TELFAST 120 mg FILM-COATED TABLETS
How to use TELFAST 120 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Leaflet: information for the user
Telfast 120 mg film-coated tablets
Fexofenadine hydrochloride
Read this leaflet carefully before starting to take this medicine, as it contains important information for you.
Follow the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if it worsens or does not improve after 7 days.
Contents of the leaflet
- What is Telfast and what is it used for
- What you need to know before taking Telfast
- How to take Telfast
- Possible side effects
- Storage of Telfast
- Package contents and additional information
1. What is Telfast and what is it used for
Telfast contains fexofenadine hydrochloride, which is a non-drowsy antihistamine.
Telfast 120 mg is used in adults and adolescents from 12 years of age to relieve symptoms associated with allergic rhinitis (such as hay fever), such as sneezing, itching, runny or stuffy nose, and itching, redness, and tearing of the eyes.
You should consult a doctor if it worsens or does not improve after 7 days.
2. What you need to know before taking Telfast
Do not take Telfast
- If you are allergic to fexofenadine or any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Telfast if:
- you have liver or kidney problems.
- you have or have had cardiovascular disease, as this medicine may cause a fast 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 or have recently taken or may take any other medicine.
If you are taking apalutamide (a medicine for prostate cancer), as the effect of fexofenadine may decrease.
Indigestion remedies containing aluminum 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take Telfast if you are pregnant, unless necessary.
Telfast is not recommended during breastfeeding.
Driving and using machines
It is very unlikely that Telfast will affect your ability to drive or operate machinery. However, you should make sure that when taking these tablets you do not feel drowsy or dizzy before driving or operating machinery.
Telfast contains sodium.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Telfast
Follow the administration instructions of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and children from 12 years of age
The recommended dose is 1 tablet (120 mg) once a day.
Take the tablet with water before meals.
The effect of the medicine starts after 1 hour and lasts 24 hours.
If you take more Telfast than you should
If you take many tablets, consult your doctor or pharmacist, or go to the emergency department of the nearest hospital. The symptoms of overdose in adults are dizziness, drowsiness, fatigue, and dry mouth.
In case of overdose or accidental ingestion, consult 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 forgotten doses.
Take the next dose at the usual time indicated by your doctor.
If you stop taking Telfast
Consult your doctor if you want to stop taking Telfast before finishing the treatment. If you stop taking Telfast before planned, you may experience symptoms again.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Consult your doctor immediately and stop taking Telfast if you notice that:
- your face, lips, tongue, or throat swell 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 medicine (placebo).
Common side effects(may affect up to 1 in 10 people):
- headache
- drowsiness
- feeling unwell (nausea)
- dizziness.
Uncommon side effects(may affect up to 1 in 100 people):
- fatigue / tendency to sleep
Other side effects(frequency not known: cannot be estimated from available data) that may occur are:
- difficulty sleeping (insomnia)
- sleep disorders
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhea
- skin rash and itching
- hives
- severe allergic reactions that may cause swelling of the face, lips, tongue, or throat, shortness of breath, chest tightness, and difficulty breathing.
- blurred vision.
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side 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 expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.
This medicine does not require special storage conditions.
Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Telfast 120 mg
The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.
The other ingredients are:
Core components: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.
Coating components: hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol, and red iron oxide (E 172) and yellow iron oxide (E172).
Appearance of the product and package contents
Telfast 120 mg are film-coated tablets, 6.1 x 15.8 mm in size, oblong in shape, and pale orange in color, engraved with "012" on one side and an "e" written on the other side.
Telfast is available in blisters. Each tablet is inside the blister.
Telfast is available in packs 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 manufacturer
Marketing authorization holder
Opella Healthcare Spain, S.L.
C/ Roselló i Porcel, 21
08016 - Barcelona
Spain
Sanofi Group
Manufacturer
Sanofi-Winthrop Industrie
Avenue Gustave Eiffel, 30 – 36
Tours (France)
or
Opella Healthcare International SAS
56, route de Choisy
60200 Compiègne (France)
This medicine is authorized in the Member States of the European Economic Area 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
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
United Kingdom: Telfast 120 mg film-coated tablets
Date of the last revision of this leaflet:September 2023
You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/61910/P_61910.html
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to TELFAST 120 mg FILM-COATED TABLETSDosage form: TABLET, 120 mgActive substance: fexofenadineManufacturer: Cipla EuropePrescription requiredDosage form: TABLET, 180 mgActive substance: fexofenadineManufacturer: Cipla EuropePrescription requiredDosage form: TABLET, 180 mg fexofenadine hydrochlorideActive substance: fexofenadineManufacturer: Opella Healthcare Spain S.L.Prescription required
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