Telfast 120 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Telfast 120 mg film-coated tablets
Fexofenadine hydrochloride
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for taking this medicine as described in this leaflet or as advised by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Telfast is and what it is used for
- What you need to know before taking Telfast
- How to take Telfast
- Possible side effects
- How to store Telfast
- Contents of the pack and other information
1. What Telfast is and what it is used for
Telfast contains fexofenadine hydrochloride, which is a non-sedating antihistamine.
Telfast 120 mg is used in adults and adolescents aged 12 years and older to relieve symptoms associated with allergic rhinitis (such as hay fever), including sneezing, itching, runny or stuffy nose, and itchy, red, watery eyes.
You should consult a doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before starting Telfast
Do not take Telfast
- If you are allergic to fexofenadine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Telfast if:
- you have problems with your liver or kidneys.
- you have or have had cardiovascular disease, as this medicine may cause 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 medicines and Telfast
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.
Indigestion remedies containing aluminium and magnesium may affect the action of Telfast, reducing the amount of medicine absorbed.
It is recommended to leave an interval of about 2 hours between taking Telfast and the indigestion remedy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take Telfast if you are pregnant, unless it is necessary.
Use of Telfast during breastfeeding is not recommended.
Driving and using machines
It is very unlikely that Telfast will affect your ability to drive or operate machinery. However, you should ensure that you do not experience drowsiness or dizziness when taking these tablets before driving or operating machinery.
Telfast contains sodium.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially "sodium-free".
3. How to take Telfast
Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is 1 tablet (120 mg) once daily.
Take the tablet with water before a meal.
The effect of the medicine starts within 1 hour and lasts for 24 hours.
If you take more Telfast than you should
If you take too many tablets, consult your doctor or pharmacist, or go to the nearest hospital emergency department. Symptoms of overdose in adults include dizziness, drowsiness, fatigue, and dry mouth.
In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone 91 562 04 20).
If you forget to take Telfast
Do not take a double dose to make up for missed doses.
Take the next dose at the regular time indicated by your doctor.
If you stop taking Telfast
Consult your doctor if you wish to stop taking Telfast before completing the treatment. If you stop treatment with Telfast earlier than planned, your symptoms may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Consult your doctor immediately and stop taking Telfast if you notice:
- swelling of the face, lips, tongue or throat and 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 medicine (placebo).
Frequent adverse effects (may affect up to 1 in 10 people):
- headache
- drowsiness
- feeling unwell (nausea)
- dizziness.
Uncommon adverse effects (may affect up to 1 in 100 people):
- tiredness/somnolence
Other adverse effects (frequency not known: cannot be estimated from available data) that may occur are:
- difficulty sleeping (insomnia)
- sleep disorders
- nightmares
- nervousness
- rapid or irregular heartbeat
- diarrhoea
- skin rash and itching
- urticaria
- severe allergic reactions which may cause swelling of the face, lips, tongue or throat, flushing, chest tightness, and difficulty breathing
- blurred vision
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Telfast
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Telfast 120 mg
The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.
The other components are:
Core components: microcrystalline cellulose, pregelatinized corn starch, croscarmellose sodium, magnesium stearate.
Coating components: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol, red iron oxide (E 172), and yellow iron oxide (E172).
Appearance of the product and contents of the pack
Telfast 120 mg are film-coated tablets measuring 6.1 x 15.8 mm, oblong in shape, pale orange in colour, marked with "012" on one side and a "e" on the other side.
Telfast is presented in blisters. Each tablet is contained within the blister.
Telfast is available in pack sizes of 2 (samples only), 7, 10, 15, 20, 30, 50, 100 and 200 (10x20) tablets per pack.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Opella Healthcare Spain, S.L.
C/ Rosselló i Porcel, 21
08016 Barcelona,
Spain
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 and in the United Kingdom (Northern Ireland) under the following names:
Austria: Allegra 120 mg Filmtabletten
Belgium: Allegratab 120 mg filmomhulde tabletten
Croatia: Allegra 120 mg filmom obložene tablete
Denmark: Telfast, filmovertrukne tabletter 120 mg
Finland: Telfast 120 mg tabletti, kalvopäällysteinen
Germany: Telfast 120 mg-Filmtabletten
Greece: Allegra 120 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α
Ireland: Telfast 120 mg film-coated tablets
Italy: Telfast 120 mg compresse rivestite con film
Luxembourg: Allegratab 120 mg comprimés pelliculés
Malta: Telfast 120 mg film-coated Tablets
Portugal: Telfast 120, comprimidos revestidos por película
Slovenia: Telfast 120 mg filmsko obložene tablete
Spain: Telfast 120 mg comprimidos recubiertos con película
Sweden: Allegra 120 mg filmdragerade tabletter
United Kingdom: Telfast 120 mg film-coated tablets
**Date of the most recent review of this leaflet:November 2025
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/61910/P_61910.html
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/