APPLICATION INSTRUCTION
NEOZOLIN

GENERIC NAME: Xylometazoline;
DRUG FORM:
0,1% and 0,05% nasal drops.
0,1% and 0,05% nasal spray.
PHARMACOLOGICAL GROUP: Alfa-adrenomimetic means.
COMPOSITION:
1 ml of “Neozolin” nasal drops and spray contains:
Xylomethazolin hydrochloride – 1mg (0,1% solution) or 0,5 mg (0,05% solution);
Excipients: Benzalkonium chloride or Nipagin, edetate disodium, sodium chlorides, sodium dihydrogen dehydrate, sodium hydrophosphate anhydrous, distilled water.
PHARMACOLOGICAL OPERATION:
Pharmacodynamics: Xylomethazolin belongs to local vasoconstrictor means with Alfa-adrenomimetic activity (nonselective Alfa-adrenomimetic). It causes nasal mucosa vessels constriction, reduces nose and gullet mucous tunic edema, hyperemia, exudation. Restores nasal patency and facilitate nasal breath at time of cold. In therapeutic concentration doesn’t irritate mucous, doesn’t cause a hyperemia. Action of the preparation starts in a few minutes and proceeds within several hours (4-5 h). Long use of preparation (more than 2 weeks) may cause secondary expansion of blood vessels (medicamentous rhinitis), decrease of arterial pressure, which is related to the irritation of presynaptic alfa2-adrenoreceptors of brain vessels moving center, mediators excretion lowering and reduction of sympathetic impulses streams of the central nervous system.
Pharmacokinetics: At time of local use it isn’t absorbed practically and has no systemic operation.
INDICATIONS: IT IS USED IN COMPLEX THERAPY, AS AN AID MEAN:
· Acute infectious rhinitis;
· Acute allergic rhinitis;
· Acute respiratory disease with rhinitis symptoms;
· Pollinosis;
· Sinusitis;
· Middle ear inflammation (in complex therapy for reduction of rhinopharynx mucous membrane edema);
· For the sick preparation to carry out rhinoscopy.
CONTRAINDICATIONS:
· Hypersensitivity toward compound components or acting substances;
· Pregnancy and lactation period;
· Arterial hypertensia;
· Tachycardia;
· Expressed atherosclerosis;
· Surgical interventions on brain covers (in the anamnesis);
· Atrophic rhinitis.
ORDER OF INTAKE AND DOSAGE: “Neozolin” is used intranasal;
0,05% nasal drops for children from 2 to 12 years:
Children from 2 to 6 years – 1-2 drops in each nostril, 1-2 times in a day (not more than 3 times in a day);
Children from 6 to 12 years – 1-3 drops in each nostril, 2-3 times in a day (not more than 3 times in a day);
0,1% nasal drops is used in adults and children more than 12 years: 2-3 drops in each nostril (not more than 3 times in a day);
0,05% nasal spray is used for children from 6 to 12 years: 1 spray in each nostrils 1-3 times in a day.
0,1% nasal spray is used for adults more than 12 years: 1 spray in each nostrils 2-3 times in a day.
Preparation is used not more than 7 days.
SIDE EFFECTS: “Neozolin’s” frequent and/or long application has following side-effects: irritation of rhinopharynx mucous membrane, dryness, and feeling of burning, sneezing, hypersecretion. Seldom – nasal mucous membrane edema, increase of arterial pressure, arrhythmia, dizziness, headaches, nausea, sleep disturbance; depression (at time of long application with great doses).
SPECIAL INSTRUCTIONS: “Neozolin” is prescribed carefully at time of diabetes mellitus, and also to those patients, having hypersensitivity toward adrenergic means.
Its long use isn’t recommended. The vial is intended for individual use. It isn’t allowed to transfer to other persons, for the purpose of avoiding possible spread of infection.
PREGNANCY AND LACTATION: Use of “Neozolin” during pregnancy and lactation isn’t recommended. It is possible to intake only if the expected effect for mother sharply exceeds potential risk of negative impact on the fetus.
INTERACTION WITH OTHER MEDICINES OR OTHER SORT INTERACTION: “Neozolin” isn’t used with tricyclic antidepressant, MAO inhibitors and sympathetic nervous system exciting preparations, as it may cause increase of arterial pressure.
OVERDOSE:
Symptoms: Reinforce of side effects;
Treatment: Treatment is symptomatic.
INFLUENCE OF VEHICLE AND MECHANISMS MANAGEMENT SKILL: “Neozolin” may influence on vehicle and mechanisms management skill. So, patients whose activity needs attention concentration and quick psychomotor action should be careful.
PACKAGE: 10 ml in a transparent or white polymeric material vials with a dropper. The vial is placed in a cardboard box with instruction.
15ml in polymeric material vials with sprayer and protective cover. The vial is placed in a cardboard box with instruction.
STORAGE CONDITIONS: Store on 15-25ºC temperature in a dry, protected from light place and keep away from children.
After opening the bottle preparation is fit for the 1st month.
In case of visual defects and expiry of validity date, the preparation can not be used.
ISSUE: III group of a pharmaceutical product – issued without a prescription.
SHELF LIFE: 10 ml drops in a transparent or white polymeric material vials – shelf life 3 years. 15ml solution in polymeric material vials with sprayer – shelf life 2 years.
MANUFACTURER: “Neopharmi” Ltd.

12th km David Agmashenebeli alley, Tbilisi, Georgia
Tel/Fax: +995 (032) 259-64-46; 259-57-90.