Fexofenadine Hydrochloride 180 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fexofenadine hydrochloride

Available from:

Azure Pharmaceuticals Ltd

ATC code:

R06AX26

INN (International Name):

Fexofenadine hydrochloride

Dosage:

180 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

fexofenadine

Authorization status:

Marketed

Authorization date:

2020-06-26

Patient Information leaflet

Fexofenadine Hydrochloride 60 mg,
120 mg and 180 mg Film-coated
Tablets
Module 1 Administrative Information and
Prescribing Information
1.3 Product Information PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FEXOFENADINE HYDROCHLORIDE 180 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.
•
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 illness are the same as yours.
•
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.
The name of your medicine is Fexofenadine Hydrochloride 180 mg
Film-coated Tablets (referred to as
Fexofenadine Hydrochloride Tablets throughout this leaflet).
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 Tablets contains fexofenadine
hydrochloride, which is an antihistamine.
Fexofenadine Hydrochloride 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
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

Summary of Product characteristics

Health Products Regulatory Authority
16 June 2023
CRN00DKD8
Page 1 of 5
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.
Excipient(s) with known effect: Each tablet contains 228.63 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 17.10 mm x 7.60 mm
x 5.30 mm, debossed as '180' on one side and 'FX'
on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fexofenadine Hydrochloride 180 mg is 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 one daily taken before a
meal.
- 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_
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
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
older people and renally or hepatically impaired patients.
Fexofenadine hydrochloride should be administered with care in these
special groups.
Patients with a history of or ongoing cardiovascular