Telfast

Package leaflet: Information for the user

TELFAST 120 mg film-coated tablets

fexofenadine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Telfast is and what it is used for
2. What you need to know before taking Telfast
3. How to take Telfast
4. Possible side effects
5. How to store Telfast
6. 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 of allergic rhinitis (e.g. hay fever), such as sneezing, itching of the nose, runny or blocked nose, and itchy, red and watery eyes.

2. What you need to know before taking 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 liver or kidney problems,
• you currently have or have previously had heart disease, as this type of medicine may cause a fast or irregular heartbeat,
• you are elderly. If any of the above conditions apply to you or if you have any doubts, inform your doctor before taking Telfast.

Other medicines and Telfast
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking apalutamide (a medicine used for the treatment of prostate cancer), as the effect of fexofenadine may be reduced.
Medicines used to treat digestive problems that contain aluminium and magnesium may affect the action of Telfast by reducing the amount of medicine absorbed.
It is recommended to leave an interval of about 2 hours between taking Telfast and taking the medicine for digestive problems.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Telfast during pregnancy unless clearly necessary.
The use of Telfast is not recommended during breastfeeding.

Driving and using machines
It is unlikely that Telfast will affect your ability to drive or use machinery. However, make sure that the tablets do not cause you to feel drowsy or dizzy before driving or operating machinery.

Telfast contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take Telfast

Take this medicine exactly as prescribed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Adults and children aged 12 years and older
The recommended dose is one tablet (120 mg) once daily.
Take the tablet with water before meals.
This medicine starts relieving symptoms within 1 hour and lasts for 24 hours.
If you take more Telfast than you should
If you take too many tablets, contact your doctor or the nearest emergency department immediately.
Symptoms of overdose in adults include dizziness, drowsiness, fatigue, and dry mouth.
If you forget to take Telfast
Do not take a double dose to make up for the forgotten tablet.
Take the next dose at the same time as usual, as prescribed by your doctor.
If you stop taking Telfast
Consult your doctor if you intend to stop taking Telfast before completing the treatment course.
If you stop taking Telfast too early, symptoms may return.
If you would like more information about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately and stop treatment with Telfast if you experience

• swelling of the face, lips, tongue or throat and breathing difficulties, as these symptoms may indicate a severe allergic reaction.

The following side effects were reported in clinical studies with a frequency similar to that observed in patients who did not receive the active drug (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:

• tiredness/drowsiness.

Additional side effects (frequency not known: cannot be estimated from the available data) that may occur include:

• difficulty falling asleep (insomnia)
• sleep disturbances
• nightmares
• nervousness
• fast or irregular heartbeat
• diarrhoea
• skin rash and itching
• hives (urticaria)
• severe allergic reactions that may cause swelling of the face, lips, tongue or throat, hot flushes, chest tightness and breathing difficulties
• blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telfast

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after (Exp.).
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Telfast 120 mg contains
The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of
fexofenadine hydrochloride.
The other components are:

• Tablet core: microcrystalline cellulose, pregelatinized corn starch, croscarmellose sodium, magnesium stearate.
• Film coating: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol, red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Telfast 120 mg and package contents
Telfast 120 mg film-coated tablets measure 6.1 x 15.8 mm, are peach-coloured, capsule-shaped, with "012" engraved on one side and the letter "e" on the opposite side.
Telfast is supplied in blister packs. Each tablet is packaged in a blister.
Telfast is available in pack sizes of 2 (sample), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per box.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Opella Healthcare Italy S.r.l. - Viale L. Bodio, 37/B – 20158 Milan, Italy
Manufacturer
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel - 37100 Tours (France)
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 under the following names:
Austria: Allegra 120 mg Filmtabletten
Belgium: Allegra tab 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: Allegra tab 120mg, 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

Package leaflet: Information for the user

TELFAST 180 mg film-coated tablets

fexofenadine hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Telfast is and what it is used for
2. What you need to know before taking Telfast
3. How to take Telfast
4. Possible side effects
5. How to store Telfast
6. 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 180 mg is used in adults and adolescents aged 12 years and older to relieve symptoms of chronic allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and skin rash.

