Kestine 10mg film-coated tablets

Country: Malaysia

Language: English

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

Active ingredient:

Ebastine

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

Ebastine

Units in package:

10 Tablets; 20 Tablets; 30 Tablets; 50 Tablets; 100 Tablets

Manufactured by:

Industrias Farmaceuticas Almirall, S.A. (IFA)

Patient Information leaflet

KESTINE
® FILM-COATED TABLETS
Ebastine (10mg, 20mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Kestine_
is used for
2.
How
_Kestine_
works
3.
Before you use
_Kestine_
4.
How to use
_Kestine_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Kestine_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _KESTINE_ IS USED FOR
Kestine is indicated for the symptomatic
treatment of allergic conditions such as
seasonal and perennial allergic rhinitis
with or without allergic conjunctivitis
(runny nose, itchy nose or eyes, watery
eyes, sneezing, etc.), and chronic
urticaria (Kestine 10mg only).
HOW _KESTINE_ WORKS
Kestine belongs to a group of drugs
known as antihistamines (antiallergics).
BEFORE YOU USE _KESTINE _
-
_When you must not use it_
_ _
If you are allergic to ebastine or any of
the other ingredients of this medicine
(included in section Product
Description).
If you or your child is under 12 years of
age.
_ _
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think you might be pregnant or plan to
become pregnant, consult your doctor or
pharmacist before using this medicine.
_Pregnancy _
Due to insufficient data to ensure the
perfect safety of this drug when
administered during pregnancy, its use is
not recommended in pregnant women.
_ _
_Breast-feeding_
It is not known whether the drug passes
into human milk, and therefore it is not
recommended for women who are
breast-feeding.
_ _
-
_Before you start to use it _
Ask your doctor or pharmacist for advice
before taking Kestine.
_ _
This medicine should be used with
precaution:
•
If you have a history of heart
disease, cardiac discomfort or
palpitations, tell your doctor.
•
if you suffer from severe liver
disease, tell your doctor (see "How
to use Kestine").
•
Kestine can cause dry mouth. At
long term treatment it is therefore
important to have a good mouth
hygiene to prevent risk for caries
(the teeth should be cleaned with
fluoride con

Summary of Product characteristics

Ebastine
Kestine ® 10 mg Film-coated Tablet
Antihistamine
FORMULATION:
Each Ebastine (Kestine®) Film -coated tablet contains:
Ebastine ……………………………….......….. 10mg
Excipients: microcrystalline cellulose, pregelatinised maize starch, lactose monohydrate,
croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000 and titanium
dioxide. PHARMACEUTICAL FORM AND CONTENT OF PACKAGE:
Round, white film -coated tablets with one side marked E10. Boxes containing 10 (1x10), 20
(2x10) 30 (3x10), 50 (5x10) and 100 (10x10) tablets in PVC/Aluminium blisters.
Not all the presentations are available in all markets. INDICATION:
Ebastine (Kestine®) is indicated in the treatm ent of allergic rhinitis (seasonal and perennial) with
or without allergic conjunctivitis and chronic idiopathic urticaria. MECHANISM OF ACTION:
Ebastine (Kestine®) produces rapid and prolonged inhibition of the effects induced by histamines,
showing a strong af finity for binding to H1 receptors. After oral administration, neither ebastine
(Kestine®) nor it’s metabolites cross the blood- brain barrier. This characteristic is consistent with
the low sedation observed in the results of experiments in which the effects of ebastine (Kestine®)
on the central nervous system were studied.
The in vitro and in vivo data demonstrate that ebastine (Kestine®) is a powerful antagonist with a
prolonged effect and highly selective of the histamine H1 receptors, free of CNS side effects and
anticholinergic effects. PHARMACOKINETIC PROPERTIES:
Ebastine is rapidly absorbed after oral intake and undergoes a very significant intestinal and
hepatic first -pass effect. It is almost completely transformed into its pharmacologically active acid
metabolite, carebastine.
After a single oral 10 mg dose, the peak plasma concentration is reached after 2 to 4 hours, with
levels ranging from 80 to 100 ng/ml.
In vitro studies in human liver microsomes show that ebastine is metabolised pri marily to
carebastine via cytochrome CYP3A4.
The half -life