Afrin, moisturizing spray 0.05% 15 ml

Alpha-adrenergic stimulant for topical use.

It has a vasoconstrictor effect. Oxymetazoline causes vasoconstriction of mucous membranes of the nose, sinuses and eustachian tube which leads to reduction of their edema and release of nasal breathing in allergic and/or infectious-inflammatory rhinitis (runny nose).

With the presence of excipients in the composition of the drug (microcrystalline cellulose and sodium carmellose and povidone-K29-32) Afrin® moistening nasal spray does not leak from the nose and does not run down the throat because after injection into the nasal passages the spray becomes more viscous and is held on the nasal mucosa more effectively than the standard water solution.

This medication contains humectants (glycerol and macrogol – 1450) to help retain moisture, which helps provide hydration to dry or irritated nasal mucosa. According to clinical studies, the drug starts working within 1 minute and the action lasts up to 12 hours.

Indications

The drug Afrin® moisturizing is indicated for use in adults and children over 12 years of age:

• for acute respiratory diseases with symptoms of rhinitis (runny nose);
• for acute allergic rhinitis;
• with exacerbation of vasomotor rhinitis (a chronic disease in which there is nasal congestion or a runny nose, not associated with any allergen or infection);
• to restore fluid outflow (drainage) in case of inflammation of the paranasal sinuses (sinusitis), eustachitis (inflammation of the mucous membrane of the auditory tube and tympanic cavity), otitis media;
• to eliminate swelling before diagnostic manipulations in the nasal passages.

If improvement does not occur within 3 days or you feel worsening, you should consult your doctor.

Pharmacological effect

The drug Afrin® moisturizing, nasal spray, contains the active ingredient oxymetazoline hydrochloride. Oxymetazoline causes constriction of the vessels of the nasal mucosa, paranasal sinuses and eustachian tube, which leads to a decrease in their swelling and easier nasal breathing. Glycerol and macrogol-1450, which are part of the drug, help retain moisture and moisturize the nasal mucosa when it is dry and irritated.

Due to the presence of excipients in the composition of the drug (microcrystalline cellulose and sodium carmellose and povidone-K29-32), the Afrin® moisturizing drug after administration into the nasal passages becomes more viscous (turns into a gel) and is retained on the nasal mucosa more effectively than a regular aqueous solution.

According to clinical studies, the drug begins to act within 1 minute and the effect lasts up to 12 hours.

Special instructions

Before using Afrin® moisturizer, consult your doctor or pharmacist.

Tell your doctor or pharmacist if you have:

– increased intraocular pressure,
– chronic heart failure,
– acute cardiovascular diseases or acute left ventricular failure (manifested in the form of shortness of breath, fatigue, etc.),
– severe uncontrolled arterial hypertension (increased blood pressure),
– diseases of the coronary arteries, including angina pectoris (a feeling of discomfort or squeezing pain in the chest),
– arrhythmia (heart contraction disorder),
– chronic renal failure,
– prostatic hyperplasia with clinical symptoms (urinary retention),
– severe atherosclerosis,
– hyperthyroidism (increased levels of thyroid hormones),
– diabetes mellitus
– pheochromocytoma (hormonally active tumor),
– tachycardia (increased heart rate),
– porphyria (pigment metabolism disorder),
– the need to take monoamine oxidase inhibitors (MAO) (including during the previous 2 weeks and within 2 weeks after their discontinuation) and tricyclic antidepressants, as well as other drugs that increase blood pressure and bromocriptine;
– if you are pregnant or breastfeeding.

Avoid contact of the drug with the eyes.

Children and teenagers

Afrin® moisturizer is not intended for use in children under 12 years of age.

Driving vehicles and working with machinery

Afrin® moisturizing drug, when used correctly and in recommended doses, does not affect the ability to drive vehicles and operate machinery, however, if side effects such as dizziness occur, you should refrain from such activities.

Active ingredient

Oxymetazoline

Composition

The active ingredient is oxymetazoline hydrochloride; 1 ml of spray contains 0.5 mg of oxymetazoline hydrochloride. Other ingredients (excipients) are: microcrystalline cellulose and carmellose sodium (Avicel RC-591), sodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate, disodium edetate dihydrate, macrogol-1450, povidone-K29-32, benzyl alcohol, lemon flavor, benzalkonium chloride (in the form of a 17% solution), glycerol, water purified.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine. The safety of the drug in pregnant women and during lactation has not been established, therefore, if you are pregnant or breastfeeding, the drug can only be taken on the recommendation of a doctor. Caution should be exercised if you have hypertension (increased blood pressure) or signs of decreased placental blood flow (circulation problems in the placenta detected by ultrasound or other means). Frequent or prolonged use of the drug in large doses may lead to a decrease in placental blood flow.

