Afrin Extra nasal spray with eucalyptus and menthol 0.05%, 15 ml

• Symptomatic therapy of rhinitis (runny nose) of allergic and / or infectious-inflammatory etiology, sinusitis, eustachitis, hay fever.

• Otitis media (to reduce swelling of the nasopharyngeal mucosa).

• To facilitate the outflow of secretions in diseases of the paranasal sinuses. Preparing the patient for diagnostic manipulations in the nasal passages.

Intranasally.

Shake the spray bottle vigorously before each use.

Before using the nasal spray for the first time, it is necessary to УcalibrateФ it by pressing the spray head several times. Adults and children over 10 years old - 1-2 injections into each nasal passage with an interval of 12 hours.

Children from 6 to 10 years old - 1 injection into each nasal passage with an interval of 12 hours.

It is not recommended to exceed the indicated dose.

If symptoms worsen or do not improve within 3 days, a doctor should be consulted.

In the recommended dose, without consulting a doctor, use for no more than 7 days.

With frequent and prolonged use of the drug, the feeling of 'stuffiness' in the nose may reappear or worsen.

If these symptoms appear, you should stop treatment and consult a doctor.

1 ml spray contains

active substance:

oxymetazoline hydrochloride 0.5 mg;

excipients: microcrystalline cellulose and sodium carmellose (Avicel RC-591) 30 mg, sodium hydrogen phosphate 0.975 mg, sodium dihydrogen phosphate monohydrate 5.525 mg, disodium edetate dihydrate 0.3 mg, macrogol-1450 50 mg, povidone-K29-32 30 mg, benzyl alcohol 3 mg, cineole 0.2 mg, camphor 0.2 mg, levomenthol 0.6 mg, benzalkonium chloride solution 17% 1.471 mg, polypropylene glycol 5 mg, purified water qs up to 1.0 ml.

• Hypersensitivity to sympathomimetic drugs or to any component of the drug.

• The use of monoamine oxidase inhibitors within the previous 2 weeks and within 2 weeks after their withdrawal. Angle-closure glaucoma.

• Surgical interventions on the dura mater (in history).

• Condition after transphenoidal hypophysectomy.

• Atrophic (dry) rhinitis.

• Acute cardiovascular disease or acute left ventricular failure.

• Severe uncontrolled arterial hypertension.

• Children under 6 years of age.

Carefully

Disease of the coronary arteries, arrhythmias, chronic heart failure, severe atherosclerosis, arterial hypertension, angina pectoris, arrhythmia, tachycardia, with increased intraocular pressure, hyperthyroidism, diabetes mellitus, chronic renal failure, prostatic hyperplasia with clinical symptoms, pregnancy, lactation period, porphyria, therapy with tricyclic antidepressants, as well as other drugs that increase blood pressure.

pharmachologic effect

Pharmacodynamics
Topical alpha adrenergic stimulant. Has a vasoconstrictor effect. Oxymetazoline causes vasoconstriction of the mucous membranes of the nose, paranasal sinuses and the Eustachian tube, which leads to a decrease in their edema and the release of nasal breathing in allergic and / or infectious-inflammatory rhinitis (rhinitis). Due to the presence in the composition of the drug of excipients (microcrystalline cellulose and sodium carmellose and povidone-K29-32) AfrinЃ extra nasal spray does not flow out of the nose and does not flow down the throat, since after being introduced into the nasal passages the spray becomes more viscous and retains more effective on nasal mucous membranes than standard aqueous solution. Based on published clinical studies, intranasal administration of an aromatic composition,Similar to the formulation containing levomenthol (also known as menthol), cineole (also known as eucalyptus) and camphor, it causes a temporary cooling sensation in the nasal mucosa as a result of interaction with the cold receptors of the trigeminal nerve on the surface of the mucous membrane. According to clinical studies, the drug begins to act within 1 minute, and the effect lasts up to 12 hours.According to clinical studies, the drug begins to act within 1 minute, and the effect lasts up to 12 hours.According to clinical studies, the drug begins to act within 1 minute, and the effect lasts up to 12 hours.

Pharmacokinetics
When used as a nasal spray, oxymetazoline is practically not detected in blood plasma. The half-life of oxymetazoline when administered intranasally is 36 hours. 2.1% of oxymetazoline is excreted by the kidneys and about 1.1% through the intestines.

Application during pregnancy and lactation

The safety of the drug in pregnant women and during lactation has not been established, therefore, the drug should be prescribed to pregnant or breastfeeding women only on the recommendation of a doctor if the expected benefit from using the drug for the mother outweighs the potential risk to the fetus or infant. Caution should be exercised in the presence of arterial hypertension or signs of decreased placental blood flow. Frequent or prolonged use of the drug in high doses can lead to a decrease in placental blood flow.

Side effect

In general, the drug is well tolerated and possible adverse events are usually mild and transient.

From the immune system: allergic reactions, including Quincke's edema, itching.

From the nervous system: nervousness, anxiety, dizziness or lightheadedness, insomnia, drowsiness, trembling, headache, hallucinations (especially in children).

From the senses: blurred vision.

From the side of the cardiovascular system: tachycardia, palpitations, high blood pressure.

From the respiratory system: a burning sensation and tingling in the nasal cavity, sneezing, an increase in nasal discharge, increased nasal congestion, hyperemia, dryness or atrophy of the nasal mucosa, dry mouth, irritation of the nasal mucosa and throat, sore throat, stop breathing (in children).

From the digestive system: nausea.

From the musculoskeletal system and connective tissue: convulsions (especially in children).

Other: weakness, tachyphylaxis. Benzalkonium chloride, which is part of the drug, can cause local skin reactions.

Overdose

With a significant overdose or accidental ingestion, the following are possible: pupil dilation, nausea, vomiting, cyanosis, fever, spasms, tachycardia, arrhythmia, increased blood pressure, shortness of breath, cardiac arrest, hallucinations, mental disorders, convulsions, pulmonary edema, depression of the central nervous system ( drowsiness, decreased body temperature, bradycardia, decreased blood pressure, respiratory arrest and coma).

Treatment: symptomatic; in case of severe overdose - intensive care; in case of accidental ingestion - gastric lavage, activated charcoal. Non-selective adrenergic blockers, such as phentolamine, can be used to lower high blood pressure.

Interaction with other medicinal products

Concomitant use with other vasoconstrictor drugs increases the risk of side effects. With the simultaneous use of tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors (including a period of 14 days after their cancellation) - an increase in blood pressure. The drug slows down the absorption of local anesthetic drugs, lengthens their effect.

special instructions

With prolonged use (more than one week), the symptoms of nasal congestion may recur. If it is necessary to continue treatment for more than 7 days, a consultation with a doctor is required. Avoid getting the drug in the eyes.

Influence of a medicinal product for medical use on the ability to drive vehicles, mechanisms

The drug, when used correctly and in the recommended doses, does not affect driving vehicles and working with mechanisms, however, if side effects such as dizziness occur, you should refrain from these types of activities.