Description
Description
Nasal drops in the form of a clear solution from colorless to slightly yellow in color, with a faint smell of lavender.
Release form
Nasal drops 15 ml in a dark glass bottle with a screw-on pipette cap.
The bottle, along with instructions for use, is placed in a cardboard box.
On the secondary packaging, a first opening control is allowed.
Pharmacological action
Vibrocil ® is a combined preparation containing phenylephrine and dimethindene.
Phenylephrine is a sympathomimetic, with local application it has a moderate vasoconstrictor effect (due to the stimulation of 1-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminates swelling of the nasal mucosa and sinuses.
Dimethinden is an antiallergic agent – an antagonist of histamine H1 receptors does not reduce the activity of ciliated epithelium of the nasal mucosa.
Indications
Acute rhinitis (including for colds)
allergic rhinitis (including with hay fever)
vasomotor rhinitis
chronic rhinitis
acute and chronic sinusitis
acute otitis media (as an adjuvant)
preparation for surgical interventions in the nose and elimination of swelling of the nasal mucosa and sinuses after surgery.
Contraindications
hypersensitivity to the components of the drug
atrophic rhinitis (including those with offensive discharge – ozena)
simultaneous administration of MAO inhibitors and the period up to 14 days after their cancellation
children under 6 years of age
pregnancy and lactation.
Precautions: for cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), thyroid diseases, angle-closure glaucoma, benign prostatic hyperplasia, and insulin-dependent diabetes mellitus.
Caution: in patients with severe reactions to sympathomimetics, such as insomnia and dizziness.
Use during pregnancy and lactation
Given the possible systemic vasoconstrictor effect, Vibrocil ® is not recommended for use during pregnancy and during lactation (breastfeeding).
Special instructions
Vibrocil should not be used for more than 1 week without consulting a doctor. Long-term (more than 2 weeks) or excessive use of the drug, exceeding the recommended doses can cause tachyphylaxis and drug rhinitis, leading to the development of systemic vasoconstrictor action.
Do not exceed recommended doses of vibrocil. Otherwise, symptoms of the systemic effect of the drug may occur.
Use in pediatrics. Used in children under 6 years of age.
Influence on the ability to drive vehicles and control mechanisms. Vibrocil does not have a sedative effect (does not affect the speed of psychomotor reactions).
Composition
Active substances:
Phenylephrine 2.5 mg
Dimethindene maleate 250 mcg.
Excipients:
Benzalkonium chloride 50% solution (in terms of benzalkonium chloride) – 0.2 mg (0.1 mg)
Citric acid monohydrate – 2.6 mg
Sodium hydrogen phosphate – 4.4 mg
Sorbitol – 35 mg
Lavender oil – 0.2 mg – up to 1 ml.
Dosage and administration of
For children under 1 year of age: contraindicated.
For children aged 1 to 6 years (under adult supervision): 1-2 drops in each nasal passage 3-4 times / day.
For children aged 6 to 12 years (under adult supervision): 3-4 drops in each nasal passage 3-4 times / day.
Adolescents over the age of 12 years and adults: 3-4 drops in each nasal passage 3-4 times / day.
Before use, it is recommended that the nasal passages be thoroughly cleaned, instilled into the nose, head thrown back. This position of the head is maintained for several minutes.
The drug should not be used continuously for more than 7 days. If symptoms persist, consult a physician.
Side effects
Local reactions: burning sensation and dryness of the nasal mucosa.
Drug Interactions
The drug should not be given simultaneously with tricyclic antidepressants or antihypertensive drugs, such as beta-blockers.
overdose
Symptoms: There are no serious side effects when accidentally taking Vibrocil in young children. In most cases, there were no symptoms of overdose, however, symptoms such as fatigue, stomach pain, tachycardia, hypertension, agitation, insomnia, pallor of the skin (sometimes in children with accidental ingestion) have sometimes been reported.
Treatment: Activated charcoal and possibly laxative (gastric lavage is not required) for adults and children over 6 years of age have shown the introduction of a large amount of fluid. There is no specific antidote.
Storage conditions
The product should be stored out of the reach of children, at temperatures not exceeding 30 ° C.
Shelf life
3 years.
dosage form
nasal drops
Appointment Appointment
Adult, For children from birth
Novartis Farma Stein AG, Switzerland
