Bilata 20 mg Tablett

Страна: Швеция

Език: шведски

Източник: Läkemedelsverket (Medical Products Agency)

Активна съставка:

bilastin

Предлага се от:

Alfred E Tiefenbacher (GmbH & Co. KG)

АТС код:

R06AX29

INN (Международно Name):

bilastine

дозиране:

20 mg

Лекарствена форма:

Tablett

Композиция:

bilastin 20 mg Aktiv substans; mannitol Hjälpämne

Вид предписание :

Receptbelagt

Каталог на резюме:

Förpacknings: Blister, 6 tabletter (Al); Blister, 6 tabletter (plast/Al); Blister, 10 tabletter (Al); Blister, 10 tabletter (plast/Al); Blister, 100 tabletter (Al); Blister, 100 tabletter (plast/Al); Blister, 20 tabletter (Al); Blister, 20 tabletter (plast/Al); Blister, 30 tabletter (Al); Blister, 30 tabletter (plast/Al); Blister, 50 tabletter (Al); Blister, 50 tabletter (plast/Al)

Статус Оторизация:

Godkänd

Дата Оторизация:

2022-03-11

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bilata 20 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of bilastine.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Round, white to off-white biconvex, tablets of approximately 7 mm in
diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and
perennial) and urticaria.
is indicated in adults and adolescents (12 years of age
and over).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults and adolescents (12 years of age and over)_
20 mg bilastine (1 tablet) once daily for the relief of symptoms of
allergic rhinoconjunctivitis (SAR
and PAR) and urticaria.
The tablet should be taken one hour before or two hours after intake
of food or fruit juice (see
section 4.5).
Duration of treatment:
For allergic rhino-conjunctivitis the treatment should be limited to
the period of exposure to
allergens. For seasonal allergic rhinitis treatment could be
discontinued after the symptoms have
resolved and reinitiated upon their reappearance. In perennial
allergic rhinitis continued treatment
may be proposed to the patients during the allergen exposure periods.
For urticaria the duration of
treatment depends on the type, duration and course of the complaints.
_Special populations_
Elderly
No dosage adjustments are required in elderly patients (see section
5.1 and 5.2).
Renal impairment
Studies conducted in adults in special risk groups (renally impaired
patients) indicate that it is not
necessary to adjust the dose of in adults (See section
5.2).
Hepatic impairment
There is no clinical experience in patients with hepatic impairment.
However, since bilastine is not
metabolized and is eliminated as unchanged in urine and faeces,
hepatic impairment is not expected
to increase systemic exposure above the safety margin in adult
patients. Therefore, no dosage
adjustment is required in patients with he