Grippostad® rino 0.1% nasal spray

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GRIPPOSTAD® RHINO 0.1% NASAL SPRAY (GRIPPOSTAD® RHINO 0.1% NAS/AL SPRAY)

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of nasal spray contains xylometazoline hydrochloride 1 mg;

Excipients: benzalkonium chloride solution; citric acid, monohydrate; sodium citrate; glycerol (85%); purified water.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical properties: clear, almost colorless solution, free from visible extraneous particles, odorless.

Pharmacotherapeutic group. Anti-edema preparations for local use in nasal cavity diseases. Sympathomimetics, simple preparations. ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is an imidazoline derivative and an alpha-adrenergic sympathomimetic agent. It directly stimulates alpha-adrenergic receptors, causing vasoconstriction. When applied locally, it reduces swelling of the nasal and nasopharyngeal mucosa. It restores nasal airway patency and facilitates nasal breathing by decongesting the mucosa and improving secretion drainage.

The drug begins to act within 5–10 minutes and its effect lasts for several hours (on average, 6–8 hours).

With intranasal administration, the amount of the drug absorbed may occasionally be sufficient to produce systemic effects, for example, on the central nervous system and cardiovascular system.

Pharmacokinetics.

After topical application, xylometazoline is hardly detectable in blood plasma (plasma concentration is below the limit of detection).

Clinical characteristics.

Indications.

Symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, and sinusitis.

For facilitating drainage of secretions in diseases of the nasal accessory sinuses.

Adjunctive therapy in cases of otitis media (to relieve mucosal swelling).

For facilitating rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline or to any other component of the medicinal product, acute coronary diseases, coronary asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical interventions involving exposure of the meninges in medical history, dry rhinitis (rhinitis sicca), or atrophic rhinitis. Concomitant treatment with monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after discontinuation of their use.

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of MAO inhibitors and induce a hypertensive crisis. Do not use xylometazoline in patients taking or who have taken MAO inhibitors within the previous two weeks.

Tricyclic and tetracyclic antidepressants: concomitant use of tricyclic or tetracyclic antidepressants and sympathomimetic agents may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant administration of these medicinal products is not recommended.

Concomitant use with beta-blockers may cause bronchospasm or decreased blood pressure.

Special precautions for use.

GRIPEX® RINO 0.1% NASAL SPRAY is intended for use in adults and children aged 12 years and older.

The product should not be used for more than 10 consecutive days. Prolonged or excessive use may lead to recurrence of nasal congestion and/or atrophy of the nasal mucosa.

Like other sympathomimetics, this medication should be used with caution in patients who are particularly sensitive to adrenergic agents, which may manifest as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

The recommended dose should not be exceeded, especially when treating children and elderly patients.

The drug should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, hyperthyroidism, phaeochromocytoma, or benign prostatic hyperplasia. It should not be administered to patients who have received concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after discontinuation of such therapy.

Patients with prolonged QT syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias.

The product contains benzalkonium chloride, which may cause irritation of the nasal mucosa.

Use during pregnancy or breastfeeding.

The drug should not be used during pregnancy due to its potential vasoconstrictive effects.

There is no evidence of any adverse effect on the infant.

Due to lack of data on whether the active substance is excreted in breast milk, the drug should not be used during breastfeeding.

Fertility

There are no adequate data on the effect of the drug on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.

Ability to affect reaction speed when driving or operating machinery.

Generally, the drug has no or negligible influence on the ability to drive or operate machinery.

Administration and Dosage

Grippostad® Rino 0.1% Nasal Spray should be used by adults and children aged 12 years and older, with one spray administered into each nostril up to three times daily. Do not exceed three applications into each nostril per day.

The duration of treatment depends on the course of the illness and should not exceed 10 consecutive days. The spray should be used as follows:

• thoroughly clear the nasal passages before using the medication;
• spray once into each nostril and keep the head tilted backward for a short period to ensure the medication spreads throughout the nasal cavity;
• to prevent infection, each bottle of the medication should be used by only one person.

The last application is recommended to be performed immediately before bedtime.

Children.

Grippostad® Rino 0.1% Nasal Spray should not be used in children under 12 years of age.

Overdose.

Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to pronounced dizziness, increased sweating, significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and seizures. Elevated arterial pressure may be followed by a drop in pressure. Younger children are more sensitive to the toxic effects than adults.

All patients suspected of overdose should receive appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include monitoring of the patient for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Side effects.

Immune system:

Rare (<1/10,000): hypersensitivity reactions, including angioneurotic edema, rash, itching.

Nervous system:

Common (≥1/100, <1/10): headache.

Eye disorders:

Rare (<1/10,000): temporary visual disturbances.

Cardiovascular system:

Rare (<1/10,000): irregular or rapid heartbeat.

Respiratory, thoracic and mediastinal disorders:

Common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa;

Uncommon (≥1/1,000, <1/100): epistaxis.

Gastrointestinal disorders:

Common (≥1/100, <1/10): nausea.

General disorders and administration site conditions:

Common (≥1/100, <1/10): burning sensation at the application site.

Shelf life. 5 years.

Shelf life after opening the bottle: 6 months.

Do not use the medicinal product after the expiry date.

Storage conditions.

Store at temperatures not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

10 ml of solution in amber glass bottles with an automatic spray pump and nasal applicator, in a cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

STADA Arzneimittel AG, Germany.

Manufacturer's address and place of business.

Stadastrasse 2-18, 61118 Bad Vilbel, Germany.