Desloratadine Sandoz 5mg Film Coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DESLORATADINE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DESLORATADINE

Unit dalam pakej:

10tablet Tablets; 10tablet Tablets

Dikeluarkan oleh:

Sandoz Private Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DESLORATADINE SANDOZ FILM COATED TABLET
Desloratadine (5mg)
1
WHAT IS IN THIS LEAFLET:
1.
What Desloratadine Sandoz is used
for
2.
How Desloratadine Sandoz works
3.
Before you take Desloratadine
Sandoz
4.
How to take Desloratadine Sandoz
5.
While you are using Desloratadine
Sandoz
6.
Side effects
7.
Storage and disposal of
Desloratadine Sandoz
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT DESLORATADINE SANDOZ IS USED
FOR
Desloratadine Sandoz relieves symptoms
associated with allergic rhinitis
(inflammation of the nasal passages caused
by an allergy to dust mites). These
symptoms include nose, itchy palate, and
itchy, red or watery eyes.
Desloratadine Sandoz 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.
HOW DESLORATADINE SANDOZ WORKS
Desloratadine Sandoz is an anti-allergy
medicine that does not make you
drowsy. It helps control your allergic
reaction and its symptoms.
BEFORE YOU USE DESLORATADINE SANDOZ
-
_When you must not use it _
Do NOT take Desloratadine Sandoz
•
If you are allergic (hypersensitive) to
desloratadine, to any of the other
ingredients of Desloratadine Sandoz
or to loratadine.
-
_Before you start to use it _
Efficacy and safety of Desloratadine
Sandoz in children under 12 years of age
have not been established.
PREGNANCY AND BREAST-FEEDING
_PREGNANCY _
Women who are pregnant and intend to
become pregnant should consult their
doctor before taking Desloratadine
Sandoz.
_LACTATION_
It is known that desloratadine appears
in human breast milk. If you are
breast-feeding, taking Desloratadine
Sandoz is not recommended.
-
_Taking other medicines _
There are no known interactions of
Desloratadine Sandoz with other
medicines.
Please tell your doctor or pharmacist
if you are taking or have recently
taken

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
Desloratadine Sandoz 5 mg Film Coated Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg desloratadine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light blue, round shaped, biconvex film coated tablets, with “5”
debossed on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
For the rapid relief of symptoms associated with seasonal allergic
rhinitis (e.g., sneezing, nasal
discharge and itching, congestion/stuffiness, as well as ocular
itching, tearing and redness).
•
For the relief of symptoms associated with chronic idiopathic
urticaria (e.g., relief of itching and the size
and number of hives).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents (12 years of age and over): one 5 mg tablet
once a day, with or without a meal.
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.
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.
Convulsions
Desloratadine should be administered with caution in patients with
medical or familial history of seizures, and
mainly young children, being more susceptible to develop new seizures
under desloratadine treatment.
Healthcare providers may consider discontinuing desloratadine in
patients who experience a seizure while
on treatment.
Renal insufficiency
In the case of severe renal insufficiency, desloratadine should be
used with caution.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically relevant interactions were observed with desloratadine
tablets in which erythromycin or
ketoconazole were co-administered.
Desloratadine taken concomitantly with alcohol did not potentiate the
performance impairing effects of alcohol.
However, ca