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DESLORATADINE 5 MG FILM-COATED TABLETS

Active substance: DESLORATADINE

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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 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. 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. How to store Desloratadine
6. Contents of the pack and other information

1. WHAT DESLORATADINE IS AND WHAT IT IS
USED FOR

Other medicines and Desloratadine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Desloratadine is an antiallergy medicine that does not
There are no known interactions of Desloratadine with
make you drowsy. It helps control your allergic reaction and other medicines.
its symptoms.
Desloratadine with food, drink and alcohol
Desloratadine relieves symptoms associated with allergic
Desloratadine may be taken with or without a meal (see
rhinitis (inflammation of the nasal passages caused by an
section 3).
allergy, for example, hay fever or allergy to dust mites).
Use caution when taking Desloratadine with alcohol.
These symptoms include sneezing, runny or itchy nose,
Pregnancy and breast-feeding
itchy palate, and itchy, red or watery eyes.
If you are pregnant or breast-feeding, think you may be
Desloratadine is also used to relieve the symptoms
pregnant or are planning to have a baby, ask your doctor or
associated with urticaria (a skin condition caused by an
pharmacist for advice before taking this medicine.
allergy). These symptoms include itching and hives.
If you are pregnant or nursing a baby, taking
Relief of these symptoms lasts a full day and helps you to
Desloratadine is not recommended.
resume your normal daily activities and sleep.
Driving and using machines
Desloratadine is indicated for adults and adolescents (12
At the recommended dose, Desloratadine is not expected
years of age and older).
to cause you to be drowsy or less alert. However, very rarely
some people experience drowsiness, which may affect their
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ability to drive or use machines.

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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Desloratadine if you have poor kidney function.

Desloratadine contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.


3. HOW TO TAKE DESLORATADINE

If this applies to you, or if you are not sure, please check
with your doctor before taking Desloratadine.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Children
Desloratadine should not be used in children under 12
years old.

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, 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 tablet.
If you have any further questions on the use of this
medicinal product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
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. If you

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

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
If you 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
Adults
via the Yellow Card Scheme at: www.mhra.gov.uk/
During the marketing of Desloratadine, the following side
yellowcard.
effects were reported as:
By reporting side effects you can help provide more
Very rare: the following may affect up to 1 in 10,000 people: information on the safety of this medicine.
• severe allergic reactions
• palpitations
5. HOW TO STORE DESLORATADINE
• rapid heartbeat
• stomach pain
Keep this medicine out of the sight and reach of children.
• nausea (feeling sick)
Do not use this medicine after the expiry date which is
• vomiting
stated on the packaging after “EXP:”. The expiry date refers
• upset stomach
to the last day of that month.
• diarrhoea
• dizziness
Store in the original package in order to protect from
• drowsiness
moisture.
• inability to sleep
After first opening of the tablet container, the medicinal
• muscle pain
product should be used within 3 months.
• hallucinations
• seizures
Do not throw away any medicines via wastewater or
• restlessness with increased body movement
household waste. Ask your pharmacist how to throw away
• rash
medicines you no longer use. These measures will help
• liver inflammation
protect the environment.
• abnormal liver function tests.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
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 (E171) 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, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5,
27472 Cuxhaven, Germany
This leaflet was last revised in May 2015.

P0346

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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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