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

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

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

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

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.

There are no known interactions of Desloratadine
with other medicines.

Desloratadine is also used to relieve the symptoms
associated with urticaria (a skin condition caused by
an allergy). These symptoms include itching and
hives.

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.

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

Desloratadine with food and drink
Desloratadine may be taken with or without a meal
(see section 3).

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 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
Always take this medicine exactly as your doctor or

pharmacist has told you. Check with your doctor or
pharmacist if you 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, 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.
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) have been
reported very rarely.
During the marketing of Desloratadine, the following
side effects were reported as:
Very rare: the following may affect up to 1 in 10,000
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.
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 via the Yellow Card Scheme at: www.
mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE Desloratadine
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. Ask your 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 filmcoated 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 June 2014.
P0238

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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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