Fexofenadine hydrochloride 120 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fexofenadine hydrochloride

Available from:

Chanelle Medical Unlimited Company

ATC code:

R06AX; R06AX26

INN (International Name):

Fexofenadine hydrochloride

Dosage:

120 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antihistamines for systemic use; fexofenadine

Authorization status:

Not marketed

Authorization date:

2007-09-14

Patient Information leaflet

ID1088 MRP _ IE
VERSION: 08
EFFECTIVE DATE: 21/02/2023
PAGE 1 OF 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEXOFENADINE HYDROCHLORIDE 120 MG FILM-COATED TABLETS
FEXOFENADINE HYDROCHLORIDE 180 MG FILM-COATED TABLETS
FEXOFENADINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of symptoms are the same as yours.
-
If you get any of the side effects talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet, .(see section 4).
IN THIS LEAFLET:
1.
What Fexofenadine hydrochloride is and what it is used for
2.
What you need to know before you take Fexofenadine hydrochloride
3.
How to take Fexofenadine hydrochloride
4.
Possible side effects of Fexofenadine hydrochloride
5.
How to store Fexofenadine hydrochloride
6.
Contents of the pack and other information
1.
WHAT FEXOFENADINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
FEXOFENADINE HYDROCHLORIDE contains fexofenadine hydrochloride which
is an
antihistamines.
Fexofenadine hydrochloride 120 mg tablets is used in adults and
adolescents of 12 years
and older to relieve the symptoms that occur with hay fever (seasonal
allerigic rhinitis) such
as sneezing, itchy, running or blocked nose and itchy, red an watery
eye ).
Fexofenadine hydrochloride 180 mg tablets is used in adults and
adolescents of 12 years
and older to relieve the symptoms that occur with long term allergic
skin reactions ( chronic
idiopathic urticaria) such as itching, swelling and rashes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEXOFENADINE HYDROCHLORIDE
DO NOT TAKE FEXOFENADINE HYDROCHLORIDE:
-
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

Summary of Product characteristics

Health Products Regulatory Authority
17 October 2023
CRN00DFWL
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
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Peach coloured oblong, bi-convex film-coated tablet with dimensions of
14.9-15.3 mm x 6.4-6.8 mm; plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fexofenadine hydrochloride 120 mgis indicated in adults and chlidren
12 years and older for the relief of symptoms associated
with seasonal allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posolgy
_ _
_Adults_
The recommended dose of fexofenadine hydrochloride in 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 once daily taken before
a meal.

_Children under 12 years:_
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 (older people renally or hepatically
impaired patients) indicate that it is not necessary to adjust
the dose of fexofenadine hydrochloride in these patients.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
17 October 2023
CRN00DFWL
Page 2 of 6
Hypersensitivity to the active substance or to any of the excipients
(listed in section 6.1).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with most new medicinal products there is only limited data in the
elderly and renally or hepatically impaired pati