Azomyr 5 mg oral lyophilisate

 

What is it and how is it used?

Azomyr oral lyophilisate is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

Azomyr oral lyophilisate relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Azomyr oral lyophilisate is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

What do you have to consider before using it?

Do not take Azomyr oral lyophilisate

  • if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Azomyr oral lyophilisate, or to loratadine.

Azomyr oral lyophilisate is indicated for adults and adolescents (12 years of age and older).

Take special care with Azomyr oral lyophilisate

  • if you have poor kidney function.

If this applies to you, or if you are not sure, please check with your doctor before taking Azomyr.

Taking other medicines
There are no known interactions of Azomyr with other medicines.

Taking Azomyr oral lyophilisate with food and drink
Azomyr oral lyophilisate does not need to be taken with water or liquid. Additionally, Azomyr oral lyophilisate may be taken with or without a meal.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-

feeding.

If you are pregnant or nursing a baby, taking Azomyr is not recommended.

Driving and using machines
At the recommended dose, Azomyr is not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

Important information about some of the ingredients of Azomyr oral lyophilisate This product contains aspartame 1.75 mg/dose. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.

How is it used?

Before using, carefully peel open the blister and remove the dose of oral lyophilisate without crushing it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed to swallow the dose.

Adults and adolescents (12 years of age and older): take one dose of Azomyr oral lyophilisate once a day. Take the dose immediately after removal from the blister.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr oral lyophilisate. If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Azomyr oral lyophilisate than you should
Take Azomyr oral lyophilisate only as prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Azomyr oral lyophilisate than you were told to, contact your doctor or pharmacist.

If you forget to take Azomyr oral lyophilisate
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

What are possible side effects?

Like all medicines, Azomyr can cause side effects, although not everybody gets them. In adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.

During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely. Cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation and abnormal liver function tests have also been reported very rarely.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.
Store in the original package.

Do not use Azomyr oral lyophilisate after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Tell your pharmacist if you notice any change in the appearance of Azomyr oral lyophilisate.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is it?

Azomyr is a medicine containing the active substance desloratadine. It is available as a 5 mg tablet, a 5 mg oral lyophilisate (dispersible tablet), 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.

What is it used for?

Azomyr is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
The medicine can only be obtained with a prescription.

How is it used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day. The dose in children depends on their age. For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution. For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet. Adults and adolescents can use any form of the medicine.
Azomyr can be taken with or without food.

How does it work?

The active substance in Azomyr, desloratadine, is an antihistamine. It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has it been studied?

Azomyr has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma). The effectiveness of Azomyr was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.

Azomyr has also been studied in 416 patients with urticaria. The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.
In all studies, the effectiveness of Azomyr was compared with that of placebo (a dummy treatment). Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.

What benefits has it shown during the studies?

In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Azomyr led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo. In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Azomyr was 58 and 67%, compared with 40 and 33% in placebo-treated patients.

What is the risk associated?

In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%). The side effects seen in children are similar. In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%). For the full list of all side effects reported with Azomyr, see the Package Leaflet.
Azomyr should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr’s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria. The Committee recommended that Azomyr be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Azomyr to SP Europe on 15 January 2001. The marketing authorisation was renewed on 15 January 2006.