Merelis® plus

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MERALYS® PLUS (MERALYS® PLUS)

Composition:

Active substances: xylometazoline hydrochloride, dexpanthenol;

1 ml of solution contains 1 mg xylometazoline hydrochloride and 50 mg dexpanthenol;

Excipients: potassium dihydrogen phosphate, disodium phosphate dodecahydrate, purified seawater, purified water.

Pharmaceutical form. Nasal spray, solution.

Main physico-chemical characteristics: clear, colorless solution.

Pharmacotherapeutic group. Decongestants and other locally acting rhinological preparations. Sympathomimetics, combinations, excluding corticosteroids.

ATC code R01A B06.

Pharmacological Properties

Pharmacodynamics

A rhinological preparation, a combination of an alpha-sympathomimetic agent with a vitamin analogue for local application to the nasal mucosa. Xylometazoline has vasoconstrictor activity, thereby reducing swelling of the mucous membrane. Dexpanthenol is a derivative of pantothenic acid (vitamin B5) that promotes wound healing and protects mucous membranes.

Xylometazoline hydrochloride

Xylometazoline hydrochloride, an imidazole derivative, is an alpha-adrenergic sympathomimetic agent. The onset of action usually occurs within 5–10 minutes, resulting in improved nasal breathing due to reduction of swelling and enhanced drainage of secretions.

Dexpanthenol

Dexpanthenol (D-(+)-pantothenyl alcohol) is an alcohol analogue of pantothenic acid and, through intermediate conversion, exhibits the same biological activity as pantothenic acid, although only the dextrorotatory D-configuration is biologically active. Pantothenic acid and its salts are water-soluble vitamins that, as coenzyme A, participate in numerous metabolic processes, including promoting the synthesis of proteins and corticoids, as well as antibody production. Coenzyme A is also involved in the formation of lipids, including those that constitute sebaceous gland secretions, which play an important protective role. Furthermore, coenzyme A plays a role in the acetylation of amino sugars, which serve as fundamental building blocks for various mucopolysaccharides.

Dexpanthenol protects epithelial layers and promotes wound healing.

Pharmacokinetics

Xylometazoline hydrochloride

In some cases, intranasal administration leads to significant absorption, causing systemic effects, for example on the central nervous and cardiovascular systems.

Pharmacokinetic data in humans are lacking.

Dexpanthenol

Dexpanthenol is absorbed through the skin and undergoes enzyme-catalyzed oxidation to pantothenic acid in the body and skin cells. The vitamin is transported in plasma in protein-bound form. As an essential structural component, pantothenic acid combines with coenzyme A and is distributed throughout the body. Detailed studies on metabolism in the skin and mucous membranes are lacking. 60–70% of an orally administered dose is excreted in urine and 30–40% in feces.

Clinical characteristics.

Indications.

• Nasal congestion due to acute rhinitis.
• For promoting healing of the skin around the nasal passages and injuries of the mucous membrane in the nasal cavity.
• Vasomotor rhinitis.
• Impaired nasal breathing following surgical interventions in the nasal cavity.

Contraindications.

Hypersensitivity to any component of the medicinal product, dry inflammation of the nasal mucosa, acute coronary conditions including cardiac asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical procedures involving exposure of the meninges in medical history. Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use.

Do not use in children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Xylometazoline hydrochloride

Concomitant use of the drug with monoamine oxidase inhibitors (MAOIs) such as tranylcypromine, tricyclic or tetracyclic antidepressants, or β-adrenergic blockers may lead, due to the effects of these drugs on the cardiovascular system, to increased arterial pressure.

Dexpanthenol

Unknown.

Special precautions for use

This medicinal product should be used only after careful assessment of the risk/benefit ratio:

• in patients taking medicinal products capable of increasing blood pressure;
• in patients with increased intraocular pressure;
• in patients with phaeochromocytoma;
• in patients with benign prostatic hyperplasia;
• in patients with porphyria.

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

Sympathomimetic decongestants may, particularly with prolonged use or in case of overdose, cause reactive hyperaemia of the nasal mucosa.

This reversible effect leads to narrowing of the airways, forcing the patient to reapply the medicinal product.

This results in chronic oedema, progressing to atrophy of the nasal mucosa.

In mild cases, it may be sufficient to discontinue the sympathomimetic agent first in one nostril, and then, as symptoms resolve, repeat this with the other nostril, to maintain at least partial nasal breathing.

