Kestine tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ebastine

Available from:

Industrias Farmaceuticas Almirall S.A.

ATC code:

R06AX22

INN (International Name):

ebastine

Dosage:

10mg

Pharmaceutical form:

tablets film-coated

Units in package:

(5/1x5/) in blister, (10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-09-23

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Kestine 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of ebastine.
EXCIPIENT WITH KNOWN EFFECT:_ _Each film-coated tablet contains 88.5
mg of lactose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets are white to almost white, round, engraved
with “E/10” on one side.
The engraved line is not intended for breaking the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kestine is indicated in the symptomatic treatment of:
•
allergic rhinitis (seasonal and perennial) associated or not with
allergic conjunctivitis
•
urticaria of different etiology including idiopathic chronic urticaria
4.2 POSOLOGY AND
METHOD OF
ADMINISTRATION
_Posology _
ADULTS AND CHILDREN OVER 12 YEARS OF AGE
The recommended dose is 10 mg of ebastine once daily. If the effect is
not sufficient, it is
advised to take two tablets of Kestine 10 mg, once daily.
ELDERLY PATIENTS
It is no necessary to adjust the dose.
RENAL INSUFFICIENCY
It is not necessary to adjust the dose in patients with mild, moderate
or
severe renal
insufficiency.
HEPATIC INSUFFICIENCY
It is not necessary to adjust the dose in patients with mild or
moderate hepatic impairment
(Child-Pugh Classes A and B). There is no experience with doses over
10 mg in patients with
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severe
hepatic
insufficiency
(Child-Pugh
Class
C);
therefore,
the
dose
of
10
mg
of
ebastine/day should not be exceeded in these patients.
Treatment may be prolonged until symptoms disappear.
_Method of administration _
For oral use.
The tablets may be taken with or without food and with a glass of
water.
4.3 CONTRAINDICATIONS
Known hypersensitivity to the active substance or to any excipient
listed in section 6.1.
Pregnancy, lactation period, children under 12 years of age, deficit
of lactase, intolerance of
lactose, malabsorption of glucose-galactose.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Adm