Azomyr 5 mg oral lyophilisate

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.

Do not take Azomyroral 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 Azomyroral lyophilisate This product contains aspartame 1.75 mg/dose. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.

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 Azomyroral 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.

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.

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 Azomyr oral lyophilisate contains

• The active substance is desloratadine 5 mg
• The other ingredients are gelatin, mannitol, aspartame (E951), polacrilin potassium, Dye Opatint Red (containing red iron oxide (E172) and hypromellose (E464)), flavour Tutti-Frutti, and citric acid anhydrous.

What Azomyr oral lyophilisate looks like and contents of the pack

Azomyr oral lyophilisate is packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, and 100 doses of oral lyophilisate.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.

Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Rue de StalleStallestraat 73 B-1180 BruxellesBrusselBrüssel TélTel 32-02 370 92 11 LuxembourgLuxemburg Rue de Stalle 73 B-1180 BruxellesBrüssel BelgiqueBelgien TélTel 32-02 370 92 11

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