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DESLORATADINE 5MG FILM COATED TABLETS

Active substance(s): DESLORATADINE / DESLORATADINE / DESLORATADINE

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Pharmacod 4500

PACKAGE LEAFLET: INFORMATION
FOR THE USER

control your allergic reaction and its
symptoms.

Desloratadine 5 mg film-coated tablets

When desloratadine should be used
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) in adults
and adolescents 12 years of age and
older. 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.

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 which
worry you, talk to your doctor,
pharmacist or nurse. 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
What desloratadine is
Desloratadine is an antihistamine.
How desloratadine works
Desloratadine is an antiallergy medicine
that does not make you drowsy. It helps

2. What you need to know before your
take desloratadine
Do not take desloratadine
- if you are allergic to desloratadine or
any of the other ingredients of the
medicine (listed in section 6) or to
loratadine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking desloratadine:
- if you have poor kidney function.
- if you have medical or familial history
of seizures
Children and adolescents
Do not give this medicine to children less
than 12 years of age.
Other medicines and desloratadine
There are no known interactions of

desloratadine with other medicines. Tell
your doctor or pharmacist if you are
taking or have recently taken any other
medicines
Desloratadine with food, drink and
alcohol
Desloratadine may be taken with or
without a meal.
Use caution when taking desloratadine
with alcohol.

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.

Driving and using machines
At the recommended dose, this medicine
is not expected to affect your ability to
drive or use machines. Although most
people do not experience drowsiness, it
is recommended not to engage in
activities requiring mental alertness,
such as driving a car or operating
machinery until you have established
your own response to the medicinal
product.

Adults and adolescents (12 years of age
and older):
The recommended dose is one tablet
once a day with water, with or without
food.
This medicine is for oral use.
Swallow the tablet whole.
Regarding the duration of treatment,
your doctor 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 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.

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

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.

Pregnancy and breast-feeding and
fertility
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. Taking desloratadine is
not recommended if you are pregnant or
nursing a baby.
Fertility
There is no data available on male/female
fertility.

However, if you take more desloratadine
than you were told to, tell your doctor,
pharmacist or nurse immediately.
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 stop taking desloratadine
If you have any further questions on the
use of this medicine, ask your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, desloratadine 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
Adults
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
·
rash
·
pounding or irregular heartbeat
·
fast heartbeat
·
stomach ache
·
feeling sick (nausea)
·
vomiting
·
upset stomach
·
diarrhoea
·
dizziness
·
drowsiness
·
inability to sleep
·
muscle pain
·
hallucinations
·
seizures
·
restlessness with increased body
movement
·
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
·
changes in the way the heart beats
·
abnormal behavior
·
aggression

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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
S c h e m e ,
w e b s i t e :
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
This medicinal product should be stored
below 25ºC and in the original package.
You should keep this medicine out of the
sight and reach of children. Do not use
the medicine after the expiry date which
is stated on the carton and blister after
EXP. The expiry date refers to the last
day of that month.
Tell your pharmacist if you notice any
changes in the colour of the tablets or if
the package is damaged.
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 desloratadine
- The other ingredients of the tablet are:
starch pregelatinised, microcrystalline cellulose, lactose anhydrous, hypromellose, hydrogenated
vegetable oil, silica colloidal anhydrous
- The tablets are coated and the coating
contains the following: Hypromellose
(E464), titanium dioxide (E171),
macrogol, Indigo carmine (E132)
What desloratadine looks like and
contents of the pack
Desloratadine tablets are light blue,
circular biconvex film coated tablets,
plain on both the sides and are
approximately 6mm.
The product is available in blister packs
containing 1, 2, 3, 5, 6, 7, 10, 12, 14, 15,
18, 20, 21, 30, 50, 60, 90, 100 tablets
although not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire WA16 0PF
United Kingdom
This leaflet was last revised in 06/2017
Code No.: GO/DRUGS/654
ID#: 253244

Expand Transcript

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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