Nazole Kids - instructions for use, dose, side effects, contraindications

	100 ml contains:	1 dose contains:
active substance:
phenylephrine hydrochloride	0.25 g	0.125 mg
Excipients:
benzalkonium chloride	0.018 g	0.009 mg
eucalyptol (cineole)	0.040 g	0.02 mg
glycerol	4,000 g	2 mg
Macrolith 1500	1,500 grams	0.75 mg
sodium hydrogen phosphate dihydrate	0.226 g	0.113 mg
potassium dihydrogen phosphate	0.101 g	0.0505 mg
disodium edetate dihydrate	0.020 g	0.01 mg
purified water	95.845 grams	47.9225 mg

Description:Transparent solution from colorless to light yellow with a faint odor of eucalyptus.

Pharmacotherapeutic group:Alpha-adrenomimetic

ATX: & nbsp

S.01.F.B.01 Ibopamine

Pharmacodynamics:

The drug for symptomatic local treatment of rhinitis. Phenylephrine hydrochloride is an alpha 1-adrenergic receptor agonist (sympathomimetic), which has a vasoconstrictive effect by stimulating alpha 1 receptors in the mucous membranes of the nasal cavity, reduces mucosal swelling and tissue hyperemia, congestion in the mucosa of the nasal cavity, and improves patency nasal airways. Restoration of air passability of the nasopharynx improves the patient's well-being and reduces the danger of possible complications caused by congestion of the mucous secretion.

Pharmacokinetics:

With topical application, systemic absorption is low.

Indications:

Symptomatic treatment: to facilitate breathing through the nose for colds, flu, hay fever or other allergic diseases of the upper respiratory tract, accompanied by acute rhinitis or sinusitis.

Contraindications:

Increased individual sensitivity to the ingredients of the drug, diseases of the cardiovascular system (including severe atherosclerosis, stenocardia, tachycardia), thyroid disease (thyrotoxicosis), diabetes mellitus,arterial hypertension, simultaneous administration of MAO inhibitors (and also 2 weeks after their cancellation), children's age up to 4 years.

Carefully:

Children's age (up to 6 years).

Pregnancy and lactation:

Not recommended for use during pregnancy and during breastfeeding.

Dosing and Administration:

Intranasally.

1 dose contains 0.125 mg of phenylephrine hydrochloride.

For children aged 4 to 6 years - 1-2 doses per each nasal passage, not more often than every 6 hours; from 6 to 12 years - 2-3 doses in each nasal passage, not more often than every 4 hours.

The duration of treatment without consulting a doctor is no more than 3-5 days.

Side effects:

Local Reactions: a burning sensation, tingling or tingling in the nose, irritation of the mucous membranes of the nasal cavity.

System Effects: headache, dizziness, palpitations, arrhythmia, increased blood pressure, sweating, pallor, tremor, sleep disturbance. Benzalkonium chloride, which is part of the drug, can cause irritation of the mucous membrane of the nasal cavity.

Overdose:

It can be manifested by heart rhythm disturbances, increased blood pressure, agitation.

In case of an overdose, see a doctor. Treatment is symptomatic.

Interaction:

Inhibitors of monoamine oxidase (procarbazine, selegiline), tricyclic antidepressants, maprotiline, guanedrel, guanethidine increase the pressor effect and arrhythmogenicity of phenylephrine (with systemic absorption).

Thyroid hormones with systemic absorption of phenylephrine increase (mutually) associated with it the risk of coronary insufficiency (especially in coronary atherosclerosis).

Special instructions:

In children, the systemic absorption of phenylephrine and the associated risk of side effects are higher than in adults.

The duration of the drug should not exceed 3 days, with the preservation of obstructed nasal breathing, further use of the drug should be agreed with the doctor.

Do not assign phenylephrine patients within 2 weeks after the abolition of monoamine oxidase inhibitors, as they can increase the severity of adrenergic effects of sympathomimetic drugs and increase the risk of side effects from the cardiovascular system.

It is not recommended to use the same vial to several people, in order to avoid the spread of infection.

When the bottle is compressed in the vertical position, the solution is released from it in the form of a spray, when the bottle is compressed in an inverted position, dropwise.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of a negative effect of the drug on the ability to drive and other vehicles. But with the manifestation of symptoms of side effects of the drug should refrain from driving and performing actions that require concentration of attention or psychomotor reactions.

Form release / dosage:

Spray nasal dosed [for children] 0.125 mg / dose.

Packaging:

For 10 ml (150 doses) in a vial of high-density polyethylene with a dispenser, a polypropylene sprayer and a polyethylene protective cap. A label is attached to the bottle. The bottle, along with instructions for medical use, is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000541

Date of registration:05.04.2010 / 20.05.2016

Expiration Date:Unlimited

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

INSTITUTO de ANGELI, S.r.L. Italy

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp29.05.2018

Illustrated instructions

Instructions

Nazol® Kids (Nazol® Kids)