TELFAST 180 mg Фильм-Coated Таблетки

Содержание инструкции

1. TELFAST 120 mg film-coated tablets
   1. What Telfast is and what it is used for
   2. What you need to know before you take Telfast
   3. How to take Telfast
   4. Possible side effects
   5. How to store Telfast
   6. Package Contents and Other Information
2. TELFAST 180 mg film-coated tablets
   1. What Telfast is and what it is used for
   2. What you need to know before you take Telfast
   3. How to take Telfast
   4. Possible side effects
   5. How to store Telfast
   6. Contents of the pack and other information

TELFAST 120 mg film-coated tablets

fexofenadine hydrochloride

Read this leaflet carefully before you start to take 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 an antihistamine that does not cause drowsiness.
Telfast 120 mg is used in adults and adolescents aged 12 years and over to relieve
the symptoms that occur with allergic rhinitis (e.g. hay fever) such as sneezing, nasal itching,
runny or blocked nose and itching, redness and watery eyes.

2. What you need to know before you take Telfast

Do not take Telfast

• if you are allergic to fexofenadine or 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 currently have or have had heart disease in the past, as this type of medicine can cause a fast or irregular heartbeat,
• you are elderly. If any of the above conditions apply to you or if you have any doubts, tell 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.
Tell your doctor or pharmacist if you are taking apalutamide (a medicine 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 can
affect the action of Telfast by decreasing the amount of medicinal product absorbed.
It is recommended to observe an interval of about 2 hours between taking Telfast and the medicine for
digestive problems.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Telfast during pregnancy unless 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 of sodium (23 mg) per tablet, i.e. it is essentially
‘sodium-free’.

3. How to take Telfast

Take this medicine following the instructions of your doctor exactly.
If you have any doubts, consult your doctor or pharmacist.

Adults and children 12 years of age or older
The recommended dose is one tablet (120 mg) once a day.
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 emergency room immediately. The symptoms
of overdose in adults are 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 same time you usually take it, as prescribed by your doctor.

If you stop taking Telfast
Consult your doctor if you intend to stop taking Telfast before completing the
treatment cycle. If you stop taking Telfast prematurely, symptoms may
reappear.
If you would like more information on 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 gets them.

Immediately inform your doctor and stop treatment with Telfast if you experience

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

The following side effects have been reported in clinical studies and with a similar frequency to
that observed in patients who did not receive the 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 are:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is reported on the package and on the blister after
(Expiry.).
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of
fexofenadine hydrochloride.
The other ingredients are:

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

Description of the appearance of Telfast 120 mg and package contents
The film-coated tablets of Telfast 120 mg, measuring 6.1 x 15.8 mm, are peach-colored, capsule-shaped with “012” imprinted on one side and the writing “e” on the opposite side.
Telfast is available in blister packs. Each tablet is packaged in a blister.
Telfast is available in packs 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l. - Viale L. Bodio, 37/B – 20158 Milan

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 authorised in the Member States of the European Economic Area under the
following denominations:
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

TELFAST 180 mg film-coated tablets

fexofenadine hydrochloride

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 an antihistamine that does not cause drowsiness.
Telfast 180 mg is used in adults and adolescents aged 12 years and over to
relieve the symptoms that occur following chronic allergic skin reactions (chronic idiopathic urticaria) such as itching, swelling and rash.

2. What you need to know before you take Telfast

Do not take Telfast

• if you are allergic to fexofenadine or 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 had heart disease in the past, as this type of medicine can cause a fast or irregular heartbeat,
• you are elderly. If any of the above conditions apply to you or if you have any doubts, tell 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.
Medicines used to treat digestive problems that contain aluminium and magnesium can
affect the action of Telfast by decreasing the amount of medicinal product absorbed.
It is recommended to observe an interval of about 2 hours between taking Telfast and the 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 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 following exactly the instructions of your doctor.
If you have any doubts, consult your doctor or pharmacist.

Adults and children 12 years of age or older
The recommended dose is one tablet (180 mg) once a day.
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 emergency room immediately. The
symptoms of overdose in adults are 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 same time you usually take it, as prescribed by your
doctor.

If you stop taking Telfast
Consult your doctor if you intend to stop taking Telfast before completing the
treatment cycle. If you stop taking Telfast prematurely, symptoms may
reappear.
If you would like more information on 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 gets them.

Immediately inform your doctor and stop treatment with Telfast if you experience

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

The following side effects have been reported in clinical studies and with a similar frequency to
that observed in patients who did not receive the drug (placebo):
Common side effects can affect up to 1 in 10 people:

• headache
• drowsiness
• feeling unwell (nausea)
• dizziness.

Uncommon side effects can 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 are:

• difficulty falling asleep (insomnia)
• sleep disorders
• nightmares
• nervousness
• fast or irregular heartbeat
• diarrhea
• skin rash and itching
• hives
• severe allergic reactions that can cause swelling of the face, lips, tongue or throat, flushing, chest tightness and difficulty breathing.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the pack after (Exp.).
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine
hydrochloride.
The other ingredients 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
The film-coated tablets of Telfast 180 mg are peach-colored, capsule-shaped with “018”
imprinted on one side and with the writing “e” on the opposite side.
Telfast is available in blister packs. Each tablet is packaged 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

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 authorised in the Member States of the European Economic Area under the following
denominations:
Belgium: Telfast 180 mg film-coated tablets
Denmark: Telfast, film-coated tablets 180 mg
Finland: Telfast 180 mg tablets, film-coated
Germany: Telfast 180 mg
Ireland: Telfast 180 mg film-coated tablets
Italy: Telfast 180 mg compresse rivestite con film
Luxembourg: Telfast 180 mg film-coated tablets
Malta: Telfast 180 mg film-coated Tablets
Portugal: Telfast 180, film-coated tablets
Spain: Fexofenadina Opella 180 mg comprimidos recubiertos con película
Sweden: Telfast 180 mg film-coated tablets
United Kingdom: Telfast 180 mg film-coated tablets