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DESLORATADINE 0.5MG/ML ORAL SOLUTION

Active substance(s): DESLORATADINE / 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.
• K
 eep 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 How to take Desloratadine Oral Solution
4 Possible side effects
5 How to store Desloratadine Oral Solution
6 Contents 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

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

2

Desloratadine Oral Solution contains
sorbitol

If you have been told by your doctor that you have
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

Desloratadine Oral Solution contains sodium
This medicinal product contains 1.672 mmol (or
38.54 mg) sodium per 10 ml adult dose. To be taken
into consideration by patients on a controlled
sodium diet.
3

H
 ow to take Desloratadine Oral Solution

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

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

What you need to know before you take
Desloratadine Oral Solution

The recommended dose of Desloratadine Oral
Solution is:

Do not take Desloratadine Oral Solution

Children 1 through to 5 years of age: 2.5ml
(as marked on spoon) of oral solution once a day.

• 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.
• If you have medical or familial history of seizures

Use in children and adolescents

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

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.

Continued top of next column
BBBA1047

Continued over page

Desloratadine 0.5mg/ml Oral Solution PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1047

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

Debbie Rhodes
12.07.2017
21.07.2017
DR

Date sent:
NA
Date received: NA

Dimensions:
170 x 330
Min Body Text Size: 9.5pts
Supplier:
Specifar S.A.

Colours

Non Printing Colours

1. Black

1. Code Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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.

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.

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:
Adults
Very rare: the following may affect up to 1 in 10,000
people
• severe allergic reactions
• rash
• pounding or irregular heartbeat
• fast heartbeat
• stomach ache
• 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
• abnormal behaviour
• aggression
• change in the way the heart beats.

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:
100ml and 150ml.
Desloratadine 0.5mg/ml Oral Solution is supplied
in amber glass bottles containing 100ml or 150ml
and closed with a plastic child resistant screw cap.
Each bottle is supplied in a cardboard box with a
measuring spoon marked for doses of 2.5ml and 5ml.
Marketing Authorisation Holder
Caduceus Pharma Ltd
2 Martin House
179-181 North End Road
London
W14 9NL
UK
Manufacturer
Specifar S.A.
1, 28 Octovriou str
Ag. Varvara,
12351 Athens
Greece
This leaflet was last revised in June 2017.

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

Continued top of next column
BBBA1047

Actavis, Barnstaple, EX32 8NS, UK

Desloratadine 0.5mg/ml Oral Solution PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1047

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

Debbie Rhodes
12.07.2017
21.07.2017
DR

Date sent:
NA
Date received: NA

Dimensions:
170 x 330
Min Body Text Size: 9.5pts
Supplier:
Specifar S.A.

Colours

Non Printing Colours

1. Black

1. Code Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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.

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

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 breastfeeding.

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 How to take Desloratadine Oral
Solution
4 Possible side effects
5 How to store Desloratadine Oral
Solution
6 Contents of the pack and other
information
1

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.

2

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.

Desloratadine Oral Solution contains
sodium

This medicinal product contains 1.672 mmol
(or 38.54 mg) sodium per 10 ml adult dose.
To be taken into consideration by patients
on a controlled sodium diet.
3

How to take Desloratadine Oral
Solution

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

Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.

 hat you need to know before you
W
take Desloratadine Oral Solution

The recommended dose of Desloratadine
Oral Solution is:

Do not take Desloratadine Oral
Solution

Children 1 through to 5 years of age: 2.5ml
(as marked on spoon) of oral solution once
a day.

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

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.

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.
• If you have medical or familial history of
seizures

In case an oral measuring syringe is provided
with the bottle of oral solution, you can
alternatively use it to take the appropriate
amount of oral solution.

Use in children and adolescents

Swallow the dose of oral solution, then drink
some water. You can take this medicine with
or without food.

Other medicines and Desloratadine
Oral Solution

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.

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

There are no known interactions of
Desloratadine Oral Solution with other
medicines.
Continued top of next column
BBBA1049

Continued over page

Desloratadine 0.5mg/ml Oral Solution PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no: BBBA1049
Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

Debbie Rhodes
12.07.2017
17.07.2017
DR

Date sent:
12.07.2017
Date received: 21.07.2017

Dimensions:
160x400
Min Body Text Size: 10pt
Supplier:
Balkanpharma Troyan
Bulgaria

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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

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

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

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:

H
 ow 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

 ontents of the pack and other
C
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.

Adults
Very rare: the following may affect up to 1 in
10,000 people
• severe allergic reactions
• rash
• pounding or irregular heartbeat
• fast heartbeat
• stomach ache
• feeling sick (nausea)
• vomiting
• upset stomach
• diarrhoea
• dizziness
• drowsiness
• inability to sleep
• muscle pain
• hallucinations
• seizures
• r estlessness with increased body
movement
• liver inflammation
• abnormal liver function tests.

