Aerinaze

What is Aerinaze?

Aerinaze is a drug containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg). it is available in blue and white modified release tablets. The term "modified release" means that the tablets are made so that one of the active ingredients is released immediately and the other during a few hours.

What is Aerinaze used for?

Aerinaze is indicated for the treatment of symptoms of seasonal allergic rhinitis (hay fever, which is an inflammation of the sinuses caused by a pollen allergy) in patients with nasal congestion (stuffy nose).

The medicine can only be obtained with a prescription.

How is Aerinaze used?

In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, swallowed whole with a full glass of water. The tablet can be taken with or without food. The duration of treatment should be as short as possible and the medicine should be stopped after the symptoms have disappeared, especially congestion (stuffy nose). Treatment for more than 10 days is not recommended, as the medicine's effectiveness on nasal congestion may decrease. After congestion improvement, patients can use desloratadine alone (alone).

How does Aerinaze work?

Aerinaze contains two active ingredients: desloratadine, an antihistamine, and pseudoephedrine, a nasal decongestant. Desloratadine blocks the receptors on which histamine, a substance in the body that causes allergic symptoms, is usually fixed. Once the receptors are blocked, histamine cannot produce its effects and a decrease in allergy symptoms is observed. Pseudoephedrine works by stimulating the release by the nerve endings of the chemical Norepinephrine, which causes the constriction (narrowing) of blood vessels. In this way, the amount of fluid released by the vessels is reduced and, consequently, the swelling and the mucus production in the nose is reduced. In Aerinaze, the two active ingredients are used together, because an antihistamine alone may not provide adequate relief for patients with nasal congestion.

Aerinaze tablets have two layers: the first containing desloratadine, the second containing pseudoephedrine. Desloratadine is released from its layer immediately after intake, while

pseudoephedrine is released slowly over 12 hours. In this way patients should take the tablet only twice a day.

Desloratadine has been available in the European Union (EU) since 2001, while pseudoephedrine has been widely used for many years in over-the-counter medicines.

How has Aerinaze been studied?

The efficacy of Aerinaze was examined in two main studies involving a total of 1, 248 adult and adolescent patients. In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine monotherapy. The main indicators of effectiveness were the change in the severity of hayfever symptoms reported by patients before the start of treatment and during the 15 days of treatment. During the study the patients recorded the symptoms in a diary every 12 hours, attributing to the severity of the symptoms that emerged during the previous 12 hours a score based on a standard scale.

What benefit has Aerinaze shown during the studies?

Aerinaze was more effective in reducing symptoms than both active ingredients taken alone. Regarding all symptoms of hay fever, except for nasal congestion, patients who took Aerinaze reported a reduction in symptoms of 46.0%, compared to 35.9% of patients treated with pseudoephedrine alone. Regarding nasal congestion, patients who took Aerinaze reported a reduction in symptoms by 37.4%, compared to 26.7% of patients treated with desloratadine alone. Similar results were observed in the second study.

What is the risk associated with Aerinaze?

The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (increased heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue, insomnia, drowsiness, sleep disturbances and nervousness. For the full list of all side effects reported with Aerinaze, see the Package Leaflet.

Aerinaze should not be used in people who may be hypersensitive (allergic) to desloratadine, pseudoephedrine or other ingredients, to adrenergic agents or loratadine (another medicine used to treat allergies). It must not be used in patients being treated with monoamine oxidase inhibitors (such as some medicines used to treat depression) or who have stopped treatment for less than two weeks. Aerinaze must also not be taken by people with narrow-angle glaucoma (increased pressure inside the eye), urinary retention (difficulty urinating), cardiovascular diseases including hypertension (increased blood pressure), hyperthyroidism (excessive activity of the thyroid gland) or a history or risk factors for hemorrhagic stroke (stroke caused by a cerebral hemorrhage).

Why has Aerinaze been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze's benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis accompanied by nasal congestion and therefore recommended that it be given marketing authorization. .