Expiration date: 01/2025

The composition and form of issue:

Spray for nasal use (for kids) 1 FL.

Phenylephrine hydrochloride 2.5 mg

excipients: evkaliptola — 0.4 mg glycerol macrogol sodium hydrogen phosphate potassium dihydrogen phosphate disodium edetate benzalkonium chloride purified water 

in plastic bottles or PE low density with screw cap and sprayer for 15 and 30 ml cartons 1 a bottle.

Description pharmaceutical form:

Transparent colourless or yellowish solution with a faint odor of eucalyptus.

Pharmacokinetics:

The local application of systemic absorption is low.

Description pharmacological action:

Phenylephrine hydrochloride is an agonist of alpha1-adrenergic receptors (sympathomimetic), have a vasoconstrictor effect by stimulating alpha1-receptors in the nasal mucosa. Reduces swelling of mucous membranes and hyperemia of the tissues, congestion in the nasal mucosa, and improves the patency of the nasal Airways.

Indications:

To facilitate breathing through the nose:

• 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
  
• cardiovascular disease (including severe atherosclerosis, angina, tachycardia)
  
• thyroid disease (hyperthyroidism)
  
• diabetes
  
• hypertension
  
• children up to age 4 years.
  

Application of pregnancy and breast-feeding:

Sufficient experience in use of the drug during pregnancy is not.

Use during pregnancy and lactation only if the potential benefit to the mother outweighs the potential risk to the fetus and child.

Side effects:

Local reactions: sometimes — burning sensation, tingling or tingling in the nose.

Systemic effects: headache, dizziness, palpitations, arrhythmia, increased blood pressure, sweating, pallor, tremor, sleep disturbance.

Drug interactions:

MAO inhibitors (procarbazine, selegiline), tricyclic antidepressants, maprotiline, guanadrel, guanetidin amplify the Pressor effect and aritmogennosti Phenylephrine (with systemic absorption).

When systemic absorption Phenylephrine thyroid hormones increase (mutually) the associated risk of coronary insufficiency (especially in coronary atherosclerosis).

Method of application and dose:

The intranasal route.

Children 6 to 12 years — on 2-3 injection in each nasal passage, no more frequently than every 4 hours.

Overdose:

Symptoms: heart rhythm disturbances, increased blood pressure, agitation. In case of overdose you must contact your doctor.

Treatment: symptomatic.

Special instructions:

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

Duration of the drug should not exceed 3 days, while maintaining the difficulty of nasal breathing further use of the drug should be agreed with your doctor.

Should not be administered phenylephrine to patients for 2 weeks after discontinuation of MAO inhibitors because they may increase the severity of adrenergic effects of sympathomimetic agents and increase the risk of side effects from the cardiovascular system.

It is not recommended to use the same bottle for several individuals to prevent the spread of infection.

Upon compression of the bottle in an upright position, the solution is extracted from it in the form of a spray, upon compression of the bottle in an inverted position — in drops.