Fexofenadine hydrochloride 180 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:

180 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 180 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 180 mg of fexofenadine hydrochloride which is
equivalent to 168 mg of fexofenadine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, oblong, bi-convex film coated tablet with dimensions
of 16.9-17.3 mm x 7.9-8.3 mm; plain on one side with a
central breakline on the other. 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
Fexofenadine hydrochloride 180 mg indicated in adults and children 12
years and older for the relief of symptoms associated
with chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults_
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.
_Paediatric population _
_ _

Children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for children aged
12 years and over is 180 mg once daily taken before
a meal.
_ _
The tablet should be swallowed with a sufficient amount of water.

Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 180 mg has not
been studied in children under 12.
_SPECIAL POPULATIONS _
Health Products Regulatory Authority
17 October 2023
CRN00DFWL
Page 2 of 6
Studies in special risk groups (olderly 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
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 limi