BILAXTEN

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

BILASTINE

Disponibil de la:

RAFA LABORATORIES LTD

Codul ATC:

R06AX29

Forma farmaceutică:

TABLETS

Compoziție:

BILASTINE 20 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

FAES FARMA S.A, SPAIN

Zonă Terapeutică:

BILASTINE

Indicații terapeutice:

Bilaxten is indicated for the symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticariai in adults and adolescents (12 years of age and over).

Data de autorizare:

2022-07-31

Prospect

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is sold with a doctor's prescription only
BILAXTEN
TABLETS
ACTIVE INGREDIENT:
Each tablet of Bilaxten contains: 20 mg bilastine
For a list of the other ingredients, please see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any
further questions, please refer to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your condition.
Do not pass
it on to others. It may harm them, even if it seems to you that their
medical condition
is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for symptomatic treatment of allergic
rhinitis and
allergic inflammation of the conjunctiva (seasonal or perennial) and
itchy skin
rashes (urticaria/hives) in adults and adolescents over 12 years of
age.
THERAPEUTIC GROUP: anti-histamines.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients this medicine contains (for a list of the other
ingredients, please see
section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
If the symptoms continue, consult your doctor. Do not exceed the
recommended dose.
BEFORE STARTING TREATMENT WITH BILAXTEN TELL YOUR DOCTOR:
If you suffer or have suffered in the past from moderate to severe
kidney function
impairment.
USE IN CHILDREN:
Do not use this medicine in children under the age of 12.
DRUG INTERACTIONS: IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER
MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITION
SUPPLEMENTS,
PLEASE TELL YOUR DOCTOR OR PHARMACIST.
Especially inform your doctor or pharmacist if you are taking the
following
medicines (it should be noted that the following list mentions the
active
ingredients of the medicines. If you are unsure whether you are using
any of
these medicines, please consult with your doctor or pharmacis

Caracteristicilor produsului

Bilaxten -DL-Aug 2017_Dec 2019 -02-notif
1
DOCTOR LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
Bilaxten
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.
Oval biconvex scored white tablets.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bilaxten is indicated for the symptomatic treatment of allergic
rhino-conjunctivitis (seasonal and
perennial) and urticaria 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 sections
_ _
5.1 and 5.2).
Renal impairment
No dosage adjustment is required in patients with renal impairment
(see section 5.2).
2
Hepatic impairment
There is no clinical experience in patients with hepatic impairment.
Since bilastine is not
metabolized and renal clearance is its major elimination route,
hepatic impairment is not expected
to increase systemic exposure above the safety margin. Therefore, no
dosage adjustment is
required in patients with hepatic impairm