Desloratadine Glenmark 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Desloratidine

Available from:

Glenmark Pharmaceuticals Europe Limited

ATC code:

R06AX; R06AX27

INN (International Name):

Desloratidine

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antihistamines for systemic use; desloratadine

Authorization status:

Not marketed

Authorization date:

2012-04-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORATADINE GLENMARK 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 Glenmark 5 mg Tablets are and what they are used
for
2.
What you need to know before you take Desloratadine Glenmark 5 mg
Tablets
3.
How to take Desloratadine Glenmark 5 mg Tablets
4.
Possible side effects
5.
How to store Desloratadine Glenmark 5 mg Tablets
6.
Contents of the pack and other information
1.
WHAT DESLORATADINE GLENMARK 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE GLENMA

Summary of Product characteristics

Health Products Regulatory Authority
02 October 2020
CRN009S4Z
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desloratadine Glenmark 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg desloratadine.
Excipient(s) with known effect:
This medicine contains lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Off white to light pink, circular, biconvex with ‘L5’ debossed on
one side and plain on the other side.
Diameter: approximately 10.5mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desloratadine Glenmark 5mg Tablets are indicated in adults and
adolescents aged 12 years and older for the relief of
symptoms associated with:
- allergic rhinitis (See section 5.1)
- urticaria (see section 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents (12 years of age and over)_
The recommended dose of Desloratadine Glenmark 5mg Tablets is one
tablet once a day.
Intermittent allergic rhinitis (presence of symptoms for less than 4
days per week or for less than 4 weeks) should be managed
in accordance with the evaluation of patient's disease history and the
treatment could be discontinued after symptoms are
resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or
more per week and for more than 4 weeks), continued
treatment may be proposed to the patients during the allergen exposure
periods.
_ _
_Paediatric population_
There is limited clinical trial efficacy experience with the use of
desloratadine in adolescents 12 through 17 years of age (see
sections 4.8 and 5.1).
The safety and efficacy of Desloratadine Glenmark in children under
the age of 12 years have not been established.
Method of administration:
Oral use.
The tablet should be swallowed with a sufficient amount of fluid (e.g.
one glass of water).
The dose can be taken with or without food.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, to any of the excipients