TELFAST 180 Milligram Film Coated Tablet
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
14-06-2024
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Ingredient activ:
FEXOFENADINE HYDROCHLORIDE
Disponibil de la:
G & A Licensing Limited
INN (nume internaţional):
FEXOFENADINE HYDROCHLORIDE
Dozare:
180 Milligram
Forma farmaceutică:
Film Coated Tablet
Tip de prescriptie medicala:
Product subject to prescription which may be renewed (B)
Statutul autorizaţiei:
Withdrawn
Data de autorizare:
2013-03-01
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telfast 180mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 180 mg of fexofenadine hydrochloride (equivalent to 168mg of fexofenadine)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from Italy:_
Peach, capsule-shaped, film-coated tablet debossed with an ‘e’ on one side and ‘018’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms associated with chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND CHILDREN AGED 12 YEARS AND OVER_
The recommended dose of fexofenadine hydrochloride for adults and children aged 12 years and over is 180 mg once
daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
_CHILDREN UNDER 12 YEARS OF AGE_
The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12.
_SPECIAL RISK GROUPS_
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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with most new drugs there is only limited data in the elderly 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 disease should be warned that, antihistamines as a drug class, have
been associated with the adverse events, tachycardia and palpitations (see section 4.8).
IRISH MEDICINES BOARD
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