Azomyr 0.5 mg/ml oral solution

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

Azomyr oral solution 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 solution 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, loratadine, or to any of the other ingredients of Azomyr.

Azomyr oral solution is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.

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 Azomyrwith 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 oral solution 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 oral solution contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Children 1 through 5 years of age: take 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.

Children 6 through 11 years of age: take 5 ml (one 5 ml spoonful) of oral solution once a day.

Adults and adolescents (12 years of age and older): take 10 ml (two 5 ml spoonfuls) of oral solution once a day.

In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use it to take the appropriate amount of oral solution.

Swallow the dose of oral solution, then drink some water. You can take this medicine 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 oral solution. 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 oral solution only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Azomyr oral solution 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 oral solution can cause side effects, although not everybody gets them. In most children and adults, side effects with Azomyr were about the same as with a dummy solution or tablet. However, common side effects in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.

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 freeze. Store in the original package.

Do not use Azomyr after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

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

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 0.5 mg/ml
• The other ingredients of the oral solution are sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate and purified water.

What Azomyr looks like and contents of the pack

Azomyr oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap. For all packages except the 150 ml bottle, a measuring spoon is provided, marked for doses of 2.5 ml and 5 ml. For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.

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

. 359 2 819 3737 info-msdbgmerck.com Magyarország Alkotás u. 53. H-1123 Budapest Tel. 36 1 457-8500

eská republika Ke tvanici 3 CZ-186 00 Praha 8 Tel 420 221771250 Malta Associated Drug Co. Ltd. Triq l-Esportaturi Mriehel Birkirkara BKR 3000 Tel. 35622778000

Danmark Lautrupbjerg 2 DK-2750 Ballerup Tlf 45-44 39 50 00 Nederland Merck Sharp Dohme BV Tel 31 0800 9999000 31 23 5153153 medicalinfo.nlmerck.com

Norge Pb. 398 N-1326 Lysaker Tlf 47 67 16 64 50 Deutschland Thomas-Dehler-Straße 27 D-81737 München Tel 49-089 627 31-0 Infoessex-pharma.de

Eesti A. H. Tammsaare tee 47 EE-11316 Tallinn Tel 372 6139 750 Österreich Merck Sharp Dohme Ges.m.b.H. Tel 43 0 1 26 044 msd-medizinmerck.com

MSD ..... 30 210 98 97 300 cora.greece.gragcmmerck.com Polska POLPHARMA Biuro Handlowe Sp. z o.o. Ul. Bobrowiecka 6 00-728 Warszawa Tel. 022 364 61 01

España Laboratorios Menarini S.A. CAlfonso XII, 587 E-08918 - Badalona Barcelona Tel 34-93 462 88 00 Portugal Ferraz, Lynce, S.A. R. Consiglieri Pedroso n.123 Queluz de Baixo P-2731-901 Barcarena Tel 351-21 434 52 12

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Latvija Skanstes iela 13 Rga, LV-1013 Tel 371-67364224 United Kingdom Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medicalinformationukmerck.com

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