Contraindications

Do not take Afrin® moisturizer:

• if you are allergic to oxymetazoline or any of the excipients listed in section 6 of this leaflet;
• if you have atrophic (dry) rhinitis;
• if you have angle-closure glaucoma;
• if you have undergone transsphenoidal hypophysectomy;
• if you have had surgical interventions on the dura mater (in history);
• if you have inflammation of the skin and mucous membrane of the nasal vestibule area.

Side Effects

Like all medicines, Afrin® Moisturizer can cause side effects, although not everyone gets them. Contact your doctor immediately if you notice any of the following serious side effects

– You may need emergency medical attention:

• seizures (especially in children),
• hallucinations (especially in children),
• respiratory arrest (in children).

Other adverse reactions

Tell your doctor if you notice any of the following side effects:

Uncommon

– may occur in no more than 1 person in 100:
• Quincke’s edema (swelling of the lips, eyelids, oral mucosa, larynx, etc.),
• itching,
• burning or dryness of the nasal mucosa,
• sneezing,
• nosebleeds.

Rarely

– may occur in no more than 1 person in 1,000:

• anxiety,
• irritability,
• sleep disturbance (in children),
• insomnia,
• headache,
• dizziness,
• visual impairment (if in contact with eyes),
• increased blood pressure,
• feeling of heartbeat,
• tachycardia (increased heart rate),
• a feeling of nasal congestion that occurs after the effect of using the drug wears off (reactive hyperemia),
• nausea.

Very rarely

– may occur in no more than 1 person in 10,000:

• anxiety,
• fatigue,
• drowsiness,
• sedative effect.

Unknown

– Based on the available data, the frequency of occurrence cannot be determined:

• dryness of the mucous membranes of the mouth and throat,
• increase in the volume of secretions released from the nose
• exanthema (skin rash).

Interaction

Tell your doctor or pharmacist if you are taking, have recently taken, or may start taking any other medications. Concomitant use with other vasoconstrictor drugs increases the risk of side effects.

With the simultaneous use of tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors (including the period of 14 days after their withdrawal), an increase in blood pressure is possible. Oxymetazoline slows down the absorption of local anesthetic drugs and prolongs their effect.

Overdose

In case of significant overdose or accidental ingestion, the following are possible: dilation or constriction of the pupil, nausea, vomiting, cyanosis (bluish discoloration of the skin and/or mucous membranes), increased body temperature, spasms, tachycardia (increased heart rate), arrhythmia (impaired frequency, rhythm and sequence of heart contractions), 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 heart rate), decreased blood pressure, respiratory arrest and coma).

In case of accidental ingestion, gastric lavage is performed and activated charcoal is prescribed. If you use too much Afrin® Moisturizer, contact your doctor or the nearest hospital emergency department immediately. If possible, take the bottle, packaging and/or leaflet with you to show your doctor which drug you used.

Recommendations for use

Always take the drug in full accordance with the recommendations of your doctor.

If in doubt, consult your doctor.

Recommended dose Adults 1 injection into each nasal passage 1-2 times a day.

Use in children and adolescents Children over 12 years of age

The dosage regimen is similar to that for adults. Afrin® moisturizing drug is contraindicated for use in children under 12 years of age.

It is not recommended to exceed the indicated dose.

Route and method of administration

Used intranasally.

Before each use, shake the spray bottle vigorously. Before using the nasal spray for the first time, it is necessary to “calibrate” it by pressing the spray head several times. Keep the bottle upright during use.

Duration of therapy

The drug is used for 3 to 5 days. Use the drug at the recommended dose for no more than 7 days without consulting a doctor. If symptoms worsen or improvement does not occur within 3 days, you should consult your doctor. A repeated course of the drug is possible only after several days during which the drug was not used. With frequent and prolonged use of the drug, the feeling of nasal congestion may reappear or worsen. In this case, you should stop treatment and consult a doctor.

If you forget to take Afrin® moisturizer

Do not take a double dose to make up for a missed dose.

How long to take Afrin® moisturizing

If you have questions about the use of the drug, contact your doctor or pharmacist.

Storage conditions

Store the drug at a temperature not exceeding 25 ° C

Shelf life

5 years

Manufacturer

Delpharm Montreal Inc., Canada