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DESLORATADINE MYLAN 5 MG FILM-COATED TABLETS

Active substance(s): DESLORATADINE / DESLORATADINE

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Package leaflet: Information for the patient

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. 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
Desloratadine is an antiallergy medicine that does
not make you drowsy. It helps control your allergic
reaction and its symptoms.
Desloratadine is indicated for adults and adolescents
(12 years of age and older) to:
relieve 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 and sleep.
You must talk to a doctor if you do not feel better or if
you feel worse.

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.
If this applies to you, or if you are not sure, please
check with your doctor or pharmacist.

Children

Other medicines and Desloratadine

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

Desloratadine with alcohol

Caution is advised when taking desloratadine
with alcohol.

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
this medicine.
If you are pregnant or breast-feeding 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.
Desloratadine contains Sunset Yellow Aluminium
Lake (E110), which may cause allergic reactions.

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.
The recommended dose for adults and adolescents
(12 years of age and older) is one tablet once a day.
Swallow the tablet whole with water, with or
without food.
Regarding the duration of treatment, your doctor
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 doctor 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 doctor 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 doctor.

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 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.

Desloratadine tablets are not suitable for children
under 12 years of age.
721956
LT1810AD

Description Desloratadine 5 mg all
Component Type Leaflet
Affiliate Item Code 721956
Superceded Affiliate Item Code 580389
TrackWise PR No. 721956
MA No. n/a
Packing Site/Printer n/a
Supplier Code LT1810AD

Pharma Code 81
SAP No. n/a
Vendor Job No. 264442
Trackwise Proof No. 2
Glams Proof No. n/a
Client Market United Kingdom
Keyline/Drawing No. n/a
Barcode Info n/a

Date: 26 Oct 2016
No. of colours
Colours

1

Time: 12:11
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 240 mm

Body Text Size 9 pt
Min Text Size used 8 pt

Sign-offs

v1/May 2015

4. 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.
If you notice any of the following side effects, stop
taking this medicine and contact your doctor or
go to the nearest hospital casualty department
straight away:

Very rare: (may affect up to 1 in 10,000 people):
• Severe allergic reactions such as difficulty in
breathing, shortness of breath, wheezing, itching,
hives and swelling of the face, lips, tongue or other
parts of the body and rash
• Fits (seizures)
• Liver disease (nausea, vomiting, loss of appetite,
feeling generally unwell, fever, itching, yellowing
of the skin and eyes, light coloured bowel motions,
dark coloured urine)

Not known: (frequency cannot be estimated
from available data):
• A change in the way the heart beats, which may
make you feel dizzy or faint. This may be seen
in tests of the electrical activity of the heart
(‘electrocardiogram’ or ECG)
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
During the marketing of desloratadine, the following
side effects were reported in adults, as:

Very rare: (may affect up to 1 in 10,000 people):

• Fast heartbeat
• Being sick (vomiting)
• Dizziness
• Muscle pain
• Restlessness with increased body movement
• Stomach ache
• Upset stomach
• Drowsiness
• Seeing, feeling or hearing things that are not
there (Hallucinations)
• Pounding or irregular heartbeat
• Feeling sick (nausea)
• Diarrhoea
• Inability to sleep
• Abnormal liver function tests

Not known: (frequency cannot be estimated
from available data)

• Unusual weakness
• Increased sensitivity of the skin to the sun, even in
the case of hazy sun, and to UV light, for instance to
UV lights of a solarium

Additional side effects in children and
adolescents
Not known: (frequency cannot be estimated
from available data):
• Slow heart beat

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.
This medicine does not require any special
storage conditions.
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.
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 protect the environment.

6. Contents of the pack and
other information
What Desloratadine contains

The active substance is desloratadine. Each tablet
contains 5 mg of desloratadine.
The other ingredients of the tablet are: magnesium
stearate, sodium lauril sulfate, silica colloidal
anhydrous, microcrystalline cellulose and
pregelatinised maize starch.
The tablet film coating contains: poly (vinyl alcohol),
indigo carmine aluminium lake (E132), sunset yellow
aluminium lake (E110) (see section 2 Desloratadine
contains sunset yellow), macrogol, talc (E553b) and
titanium dioxide (E171).

What Desloratadine looks like and contents of
the pack

Desloratadine are blue, round, tablets with sides that
curve outwards marked “DE 5” on one side of the
tablet and “M” on the reverse.
Desloratadine 5 mg film-coated tablets are packed in
blisters in packs of 2, 3, 5, 7, 10, 15, 20, 30, 50, 60, 90
and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturers

Generics [UK] Limited, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
This leaflet was last revised in October 2016.

Description Desloratadine 5 mg all
Component Type Leaflet
Affiliate Item Code 721956
Superceded Affiliate Item Code 580389
TrackWise PR No. 721956
MA No. n/a
Packing Site/Printer n/a
Supplier Code LT1810AD

Pharma Code 81
SAP No. n/a
Vendor Job No. 264442
Trackwise Proof No. 2
Glams Proof No. n/a
Client Market United Kingdom
Keyline/Drawing No. n/a
Barcode Info n/a

Date: 26 Oct 2016
No. of colours
Colours

1

721956
LT1810AD

Time: 12:11
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 240 mm

Body Text Size 9 pt
Min Text Size used 8 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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