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Instructions for medical use of
Nazol® Advance
Trade name:
Nazol® Advance
International nonproprietary name
Oxymetazoline
Dosage form
Nasal spray
Composition
1 ml of solution contains:
Active substance:oxymetazoline hydrochloride 0.5 mg;
Adjuvants: levomenthol, racemic camphor, cineole (eucalyptole), benzalkonium chloride, polysorbate 80, propylene glycol, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, disodium edetate dihydrate, concentrated hydrochloric acid, purified water.
Description
Transparent solution, colored from colorless to light yellow, with a faint smell of menthol, eucalyptus and camphor.
Pharmacotherapeutic group
Nasal preparations. Anti-congestants and other nasal preparations for local use.
Sympathomimetics. Oxymetazoline.
Code АТХ R01AA05
Pharmacological properties
Oxymetazoline hydrochloride is a synthetic adrenomimetic. Stimulating
Nasal breathing reliefs in 5-10 minutes after spraying into the nasal cavity and lasts about 12 hours.
Menthol, camphor, eucalyptol have a local anti-edema, anti-inflammatory, antiseptic effect, dilute the thick mucus and improve its outflow from the paranasal sinuses, as well promote prolongation of the drug effect.
Glycols contained in the drug soften the irritated mucous membrane of the nasal cavity and protect it from excessive drying.
Indications
Difficult nasal breathing at colds, influenza, acute respiratory virus diseases, hay fever, allergic rhinitis, sinusitis; additional treatment for inflammation of the eardrum infection.
Dosage and methods of use
Shake well before use.
Spray into each nostril; do not throw your head back at spraying. Hold the bottle upright.
Adult and children older than 10 years old: per 2 sprays into each nostril.
Children at the age from 6 to 10 years old (under supervision of the adults): per 1 spray.
To repeat spraying no earlier than in 12 hours.
The treatment duration should not exceed 7 days. At prolongation of treatment, it is necessary to consult of a doctor.
Side effect
Usually oxymetazoline is well tolerated and if the side effects occur, side effects, if revealed, are always mild and short-term.
The following is possible:
Contraindications
The drug is contraindicated for patients:
Drug interaction
Simultaneous or immediate use of the tricyclic antidepressants or MAO-inhibitors before using oxymetazoline can result to hypertension.
Special indications
It is recommended to use the individual vial to avoid the spread of infection.
The oxymetazoline containing nasal sprays should be used with caution in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes mellitus or complicated urination due to prostatic hyperplasia.These patients should ask for advice of a doctor before use. Long-term use of the drug may result to a return of stuffiness in nose.
The treatment duration should not exceed 7 days, if a doctor has not been appointed it otherwise.
Pregnancy and lactation
Oxymetazoline has not been associated with an adverse pregnancy termination. It is not recommended to exceed dosage. The patient should use the drug only after consultation with a doctor. The patients with hypertension or signs of reduced placental blood flow should use the drug with caution. Frequent or prolonged use of high doses may reduce placental blood flow.
Data regarding the discharge of oxymetazoline with breast milk are absent, therefore the nasal spray should not be used during breast-feeding.
Features of the drug effect upon the ability to drive a car or potentially dangerous mechanisms.
It does not cause effects.
Overdosage
Exceeding the recommended dose may cause pain or burning, sneezing, and increase excretion from nostrils. There may be tachycardia (increased heart rate), arrhythmia, cardiac arrest, increased blood pressure, pulmonary edema, shortness of breath, mental disorders at excessive doses, especially with long-term use.
Besides,the drug may cause suppress of the Central nervous system functions, such as drowsiness, fever, bradycardia (heart rate reduction), shock-like hypotension, respiratory arrest and loss of consciousness.
At overdose in children, it is possible:
Treatment: symptomatic.
Packaging
Per 10 ml bottles made of high-density polyethylene, equipped with a white polypropylene twist-on lid.
The spraying device is mounted in the upper cone-shaped part of the bottle.
A label made of self-adhesive paper is pasted on the bottle.
Per 1 bottle together with the instruction on medical use in the state and Russian languages are packed together in a cardboard package.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf live
3 years
Do not use after the expiration date.
Conditions for drug supply
Without a prescription.
Manufacturer / packer
Istituto de Angeli S. r. l.,
50066 Reggello (Florence), Lock. Prulli 103/c, Italy.
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name, address and contact details of the organization in the territory of the Republic of Kazakhstan accepting claims (offers) from consumers concerning the drug quality:
“Bayer KAZ” LLP
Timiryazev Street, 42, Pav. 15, office 301
050057 Almaty, Republic of Kazakhstan
Tel: +7 727 258 80 40
Fax.: +7 727 258 80 39
e-mail: kz.claims@bayer.com
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
“Bayer KAZ” LLP
Timiryazev Street, 42, Pavilion 15, office 301
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – 24 hours
Tel.: +7 727 258 80 40 (106) – during working hours
Fax.: +7 727 2588 039
e-mail: pv.centralasia@bayer.com