Pack Size: 100ml.

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
• a bnormal behaviour
• a ggression
• c hange in the way the heart beats.

This leaflet was last revised in June 2017.

Desloratadine 0.5mg/ml Oral Solution is
supplied in amber glass bottles containing
100ml and closed with a plastic child
resistant screw cap. Each bottle is supplied
in a cardboard box with a measuring spoon
marked for doses of 2.5ml and 5ml or an oral
measuring syringe of a final volume of 5ml
marked on every 0.5ml.
Marketing Authorisation Holder
Caduceus Pharma Ltd
2 Martin House,
179-181 North End Road
London,
W14 9NL,
UK
Manufacturer
Balkanpharma-Troyan AD
1 Krayrechna Str., 5600 Troyan, Bulgaria

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

Continued top of next column
BBBA1049

Actavis, Barnstaple, EX32 8NS, UK

Desloratadine 0.5mg/ml Oral Solution PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no: BBBA1049
Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

Debbie Rhodes
12.07.2017
17.07.2017
DR

Date sent:
12.07.2017
Date received: 21.07.2017

Dimensions:
160x400
Min Body Text Size: 10pt
Supplier:
Balkanpharma Troyan
Bulgaria

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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.

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.

In this leaflet:
1 W
 hat Desloratadine Oral Solution
is and what it is used for
2 W
 hat 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

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

1 W
 hat 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 is also used
to relieve the symptoms associated with
urticaria (a skin condition caused by an
allergy). These symptoms include itching and
hives.

2 W
 hat you need to know before you
take 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.
• If you have medical or familial history of
seizures

Use in children and adolescents

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

Continued top of next column
BBBA1048

Desloratadine 0.5mg/ml Oral Solution PIL - UK
BBBA1048

2

Debbie Rhodes
12.07.2017
20.07.2017
DR
12.07.2017 +20.07.2017
21.07.2017

160 x 210
9pts
Specifar (Famar)

1. Black

1.

2.

2.

3.

3.

4.

4.

5.

5.

6.

6.

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

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
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 breastfeeding.

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.

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.

Desloratadine Oral Solution contains
sodium

This medicinal product contains 1.672 mmol
(or 38.54 mg) sodium per 10 ml adult dose. To
be taken into consideration by patients on a
controlled sodium diet.

3 How 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.
In case an oral measuring syringe is provided
with the bottle of oral solution, you can
alternatively use it to take the appropriate
amount of oral solution.
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.

If you take more Desloratadine Oral
Solution than you should

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.
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BBBA1048

Desloratadine 0.5mg/ml Oral Solution PIL - UK
BBBA1048

2

Debbie Rhodes
12.07.2017
20.07.2017
DR
12.07.2017 +20.07.2017
21.07.2017

160 x 210
9pts
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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.
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.

During the marketing of Desloratadine Oral
Solution, the following side effects were
reported as:
Adults
Very rare: the following may affect up to 1 in
10,000 people
• severe allergic reactions
• rash
• pounding or irregular heartbeat
• fast heartbeat
• stomach ache
• 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
• abnormal behaviour
• aggression
• 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.

Adults
Common: the following may affect up to 1 in
10 people
• fatigue
• dry mouth
• headache.

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BBBA1048

Desloratadine 0.5mg/ml Oral Solution PIL - UK
BBBA1048

2

Debbie Rhodes
12.07.2017
20.07.2017
DR
12.07.2017 +20.07.2017
21.07.2017

160 x 210
9pts
Specifar (Famar)

1. Black

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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.

5H
 ow to store Desloratadine Oral
Solution
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.
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.

6C
 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.

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 Size: 150ml.
Desloratadine 0.5mg/ml Oral Solution is
supplied in amber glass bottles containing
150ml and closed with a plastic child
resistant screw cap. Each bottle is supplied
in a cardboard box with a measuring spoon
marked for doses of 2.5ml and 5ml or an oral
measuring syringe of a final volume of 5ml
marked on every 0.5ml.
Marketing Authorisation Holder
Caduceus Pharma Ltd
2 Martin House
179-181 North End Road
London
W14 9NL
UK
Manufacturer
Famar Orleans
5 avenue de Concyr
45071 ORLEANS CEDEX 2
France
This leaflet was last revised in June 2017.

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

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.

Continued top of next column
BBBA1048

Actavis, Barnstaple, EX32 8NS, UK

Desloratadine 0.5mg/ml Oral Solution PIL - UK
BBBA1048

2

Debbie Rhodes
12.07.2017
20.07.2017
DR
12.07.2017 +20.07.2017
21.07.2017

160 x 210
9pts
Specifar (Famar)

1. Black

1.

2.

2.

3.

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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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