2. What you need to know before taking 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 liver or kidney problems,
• you currently have or have previously had heart disease, as this type of medicine may cause rapid or irregular heartbeat,
• you are elderly. If any of the above conditions apply to you or if you have any doubts, inform your doctor before taking Telfast.

Other medicines and Telfast
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines used to treat digestive problems containing aluminium and magnesium may affect the action of Telfast by reducing the amount of medicine absorbed.
It is recommended to leave an interval of approximately 2 hours between taking Telfast and taking a medicine for digestive problems.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Telfast during pregnancy unless clearly necessary.
The use of Telfast is not recommended during breastfeeding.

Driving and using machines
It is unlikely that Telfast will affect your ability to drive or operate machinery. However, make sure that the tablets do not cause you drowsiness or dizziness before driving or operating machinery.

Telfast contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take Telfast

Take this medicine exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Adults and children aged 12 years and older
The recommended dose is one tablet (180 mg) once daily.
Take the tablet with water before meals.
This medicine starts to relieve symptoms within 1 hour and lasts for 24 hours.
If you take more Telfast than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Symptoms of overdose in adults include dizziness, drowsiness, fatigue and dry mouth.
If you forget to take Telfast
Do not take a double dose to make up for the missed tablet.
Take the next dose at the usual time, as prescribed by your doctor.
If you stop taking Telfast
Consult your doctor if you intend to stop taking Telfast before completing the treatment course. If you stop taking Telfast too early, symptoms may return.
If you would like more information about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact your doctor immediately and stop treatment with Telfast if you experience

• swelling of the face, lips, tongue or throat, and breathing difficulties, as these symptoms may indicate a severe allergic reaction.

The following side effects were reported in clinical studies and occurred at a frequency similar to that observed in patients who did not receive the active drug (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
• drowsiness.

Additional side effects (frequency not known: cannot be estimated from the available data) that may occur include:

• difficulty falling asleep (insomnia)
• sleep disorders
• nightmares
• nervousness
• fast or irregular heartbeat
• diarrhoea
• skin rash and itching
• hives
• severe allergic reactions which may cause swelling of the face, lips, tongue or throat, hot flushes, chest tightness and breathing difficulties.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telfast

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after (Exp.).
The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Telfast 180 mg contains
The active substance is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine
hydrochloride.
The other components are:

• Tablet core: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.
• Film coating: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol 400, and iron oxide (E172).

Description of the appearance of Telfast 180 mg and contents of the pack
Telfast 180 mg film-coated tablets are peach-coloured, capsule-shaped tablets with "018"
imprinted on one side and the letter "e" on the other side.
Telfast is supplied in blister packs. Each tablet is packed in a blister.
Telfast is available in packs of 2 (sample), 10, 15, 20, 30, 50, 100 and 200 (as 10x20)
tablets per box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l. - Viale L. Bodio, 37/B – 20158 Milano, Italy
Manufacturers
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel - 37100 Tours (France)
Opella Healthcare International SAS
56, route de Choisy - 60200 Compiègne (France)

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Telfast 180 mg filmomhulde tabletten
Denmark: Telfast, filmovertrukne tabletter 180 mg
Finland: Telfast 180 mg tabletti, kalvopäällysteinen
Germany: Telfast 180 mg
Ireland: Telfast 180 mg film-coated tablets
Italy: Telfast 180 mg film-coated tablets
Luxembourg: Telfast 180 mg filmomhulde tabletten
Malta: Telfast 180 mg film-coated Tablets
Portugal: Telfast 180, comprimidos revestidos por película
Spain: Fexofenadina Opella 180 mg comprimidos recubiertos con película
Sweden: Telfast 180 mg filmdragerade tabletter
United Kingdom: Telfast 180 mg film-coated tablets

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