TELFAST 180 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

FEXOFENADINE HYDROCHLORIDE

Fáanlegur frá:

PHARMA SHALOM

ATC númer:

R06AX26

Lyfjaform:

FILM COATED TABLETS

Samsetning:

FEXOFENADINE HYDROCHLORIDE 180 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Not required

Framleitt af:

OPELLA HEALTHCARE INTERNATIONAL SAS, FRANCE

Meðferðarhópur:

FEXOFENADINE

Lækningarsvæði:

FEXOFENADINE

Ábendingar:

Relief of symptoms associated with chronic idiopathic urticaria.

Leyfisdagur:

2022-12-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed without a doctor’s prescription
TELFAST 180 MG,
FILM COATED TABLETS
_ _
_Active ingredient and its amount: _
Each tablet contains:
Fexofenadine hydrochloride 180 mg
_INACTIVE INGREDIENTS:_
See section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
This leaflet contains concise information about the medicine. If you
have further questions, refer
to the doctor or pharmacist.
-
Take the preparation according to the instructions in the dosage
section in this leaflet. Consult
the pharmacist if you need further information. Refer to the doctor if
the symptoms of the illness
worsen or are not improving after a few days.
-
The medicine is not intended for children under 12 years of age.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
The medicine is used for relief in cases of prolonged rash accompanied
by itching.
THERAPEUTIC GROUP:
Antihistamine.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
you are sensitive (allergic) to fexofenadine or to any of the other
ingredients of the medicine (see
section 6).
_SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE _
Before taking Telfast, consult the doctor if:
•
you suffer from impaired function of the kidney or liver.
•
you suffer or have suffered in the past from heart disease, since this
kind of medicine may lead
to a fast or irregular heartbeat.
•
you are elderly.
If any of these conditions apply to you, or if you are not sure, tell
your doctor before taking Telfast.
IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING
NON-PRESCRIPTION
MEDICINES AND FOOD SUPPLEMENTS, TELL THE DOCTOR OR PHARMACIST.
In particular, inform the doctor
or pharmacist if you are taking medicines for digestive problems that
contain aluminium or
magnesium which may affect the action of Telfast by lowering the
amount of Telfast absorbed. It is
recommended that you take these me

Vara einkenni

1. NAME OF THE MEDICINAL PRODUCT
Telfast 120 mg film-coated tablets
Telfast 180 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TELFAST 120 MG FILM-COATED TABLETS
:
Each tablet contains 120 mg of fexofenadine hydrochloride, which is
equivalent to 112 mg of
fexofenadine.
TELFAST 180 MG FILM-COATED TABLETS:
Each tablet contains 180 mg of fexofenadine hydrochloride, which is
equivalent to 168 mg of
fexofenadine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TELFAST 120 MG FILM-COATED TABLETS:
Relief of symptoms associated with seasonal allergic rhinitis.
TELFAST 180 MG FILM-COATED TABLETS:
Relief of symptoms associated with chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS _
TELFAST 120 MG FILM-COATED TABLETS:
The recommended dose of fexofenadine hydrochloride for adults is 120
mg once daily
taken before a meal.
TELFAST 180 MG FILM-COATED TABLETS:
The recommended dose of fexofenadine hydrochloride for adults is 180
mg once daily
taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
_PEDIATRIC POPULATION _
•
_CHILDREN AGED 12 YEARS AND OVER_
TELFAST 120 MG FILM-COATED TABLETS:
The recommended dose of fexofenadine hydrochloride for children aged
12 years and over
is 120 mg once daily taken before a meal.
TELFAST 180 MG FILM-COATED TABLETS:
The recommended dose of fexofenadine hydrochloride for
children aged 12 years and
over is 180 mg once daily taken before a meal.
•
_CHILDREN UNDER 12 YEARS OF AGE_
The efficacy and safety of fexofenadine hydrochloride has not been
studied in children
under 12.
_SPECIAL POPULATIONS _
Studies in special risk groups (elderly, renally or hepatically
impaired patients) indicate
that it is not necessary to adjust the dose of fexofenadine
hydrochloride in these patients.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS