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DESLORATADINE 5 MG FILM-COATED TABLETS

Active substance(s): 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,
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 is an antihistamine.
How Desloratadine works
Desloratadine is an anti-allergy 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 or 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, 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.
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 in 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 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 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.

4. POSSIBLE SIDE EFFECTS

Regarding the duration of treatment, your physician will
determine the type of allergic rhintis 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 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.

• unusual weakness • yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even in case

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

of hazy sun, and to UV light, for instance to UV lights of a
solarium • change in the way the heart beats

What Desloratadine contains

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.

Children
Not known: frequency cannot be estimated from the
available data
• slow heartbeat • change in the way the heart beats

• The other ingredients in the tablet core are:

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

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.

Adults
Do not use this medicine after the expiry date which is
During the marketing of Desloratadine, the following side stated on the packaging after “EXP”. The expiry date refers
effects were reported as:
to the last day of that month.
Very rare: the following may affect up to 1 in 10,000
Store in the original package in order to protect from
people:
moisture.
• severe allergic reactions • pounding or irregular
After first opening of the tablet container, the medicinal
heatbeat • fast heartbeat • stomach ache • feeling sick
product should be used within 3 months.
(nausea) • vomiting • upset stomach • diarrhoea
• dizziness • drowsiness • inability to sleep • muscle pain Do not throw away any medicines via wastewater or
• hallucinations • seizures • restlessness with increased
household waste. Ask your pharmacist how to throw
body movement • rash • liver inflammation
away medicines you no longer use. These measures will
• abnormal liver function tests.
help protect the environment.
Not known: frequency cannot be estimated from the
available data

• The active substance is desloratadine. Each film-coated
tablet contains 5 mg desloratadine.

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 bevelled
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 October 2015.
P0381

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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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