Grippostad® rino 0.05% nasal drops

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GRIPPOSTAD® RHINO 0.05% NASAL DROPS (GRIPPOSTAD® RHINO 0.05% NASAL DROPS)

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains xylometazoline hydrochloride 0.5 mg;

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

Pharmaceutical form. Nasal drops, solution.

Main physico-chemical 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, resulting in vasoconstriction. When applied locally, it reduces swelling of the nasal and pharyngeal mucosa. It restores nasal airway patency and facilitates nasal breathing by decongesting the mucous membrane and improving secretion drainage.

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

When administered intranasally, the amount of drug absorbed may occasionally be sufficient to produce systemic effects, for example, in the central nervous system and cardiovascular system.

Pharmacokinetics.

After local 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; history of surgical interventions involving exposure of the meninges; atrophic rhinitis or dry rhinitis (rhinitis sicca). Concomitant use 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 may induce a hypertensive crisis. Xylometazoline should 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, simultaneous use of such agents is not recommended.

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

Special precautions for use.

GRIPEX® RINO 0.05% NASAL DROPS should not be used in children under 1 year of age. Use in children aged 1 to 11 years is recommended only under adult supervision.

The product should not be used in children for longer than 7–10 consecutive days. Prolonged or excessive use may lead to recurrence of nasal congestion and/or atrophy of the nasal mucosa.

Like other sympathomimetics, this medicinal product should be used with caution in patients who exhibit strong reactions to adrenergic agents, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

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

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

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 product 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 product should not be used during breastfeeding.

Fertility.

There are no adequate data on the effect of the medicinal product 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 vehicles or operating machinery.

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

Method of Administration and Dosage.

GRIPPOSTAD® RINO 0.05% NASAL DROPS are intended for nasal use.
For children aged 1 to 5 years (under adult supervision): 1–2 drops into each nostril, 1–2 times daily as needed, but not more than 3 times daily.

For children aged 6 to 11 years (under adult supervision): 2–4 drops into each nostril, 2–3 times daily as needed, but not more than 3 times daily.

Dosage should be adjusted according to individual sensitivity and disease symptoms. GRIPPOSTAD® RINO 0.05% NASAL DROPS should not be used for longer than 7–10 days.

The drops should be used as follows:

• thoroughly clean the nose before applying the medication;
• tilt the head as far back as comfortably possible;
• instill the drops into each nostril and keep the head tilted back for a short period to ensure the medication spreads throughout the nasal cavity;
• after use, clean the dropper before placing it back into the bottle;
• to prevent infection, each bottle of medication should be used by only one person.

The last dose should preferably be administered immediately before bedtime.

Children.

GRIPPOSTAD® RINO 0.05% NASAL DROPS should not be used in children under 1 year of age. Use in children aged 1 to 11 years is recommended only under adult supervision.

Overdose.

Excessive local application 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 subsequently shift to 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 observation of the patient for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Adverse reactions.

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 a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml of solution in amber glass bottles with a screw cap and a glass pipette, in a cardboard box.

Pharmaceutical category. Over-the-counter.

Manufacturer.

STADA Arzneimittel AG, Germany.

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