Allergodil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALEGRDIL® (ALLERGODIL®)

Composition:

Active substance: azelastine hydrochloride;

1 ml of solution contains azelastine hydrochloride 1 mg;

Excipients: hypromellose, disodium edetate, citric acid anhydrous, sodium hydrogen phosphate dodecahydrate, sodium chloride, purified water.

Pharmaceutical form. Metered nasal spray.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Agents used in diseases of the nasal cavity. Antiallergic agents, excluding corticosteroids. ATC code R01AC03.

Pharmacological properties.

Pharmacodynamics.

Azelnastine hydrochloride is an H1-receptor antagonist and therefore an antiallergic agent with a relatively long elimination half-life (t1/2 ≈ 20 hours).

Furthermore, data from in vivo studies in guinea pigs show that at therapeutic doses for humans, azelastine hydrochloride inhibits bronchial spasm induced by leukotrienes and inhibitors of platelet-activating factor (PAF).

Due to these properties, in animal experiments azelastine hydrochloride is also able to suppress airway inflammation caused by hypersensitivity reactions. The significance of the conclusions drawn from animal studies for the therapeutic use of the drug in humans has not been established.

Pharmacokinetics.

Azelnastine hydrochloride is rapidly and almost completely absorbed after oral administration and is mainly distributed to peripheral organs, primarily the lungs, skin, muscles, liver, and kidneys, with only minimal distribution to the brain. Dose-dependent linear kinetics have been demonstrated. Azelnastine hydrochloride and its metabolites are excreted approximately 75% in feces and approximately 25% via the kidneys. The most important metabolic pathways are ring hydroxylation, N-dimethylation, and oxidative opening of the azepine ring.

In patients with allergic rhinitis, the steady-state plasma concentration of azelastine hydrochloride observed 2 hours after administration of the total daily dose of 0.56 mg azelastine hydrochloride (1 spray into each nostril twice daily) was approximately 0.65 ng/mL, but this did not result in clinically significant systemic adverse effects.

As a consequence of dose-dependent linear kinetics, an increase in average plasma levels can be expected with increasing daily dose.

Clinical characteristics.

Indications. Symptomatic treatment of seasonal allergic rhinitis (hay fever) and non-seasonal (perennial) allergic rhinitis.

Contraindications. Hypersensitivity to the active substance, ethylenediaminetetraacetic acid (EDTA), or to any other component of the medicinal product.

The product is contraindicated in children under 6 years of age.

Interaction with other medicinal products and other forms of interaction. To date, no interactions with other medicinal products have been identified.

Special precautions for use.

None.

Use during pregnancy or breastfeeding. There are no clinical data on the use of azelastine hydrochloride in pregnant or breastfeeding women. Animal studies with high oral doses of azelastine resulted in embryolethality, developmental delay, and skeletal malformations.

Therefore, the use of this medicinal product during pregnancy or breastfeeding is not recommended.

Ability to affect reaction speed when driving or operating machinery. In individual cases, increased fatigue, exhaustion, tiredness, dizziness, or weakness may occur during treatment with this medicinal product; these symptoms may also be caused by the underlying disease itself. In such cases, the ability to react quickly when driving or operating machinery may be reduced. Particular attention should be paid to the fact that these symptoms may be intensified by concomitant intake of alcohol and other medicinal products that negatively affect reaction speed.

Method of Administration and Dosage

For nasal use.

Unless otherwise prescribed, spray 1 dose into each nostril twice daily (in the morning and evening; corresponds to a daily dose of azelastine hydrochloride 0.56 mg/day).

When using the spray, the head must be held upright.

The duration of therapy depends on the type, severity, and progression of symptoms, and is determined individually by the physician.

The drug can be used for long-term therapy.

Children. Use in children aged 6 years and older.

Overdose. There is no experience with administration of toxic doses of azelastine hydrochloride in humans. In case of overdose or intoxication, disturbances of the central nervous system are expected based on animal experiments. Treatment of these disorders should be symptomatic. There is no known antidote.

Side effects.

Adverse effects that may occur during administration of azelastine hydrochloride are classified according to the following frequency: very common (≥ 1/10), common (≥ 1/100 – < 1/10), uncommon (≥ 1/1000 – < 1/100), rare (≥ 1/10000 – < 1/1000), very rare (< 1/10000), not known (cannot be estimated from available data).

Immune system disorders: very rare – hypersensitivity reactions.

Nervous system disorders: common – dysgeusia (if used incorrectly (head tilted backwards), a bitter taste in the mouth may occur, which can lead to nausea); very rare – dizziness.

Respiratory system disorders: uncommon – irritation of the nasal mucosa with inflammation after spraying (such as burning and itching), sneezing, and nasal bleeding.

Gastrointestinal disorders: rare – nausea.

General disorders: very rare – increased fatigue (feeling of tiredness and exhaustion), dizziness or weakness, which may also be caused by the underlying disease.

Skin disorders: very rare – rash, itching, urticaria.

Somnolence, headache, and dry mouth have also been reported in some patients.

Shelf life. 3 years.

After opening the bottle, use within 6 months.

Storage conditions. Store at a temperature not exceeding 25 °C. Do not refrigerate. Keep the medication out of reach of children.

Packaging. 10 ml in a bottle with a screw-on spray pump; 1 bottle per cardboard box.

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

Manufacturer.

Madaus GmbH.

Manufacturer's address and place of business.

Lutticher Strasse 5, 53842 Troisdorf, Germany.