Description
Instructions for medical use of
Nazol® Kids
Trade name:
Nazol® Kids
International nonproprietary name
Phenylephrine
Dosage form
Nasal spray
Composition
1 ml of solution contains:
Active substance:phenylephrine hydrochloride 2.5 mg;
Adjuvants: benzalkonium chloride, cineol (eucalyptol), glycerol, macrogol 1500, disodium hydrophosphate dihydrate, potassium dihydrophosphate, disodium edetate dihydrate, purified water.
Description
Transparent solution, colored from colorless to light yellow, with a faint smell of eucalyptus
Pharmacotherapeutic group
Anti-congestants and other nasal preparations for topical use.
Sympathomimetics. Phenylephrine.
Code АТХ R01AA04
Pharmacological properties
Phenylephrine hydrochloride is an agonist of α1-adrenergic receptors (sympathomimetic), making a vasoconstrictor effect at the expense of stimulation α1-receptors in the mucous membranes of the nose.
Phenylephrine hydrochloride reduces swelling of the mucous membranes and tissue hyperemia, softens edema and congestion in the nasal cavity, and improves the permeability of the nasal respiratory tracts.
Eucalyptol has a stimulating effect on the receptors of the mucous membranes; it has local anti-inflammatory and antiseptic activity, protects the mucous membrane of the nasal passages from excessive drying.
Glycerin softens and moistures the irritated mucous membrane of the nasal cavity.
The drug acts after 3-5 minutes and lasts about 6 hours.
Indications
It facilitates breathing via the nose and provides local antiseptic action:
- at colds, flu
- hay fever or other allergic diseases of the upper respiratory tracts, accompanied by acute rhinitis or sinusitis
- acute otitis media (as an aid to reduce swelling of the nasopharyngeal mucosa)
Dosage and methods of use
Spray into each nasal passage; do not throw your head back at spraying.
Children from 4 to 6 years old: per 1-2 sprays into each nostril 3 times a day;
Children from 6 to 12 years old: per 2-3 sprays into each nostril 3 times a day.
The solution is released from the bottle in the form of a spray at compressing the vertical position of the bottle.
After use, wipe the nozzle on the bottle.
Do not exceed the recommended dosage regimen.
To continue the treatment lasts for not more than 3 days.
Side effect
At local use, phenylephrine is well tolerated and, if the side effects occur, they are always mild and short-term.
The following is possible:
- burning, sneezing, nose tingling
- – allergic reactions (itching or urticaria, swelling of the hands, face or throat, chest tightness, breathing problems)
- headache, dizziness, anxiety
- arrhythmia and hypertension
Contraindications
The drug is contraindicated for patients:
- with increased individual sensitivity to the ingredients of the drug
- with severe type of hypertension
- with acute cardiovascular diseases
- tachyarrhythmia
- with severe thyrotoxicosis
- with diabetes
- after transsphenoidal hypophysectomy
- in case of inflammation of the skin or mucous membrane of the nasal vestibule andformation of a crust (dry rhinitis);
- in patients receiving MAO inhibitors or patients receiving them for the previous 2 weeks
- children up to 4 years old
Drug interaction
Do not intake together with other drugs containing local vasoconstrictors or antihypertensive agents.
Using simultaneously with monoamine oxidase inhibitors (MAO) or within 14 days after treatment, phenylephrine can result to the increased blood pressure. It is not recommended to intake phenylephrine together with linezolid.
Special indications
It is not recommended to use the drug for treatment of children under 4 years
The phenylephrine-nasal containing sprays drug should be used with caution in patients with cardiovascular disease, hypertension, hyperthyroidism, angle-closure glaucoma, diabetes. These patients should ask for advice of a doctor before use.
The drug should be taken under supervision of adults.
If children under 12 years old demonstrate nervousness, dizziness or insomnia, discontinue use of the drug and consult a doctor.
The treatment duration is not more than 3 days. If the symptoms persist, you should consult a doctor.
It is recommended to use the Individual vial to avoid the spread of infection.
Pregnancy and lactation
The drug is intended for children. Data on the use during pregnancy and lactation are not available.
Features of the drug effect upon the ability to drive a car or potentially dangerous mechanisms. It does not cause effects.
Overdosage
Overdose at local nasal use sometimes results to such systemic effects as increased heart rate (tachycardia) and increased blood pressure, excitement. In case of overdose, it is necessary seek medical aid.
Treatment: symptomatic.
Form of output and packing
Per 10 ml in bottles made of high-density polyethylene, equipped with a dispenser with a polypropylene dispenser and a polyethylene lid.
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
2 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
