FEXOFENADINA 120 mg Фильм-Coated Таблетки

Содержание инструкции

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

Fexofenadina Mylan Italia 120 mg film-coated tablets

fexofenadine hydrochloride

Generic medicine

Read this leaflet carefully before you start 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 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 Fexofenadina Mylan Italia is and what it is used for
• 2. What you need to know before you take Fexofenadina Mylan Italia
• 3. How to take Fexofenadina Mylan Italia
• 4. Possible side effects
• 5. How to store Fexofenadina Mylan Italia
• 6. Contents of the pack and other information

1. What is Fexofenadina Mylan Italia and what it is used for

Fexofenadina Mylan Italia contains fexofenadine hydrochloride, which is an antihistamine. Fexofenadina Mylan Italia
120 mg is used in adults and adolescents aged 12 years and over to relieve symptoms that occur with
hay fever (seasonal allergic rhinitis) such as sneezing, itching, runny or blocked nose and
itchy, red and watery eyes.

2. What you need to know before you take Fexofenadina Mylan Italia

Do not take Fexofenadina Mylan Italia

• 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 Fexofenadina Mylan Italia if:

• you have liver or kidney problems
• you have or have ever had heart disease, as this type of medicine can lead to a fast or irregular heartbeat
• you are an elderly person.

If any of these conditions apply to you, or if you are not sure, tell your doctor before taking
Fexofenadina Mylan Italia.

Children
Fexofenadina Mylan Italia is not suitable for children under 12 years of age.

Other medicines and Fexofenadina Mylan Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
If you are taking apalutamide (a medicine for the treatment of prostate cancer), as the effect of
fexofenadine may be reduced.
Medicines for indigestion containing aluminium or magnesium can interfere with the action of Fexofenadina
Mylan Italia, decreasing the amount of medicinal product absorbed. It is recommended to allow 2 hours between
taking Fexofenadina Mylan Italia and the medicine for digestive problems.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine. Do not take Fexofenadina
Mylan Italia if you are pregnant unless strictly necessary. Fexofenadina Mylan Italia is not
recommended during breastfeeding.

Driving and using machines
It is unlikely that Fexofenadina Mylan Italia will affect your ability to drive or operate machinery.
However, you should check that the tablets do not make you feel sleepy or dizzy before driving or using
machinery.

Fexofenadina Mylan Italia contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

Fexofenadina Mylan Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Fexofenadina Mylan Italia

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

For adults and adolescents aged 12 years and over
The recommended dose is one tablet (120 mg) per day.
Take your tablet with water before a meal.
This medicine starts to relieve symptoms within 1 hour and its effect lasts for 24 hours.

If you take more Fexofenadina Mylan Italia than you should
If you take too many tablets, contact your doctor or the emergency room of the nearest hospital immediately.
The symptoms of an overdose in adults are dizziness, drowsiness, fatigue and dry mouth.

If you forget to take Fexofenadina Mylan Italia
Do not take a double dose to make up for the missed tablet.
Take the next dose as planned.

If you stop taking Fexofenadina Mylan Italia
If you stop taking Fexofenadina Mylan Italia prematurely, the symptoms may return.
If you have any doubts 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 gets them.
Immediately inform your doctor and stop taking Fexofenadina Mylan Italia if you experience:

• swelling of the face, lips, tongue or throat and difficulty breathing because these can be signs of a serious allergic reaction.

The following side effects have been reported in clinical studies, with a similar incidence 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.

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

• difficulty sleeping (insomnia)
• sleep disturbances
• nightmares
• nervousness
• fast and irregular heartbeat
• diarrhoea
• skin rash and itching
• urticaria
• serious allergic reaction that can cause swelling of the face, lips, tongue or throat, redness, 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
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 Fexofenadina Mylan Italia

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 box, blister and bottle after
Exp. The expiry date refers to the last day of that 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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fexofenadina Mylan Italia contains

• The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
• The other ingredients are:
• Tablet core: lactose monohydrate, low substituted hydroxypropylcellulose (E463), pregelatinized starch, anhydrous colloidal silica, microcrystalline cellulose (E460), sodium croscarmellose (E468) and magnesium stearate.
• Tablet coating: hypromellose, povidone, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), macrogol and anhydrous colloidal silica.

