TELFAST 120 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-05-2024
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Active ingredient:
FEXOFENADINE HYDROCHLORIDE
Available from:
Profind Wholesale Ltd
INN (International Name):
FEXOFENADINE HYDROCHLORIDE
Dosage:
120 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-05-02
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telfast 120mg 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 tablets.
_Product imported from Hungary:_
Peach, capsule-shaped tablet debossed with '012' on one side and 'e' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms associated with seasonal allergic rhinitis.
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 120 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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