Fexofenadine Hydrochloride 120 mg Film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Fexofenadine hydrochloride

Доступна з:

Azure Pharmaceuticals Ltd

Код атс:

R06AX26

ІПН (Міжнародна Ім'я):

Fexofenadine hydrochloride

Дозування:

120 milligram(s)

Фармацевтична форма:

Film-coated tablet

Терапевтична области:

fexofenadine

Статус Авторизація:

Marketed

Дата Авторизація:

2020-06-26

інформаційний буклет

Fexofenadine Hydrochloride 120 mg
Film-coated Tablets
Module 1 Administrative Information and
Prescribing Information
1.3 Product Information PACKAGE LEAFLET: INFORMATION FOR THE USER
FEXOFENADINE HYDROCHLORIDE 120 MG FILM-COATED TABLETS
(fexofenadine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Fexofenadine Hydrochloride Tablets is and what it is used for
_2._
_ _
What you need to know before you take Fexofenadine Hydrochloride
Tablets
_ _
_3._
_ _
How to take Fexofenadine Hydrochloride Tablets
_ _
4.
Possible side effects
_5._
_ _
How to store Fexofenadine Hydrochloride Tablets
_ _
6.
Contents of the pack and other information
1. WHAT FEXOFENADINE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR
Fexofenadine Hydrochloride 120 mg Film-coated Tablets (called
Fexofenadine Hydrochloride Tablets
throughout this leaflet) contains fexofenadine hydrochloride, which is
a non-drowsy antihistamine.
Fexofenadine Hydrochloride Tablets is used in adults and adolescents
of 12 years and older to relieve
the symptoms that occur with hay fever (seasonal allergic rhinitis)
such as sneezing, itchy, runny or
blocked nose and itchy, red and watery eyes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEXOFENADINE HYDROCHLORIDE
TABLETS
DO NOT TAKE FEXOFENADINE HYDROCHLORIDE TABLETS:
•
if you are allergic to fexofenadine or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fexofenadine

Характеристики продукта

Health Products Regulatory Authority
16 June 2023
CRN00DKD8
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fexofenadine Hydrochloride 120 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of fexofenadine hydrochloride, which is
equivalent to 112 mg of fexofenadine.
Excipient(s) with known effect: Each tablet contains 152.42 mg
lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Peach-coloured capsule-shaped film-coated tablet of 16.00 mm x 6.20 mm
x 4.90 mm, debossed as '120' on one side and 'FX'
on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fexofenadine Hydrochloride 120 mg is indicated in adults and children
12 years and older for the relief of symptoms
associated with seasonal allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ADULTS_
The recommended dose of fexofenadine hydrochloride for adults is 120
mg once daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
_PAEDIATRIC POPULATION_
- Children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for children aged
12 years and over is 120 mg one daily taken before a
meal.
- Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 120 mg has not
been studied in children under 12.
In
children
from
6
to
11
years
of
age:
fexofenadine
hydrochloride
30
mg
tablet
is
the
appropriate
formulation
for
administration and dosing in this population.
_ _
_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 AND PRECAUTIONS FOR USE
There is limited data in the elderly and renally or hepatically
impaired patients. Fexofenadine hydrochlo