Grippostad® rino maritim

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GRIPPOSTAD® RHINO MARITIME

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains 0.5 mg or 1 mg of xylometazoline hydrochloride;

Excipients: potassium dihydrogen phosphate, seawater, purified water.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical characteristics: clear, colorless solution.

Pharmacotherapeutic group. Medicinal products used in nasal disorders. Decongestants and other agents for local use in nasal conditions. Simple sympathomimetics. ATC code R01A A07.

Pharmacological Properties

Pharmacodynamics

Xylometazoline hydrochloride, a derivative of imidazole, is a sympathomimetic active substance with alpha-adrenergic activity. The drug exerts a vasoconstrictive effect, thereby reducing swelling and hyperemia of the nasal and nasopharyngeal mucosa. It also decreases associated excessive mucus secretion and facilitates removal of blocked nasal discharge, promoting clearance of nasal passages and improving nasal breathing.

The effect of the medicinal product begins within a few minutes after administration and lasts up to 12 hours.

The drug is well tolerated, including by patients with sensitive mucous membranes, and does not impair mucociliary function.

Pharmacokinetics

After topical application, the concentration of xylometazoline in blood plasma is close to the limit of detection. However, in some cases, the amount of solution absorbed may be sufficient to cause systemic effects, i.e., effects on the central nervous system and cardiovascular system.

There are no pharmacokinetic data from clinical trials in humans.

Xylometazoline has no mutagenic properties. Animal studies have also shown no evidence of teratogenic effects of xylometazoline.

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, cor pulmonale, 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 use 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 action of monoamine oxidase 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 administration of such agents is not recommended.

Concomitant use of the medicinal product with β-blockers may cause bronchospasm or decreased blood pressure.

Special precautions for use.

GRIPEX® RINO MARITIM, 0.05% nasal spray, must not be used in children under 2 years of age.

Use in children aged 2 to 11 years is recommended only under adult supervision.

The medicinal product should not be used in children for longer than 7 consecutive days.

GRIPEX® RINO MARITIM, 0.1% nasal spray, must not be used in children under 12 years of age.

The duration of treatment should not exceed 7 days. Prolonged use of xylometazoline may cause medicamentous rhinitis and swelling of the nasal mucosa, with symptoms resembling those of a common cold.

As with 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 drug should not be exceeded, especially when treating children and elderly patients.

The medicinal product should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, pheochromocytoma, or benign prostatic hyperplasia. It must not be used in patients receiving or who have received treatment with monoamine oxidase inhibitors (MAOIs) within the previous 2 weeks.

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

Use during pregnancy or breastfeeding.

The medicinal product must not be used during pregnancy due to its potential vasoconstrictive effects.

There is no evidence of any adverse effect on the infant. It is unknown whether xylometazoline is excreted in breast milk; therefore, caution is required, and the drug should be used during breastfeeding only under medical supervision.

Fertility.

There are no adequate data regarding the effect of GRIPEX® RINO MARITIM nasal spray on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely small.

Ability to influence reaction speed when driving or operating machinery.

The medicinal product usually has no or negligible influence on the ability to drive or operate machinery. However, with prolonged use of high doses of xylometazoline, systemic effects with cardiovascular manifestations cannot be excluded.

Method of Administration and Dosage.

Nasal spray 0.05%:

For children aged 2 to 11 years, apply under adult supervision: 1 spray into each nostril 1–2 times daily, but no more than 3 sprays per nasal passage per day.

The duration of treatment depends on the course of the disease and should not exceed 7 consecutive days.

Nasal spray 0.1%:

For adults and children aged 12 years and older: 1 spray into each nostril up to 3 times daily. Do not exceed 3 sprays per nasal passage per day. The duration of treatment depends on the course of the disease and should not exceed 7 consecutive days.

The spray should be used as follows:

• Thoroughly clear the nasal passages before using the spray;
• Hold the bottle vertically, supporting the bottom with the thumb and positioning the nozzle between two fingers;
• Slightly tilt the bottle and insert the nozzle into the nostril;
• Administer the spray while simultaneously taking a gentle nasal inhalation;
• After use, before replacing the cap, clean and dry the nozzle;
• To prevent infection, the bottle of medication should be used by only one person.

The last application is recommended immediately before bedtime.

Children.

GRIPOSTAD® RINO MARITIM, nasal spray 0.05% should not be used in children under 2 years of age. Use in children aged 2 to 11 years is recommended only under adult supervision.

GRIPOSTAD® RINO MARITIM, nasal spray 0.1% should not be used in children under 12 years of age. The medicinal product should not be used in children for longer than 7 consecutive days.

Overdose.

Symptoms. Excessive local application of xylometazoline hydrochloride or accidental ingestion may lead to sympatholytic effects, including central nervous system depression (e.g., drowsiness, coma), pronounced dizziness, excessive sweating, significant decrease in body temperature, pallor, headache, tachycardia, bradycardia, arterial hypertension, respiratory depression, miosis, seizures, coma, ataxia, and agitation. Elevated blood pressure may be followed by hypotension. Gastrointestinal symptoms such as nausea and vomiting may also occur. Younger children are more sensitive to toxicity than adults. Severe symptoms after accidental use have not been commonly observed; however, in newborns (2 weeks of age), administration of 1 drop of 0.1% solution into each nostril may lead to coma.

Treatment. 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. There is no specific antidote; atropine may be used in cases of bradycardia. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Adverse Reactions

Undesirable effects listed below are categorized by organ systems and frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), unknown (frequency cannot be determined from available data, includes also isolated cases).

Immune system disorders:

Very rare: hypersensitivity reactions, including angioneurotic edema, rash, itching.

Nervous system disorders:

Common: headache.

Eye disorders:

Very rare: transient visual disturbances.

Cardiovascular disorders:

Very rare: irregular or rapid heartbeat, hypertension, arrhythmia.

Respiratory, thoracic and mediastinal disorders:

Common: dryness or discomfort of the nasal mucosa, burning sensation, drug-induced rhinitis;

Uncommon: epistaxis.

Gastrointestinal disorders:

Common: nausea.

General disorders and administration site conditions:

Common: burning sensation at the application site.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicine authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy to the State Expert Center of the Ministry of Health of Ukraine via the following link: https://aisf.dec.gov.ua/

Shelf life: 5 years.

After opening the bottle — 12 months.

Storage conditions:

No special storage conditions required. Keep out of reach and sight of children.

Packaging:

15 ml of solution in polyethylene bottles with a spray pump, in a cardboard box.

Availability: Over-the-counter (without prescription).

Manufacturer:

STADA Arzneimittel AG.

Manufacturer's address and place of business:

Stadasestrasse 2-18, 61118 Bad Vilbel, Germany.