Kestine

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ebastine

Available from:

Industrias Farmaceuticas Almirall S.A.

INN (International Name):

ebastine

Dosage:

20mg

Pharmaceutical form:

tablets film-coated

Prescription type:

OTC

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kestine 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of ebastine.
EXCIPIENT WITH KNOWN EFFECT:_ _Each film-coated tablet contains 177 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 off white, round, scored and have
E20 marked on one
side.
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

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, but some
patients may require a dose
of 20 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 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
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.
Update in line with the RSI for ebastine – Version 1.0 – 23 Oct
2014
3/8
The tablets may be taken with or without food and with a glass or
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
Administer with caution in patients with known cardiac risk such as
patients with pr