Moreal Plus (Spray) Instructions for Use

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

Ursapharm Arzneimittel, GmbH (Germany)

ATC Code

R01AX10 (Other drugs)

Active Substance

Dexpanthenol (Rec.INN registered by WHO)

Dosage Form

Moreal Plus

Nasal spray 1%: bottle 20 ml with sprayer

Dosage Form, Packaging, and Composition

Nasal spray 1% transparent, colorless, odorless.

Excipients: sea water (from the North Atlantic Ocean) – 250 mg, potassium dihydrogen phosphate – 200 mcg, highly purified water – 748.6 mg.

20 ml – polyethylene bottles with a sprayer (1) – cardboard packs.

Clinical-Pharmacological Group

Agent improving tissue trophism and regeneration for topical use in ENT practice

Pharmacotherapeutic Group

Remedy for nasal conditions

Pharmacological Action

A drug for topical application, the action of which is determined by the properties of the components included in its composition.

Dexpanthenol is a derivative of pantothenic acid. In the body, it is converted into pantothenic acid, which is a constituent of coenzyme A and is involved in acetylation processes, carbohydrate and fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins; it stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. It has a regenerating, metabolic and weak anti-inflammatory effect.

When applied topically, it is rapidly absorbed from the nasal mucosa and converted into pantothenic acid, binds to plasma proteins (mainly to beta-globulins and albumins).

Moreal Plus helps to maintain the normal physiological state of the nasal mucosa. The trace elements included in Moreal Plus improve the function of the ciliated epithelium, which increases the resistance of the mucous membrane to the penetration of pathogenic bacteria and viruses and promotes its cleansing.

The drug helps to thin the mucus and normalize its production in the goblet cells of the mucous membrane.

The drug helps to wash away and remove street and room dust, bacteria, foreign particles and allergens from the nasal mucosa, and reduce the local inflammatory process.

Indications

• Violation of the integrity of the nasal mucosa (minor injuries);
• Acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx as part of complex therapy;
• Adenoiditis;
• Postoperative period after surgical interventions on the nasal cavity;
• Allergic and vasomotor rhinitis in adults and children (especially in persons with increased sensitivity to drugs or a predisposition to it);
• Prevention of nasal infections in the autumn-winter period;
• Protection against constant harmful effects on the mucous membranes of the upper respiratory tract (in smokers; drivers of vehicles; people working in hot and dusty workshops, living in regions with harsh climatic conditions);
• To maintain the physiological characteristics of the nasal mucosa when it is dry, as well as in altered microclimatic conditions in persons living and working in rooms with air conditioning and/or central heating;
• To soften and remove nasal secretions.

ICD codes

Dosage Regimen

Topically.

For therapeutic purposes

Children from 1 year to 7 years: 4 times a day, two sprays into each nasal passage;

Children from 7 to 16 years: 4-6 times a day, two sprays into each nasal passage;

Adults: 4-8 times a day, two to three sprays into each nasal passage.

The course of treatment in all cases is 2 – 4 weeks (at the discretion of the attending physician). It is recommended to repeat the course after one month.

For prophylactic purposes and for dryness of the nasal mucosa

For children from birth to 1 year, the drug can be used as follows: spray Moreal Plus onto a cotton swab and insert the swab into the nasal passage to soften and remove nasal secretions up to 1-2 times a day;

Children from 1 year to 7 years: 1 – 3 times a day, one to two sprays into each nasal passage;

Children from 7 to 16 years: 2-4 times a day, two sprays into each nasal passage;

Adults: 3-6 times a day, two to three sprays into each nasal passage.

Before first use of the drug, remove the protective cap, hold the bottle with one hand, and press it until a fine spray is achieved.

For each use of the drug, insert the nasal tip into the nostril and press the bottle 1-2 times. Spraying is performed while inhaling.

For hygienic purposes, the nasal tip should be kept dry. Each bottle should be used by only one person.

To guarantee the ideal quality of the product and the functioning of the dosing system, the bottle should not be disassembled (for example, by removing the pump cap from the bottle).

Adverse Reactions

Allergic reactions are possible.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Moreal Plus can be used during pregnancy and lactation.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

When used with topical vasoconstrictor drugs (alpha-adrenergic agonists), Moreal Plus, nasal spray should be applied first.

Drug Interactions

There is no information on drug interactions of Moreal Plus.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.