especially in children and elderly patients.

Children under the age of 6 years use only drops in the nose.

Vibrocil® does not have a sedative effect (does not affect the rate of psychomotor reactions).

Effect on the ability to drive transp. cf. and fur:Does not affect.

Form release / dosage:Nasal drops of 15 ml.

Packaging:In a bottle of dark glass with a screw cap, a pipette. The bottle together with the instruction for use is placed in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:3 of the year. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N015192 / 03

Date of registration:07.08.2008 / 16.03.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

NOVARTIS CONSUMER HEALTH, S.A. Switzerland

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp09.01.2017

Illustrated instructions

Instructions

Vibrocil® (Vibrocil®)