Meralis® Plus, like other drugs in this class, should be used with caution in patients who experience strong reactions to sympathomimetics, 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 individuals.

The product should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, or prostate hyperplasia.

Meralis® Plus must not be used in children under 6 years of age.

The medicinal product container should be used by only one person to avoid infection.

Use during pregnancy or breastfeeding

Meralis® Plus should not be used during pregnancy, as there are insufficient data on the use of xylometazoline hydrochloride in pregnant women.

The use of this product should be avoided during lactation, as it is unknown whether the active ingredient xylometazoline hydrochloride passes into breast milk.

There is no information available on the effect of xylometazoline hydrochloride on fertility.

Ability to influence reaction rate when driving or operating machinery

No effect is expected when the product is used according to instructions.

Method of Administration and Dosage

For nasal use.

Meralis® Plus should be administered to adults and children aged 6 years and older as 1 spray into each nostril, no more than 3 times daily. Dosage depends on individual sensitivity and clinical response. Meralis® Plus should not be used for longer than 7 days, except when recommended by a physician.

Regarding duration of use in children, consultation with a physician is always required.

Repeated use should only be initiated after a several-day break and following consultation with a physician.

In cases of chronic rhinitis, the medication should only be used under medical supervision due to the risk of developing nasal mucosal atrophy.

Method of Administration

Remove the protective cap from the spray nozzle. Before the first use, prime the nasal spray by pressing the nozzle 4 times until a fine, uniform mist is produced.

Holding the bottle vertically, insert the nozzle into the nostril and press once; repeat the procedure for the other nostril if necessary. The patient should gently inhale through the nose during spraying. After each use, wipe the nozzle with a paper tissue and replace the protective cap. If the product has not been used for 7 days, the spray should be primed at least once to ensure consistent dosing.

Children

Meralis® Plus should not be used in children under 6 years of age. For children aged 2 to 6 years, medications with lower concentrations of xylometazoline hydrochloride should be used.

Overdose

Symptoms of intoxication with imidazole derivatives may be clinically unclear, as periods of stimulation may alternate with periods of depression of the central nervous and cardiovascular systems.

Overdose, especially in children, may cause disturbances of the central nervous system, including convulsions, coma, bradycardia, apnea, and arterial hypertension, which may progress to arterial hypotension.

Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and seizures.

Symptoms of central nervous system depression include decreased body temperature, lethargy, drowsiness, and coma.

Additional possible symptoms include miosis, mydriasis, sweating, nausea, cyanosis, fever, pallor, tachycardia, bradycardia, cardiac arrest, cardiac arrhythmia, arterial hypertension, shock-like hypotension, pulmonary edema, respiratory depression and apnea, and occasionally impaired consciousness.

Treatment in case of overdose

Severe overdose requires hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in cases of high doses) should be administered immediately. Reduction of blood pressure can be achieved using non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretic and anticonvulsant agents should be administered, along with artificial oxygen respiration.

Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no specific therapeutic measures are required.

Adverse Reactions

To assess the frequency of adverse effects, the following categories are used: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).

System organ class: Nervous system disorders

Very rare: anxiety, insomnia, fatigue (drowsiness, sedative effect), headache, hallucinations (mainly in children).

System organ class: Cardiac disorders

Rare: palpitations, tachycardia, hypertension.

Very rare: arrhythmia.

System organ class: Respiratory, thoracic and mediastinal disorders

Very rare: increased mucosal swelling after effect wears off, epistaxis (nosebleed).

Frequency not known: burning sensation and dryness of nasal mucosa, sneezing.

System organ class: Musculoskeletal and connective tissue disorders

Very rare: muscle cramps (especially in children).

System organ class: Immune system disorders

Uncommon: hypersensitivity reactions (angioneurotic edema, rash, pruritus).

Reporting of adverse reactions following marketing authorization of the medicinal product is of great importance. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

After first opening of the bottle, store no longer than 180 days.

Storage conditions.

Store at temperatures not exceeding 30 °C. Do not freeze.

Keep out of reach and sight of children.

Packaging.

15 ml of solution in a bottle with a dosing device; 1 bottle per cardboard box.

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

Manufacturer.

Jadran-Galenski Laboratorij d.d. / Jadran-Galenski Laboratorij d. d.

Manufacturer's address and place of business.

Svilno 20, 51000 Rijeka, Croatia. / Svilno 20, 51000 Rijeka, Croatia.