Dasselta
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
09-06-2022
Summary of Product characteristics
(SPC)
09-06-2022
Public Assessment Report
(PAR)
15-12-2011
Active ingredient:
desloratadine
Available from:
Krka, d.d., Novo mesto
ATC code:
R06AX27
INN (International Name):
desloratadine
Therapeutic group:
Antihistamines for systemic use,
Therapeutic area:
Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Urticaria
Therapeutic indications:
Dasselta is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.
Product summary:
Revision: 13
Authorization status:
Authorised
Authorization date:
2011-11-28
Patient Information leaflet
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
DASSELTA 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 Dasselta is and what it is used for
2.
What you need to know before you take Dasselta
3.
How to take Dasselta
4.
Possible side effects
5.
How to store Dasselta
6.
Contents of the pack and other information
1.
WHAT DASSELTA IS AND WHAT IT IS USED FOR
WHAT DASSELTA IS
Dasselta contains desloratadine which is an antihistamine.
HOW DASSELTA WORKS
Dasselta is an antiallergy medicine that does not make you drowsy. It
helps control your allergic
reaction and its symptoms.
WHEN DASSELTA SHOULD BE USED
Dasselta 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.
Dasselta 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 DASSELTA
DO NOT TAKE DASSELTA
-
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 Dass
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dasselta 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).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated 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
Dasselta 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 Dasselta 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 Dasselta 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.
3
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In the case of severe renal insufficiency, Dasselta should be used
with caution (se
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