Desloratadine Cipla Tablet, film coated 5mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

DESLORATADINE

Tilgjengelig fra:

Cipla Europe N.V. Uitbreidingstraat 80, 2600 Antwerp, Belgium

ATC-kode:

R06AX27

INN (International Name):

DESLORATADINE 5 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

DESLORATADINE 5 mg

Resept typen:

POM

Terapeutisk område:

ANTIHISTAMINES FOR SYSTEMIC USE

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2016-04-22

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Desloratadine Cipla 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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.


If you get any side effect talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Desloratadine Cipla is and what it is used for
2.What you need to know before you take Desloratadine Cipla
3. How to take Desloratadine Cipla
4. Possible side effects
5. How to store Desloratadine Cipla
6. Contents of the pack and other information
1.
WHAT DESLORATADINE CIPLA IS AND WHAT IT IS USED FOR
Desloratadine Cipla is an antiallergy medicine that does not make you
drowsy. It helps
control your allergic reaction and its symptoms.
Desloratadine relieves symptoms associated with allergic rhinitis
(inflammation of the
nasal passages caused by an allergy, for example, _ hay fever or_
allergy to dust _ mites_).
These symptoms include sneezing, runny or itchy nose, itchy palate,
and itchy, red or
watery eyes.
Desloratdine Cipla 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 CIPLA
DO NOT TAKE Desloratadine Cipla

if you are allergic to desloratadine, or any of the other ingredients
of Desloratadine
Cipla or to loratadine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Desloratadine Cipla

if you have poor kidney function.

Children and adolescents
Deslo

Preparatomtale

1.
NAME OF THE MEDICINAL PRODUCT:
Desloratadine Cipla 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains 5 mg desloratadine
Excipient(s) with known effect: 116.5 mg of mannitol
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Film-coated tablet
Light blue coloured, circular, biconvex, film-coated tablet with
diameter of 7.00 mm
plain on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desloratadine is indicated 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
_ _
_ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OVER): _
One tablet once a day, with or without a meal for the relief of
symptoms associated with
allergic rhinitis (including intermittent and persistent allergic
rhinitis) and urticaria (
See section 5.1).
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).
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.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, to any of the excipients, or
to loratadine.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Efficacy and safety of desloratadine tablets in children under 12
years of age have not
been established.
In the case of severe renal insufficiency, desloratadine should be
used with caution
(See section 5.2).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically relevant interactions w