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DESLORATADINE SANDOZ 5 MG FILM-COATED TABLETS
Desloratadine 5 mg Film-coated Tablets
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
3. How to take Desloratadine
4. Possible side effects
5. How to store Desloratadine
6. Contents of the pack and other information
What Desloratadine is and what it
is used for
Desloratadine is an anti-allergy 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.
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
Desloratadine is indicated for adults and
adolescents (12 years of age and older).
What you need to know before you
Do not take Desloratadine
• if you are allergic (hypersensitive) to
desloratadine, to any of the other ingredients of
Desloratadine or to loratadine.
Warnings and precautions
Talk to your doctor or pharmacist before taking
• if you have poor kidney function.
If this applies to you, or if you are not sure, please
check with your doctor before taking Desloratadine.
Other medicines and Desloratadine
There are no known interactions of Desloratadine
with other medicines.
Desloratadine with food and drink
Desloratadine may be taken with or without a
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy and
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.
How to take Desloratadine
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The usual dose is:
Adults and adolescents (12 years of age and
older): take one tablet once a day.
Swallow the tablet with or without food.
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
• 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.
Continued on the next page >>
• For urticaria, the duration of treatment may be
variable from patient to patient and therefore
you should follow the instructions of your
If you take more Desloratadine than you
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.
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, following
side effects have been reported very rarely (may
affect up to 1 in 10,000 people):
• Severe allergic reactions (difficulty in
breathing, wheezing, itching, hives and
swelling) and rash. Stop taking the medicine
and seek medical help immediately if you
experience any of these symptoms.
• 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
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
How to store Desloratadine
Keep this medicine out of the sight and reach of
Do not use Desloratadine after the expiry date
which is stated on the carton and blister after
EXP. The expiry date refers to the last day of that
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 to protect the environment.
Contents of the pack and other
What Desloratadine contains
• The active substance is desloratadine. Each
film-coated tablet contains 5 mg desloratadine.
• The other ingredients are:
Film-coated tablet core: Maize starch,
Cellulose, microcrystalline, Hypromellose, Silica
Colloidal anhydrous, Hydrogenated vegetable
oil (Type 1).
Film-coated tablet coating: Opadry Blue
03B50689 (Hypromellose E464, Titanium
dioxide E171, Macrogol 400 E1521, Indigo
Carmine Aluminum Lake E132)
What Desloratadine looks like and contents of
Desloratadine is a Light blue, round shaped,
biconvex film coated tablets, with “5” debossed on
one side. Diameter 6.50 ± 0.10 mm.
Desloratadine is supplied in blister pack
comprising of OPA/ ALU/ PVC/ ALU and in blister
pack comprising of PVC/ Aclar/ ALU)
Pack sizes (unit dose):
1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 and
100 film coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Lek Pharmaceuticals d.d.,
Salutas Pharma GmbH,
ul. Domaniewska 50 C,
This leaflet was last approved in 03/2012 (to be
amended upon approval).
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.