DESLORATADINE MYLAN 5 MG FILM-COATED TABLETS

Active substance: DESLORATADINE

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170 mm

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.

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.

depend on the evaluation of the history of your
disease.

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

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.

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 Sunset Yellow aluminium
lake (E110), 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.

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.

You must talk to a doctor if you do not feel 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.

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

For urticaria, the duration of treatment may be
variable from patient to patient and therefore you
should follow the instructions of your 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, 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) 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.

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. 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 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 (E132), sunset yellow aluminium
lake (E110), macrogol, talc (E553b) and titanium
dioxide (E171).
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.

If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not
listed in this leaflet.
5. HOW TO STORE DESLORATADINE
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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10004563

240 mm

1. WHAT DESLORATADINE IS AND WHAT IT IS
USED FOR

Desloratadine is indicated for adults and
adolescents (12 years of age and older).

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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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