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DESLORATADINE GEDEON RICHTER 5 MG FILM-COATED TABLETS

Active substance(s): DESLORATADINE HEMISULPHATE / DESLORATADINE HEMISULPHATE / DESLORATADINE HEMISULPHATE

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Package leaflet: information for the user

Desloratadine 5mg
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, pharmacist or nurse.
− 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, 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 contains desloratadine which is an
antihistamine.
How Desloratadine works
Desloratadine is an antiallergy medicine that does not
make you drowsy. It helps control your allergic reaction and
its symptoms.
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.

2. What you need to know before you take
Desloratadine
Do not take Desloratadine
− if you are allergic to desloratadine or any of the other
ingredients of this medicine (listed in section 6), to peanut
or to loratadine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Desloratadine
− if you have poor kidney function.
Use in 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, have recently
taken or might take 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.
Pregnancy, 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.
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.
Desloratadine contains soya oil
Desloratadine contains soya lecithin. If you are allergic to
peanut or soya, do not use 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 over
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 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
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
physician 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 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 or nurse immediately.

If you forget to take Desloratadine
If you forget to take your dose on time, take it as soon as
possible, and 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, this medicine can cause side effects,
although not everybody gets them.
During the marketing of desloratadine, cases of severe
allergic reactions (diffculty in breathing, wheezing, itching,
hives and swelling) and rash 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 (i.e. a tablet without containing the
active substance). 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
During the marketing of Desloratadine, the following side
effects were reported as:
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
− fast heartbeat
− vomiting
− dizziness
− muscle pain
− restlessness with increased body movement
− rash
− stomach ache
− upset stomach
− drowsiness
− hallucinations
− liver inflammation
− pounding or irregular heartbeat
− feeling sick (nausea)
− diarrhoea
− inability to sleep
− seizures
− abnormal liver function tests
Not known: frequency cannot be estimated from the
available data
− 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
− unusual weakness
− yellowing of the skin and/or eyes
− 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 via the Yellow Card
Scheme (website: 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.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
conditions.
Do not use this medicine if you notice any change in the
appearance of the tablets.
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 5mg
(as desloratadine hemisulphate).
− The other ingredients are:
Tablet core: cellulose, microcrystalline, calcium hydrogen
phosphate dihydrate, maize starch, pregelatinised silica,
colloidal anhydrous, magnesium stearate.
Film-coating: poly(vinyl alcohol) (E1203), titanium dioxide
(E171), talc (E553b), lecithin (soya) (E322), quinoline
yellow aluminium lake (E104), xanthan gum (E415), iron
oxide yellow (E172), indigo carmine aluminium lake (E132).
What Desloratadine looks like and contents of the pack
Desloratadine 5mg film-coated tablets are yellow, round,
biconvex film-coated tablets, of about 6mm diameter, one
side engraved with ‘R03’.
Desloratadine 5mg film-coated tablets are packaged in
PVC/PE/PVDC//Al blisters. The blisters are packed into
cardboard cartons.
Pack sizes are: 7, 10, 20, 30, 50, 90, 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyömrői út 19-21
H-1103 Budapest,
Hungary
Manufacturer:
Gedeon Richter Romania SA
99-105, Cuza Vodă Street
540306 Târgu-Mureş
Romania
Distributor:
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
This leaflet was last revised
in 01/2017
1010173 P5.1

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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