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DESLORATADINE GLENMARK 5 MG TABLETS

Active substance(s): DESLORATADINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Desloratadine 5 mg tablets

Read all of this leaflet carefully before you start taking/
using 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 Desloratadine 5 mg Tablets are and what they are
used for
2. What you need to know before you take Desloratadine
5 mg Tablets
3. How to take Desloratadine 5 mg Tablets
4. Possible side effects
5. How to store Desloratadine 5 mg Tablets
6. Contents of the pack and other information

1. W
 hat Desloratadine 5 mg Tablets are and what they
are used for
What Desloratadine 5 mg Tablets is
Desloratadine 5 mg Tablets contain desloratadine which is an
antihistamine.
How Desloratadine 5 mg Tablets works
Desloratadine 5 mg Tablets is an antiallergy medicine that
does not make you drowsy. It helps control your allergic
reaction and its symptoms.
When Desloratadine 5 mg Tablets should be used
Desloratadine relieves symptoms associated with allergic
rhinitis (inflammation of the nasal passages caused by an
allergy, hay fever or allergy to dust mites) in adults and
adolescents 12 years of age and older. These symptoms
include sneezing, runny or itchy nose, itchy palate, and itchy,
red or watery eyes.
Desloratadine is also used to relieve symptoms of 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. W
 hat you need to know before you take
Desloratadine 5 mg Tablets
Do not take Desloratadine 5 mg Tablets if
• if you are allergic to desloratadine, or any of the other
ingredients of this medicine (listed in section 6) or to
loratadine.
Warnings – talk to your doctor, pharmacist or nurse
Talk to your doctor, pharmacist or nurse before taking
Desloratadine:
• if you have poor kidney function.
Use in children and adolescents
Do not give this medicine to children less than 12 years of age.

Other medicines and Desloratadine
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.
Desloratadine with food, drink and alcohol
Desloratadine Glenmark may be taken with or without a meal.
Use caution when taking Desloratadine Glenmark 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 Desloratadine 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 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.
Desloratadine tablets contain lactose
If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before taking
this medicinal product.

3. How to take Desloratadine 5 mg Tablets
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 aged 12 years of age and over
The recommended dose is one tablet once a day, with water
with or without food.
This medicine is for oral use.
Swallow the tablet whole.
Regarding the duration of treatment, your doctor will
determine the type of allergic rhinitis you are suffering from
and will decide for how long you should take Desloratadine
Glenmark.
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 5 mg Tablets 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, tell your
doctor, pharmacist or nurse immediately.
If you forget to take Desloratadine 5 mg Tablets
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 stop taking Desloratadine 5 mg Tablets
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
During the marketing of Desloratadine 5 mg Tablets, cases of
severe allergic reactions (difficulty in breathing, wheezing,
itching, hives and swelling of the face, tongue or throat) have
been reported very rarely.
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 5 mg Tablets, the
following side effects were reported as:
Common: the following may affect up to 1 in 10 people
• fatigue
• dry mouth
• headache
Adults
During the marketing of Desloratadine 5 mg Tablets, the
following side effects were reported as:
Very rare: the following may affect up to 1 in 10,000 people
• severe allergic reactions
• fast heartbeat

• vomiting

• dizziness


• muscle pain


• restlessness with increased body movement
• rash
• stomach ache
• upset stomach
• drowsiness
• hallucinations
• liver inflammation
• pounding or irregular heartbeat
• feeling sick (nausea)
• diarrhoea
• inability to sleep
• seizures
• 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
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 Yellow
Card Scheme (Website: 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 5 mg Tablets
Keep 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 medicine does not require any special storage conditions.
Do not use this medicine if you notice any changes in the
appearance of the tablets.
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.
6. Contents of the pack and other information
What Desloratadine 5 mg tablets contain
• The active substance is desloratadine. Each tablet contains
5 mg desloratadine
• The other ingredients of the tablet are Microcrystalline
cellulose, Lactose monohydrate, Maize starch, Silica,
colloidal anhydrous; Magnesium stearate
What Desloratadine 5 mg tablets look like and contents of
the pack
Desloratadine tablets are off-white to light-pink, circular,
biconvex tablets with ‘L5’ engraved on one side and plain on
the other side.
The tablets are available in blister packs containing 7, 10, 14,
15, 20, 28, 30, 50 or 100 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder:
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Harrow, Middlesex HA3 0BU, UK
Manufacturers:
Glenmark Pharmaceuticals s.r.o
Fibichova 143,566 17 Vysoké Mýto,
Czech Republic
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom
This leaflet was last revised in 05/2015.

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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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