Package Insert: Information for the User

Telfast 120 mg Film-Coated Tablets

Fexofenadine Hydrochloride

Read this package insert carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

• Keep this package insert, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Telfast contains fexofenadine hydrochloride, which is an antihistaminethat does not cause drowsiness.

Telfast 120 mg is used in adults and adolescents 12 years of age and older, to relieve symptoms associated with allergic rhinitis (for example hay fever) such as sneezing, itching, runny or stuffy nose and itchy, red, watery eyes.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Telfast

-If you are allergic to fexofenadine or to any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Telfast if:

• You have problems with your liver or kidneys.
• You have or have had cardiovascular disease, as this medication may cause a rapid or irregular heartbeat.

- You are an elderly patient.

If you are in any of these situations or are unsure, consult your doctor before taking Telfast.

Other medications and Telfast

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

If you are taking apalutamide (a medication for prostate cancer), as the effect of fexofenadine may be reduced.

Antacids containing aluminum and magnesium may affect the action of Telfast, reducing the amount of medication absorbed.

It is recommended to leave a gap of about 2 hours between taking Telfast and the antacid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take Telfast if you are pregnant, unless necessary.

The use of Telfast during breastfeeding is not recommended.

Driving and operating machinery

It is highly unlikely that Telfast will affect your ability to drive or operate machinery. However, you must ensure that you do not feel drowsy or dizzy before driving or operating machinery.

Telfast contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults and children 12 years and older

The recommended dose is 1 tablet (120 mg) once a day.

Take the tablet with water before a meal.

The effect of the medication begins after 1 hour and lasts 24 hours.

If you take more Telfast than you should

If you take many tablets, consult with your doctor or pharmacist, or go to the nearest hospital emergency department. The symptoms of overdose in adults are dizziness, drowsiness, fatigue, and dry mouth.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone 91 562 04 20).

If you forgot to take Telfast

Do not take a double dose to compensate for the missed doses.

Take the next dose at the usual time indicated by your doctor.

If you interrupt treatment with Telfast

Consult with your doctor if you want to stop taking Telfast before completing the treatment. If you interrupt treatment with Telfast before the planned time, you may experience the symptoms again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Consult your doctor immediately and stop taking Telfast if you notice that:

• your face, lips, tongue, or throat become swollen and you have difficulty breathing, as these may be symptoms of a severe allergic reaction.

The following unwanted effects have been reported in clinical trials, with an incidence similar to that observed in patients who did not receive the medication (placebo).

Frequent Adverse Effects(may affect up to 1 in 10 people):

• headache
• drowsiness
• unpleasant sensation (nausea)
• dizziness.

Less Frequent Adverse Effects(may affect up to 1 in 100 people):

• fatigue / tendency to sleep

Other Adverse Effects(unknown frequency: cannot be estimated from available data) that may occur are:

• difficulty sleeping (insomnia)
• sleep disorders
• nightmares
• anxiety
• rapid or irregular heartbeat
• diarrhea
• skin rash and itching
• urticaria
• severe allergic reactions that may cause facial, lip, tongue, or throat inflammation, shortness of breath, chest tightness, and difficulty breathing.
• blurred vision.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Telfast 120 mg Composition

The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.

The other components are:

Core components: microcrystalline cellulose, pregelatinized maize starch, sodium croscarmellose, magnesium stearate.

Coating components: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol, and iron oxide red (E 172) and iron oxide yellow (E172).

Product appearance and packaging contents

Telfast 120 mg are oblong, pale orange film-coated tablets, 6.1 x 15.8 mm in size, with “012” engraved on one face and an “e” written on the other face.

Telfast is presented in blisters.Each tablet is inside the blister.

Telfast is available in packaging sizes of 2 (only samples), 7, 10, 15, 20, 30, 50, 100, and 200 (10x20) tablets per pack.

Not all pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Roselló i Porcel, 21

08016 - Barcelona

Spain

Sanofi Group

Responsible manufacturer

Sanofi-Winthrop Industrie

Avenue Gustave Eiffel, 30 – 36

Tours (France)

or

Opella Healthcare International SAS

56, route de Choisy

60200 Compiègne (France)

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Austria: Allegra 120 mg Filmtabletten

Bélgica: Allegratab 120 mg filmomhulde tabletten

Croacia: Allegra 120 mg filmom obložene tablete

Dinamarca: Telfast, filmovertrukne tabletter 120 mg

Finlandia: Telfast 120 mg tabletti, kalvopäällysteinen

Alemania: Telfast 120 mg-Filmtabletten

Grecia: Allegra

Irlanda: Telfast 120 mg film-coated tablets

Italia: Telfast 120 mg compresse rivestite con film

Luxemburgo: Allegratab 120 mg comprimés pelliculés

Malta: Telfast 120 mg film-coated Tablets

Portugal: Telfast 120, comprimidos revestidos por película

Eslovenia: Telfast 120 mg filmsko obložene tablete

España: Telfast 120 mg comprimidos recubiertos con película

Suecia: Allegra

Reino Unido: Telfast 120 mg film-coated tablets

Last reviewed date of this leaflet:September 2023

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information on the following internet address: https://cima.aemps.es/cima/dochtml/p/61910/P_61910.html

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/