Allergodil Nasal Spray is an anti-allergic agent / antihistaminic agent.
For symptomatic treatment of seasonal allergic rhinitis (hay fever) and for symptomatic treatment of non-seasonal (perennial) allergic rhinitis in adults, adolescents and children aged 6 years and older.

To be sprayed into the nose; for nasal application.
Unless otherwise prescribed, spray Allergodil Nasal Spray once into each nostril twice daily (mornings and evenings; equivalent to a daily dose of 0.56 mg of azelastine hydrochloride / day).
Spray the solution into each nostril with the head held upright.
Duration of treatment depends on the type, severity and the development of the symptoms. Allergodil Nasal Spray may be used for long-term treatment; there is no time limit for its use.

None.

So far, no interactions have been reported.

Fertility
In animal studies, effects on fertility have been seen after oral administration (see section 5.3).
Pregnancy
Although doses far in excess of the therapeutic dose range tested in laboratory animals failed to generate any evidence of an embryotoxic effect of this medicinal product, current medical concepts discourage use of Allergodil Nasal Spray in the first trimester of pregnancy.
Lactation
Allergodil Nasal Spray should not be used by nursing mothers, because there is insufficient evidence of the safety of this medicinal product during lactation.

Very rarely, fatigue, weariness, exhaustion, dizziness or weakness that may also be caused by the disease itself, may occur when using Allergodil Nasal Spray. In these cases, the ability to drive and use machines may be impaired. Special attention should be paid to the fact that this effect may be intensified in combination with alcohol and other medications which for their part have a negative impact on reactivity.

The following convention has been used for the classification of undesirable effects in terms of frequency:
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)
Not known (Cannot be estimated from the available data)

Immune system disorders
Very rare: Hypersensitivity reactions
Nervous system disorders
Common: Improper administration (with head reclined back; see section 4.2) may produce a bitter taste which may lead to nausea occasionally.
Very rare: Vertigo
Respiratory, thoracic and mediastinal disorders

Uncommon: Irritations of the inflamed nasal mucosa can occur on spraying (e.g. stinging, itching), sneezing and nasal bleeding.
Gastrointestinal disorders
Rare: Nausea
Skin and subcutaneous tissue disorders
Very rare: Rash, itching, nettle fever.
General disorders and administration site conditions
Very rare: Fatigue (weariness, exhaustion), dizziness or weakness that may also be caused by the disease itself.
-To report any side effect(s):

There is no experience after administration of toxic doses of Azelastine hydrochloride in humans. In the case of overdosage or intoxication, disturbances of the central nervous system are to be expected on the basis of results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.

Pharmacotherapeutic group: Decongestants and other nasal preparations for topical use; Antiallergic agents, excluding corticosteroids
ATC Code: R01AC03
Azelastine hydrochloride is an H1-antagonistic and therefore an anti-allergically active substance with a relatively long half-life (t ½ ≅ 20 hours).
Furthermore, in vivo studies in the guinea pig have shown that, in doses relevant for human therapy, azelastine hydrochloride also inhibits the bronchial constriction induced by leukotrienes and PAF.

It is due to these properties that, in animal experiments, azelastine hydrochloride also has been able to suppress the inflammation in the respiratory tract causing this hyper-reactivity. The significance of the findings obtained in animals for the therapeutic application of azelastine hydrochloride in humans is unclear.

In animals and humans, azelastine hydrochloride was absorbed rapidly and almost quantitatively after oral administration and mainly distributed in the peripheral organs, above all in the lungs, skin, muscles, liver and kidneys, but only to a minor extent in the brain. A dose-linear kinetic effect was demonstrated. Azelastine hydrochloride and its metabolites were excreted approx. 75 % via the faeces and approx. 25 % via the kidneys. The most important metabolic pathways are ring hydroxylation, N-dimethylation and oxidative opening of the azepine ring.
In patients suffering from allergic rhinitis, steady state mean plasma concentrations of azelastine hydrochloride observed two hours after a total daily dose of 0.56 mg azelastine hydrochloride (e. g. one spray puff per nostril twice daily) were about 0.65 ng/ml but these did not result in clinically relevant systemic side-effects. Due to the dose-linear effect, an elevation of mean plasma levels can be expected if the daily dose is increased.

Toxicity with repeated administration
With repeated oral administration of azelastine hydrochloride to rats and dogs, the first general toxic symptoms were observed at doses which exceeded the maximum daily dose used for humans 75 times.
In rats, the liver (increased serum enzyme activity of ASAT, ALAT, and AP as well as increased organ weight, cellular hypertrophy, fat infiltration) and the kidneys (increase in urea nitrogen, increased urine volume and increased excretion of sodium, potassium and chloride as well as increased organ weight) proved to be the target organs and this in doses which, related to body weight, exceeded the oral daily therapeutic dose used for humans 200 times.
The nontoxic dose for both young and adult animals was at least 30 times the maximum oral therapeutic daily dose for humans.
Six months intranasal administration to rats and dogs up to the maximum possible doses of Allergodil Nasal Spray (rat: approx. 130, dog: approx. 25 times the intranasal therapeutic dose in humans related to body weight) yielded no local or organ-specific toxicity findings.
Sensitization
Azelastine hydrochloride displayed no sensitizing properties in studies in the guinea pig.

Mutagenicity / carcinogenicity
In-vivo and in-vitro mutagenicity tests and carcinogenicity studies in mice and rats revealed no mutagenic or tumoragenic potential of azelastine hydrochloride.
Reproductive toxicity
In animal experiments, small quantities of azelastine hydrochloride passed through the placenta and entered in the mother’s milk. Embryotoxicity studies after oral administration in rats, mice and rabbits revealed signs of teratogenic effects in the maternal toxic dose range (68.6 mg/kg/day) only in mice. The smallest embryotoxic dose per os was 30 mg/kg/day in all three species.
Fertility disorders were observed in female rats with a dose of 3 mg/kg/day p.o. or more.

6.1 List of excipients
Sodium edetate, Hypromellose, Sodium monohydrogen phosphate dodecahydrate, Citric acid, Sodium chloride, purified water.

Not applicable

Store between +8°C & +30°C.

Brown glass bottle with spray pump.
Pack sizes:
5 ml of solution.
10 ml of solution (N1).
17 ml of solution (N2).
Hospital pack containing 10 x 10 ml of solution.
Not all pack sizes may be marketed.

No special requirements.