Azomyr 5 mg film-coated tablets

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

Azomyr 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 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 Azomyr

• if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Azomyr or to loratadine. Azomyr is indicated for adults and adolescents (12 years of age and older).

Take special care with Azomyr

• 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 with food and drink
Azomyr 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
Azomyr tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Adults and adolescents (12 years of age and older): take one tablet once a day.
Swallow the tablet whole with water, with or without food.

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.
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 than you should

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

If you forget to take Azomyr
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.

Do not store above 30°C. Store in the original package.

Do not use Azomyr 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 the tablets.

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 contains

• The active substance is desloratadine 5 mg
• The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.

What Azomyr looks like and contents of the pack

Azomyr 5 mg film-coated tablets are packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets.
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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