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DESLORATADINE 2.5 MG ORODISPERSIBLE TABLETS

Active substance(s): DESLORATADINE

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Desloratadine 2.5 mg orodispersible 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, 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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
This medicine contains the active substance desloratadine which is an
antihistamine.
This medicine is an anti allergy medicine that does not make you drowsy.
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) in adults, adolescents and children 6
years of age and older. These symptoms include sneezing, runny or
itchy nose, itchy palate, and itchy, red or watery eyes.
This medicine is also used to relieve the symptoms associated with
urticaria (a skin condition caused by an allergy). These symptoms include

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2. What you need to know before you
take this medicine

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.
This medicine contains aspartame
Aspartame is a source of phenylalanine, which may be harmful for people
with phenylketonuria.

Do not take this medicine
- if you are allergic to desloratadine, or any of the other ingredients of
this medicine (listed in section 6), or to loratadine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine:
- if you have poor kidney function.
Use in children and adolescents
Do not give this medicine to children less than 6 years of age.
Taking other medicines
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.
Taking with food, drink and alcohol
This medicine does not need to be taken with water or liquid. Additionally,
it 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 this medicine 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

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 two tablets once a day with or without food.
This medicine is for oral use.
Before using, carefully peel open the blister and remove the dose of
orodispersible tablet without crushing it. Place it in your mouth and it will
disperse immediately. Water or other liquid is not needed to swallow the
dose. Take the dose immediately after removal from the blister.
Children from 6 to 11 years of age
The recommended dose is one tablet once a day 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 this medicine.
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 of this medicine than you should
Take this medicine only as prescribed for you. No serious problems are

itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your
normal daily activities and sleep.

3. How to take this medicine

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Package leaflet: Information for the patient

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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
(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: 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: may affect up to 1 in 10,000 people:
• severe allergic reactions
• rash

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• pounding or irregular heart beat
• fast heart beat
• stomachache
• 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
• 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
• abnormal behaviour (including anger, aggression and agitation)
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 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 this medicine
• Keep this medicine out of the sight and reach of children.

• Do not use this 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.
• This medicinal product does not require any special storage conditions
• Do not throw away any medicines via waste water 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 this medicine contains
• The active substance is desloratadine 2.5mg.
• The other ingredients are polacrillin potassium, citric acid monohydrate,
potassium hydroxide, iron oxide red (E172), magnesium stearate,
croscarmellose sodium, mannitol (E421), microcrystalline cellulose,
aspartame (E951) and flavour Tutti Frutti (consists of flavouring
substances, maltodextrin, propylene glycol, modified starch.).
What this medicine looks like and contents of the pack
• These tablets are red-brick, round, flat tablets with beveled edges and
‘2.5’ embossed on one side. The tablet dimensions are 6.4 mm x
2.4 mm.
• This medicine is available in blister packs of 5, 6, 10, 12,15, 18, 20, 30,
50, 60, 90 and 100.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, United Kingdom, HP4 1EG
Telephone:
0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
Email:
info@bristol-labs.co.uk
Desloratadine 2.5 mg orodispersible tablets; PL 17907/0499
This leaflet was last revised in March 2016
To request a copy of this leaflet in Braille, large print or audio format,
please contact the licence holder at the address (or telephone, fax, email)
V2 21-03-16 D0
above.

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expected with accidental overdose. However, if you take more of this
medicine than you were told to, tell your doctor, pharmacist or nurse
immediately.
If you forget to take this medicine
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 forgotten individual doses.
If you stop taking this medicine
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

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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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