Milt nasal drops®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MILT NASAL DROPS® (MILT NASAL DROPS)

Composition:

Active substances: phenylephrine, dimetindene maleate;

1 ml of the preparation contains: phenylephrine – 2.5 mg, dimetindene maleate – 0.25 mg;

Excipients: benzalkonium chloride; lavender extract; sorbitol (E 420); citric acid monohydrate; sodium hydrogen phosphate dodecahydrate; water for injections.

Pharmaceutical form. Nasal drops.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with a mild specific odor.

Pharmacotherapeutic group.

Decongestants and other rhinological preparations for local use. Sympathomimetics, combinations, excluding corticosteroids.

ATC code R01A B.

Pharmacological properties.

Pharmacodynamics.

Milt nasal drops® is a combined preparation containing phenylephrine and dimetindene.

The preparation reduces nasal discharge and promotes nasal passage clearance without impairing physiological functions of the ciliated epithelium and nasal mucosa.

Phenylephrine belongs to sympathomimetic amines. It is used as a nasal decongestant with moderate vasoconstrictive action, selectively stimulating α1-adrenergic receptors of the cavernous venous tissue of the nasal mucosa. Thus, it rapidly and long-lastingly reduces swelling of the nasal mucosa and paranasal sinuses.

Dimetindene is a histamine H1-receptor antagonist, exhibiting antiallergic action. It is effective at low doses and is well tolerated.

Pharmacokinetics.

The preparation is administered locally; therefore, its activity does not correlate with the concentration of active substances in blood plasma.

Following accidental oral administration, the bioavailability of phenylephrine decreases and is approximately 38%, with a half-life of about 2.5 hours.

Systemic bioavailability of dimetindene after oral administration in solution is about 70%, with a half-life of approximately 6 hours.

Clinical characteristics.

Indications.

In adults and children aged 2 years and older:

symptomatic treatment of common cold, nasal congestion, acute and chronic rhinitis, seasonal (hay fever) and non-seasonal allergic rhinitis, acute and chronic sinusitis, vasomotor rhinitis. Adjunctive therapy in acute otitis media.

Preparation for nasal surgery and reduction of mucosal edema in the nasal cavity and paranasal sinuses following surgical intervention.

Contraindications.

Hypersensitivity to phenylephrine, dimetindene maleate, or any of the excipients.

Due to the presence of phenylephrine, the drug, like other vasoconstrictive agents, is contraindicated in atrophic rhinitis, closed-angle glaucoma, and in patients receiving monoamine oxidase inhibitors (MAOIs) or who have received them within the preceding 14 days.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of the drug with MAO inhibitors and within 14 days after their discontinuation is contraindicated.

Vasoconstrictive agents should be prescribed with caution together with tricyclic and tetracyclic antidepressants and antihypertensive agents such as β-adrenergic blockers, as their concomitant use may potentiate the pressor effect of phenylephrine.

Special precautions for use.

The drug, like other sympathomimetics, should be used with caution in patients who exhibit pronounced reactions to adrenergic agents, manifested by such symptoms as insomnia, dizziness, tremor, cardiac arrhythmia, or increased arterial pressure.

Milt nasal drops® should not be used continuously for more than 3 days. If symptoms persist beyond 3 days or worsen, medical advice should be sought. Prolonged or excessive use of the drug may lead to tachyphylaxis and rebound effect (rhinitis medicamentosa).

As with other vasoconstrictive agents, the recommended dose of the drug should not be exceeded. Excessive use of the drug, particularly in children and elderly patients, may result in systemic effects of the drug.

The drug should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, hyperthyroidism, diabetes mellitus, and to patients with bladder neck obstruction (e.g. due to prostate hyperplasia).

Due to the presence of the H1-antihistamine dimetindene maleate, the drug should be used with caution in patients with epilepsy.

Use during pregnancy or breastfeeding.

Studies on the use of phenylephrine and dimetindene maleate during pregnancy or breastfeeding have not been conducted. Due to the potential systemic vasoconstrictive effect of phenylephrine, the use of the drug during pregnancy is not recommended.

The use of the drug during breastfeeding is not recommended.

Fertility

There are no adequate data on the effects of phenylephrine and dimetindene maleate on human fertility.

Ability to affect reaction speed when driving or operating machinery.

Data are lacking.

Administration and Dosage.

Before administering the medication, the nose should be thoroughly cleaned. The patient should tilt the head backward while sitting or standing, or to the side if lying in bed. After instillation of the drops, it is advisable to keep the head tilted for several minutes to allow the medication to spread throughout the nasal cavity.

The dropper cap should be washed and dried before screwing it back onto the bottle.

Children aged 2 to 6 years

1–2 drops into each nostril 3–4 times daily.

Children aged 6 years and older, and adults

3–4 drops into each nostril 3–4 times daily.

The duration of continuous treatment should not exceed 3 days and depends on the course of the disease. Use of the medication in children aged 2 to 12 years should be supervised by an adult.

Children.

This medicinal product is not recommended for use in children under 2 years of age.

Overdose.

In case of overdose, Milt nasal drops® may cause sympathomimetic and anticholinergic effects such as increased heart rate, premature ventricular contractions, occipital pain, tremor or shaking, mild tachycardia, elevated blood pressure, mydriasis, numbness, excitation, hallucinations, seizures, insomnia, and pallor. Overdose may also lead to moderate sedation, increased fatigue, coma, stomach pain, nausea, and vomiting.

No serious adverse effects have been reported following accidental ingestion of the medication. Accidental ingestion of dimetindene doses up to 20 mg did not result in severe symptoms.

Treatment: administration of activated charcoal; in young children, laxatives may be considered (gastric lavage is not necessary); adults and older children should drink large amounts of fluids.

Phenylephrine-induced arterial hypertension, which does not respond adequately to benzodiazepines, can be managed with an α-adrenergic blocker. Central anticholinergic symptoms can be treated with physostigmine. It is advisable to consult a physician regarding the use of antidotes. Since data on gastrointestinal absorption of dimetindene doses exceeding 20 mg are lacking, patients with significant overdose should be placed under medical supervision and, if deemed necessary by a physician, given a single dose of activated charcoal. Severe cases of agitation and convulsive seizures should be treated with benzodiazepines.

Adverse Reactions

The medicinal product is usually well tolerated. The adverse reactions listed below are categorized by frequency as follows: 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), frequency not known (cannot be estimated from the available data).

Respiratory system, thoracic organs and mediastinum disorders: rare – nasal discomfort, dryness of the nasal cavity, epistaxis.

General disorders and administration site conditions: rare – burning sensation at the application site; very rare – general weakness, development of allergic reactions (including skin reactions at the application site, body pruritus, eyelid swelling, facial swelling).

Shelf life.

3 years.

Shelf life after opening the bottle – 4 months.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

10 ml in a bottle. 1 bottle in a box.

Classification.

Over-the-counter (OTC).

Manufacturer: JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.