Otrivin Moisturizing Formula, spray 0.1% 10 ml

Xylometazoline has an alpha-adrenomimetic effect: it causes narrowing of nasal mucosal blood vessels, eliminating edema and hyperemia of nasopharyngeal mucosa. Xylometazoline also reduces the accompanying hypersecretion of mucus and facilitates the drainage of nasal passages blocked by secretions, thereby improving nasal breathing in cases of stuffy noses.< br> < br> Otrivin® is well tolerated by patients with sensitive mucous membranes and its effects do not interfere with the separation of mucus. Otrivin® has a balanced pH value, typical for the nasal cavity. < br> < br> Menthol and eucalyptol contained in the product have a cooling effect on the nasal mucosa, resulting in a feeling of freshness. < br> In therapeutic concentrations the drug does not irritate the mucosa, does not cause hyperemia.< br> < br> The action comes within 2 minutes after application and lasts for 12 h.< br> < br> In vitro studies have shown that in humans xylometazoline suppresses the infectious activity of rhinovirus that causes “colds”.< br>

Indications

Otrivin is used in adults and children over 6 years of age:
• for acute respiratory diseases with symptoms of rhinitis (runny nose),
• for acute allergic rhinitis (runny nose resulting from inflammation of the nasal mucosa caused by contact with an allergen),
• for hay fever (runny nose caused by an allergic reaction to pollen),
• for sinusitis (inflammation of the paranasal sinuses),
• with eustachitis (inflammation of the auditory tube),
• for otitis media (inflammation of the middle ear) – as part of combination therapy to reduce swelling of the mucous membrane of the nasopharynx,
• to prepare the patient for diagnostic manipulations in the nasal passages.

Special instructions

Driving vehicles and working with machinery
In case of development of systemic side effects (headache, palpitations, increased blood pressure, visual impairment), it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions.

Otrivin contains benzalkonium chloride
The drug Otrivin contains benzalkonium chloride, which can cause irritation of the nasal mucosa.

Active ingredient

Xylometazoline

Composition

The active ingredient is xylometazoline.
Each dose of metered nasal spray contains 140 mcg xylometazoline (as hydrochloride).
Other excipients are sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, disodium edetate, benzalkonium chloride 50% solution, sorbitol 70%, hypromellose-4 thousand, sodium chloride and purified water (see section 2 of the package insert).

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 drug.
Do not use the drug during pregnancy.
During breastfeeding, the drug should be used only after a careful assessment of the risk-benefit ratio for the mother and baby, under the supervision of a physician. Do not exceed the recommended dose.

Contraindications

Do not use Otrivin
• If you are allergic to xylometazoline or any of the other ingredients of Otrivin (listed in section 6 of the package leaflet),
• If you have high blood pressure (arterial hypertension),
• If you have a fast heartbeat (tachycardia),
• If you have cholesterol plaques in your blood vessels (severe atherosclerosis),
• If you have an eye disease accompanied by increased intraocular pressure (glaucoma),
• If you have a condition in which your thyroid gland produces too much hormone (hyperthyroidism),
• If you have prolonged inflammation of the nose, accompanied by thinning of the mucous membrane (atrophic rhinitis),
• If you have inflammatory diseases of the skin or mucous membrane of the nasal vestibule,
• If you have had previous surgery on the meninges,
• If you have had surgery to remove your pituitary gland (transsphenoidal hypophysectomy),
• If you are using monoamine oxidase inhibitors (including 14 days after their discontinuation), tricyclic or tetracyclic antidepressants.

Special instructions and precautions
Before using Otrivin, consult your doctor or pharmacist.
This is especially important if:
• You have diabetes mellitus
• You have severe cardiovascular diseases (including coronary heart disease, angina),
• You have an enlarged prostate gland (prostatic hyperplasia),
• You have an adrenal tumor (pheochromocytoma),
• You have a pigment metabolism disorder called porphyria
• You are breastfeeding
• You have increased sensitivity to drugs that act on adrenaline receptors (adrenergic drugs), accompanied by insomnia, dizziness, heart rhythm disturbances (arrhythmia), tremors of the limbs (tremors), increased blood pressure,
• You have a specific electrocardiogram change called long QT syndrome.
Rare cases of the development of posterior reversible encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS) during therapy with sympathomimetic drugs, including xylometazoline, have been described. Symptoms included the sudden onset of severe headache, nausea, vomiting and visual disturbances. In most cases, the condition improved or the phenomenon resolved within a few days after appropriate treatment. If symptoms of SDOE or SOCV develop, you should immediately discontinue Otrivin and seek medical help.
It is not recommended to use the drug continuously for more than 7 days.
The lowest dose needed to achieve effect should be used for the shortest period of time.
Do not exceed recommended doses, especially in children and the elderly.
Long-term (more than 7 days) or excessive use of the drug may cause a rebound effect (rhinitis medicamentosa) and/or thinning (atrophy) of the nasal mucosa.
Patients with long QT syndrome using xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

