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MIDETORIN 0.5 MG/ML ORAL SOLUTION

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Midetorin 0.5 mg/ml oral solution
PACKAGE LEAFLET: INFORMATION FOR THE USER Desloratadine Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1. What Midetorin is and what it is used for 2. Before you take Midetorin 3. How to take Midetorin 4. Possible side effects 5. How to store Midetorin 6. Further information

Driving and using machines At the recommended dose, Midetorin 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 Midetorin Midetorin 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 ( 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. 3. HOW TO TAKE MIDETORIN

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

1. WHAT MIDETORIN IS AND WHAT IT IS USED FOR

Midetorin 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. Midetorin 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 Midetorin - if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients of Midetorin. Midetorin 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 Midetorin - if you have poor kidney function.

2. BEFORE YOU TAKE MIDETORIN

If this applies to you, or if you are not sure, please check with your doctor before taking Midetorin. Taking other medicines There are no known interactions of Midetorin with other medicines.

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 Midetorin 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.

Taking Midetorin with food and drink Desloratadine 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 breastfeeding. If you are pregnant or nursing a baby, taking Midetorin oral solution is not recommended.

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

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Like all medicines, Midetorin oral solution can cause side effects, although not everybody gets them. In most children and adults, side effects with Midetorin 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.

4. POSSIBLE SIDE EFFECTS

What Midetorin contains

6. FURTHER INFORMATION

The active substance is desloratadine 0.5 mg/ml Each ml of Midetorin contains 0.5 mg desloratadine. The other ingredients of the oral solution are: Sorbitol, liquid (E420) (non-crystallizing) Propylene glycol Citric acid monohydrate Sodium citrate Hypromellose 2910 Sucralose Disodium edentate Tutti frutti flavouring Purified water.

During the marketing of Midetorin, 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. 5. HOW TO STORE MIDETORIN

After first opening it should be used within 2 months. This medicinal product does not require any special storage conditions. Do not use Midetorin after the expiry date (EXP) which is stated on the bottle. The expiry date refers to the last day of that month.

What Midetorin looks like and contents of the pack Midetorin oral solution is presented as a clear colourless solution, free from foreign matters. Midetorin 0.5mg/ml oral solution is supplied in six different volume sizes 50, 60, 100, 120 150 and 300ml and packaged in 60, 100, 125, 150 ml & 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylene-faced liner. The 50 and 60 ml are both packaged in 60 ml bottles, the 100 ml are packaged in 100 ml bottles, the 120 ml are packaged in 125 ml bottles and the 150 ml are packaged in 150 ml bottles and the 300ml are packaged in 300ml bottles. The bottles are subsequently packed into cardboard boxes. All packages are supplied with a measuring spoon marked for doses of 2.5 ml and 5 ml or an oral measuring syringe of a final volume of 5 ml marked on every 0.5 ml. Pack sizes: 50ml, 60ml, 100ml, 120ml, 150ml & 300 ml volume sizes. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Specifar S.A, 1, 28 Octovriou str., Ag. Varvara, 12351 Athens, Greece. This leaflet was prepared 16/01/2012.

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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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