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TELFAST Film-coated tablet (2023)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Telfast 120 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Peach, modified capsule-shaped, film-coated tablet of 6.1 15.8 mm debossed with 012 on one side and a scripted e on the other side.

Therapeutic indications

Telfast 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis.

Posology and method of administration

Posology Adults The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine. Paediatric ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1).

Special warnings and precautions for use

There is limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups (see section 4.2). Patients with a ...

Interaction with other medicinal products and other forms of interaction

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting ...

Fertility pregnancy and lactation

Pregnancy There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, ...

Effects on ability to drive and use machines

On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective ...

Undesirable effects

The following frequency rating has been used, when applicable: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000 and not known (frequency ...

Overdose

Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily ...

Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antihistamines for systemic use <b>ATC code:</b> R06AX26 Mechanism of action Fexofenadine hydrochloride is a non-sedating H<sub>1</sub> antihistamine. Fexofenadine is ...

Pharmacokinetic properties

Absorption Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with T<sub>max</sub> occurring at approximately 1-3 hours post dose. The mean C<sub>max</sub> value ...

Preclinical safety data

Dogs tolerated 450 mg/kg administered twice daily for 6 months and showed no toxicity other than occasional emesis. Also, in single dose dog and rodent studies, no treatment-related gross findings were ...

List of excipients

<u>Tablet core:</u> Microcrystalline cellulose Pregelatinised maize starch Croscarmellose sodium Magnesium stearate <u>Film coat:</u> Hypromellose Povidone K30 Titanium dioxide (E171) Colloidal anhydrous ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PE/PVDC/Al or PVC/PVDC/Al blisters, packaged into cardboard boxes. 2(sample only), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per package. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

Marketing authorization number(s)

PA23180/003/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 11 November 1997 Date of last renewal: 20 July 2020

Date of revision of the text

12 July 2023

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