Children and teenagers
Should not be used in children aged 0 to 6 years due to the impossibility of ensuring the dosage regimen.
The drug should be used in children under adult supervision.
In children aged 6–11 years, the drug should be used on the recommendation of a doctor.
Regarding the duration of use in children, you should consult your doctor.

Side Effects

Like all medicines, Otrivin can cause side effects, although not everyone gets them.
Stop using Otrivin and call your doctor immediately if you experience any signs of an allergic reaction, some of which may be severe but are very rare (may affect up to 1 in 10,000 people):
• difficulty breathing or swallowing
• dizziness
• swelling of the face, lips, tongue or throat
• severe itching of the skin, rashes or blisters

Other possible adverse reactions that may occur when using Otrivin
Common (may affect up to 1 in 10 people):
• headache
• irritation and/or dryness of the nasal mucosa
• burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa
• inflammation of the nasal mucosa caused by too frequent and prolonged use of the drug (rhinitis medicamentosa)
• nausea
• burning at the site of application
Rare (may affect up to 1 in 1,000 people):
• insomnia
• depression (with long-term use in high doses)
• feeling of heartbeat
• increased blood pressure
• vomiting
Very rare (may affect up to 1 person in 10,000):
• impaired clarity of visual perception
• tachycardia
• arrhythmia

Interaction

Tell your doctor or pharmacist if you are taking, have recently taken, or may start taking any other medications.
Do not use Otrivin if you are currently receiving monoamine oxidase inhibitors or have received them within the previous 2 weeks.
Do not use Otrivin concomitantly with tri- or tetracyclic antidepressants and sympathomimetic drugs, as this may increase the risk of adverse reactions from the heart and blood vessels (for example, increased blood pressure, increased heart rate).

Short product description

Otrivin nasal spray dosed 0.1% .

The moisturizing formula helps reduce symptoms of irritation and dryness of the nasal mucosa. Relieves nasal congestion in 2 minutes, maintaining the effect for up to 12 hours*.

*Instructions for medical use, RU No. P N011649/04 dated 10.09.08

Action

The drug Otrivin causes a narrowing of the blood vessels of the nasal mucosa, eliminating swelling and redness (hyperemia) of the nasopharyngeal mucosa. Xylometazoline also reduces the accompanying, increased mucus production and facilitates the clearing of nasal passages blocked by secretions, and thus improves nasal breathing during nasal congestion.
Xylometazoline is well tolerated by patients with sensitive nasal mucosa; its effect does not interfere with the secretion of mucus. Xylometazoline has a balanced pH value characteristic of the nasal cavity.
The excipients included in the drug Otrivin (sorbitol and hypromellose) have an additional moisturizing effect, which helps reduce irritation and dryness of the nasal mucosa that occurs with long-term use of xylometazoline.
In therapeutic concentrations, the drug does not irritate the mucous membrane and does not cause redness (hyperemia). The effect of the drug begins 2 minutes after use and lasts for 12 hours (for example, throughout the night).
If there is no improvement or you feel worsening after 5–7 days, you should consult a doctor.

Storage conditions

Keep the drug out of the reach of children and so that the child cannot see it.
Do not use the drug after the expiration date (shelf life) indicated on the carton and bottle after “Best before:”.
The expiration date is the last day of the month.
Store at a temperature not exceeding 30 °C.
Do not throw the drug into the sewer. Ask your pharmacist how to dispose of a drug you no longer need. These measures will protect the environment.

Shelf life

3 years

Manufacturer

GSK Consumer Healthcare S.A., Switzerland