Desloratadine Actavis

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

desloratadine

Available from:

Actavis Group PTC ehf

ATC code:

R06AX27

INN (International Name):

desloratadine

Therapeutic group:

Antihistamines for systemic use,

Therapeutic area:

Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal

Therapeutic indications:

Treatment of allergic rhinitis and urticaria.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2012-01-13

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORATADINE ACTAVIS 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, 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 Actavis is and what it is used for
2.
What you need to know before you take Desloratadine Actavis
3.
How to take Desloratadine Actavis
4.
Possible side effects
5.
How to store Desloratadine Actavis
6.
Contents of the pack and other information
1.
WHAT DESLORATADINE ACTAVIS IS AND WHAT IT IS USED FOR
WHAT DESLORATADINE ACTAVIS IS
Desloratadine Actavis contains desloratadine which is an
antihistamine.
HOW DESLORATADINE ACTAVIS WORKS
Desloratadine Actavis is an antiallergy medicine that does not make
you drowsy. It helps control your
allergic reaction and its symptoms.
WHEN DESLORATADINE ACTAVIS SHOULD BE USED
Desloratadine Actavis 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.
Desloratadine Actavis 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 DESLORATADINE ACTAVIS
DO NOT TAKE DESLORATADINE AC

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Desloratadine Actavis 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg desloratadine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Blue coloured, round, with diameter of 6 mm, biconvex, film-coated
tablets with the marking ‘LT’
engraved on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Desloratadine Actavis 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 Desloratadine Actavis 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 Actavis 5 mg film-coated
tablets in children below the age of
12 years have not been established.
Method of administration
Oral use.
The dose 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, desloratadine should be
used with caution (see section 5.2).
Desloratad