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DESLORATADINE ARROW 5MG FILM-COATED TABLETS

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PIL-539UK_DESL_V2.qxp

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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.
• 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 Desloratadine is and what it is used for
2. Before you take Desloratadine film-coated tablets
3. How to take Desloratadine film-coated tablets
4. Possible side effects
5. How to store Desloratadine film-coated tablets
6. Further information
1. WHAT DESLORATADINE IS AND WHAT IT IS USED FOR
Desloratadine is an antiallergic 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.
Destoratadine 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.
2. BEFORE YOU TAKE DESLORATADINE FILM-COATED TABLETS
Do not take Desloratadine film-coated tablets:
• if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Desloratadine
5 mg film-coated tablets or to loratadine.
Desloratadine film-coated tablets are indicated for adults and adolescents (12 years of age and older).
Take special care with Desloratadine film-coated tablets:
• if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Desloratadine
film-coated tablets.
Taking other medicines:
There are no known interactions of desloratadine with other medicines.
Taking Desloratadine film-coated tablets with food and drink:
Desloratadine film-coated tablets 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 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.
3. HOW TO TAKE DESLORATADINE FILM-COATED TABLETS
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 your medicine.
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 doctor.
If you take more Desloratadine film-coated tablets 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 film-coated tablets:
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, ask your doctor or pharmacist.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, desloratadine 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 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.
5. HOW TO STORE DESLORATADINE FILM-COATED TABLETS
Keep out of the reach and sight of children.
Do not use your medicine after the expiry date which is stated on the carton and on the blister after EXP.
The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
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.
6. FURTHER INFORMATION
What Desloratadine film-coated tablets contain:
• The active substance is desloratadine 5mg.
• The other ingredients are: microcrystalline cellulose, Pregelatinised maize starch, magnesium
stearate and colloidal anhydrous silica. In addition, the coating of the tablets contain Opadry blue
03A30735 (which consists of: hypromellose, titanium dioxide, microcrystalline cellulose, stearic acid
and indigotine (E132)).
What Desloratadine film-coated tablets look like and contents of the pack:
Desloratadine 5 mg film-coated tablets are blue, round, biconvex with dimensions 6.5 mm x 3.2 mm.
Blisters in packages of: 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Arrow ApS, Sankt Peders Stræde 2, 1, 4000 Roskilde, Denmark
Manufacturer:
Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece
This leaflet was last approved in: 03/2012

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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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