Desloratadine 5 Mg Film-Coated Tablets
Out of date information, search another
3. HOWTO TAKE DESLORATADINE
4. POSSIBLE SIDE EFFECTS
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONSILIENT HEALTH i»
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.
• Ifyou have any further questions, askyour 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.
• Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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. Howto 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 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.
Desloratadine is indicated for adults and adolescents (12 years of age and older).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE
Do not take Desloratadine
• ifyou are allergic to desloratadine, to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadine ifyou have poor kidney function.
If this applies to you, or ifyou are not sure, please check with your doctor before taking Desloratadine.
Children
Desloratadine should not be used in children under 12 years old.
Other medicines and Desloratadine
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines.
There are no known interactions of Desloratadine with other medicines.
Desloratadine with food, drink and alcohol
Desloratadine may be taken with or without a meal (see section 3).
Use caution when taking Desloratadine with alcohol.
Pregnancy and breast-feeding
Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine.
Ifyou 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 lactose
Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.
Adults and adolescents (12 years of age and older):
The recommended dose is one tablet once a day. Swallow the tablet whole with water, with or without food.
Regarding the duration of treatment, your doctor will determine the type of allergic disease 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 doctor 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 doctor 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 than you should
Take Desloratadine only as it is prescribed for you. No serious problems are expected with accidental overdose. However, ifyou take more Desloratadine than you were told to, contact your doctor or pharmacist.
If you forget to take Desloratadine
Ifyou 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 tablet. Ifyou have any further questions on the use of this medicinal product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of Desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. Ifyou
5. HOW TO STORE DESLORATADINE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.
In clinical studies 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.
In clinical studies with Desloratadine, the following side effects were reported as:
Common: the following may affect up to 1 in 10 people
• fatigue
• dry mouth
• headache
Adults
During the marketing of Desloratadine, the following side effects were reported as:
Very rare: the following may affect up to 1 ini 0,000 people:
• severe allergic reactions
• 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
• rash
• liver inflammation
• abnormal liver function tests.
Not known: frequency cannot be estimated from the available data
• unusual weakness • yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium • change in the way the heart beats
Children
Not known: frequency cannot be estimated from the available data
• slow heartbeat • change in the way the heart beats
Reporting of side effects
Ifyou get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.qov.uk/ vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP:". The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
After first opening of the tablet container, the medicinal product should be used within 3 months.
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.
What Desloratadine contains
• The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.
• The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate and talc (E553b).
• The other ingredients in the film coating are: hypromellose (E464), macrogol, lactose monohydrate, titanium dioxide (El 71) and indigo carmine aluminium lake (E132).
What Desloratadine looks like and contents of the pack
Light blue, round, film-coated tablets with beveled edges (diameter 6.5 mm).
Desloratadine is available in carton boxes of 7,10,20,30, 50,90 and 100 film-coated tablets in blisters and in plastic tablet containers of 250 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Consilient Health Ltd., 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland
Manufacturers
KRKA, d.d., Novo mesto, Smarjeska cesta 6,
8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-StraRe 5,
27472 Cuxhaven, Germany
This leaflet was last revised in May 2015.
P0346