DESLORATADINE 5MG FILM-COATED TABLETS

Active substance: DESLORATADINE

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PACKAGE LEAFLET: INFORMATION
FOR THE USER
Desloratadine 5 mg tablets
Read all of this leaflet carefully
before you start taking this medicine.
· 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. 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.
In this leaflet:
1. What Desloratadine is and what it is
used for
2. What you need to know about Desloratadine
3. How to take Desloratadine
4. Possible side effects
5. How to store Desloratadine
6. Further information
1. What desloratadine is and what it
is used for
Desloratadine contains the active substance desloratadine which is an antihistamine. It helps control your allergic reaction and its symptoms.
This medicine 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 if
– you are allergic (hypersensitive) to
desloratadine or any of the other ingredients of the medicine (see section 6) or to loratadine.
· Are under 12 years
Warnings – talk to your doctor, pharmacist or nurse
– if you have poor kidney function.
Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
This medicine should not be taken if
you are pregnant or breast-feeding.
Always talk to your doctor or pharmacist before taking any medicine during
pregnancy and breast-feeding.

Driving and using machines
This medicine is not expected to make
you drowsy or less alert. However,
very rarely some people do become
drowsy. This may affect their ability to
drive or use machines. You should not
drive until you know whether or not the
medicine affects you.
Important information about some of
the ingredients of this medicine
This medicine contains lactose. If you
have been told by your doctor that you
have an intolerance to some sugars,
talk to your doctor before taking this
medicinal product.
3. How to take desloratadine
Adults and adolescents (12 years of
age and older): take one tablet once a
day.
Swallow the tablet whole with water.
Desloratadine may be taken with or
without food.
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.
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, desloratadine can
cause side effects, although not everybody gets them.
In adults, side effects were about the
same as with a dummy tablet. However, tiredness, 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.
If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
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. The expiry date refers
to the last day of the 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. Further information.
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 05/2012
CODE NO. GO/DRUGS/654
ID#: 229649

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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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