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DESLORATADINE 0.5MG/ML ORAL SOLUTION

Active substance(s): DESLORATADINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Desloratadine 0.5mg/ml
Oral Solution
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, 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.

Other medicines and Desloratadine Oral
Solution

In this leaflet:
1 What Desloratadine Oral Solution is and
what it is used for
2 What you need to know before you take
Desloratadine Oral Solution
3 H
 ow to take Desloratadine Oral Solution
4 Possible side effects
5 H
 ow to store Desloratadine Oral Solution
6 C
 ontents of the pack and other
information

Pregnancy and breast-feeding
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 any
medicine. Taking Desloratadine Oral Solution is not
recommended if you are pregnant or breast-feeding.

1

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Taking Desloratadine Oral Solution with
food, drink and alcohol
Desloratadine Oral Solution may be taken with
or without a meal. Use caution when taking
Desloratadine Oral Solution with alcohol.

Pregnancy, breast-feeding and fertility

Fertility

The effect of Desloratadine Oral Solution on fertility
is not known.

Driving and using machines

At the recommended dose, Desloratadine Oral
Solution 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. Do not 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.

What Desloratadine Oral Solution is and
what it is used for
Desloratadine Oral Solution is an antiallergy
medicine that does not make you drowsy. It helps
control your allergic reaction and its symptoms.
Desloratadine Oral Solution
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
1 year of age and older. These symptoms include
sneezing, runny or itchy nose, itchy palate and itchy,
red or watery eyes.
Desloratadine Oral Solution 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

There are no known interactions of Desloratadine
Oral Solution with other medicines.

 hat you need to know before you take
W
Desloratadine Oral Solution
Do not take Desloratadine Oral Solution

• if you are allergic (hypersensitive) to desloratadine,
loratadine, or to any of the other ingredients of
Desloratadine Oral Solution (listed in section 6).

Warnings and precautions
Take special care with Desloratadine Oral
Solution

If you have poor kidney function or if you are not
sure, please check with your doctor before taking
Desloratadine Oral Solution.

Desloratadine Oral Solution contains
sorbitol

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

H
 ow to take Desloratadine Oral Solution
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose of Desloratadine Oral
Solution is:
Children 1 through to 5 years of age: 2.5ml
(as marked on spoon) of oral solution once a day.
Children 6 through to 11 years of age: 5ml
(one 5ml spoonful) of oral solution once a day.
Adults and adolescents (12 years of age and
older): 10ml (two 5ml spoonfuls) of oral solution
once a day.
Swallow the dose of oral solution, then drink some
water. You can take this medicine with or without
food.
Your doctor will determine the duration of treatment
which will depend on the severity of the allergic
condition and may be variable from patient to
patient. Therefore you should follow the instructions
of your doctor.

Use in children and adolescents

Do not give this medicine to children less than 1 year
of age.

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If you take more Desloratadine Oral Solution
than you should

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

Take Desloratadine Oral Solution only as it is
prescribed for you. No serious problems are
expected with accidental overdose. However, if you
take more Desloratadine Oral Solution than you were
told to, tell your doctor or pharmacist immediately.

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

If you forget to take Desloratadine Oral
Solution

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.
4

Possible side effects
Like all medicines, Desloratadine Oral Solution can
cause side effects, although not everybody gets
them.

By reporting side effects you can help provide more
information on the safety of this medicine.
5

Keep out of the sight and reach of children.
Do not use Desloratadine Oral Solution after the
expiry date which is stated on the bottle. The expiry
date refers to the last day of that month.

During the marketing of Desloratadine Oral Solution,
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 most children and adults, side
effects with Desloratadine Oral Solution were
about the same as with a dummy solution or tablet.
However, common side effects in children less than
2 years of age were diarrhoea, fever and insomnia
while in adults, fatigue, dry mouth and headache
were reported more often than with a dummy tablet.
In clinical studies with Desloratadine Oral Solution,
the following side effects were reported as:
Children
Common in children less than 2 years of age:
the following may affect up to 1 in 10 children
• diarrhoea
• fever
• insomnia.
Adults
Common: the following may affect up to 1 in 10
people
• fatigue
• dry mouth
• headache.
During the marketing of Desloratadine Oral Solution,
the following side effects were reported as:

How to store Desloratadine Oral Solution

Store in the original package. Do not freeze.
After first opening use within 2 months.
Do not use this medicine and tell your pharmacist if
you notice any change in the appearance of the oral
solution. Medicines should not be disposed of via
wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the environment.
6

C
 ontents of the pack and other
information
What Desloratadine Oral Solution contains
The active substance is desloratadine.
1ml of oral solution contains 0.5mg desloratadine.

The other ingredients of the oral solution are:
Sorbitol, liquid (non-crystallizing), Propylene
glycol, Citric acid monohydrate, Sodium citrate,
Hypromellose 2910, Sucralose, Disodium edentate,
Tutti frutti, Purified water.

What Desloratadine Oral Solution looks like
and contents of the
pack
Desloratadine Oral
Solution is presented
as a clear colourless
solution, free from
foreign matters.

Pack Sizes:
Adults
100ml and 150ml.
Very rare: the following may affect up to 1 in 10,000
people
Desloratadine 0.5mg/ml Oral Solution is supplied
• severe allergic reactions
in amber glass bottles containing 100ml or 150ml
• rash
and closed with a plastic child resistant screw cap.
• pounding or irregular heartbeat
Each bottle is supplied in a cardboard box with a
• fast heartbeat
measuring spoon marked for doses of 2.5ml and 5ml.
• stomach ache
Marketing Authorisation Holder
• feeling sick (nausea)
Pharma Ltd
• vomiting Caduceus
th
6
floor
• upset stomach
94 Wigmore Street
• diarrhoea
• dizziness London
W1U 3RF
• drowsiness
UK
• inability to sleep
• muscle pain
Manufacturer
• hallucinations
Specifar S.A.
• seizures
1, 28 Octovriou str
• restlessness with increased body movement
Ag. Varvara,
• liver inflammation
12351 Athens
• abnormal liver function tests.
Greece
Not known: frequency cannot be estimated from the
This leaflet was last revised in September 2015.
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.

If you would like a
leaflet with larger
text, please contact
01271 385257.

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AAAG9625

Actavis, Barnstaple, EX32 8NS, UK

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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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