Aerius film-coated tablets 5 mg blister 10 pcs.

Aerius tablets are used to eliminate symptoms associated with:

• allergic rhinitis;
• urticaria.

Composition

Active substance – desloratadine (one tablet contains 5 mg of desloratadine).

Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, corn starch, talc, carnauba wax, white wax; film coating: lactose, hydroxypropyl methylcellulose, titanium dioxide (E 171), polyethylene glycol, indigo carmine (E 132); transparent coating: hydroxypropyl methylcellulose, polyethylene glycol.

Contraindications

Hypersensitivity to the active substance or to any excipient or to loratadine.

Method of application

Adults and children over 12 years of age: one tablet once a day, regardless of meals, to eliminate symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Therapy of intermittent allergic rhinitis (presence of symptoms less than 4 days a week or less than 4 weeks) should be carried out taking into account the anamnesis data: stop after the disappearance of symptoms and resume after their re-occurrence.

With persistent allergic rhinitis (presence of symptoms more than 4 days a week or more than 4 weeks), treatment should be continued throughout the entire period of contact with the allergen.

Features of use

Pregnant women

Desloratadine did not demonstrate teratogenicity in animal studies. The safety of the drug during pregnancy has not been established, therefore the use of the drug “Aerius” during this period is not recommended.

Desloratadine is excreted in breast milk, so the use of Aerius in women who are breastfeeding is not recommended.

Children

There are limited clinical trial data on the effectiveness of desloratadine tablets in adolescents aged 12 to 17 years. The effectiveness and safety of Aerius tablets in children under 12 years of age have not been established.

Drivers

In clinical trials assessing the ability to drive, no impairment was observed in patients taking desloratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive and operate machinery.

Overdose

In case of overdose, standard measures should be taken to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. In clinical trials in which desloratadine was administered at doses of 45 mg (9 times the recommended dose), no clinically significant adverse reactions were observed. Desloratadine is not removed by hemodialysis; its removal by peritoneal dialysis has not been established.

Adverse reactions

In clinical trials in indications including allergic rhinitis and chronic idiopathic urticaria, adverse reactions were reported 3% more frequently in patients receiving a dose of 5 mg per day than in patients receiving placebo.

The most frequently reported adverse reactions compared to placebo were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%).

In clinical studies involving 578 adolescents aged 12 to 17 years, the most common side effect was headache (in 5.9% of patients taking desloratadine and 6.9% of patients receiving placebo).

Storage conditions

Store at a temperature not exceeding 30 °C, in a dry place and out of the reach of children.

Shelf life – 2 years.