Meralis nasal spray 0.1% bottle 10 ml




Instructions for Meralis nasal spray 0.1% bottle 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains xylometazoline hydrochloride 1 mg;
excipients: Adriatic Sea seawater, potassium dihydrogen phosphate, purified water.
Dosage form
Nasal spray, solution.
Main physicochemical properties: transparent colorless solution.
Pharmacotherapeutic group
Drugs used in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATC code R01A A07.
Pharmacological properties
Pharmacodynamics
Xylometazoline is a sympathomimetic agent that acts on α-adrenergic receptors.
Meralis® causes narrowing of the nasal blood vessels, reducing swelling of the nasal mucosa and its paranasal sinuses and, thus, improving nasal breathing in case of nasal and paranasal sinus congestion.
The drug begins to act within 2 minutes after application and lasts up to 12 hours. The drug is well tolerated, including by patients with sensitive mucous membranes.
The drug does not reduce mucociliary function. Meralis® has a balanced pH value within the limits typical of the nasal cavity.
Pharmacokinetics
When applied topically, it is practically not absorbed, and concentrations in blood plasma are so low that they cannot be determined by modern analytical methods.
Indication
Symptomatic treatment of nasal congestion due to colds, hay fever, allergic rhinitis, sinusitis.
To facilitate the outflow of secretions in diseases of the paranasal sinuses.
Adjunctive therapy in cases of otitis media (to eliminate swelling of the mucous membrane).
To facilitate rhinoscopy.
Contraindication
Hypersensitivity to xylometazoline or to any of the other ingredients of the drug; dryness of the nasal mucosa with crusting (dry rhinitis); history of transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAOIs): Xylometazoline may potentiate the effects of monoamine oxidase inhibitors and induce hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAOIs within the last two weeks.
Tri- and tetracyclic antidepressants: with simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs, the sympathomimetic effect of xylometazoline may be enhanced, therefore the simultaneous use of such drugs is not recommended.
When used together with β-blockers, it may cause bronchial spasm or a decrease in blood pressure.
Application features
The drug should not be used for more than 5 consecutive days. Prolonged or excessive use may lead to the recurrence of nasal congestion and/or atrophy of the nasal mucosa.
The drug, like other sympathomimetics, should be prescribed with caution to patients who have 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 the elderly.
The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, increased intraocular pressure, especially in patients with angle-closure glaucoma, and should not be used in patients receiving concomitant treatment with MAO inhibitors and within 2 weeks after their discontinuation.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug usually has no or negligible influence on the ability to drive or use machines.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy due to its potential vasoconstrictor effect.
There is no evidence of any adverse effects on the infant. It is not known whether xylometazoline is excreted in breast milk, therefore caution is required and the drug should be used during breastfeeding only as directed by a physician.
Method of administration and doses
Before using the drug, you should thoroughly clean your nose.
Meralis®, 0.1% nasal spray, should be administered to adults and children over 12 years of age, 1 spray into each nasal passage 2-3 times a day.
The drug should be used for no more than 5 days, unless the doctor has recommended a different duration of treatment.
The use of Meralis® can be resumed after a break of several days.
Before the first use, it is necessary to spray several times (4 times) into the air to achieve a uniform dose. The bottle should be in a vertical position. If the product is not used for at least several days, one spray of the spray should be made into the air in order to achieve a uniform dose. Before using the drug, the nose should be thoroughly cleaned.
Children
Spray 0.1% should be used in children over 12 years of age.
Overdose
Excessive topical application of xylometazoline hydrochloride or accidental ingestion may result in severe dizziness, excessive sweating, a significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and convulsions. Elevated blood pressure may change to low blood pressure. Young children are more sensitive to toxicity than adults.
All patients with suspected overdose should be given appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include observation of the patient for several hours. In the case of severe overdose accompanied by cardiac arrest, resuscitation measures should last at least 1 hour.
Adverse reactions
Adverse reactions that may occur during the use of the drug are classified into the following groups according to their frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10,000 to <1/1000); rare (<1/10,000), including isolated cases, unknown.
On the part of the immune system:
rare: hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system
Rare: headache, insomnia, fatigue.
On the part of the organs of vision:
rare: temporary visual impairment.
From the cardiovascular system:
rare: irregular or rapid heartbeat, hypertension.
Respiratory, thoracic and mediastinal disorders:
Common: dryness or discomfort of the nasal mucosa, reactive hyperemia after the drug has worn off.
From the gastrointestinal system:
often: nausea.
General disorders and administration site conditions:
Common: burning sensation at the application site.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C, protected from light and out of the reach of children.
Packaging
10 ml of solution in a bottle with a dosing device; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Jadran-Galensky Laboratories, Dr.
Location of the manufacturer and its business address
Svilno 20, 51000 Rijeka, Croatia.
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