Grippostad® rino 0.1% nasal drops

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GRIPPOSTAD® RHINO 0.1% NASAL DROPS (GRIPPOSTAD® RHINO 0.1% NASAL DROPS)

Composition:

Active ingredient: xylometazoline hydrochloride;

1 ml of solution contains 1 mg of xylometazoline hydrochloride;

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

Pharmaceutical form. Nasal drops, solution.

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

Pharmacotherapeutic group. Decongestants for local use in nasal cavity disorders. Simple sympathomimetics. ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is an imidazoline derivative and an alpha-adrenergic sympathomimetic agent. It directly stimulates alpha-adrenergic receptors and causes vasoconstriction. When applied locally, it reduces swelling of the nasal and nasopharyngeal mucosa. It restores nasal passage 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).

When administered intranasally, 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, bronchial asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical interventions involving exposure of the meninges in medical history, atrophic rhinitis (rhinitis sicca). Concomitant treatment with monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after discontinuation of such treatment.

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. Xylometazoline must not be used in patients receiving or who have received MAO inhibitors within the previous 2 weeks.

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

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

Special precautions for use.

GRIPEX® RINO 0.1% NASAL DROPS must not be used in children under 12 years of age.

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, the drug should be used with caution in patients who experience strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

The recommended dose of the drug 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, pheochromocytoma, or benign prostatic hyperplasia. It should not be used in patients who have received concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after discontinuation of such treatment.

Patients with long QT syndrome receiving xylometazoline may have an 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 effect.

There is no evidence of any adverse effect on the infant. However, due to lack of data on whether the active substance is excreted in breast milk, the drug must 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.

The drug usually has no effect or only a negligible effect on the ability to drive or operate machinery.

Dosage and Administration

GRIPOSTAD® RINO 0.1% NASAL DROPS should be administered to adults and children aged 12 years and older at a dose of 2–4 drops into each nostril up to 3 times daily. Do not exceed 3 applications per nostril per day.

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

• thoroughly clean the nose before using the medication;
• tilt the head as far backward as comfortably possible;
• instill the drops into each nostril and keep the head tilted backward for a short period to allow the medication to distribute throughout the nasal cavity;
• after use, clean the dropper before placing it back into the bottle;
• 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

GRIPOSTAD® RINO 0.1% NASAL DROPS should not be used in children under 12 years of age.

Overdose

Excessive local use of xylometazoline hydrochloride or its 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 hypotension. 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 associated with 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, pruritus.

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 a screw cap and a glass pipette, packed in a cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

STADA Arzneimittel AG, Germany.

Manufacturer's address and place of business. Stadastrasse 2-18, 61118 Bad Vilbel, Germany.