Dasergin 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DESLORATADINE

Available from:

HCS bvba

ATC code:

R06AX; R06AX27

INN (International Name):

DESLORATADINE

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated 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:

2018-07-06

Patient Information leaflet

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_ - črnaU_
_NA.DASERGIN 5 MG IE _
first page
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DASERGIN 5 MG
FILM-COATED TABLETS
desloratadine
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 Dasergin is and what it is used for
2. What you need to know before you take Dasergin
3. How to take Dasergin
4. Possible side effects
5. How to store Dasergin
6. Contents of the pack and other information
1. What Dasergin is and what it is used for
WHAT DASERGIN IS
Dasergin contains desloratadine which is an antihistamine.
HOW DASERGIN WORKS
Dasergin is an antiallergy medicine that does not make you
drowsy. It helps control your allergic reaction and its symptoms.
WHEN DASERGIN SHOULD BE USED
Dasergin 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 and
adolescents 12 years of age and older. These symptoms include
sneezing, runny or itchy nose, itchy palate, and itchy, red or watery
eyes.
Dasergin 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. What you need to know before you take
Dasergin
DO NOT TAKE DASERGIN
• if you are allergic to desloratadine, to

Summary of Product characteristics

Health Products Regulatory Authority
05 January 2021
CRN00C3F0
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dasergin 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg desloratadine.
Excipient with known effect:
Each film-coated tablet contains 16.15 mg lactose (as monohydrate) and
0.201 mg (0.00875 mmol) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light blue, round, film-coated tablets with beveled edges (diameter:
6.5 mm, thickness: 2.3–3.5 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dasergin is 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 Dasergin 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 Dasergin 5 mg film-coated tablets in
children below the age of 12 years have not been established.
Method of administration
Oral use.
The tablet can be taken with or without food.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, to any of the excipients
listed in section 6.1 or to loratadine.
4.4 SPECIAL WARNINGS AND PREC