Description of the appearance of Fexofenadina Mylan Italiaand contents of the pack
Film-coated tablets in capsule shape, peach colored, of 16 mm x 6.2 mm, with “120” imprinted on one side
and “FX” on the other side.
Available in
Blister pack: 10, 15, 20, 30 or 100 film-coated tablets
HDPE bottles: 500 or 1,000 film-coated tablets

Marketing Authorisation Holder
Mylan S.p.A. Via Vittor Pisani, 20, 20124 Milano, Italy

Manufacturer
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1., Komarom, 2900,
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
This leaflet was last updated

Fexofenadina Mylan Italia 180 mg film-coated tablets

fexofenadine hydrochloride

Generic medicine

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 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 Fexofenadina Mylan Italia is and what it is used for
• 2. What you need to know before you take Fexofenadina Mylan Italia
• 3. How to take Fexofenadina Mylan Italia
• 4. Possible side effects
• 5. How to store Fexofenadina Mylan Italia
• 6. Contents of the pack and other information

1. What is Fexofenadina Mylan Italia and what is it used for

Fexofenadina Mylan Italia contains fexofenadine hydrochloride, which is an antihistamine.
Fexofenadina Mylan Italia 180 mg is used in adults and adolescents aged 12 years and over to
relieve symptoms that occur following long-term allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling and skin rashes.

2. What you need to know before you take Fexofenadina Mylan Italia

Do not take Fexofenadina Mylan Italia

• 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 Fexofenadina Mylan Italia if:

• you have liver or kidney problems
• you have or have had heart disease, as this type of medicine can lead to a fast or irregular heartbeat
• you are an elderly person.

If any of these conditions apply to you, or if you are not sure, tell your doctor before taking
Fexofenadina Mylan Italia.

Children
Fexofenadina Mylan Italia is not suitable for children under 12 years of age.

Other medicines and Fexofenadina Mylan Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
If you are taking apalutamide (a medicine for the treatment of prostate cancer), as the effect of
fexofenadine may be reduced.
Medicines for indigestion containing aluminium or magnesium can interfere with the action of Fexofenadina
Mylan Italia, decreasing the amount of medicinal product absorbed. It is recommended to allow 2 hours between
taking Fexofenadina Mylan Italia and the medicine for digestive problems.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine. Do not take Fexofenadina
Mylan Italia if you are pregnant, unless strictly necessary. Fexofenadina Mylan Italia is not
recommended during breastfeeding.

Driving and using machines
It is unlikely that Fexofenadina Mylan Italia will affect your ability to drive or operate machinery.
However, you should check that the tablets do not make you feel sleepy or dizzy before driving or using
machinery.

Fexofenadina Mylan Italia contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

Fexofenadina Mylan Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Fexofenadina Mylan Italia

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

For adults and adolescents aged 12 years or older
The recommended dose is one tablet (180 mg) per day.
Take your tablet with water before a meal.
This medicine starts to relieve symptoms within 1 hour and its effect lasts for 24 hours.

If you take more Fexofenadina Mylan Italia than you should
If you take too many tablets, contact your doctor or the emergency room of the nearest hospital immediately.
The symptoms of an overdose in adults are dizziness, drowsiness, fatigue and dry mouth.

If you forget to take Fexofenadina Mylan Italia
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 Fexofenadina Mylan Italia
If you stop taking Fexofenadina Mylan Italia before expected, the symptoms may return.
If you have any doubts 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 everybody gets them.
Immediately inform your doctor and stop taking Fexofenadina Mylan Italia if you experience:

• swelling of the face, lips, tongue or throat and difficulty breathing because these can be signs of a serious allergic reaction.

The following side effects have been reported in clinical studies, with a similar incidence 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.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store Fexofenadina Mylan Italia

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 box, blister and bottle after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Fexofenadina Mylan Italia contains

• The active ingredient is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride.
• The other ingredients are:
• Tablet core: lactose monohydrate, low substituted hydroxypropylcellulose (E463), pregelatinized starch, anhydrous colloidal silica, microcrystalline cellulose (E460), sodium croscarmellose (E468) and magnesium stearate.
• Tablet coating: hypromellose, povidone, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), macrogol and anhydrous colloidal silica.

Description of the appearance of Fexofenadina Mylan Italiaand contents of the pack
Film-coated tablets in capsule shape, peach-colored, with dimensions of 17.1 mm x 7.6 mm, with “180” imprinted on one
side and “FX” on the other side.
Available in
Blister pack: 10, 15, 20, 30 or 100 film-coated tablets
HDPE bottles: 500 or 1000 film-coated tablets

Marketing Authorisation Holder
Mylan S.p.A. Via Vittor Pisani, 20, 20124 Milan, Italy

Manufacturer
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1., Komarom, 2900,
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
This leaflet was last updated