Kestine tablets film-coated

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

ebastine

Saatavilla:

Industrias Farmaceuticas Almirall S.A.

ATC-koodi:

R06AX22

INN (Kansainvälinen yleisnimi):

ebastine

Annos:

20mg

Lääkemuoto:

tablets film-coated

Kpl paketissa:

(10/1x10/) in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2019-09-06

Valmisteyhteenveto

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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 almost white, round, engraved
with “E20” 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
•
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, 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 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
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.
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_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, severe hepatic failure
(Child-Pugh classification,
class C).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Administer with caution in patients with