Desloratadine Mylan 5 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
DESLORATADINE 5 mg FILM-COATED TABLETS
(desloratadine)
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Desloratadine is and what it is used for.
2. What you need to know before you take Desloratadine.
3. How to take Desloratadine.
4. Possible side effects.
5. How to store Desloratadine.
6. Contents of the pack and other information.
1. WHAT DESLORATADINE IS AND WHAT IT IS USED FOR
Desloratadine is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
Desloratadine 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.
Desloratadine is indicated for adults and adolescents (12 years of age and older).
Warnings and precautions
Talk to your doctor before taking Desloratadine if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor.
Children
Desloratadine is not suitable for children under 12 years of age.
Other medicines and Desloratadine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Desloratadine with food and drink
Desloratadine may be taken with or without a meal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant or nursing a baby, taking Desloratadine is not recommended.
Driving and using machines
At the recommended dose, Desloratadine 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.
Desloratadine contains SunsetYellowaluminium lake (El 10), which may cause allergic reactions.
3. HOW TO TAKE DESLORATADINE
Desloratadine is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
Always take this medicine exactly as described in this leaflet or as your physician has told you. Check with your physician or pharmacist if you are not sure.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
You musttalktoa doctor if you do notfeel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE
Do not take Desloratadine:
• if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed in Section 6) or to loratadine.
The recommended dose for adults and adolescents (12 years of age and older) is 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 Desloratadine. 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
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depend on the evaluation of the history ofyour 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 ofyour physician.
If you take more Desloratadine than you should
Take Desloratadine only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine than you were told to, contact your doctor or pharmacist.
If you forget to take Desloratadine
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.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
Like all medicines, this medicine 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 Desloratadine, 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 you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Do not use this medicine after the expiry date, which is stated on the carton and blister.The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Desloratadine contains
The active substance is desloratadine.
Each tablet contains 5 mg of desloratadine.
The other ingredients of the tablet are: magnesium stearate, sodium lauryl sulphate, silica colloidal anhydrous, microcrystalline cellulose and pregelatinised maize starch. The tablet film coating contains: polyvinyl alcohol, indigo carmine aluminium lake (El 32), sunset yellow aluminium lake (El 10), macrogol, talc (E553b) and titanium dioxide (El 71).
What Desloratadine looks like and contents of the pack
Desloratadine are blue, film-coated, round, biconvex, bevelled edge tablets marked 'DE 5' on one side of the tablet and 'M' on the reverse. Desloratadine 5 mg film-coated tablets are packed in blisters in packs of 2, 3, 5, 7,10,15, 20,30, 50,60, 90 and 100 tablets. Not all pack sizes may be marketed.
Market authorisation holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
This leafet was last revised in: June 2012
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