Fexofenadine Mylan Italia
Italy
Table of Contents
PACKAGE LEAFLET
Package leaflet: information for the user
Fexofenadine Mylan Italia 120 mg film-coated tablets
fexofenadine hydrochloride
Equivalent medicine
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 others, even if their symptoms are the same as yours, because 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:
- What Fexofenadine Mylan Italia is and what it is used for
- What you need to know before taking Fexofenadine Mylan Italia
- How to take Fexofenadine Mylan Italia
- Possible side effects
- How to store Fexofenadine Mylan Italia
- Contents of the pack and other information
1. What Fexofenadine Mylan Italia is and what it is used for
Fexofenadine Mylan Italia contains fexofenadine hydrochloride, which is an antihistamine. Fexofenadine Mylan Italia
120 mg is used in adults and adolescents aged 12 years and older to relieve symptoms of hay fever (seasonal allergic rhinitis) such as sneezing, itching, runny or blocked nose, and itchy, red, watery eyes.
2. What you need to know before taking Fexofenadina Mylan Italia
Do not take Fexofenadina Mylan Italia
- 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 Fexofenadina Mylan Italia if:
- you have liver or kidney problems
- you have or have ever had heart disease, as this type of medicine may cause a fast or irregular heartbeat
- you are elderly.
If any of these conditions apply to you, or if you are unsure, inform 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 used to treat prostate cancer), as the effect of fexofenadine may be reduced.
Indigestion medicines containing aluminium or magnesium may interfere with the action of Fexofenadina Mylan Italia, reducing the amount of medicine absorbed. It is recommended to leave a 2-hour interval between taking Fexofenadina Mylan Italia and antacids.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take Fexofenadina Mylan Italia during pregnancy 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 whether the tablets cause you drowsiness or dizziness before driving or operating machinery.
Fexofenadina Mylan Italia contains lactose
If you have been diagnosed with an intolerance to certain 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 Fexofenadine Mylan Italia
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For adults and adolescents aged 12 years and older
The recommended dose is one tablet (120 mg) daily.
Take your tablet with water before a meal.
This medicine starts relieving symptoms within 1 hour and its effect lasts for 24 hours.
If you take more Fexofenadine Mylan Italia 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 Fexofenadine Mylan Italia
Do not take a double dose to make up for the forgotten tablet.
Take the next dose as scheduled.
If you stop taking Fexofenadine Mylan Italia
If you stop treatment with Fexofenadine Mylan Italia earlier than planned, symptoms may return.
If you have any questions 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 contact your doctor and stop taking Fexofenadine Mylan Italia if you experience:
- swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a severe allergic reaction.
The following side effects have been reported in clinical studies, with an incidence similar 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):
- tiredness/drowsiness.
Other side effects (frequency not known: cannot be estimated from the available data) that
may occur include:
- difficulty sleeping (insomnia)
- sleep disturbances
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhoea
- skin rash and itching
- urticaria
- severe allergic reaction which may cause swelling of the face, lips, tongue or throat, redness, chest tightness and difficulty breathing
- blurred vision.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via
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 Fexofenadine 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 carton, blister, and container 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 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. Package contents and other information
What Fexofenadine Mylan Italia contains
- The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
- The other components are:
- Tablet core: lactose monohydrate, low-substituted hydroxypropylcellulose (E463), pregelatinized starch, colloidal anhydrous 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 colloidal anhydrous silica.
Description of the appearance of Fexofenadine Mylan Italia and package contents
Film-coated capsule-shaped tablets, peach-coloured, 16 mm x 6.2 mm, with "120" engraved 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 Authorization 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 authorized in the Member States of the European Economic Area under the following names:
This leaflet has been last updated
Package leaflet: information for the user
Fexofenadine Mylan Italia 180 mg film-coated tablets
fexofenadine hydrochloride
Generic medicine
Please read this entire 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, consult 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Fexofenadine Mylan Italia is and what it is used for
- What you need to know before taking Fexofenadine Mylan Italia
- How to take Fexofenadine Mylan Italia
- Possible side effects
- How to store Fexofenadine Mylan Italia
- Package contents and other information
1. What Fexofenadine Mylan Italia is and what it is used for
Fexofenadine Mylan Italia contains fexofenadine hydrochloride, which is an antihistamine.
Fexofenadine Mylan Italia 180 mg is used in adults and adolescents aged 12 years and older to
relieve symptoms associated with long-term allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and skin rashes.
2. What you need to know before taking Fexofenadina Mylan Italia
Do not take Fexofenadina Mylan Italia
- 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 Fexofenadina Mylan Italia if:
- you have liver or kidney problems
- you have or have ever had heart problems, as this type of medicine may cause a fast or irregular heartbeat
- you are elderly.
If any of these conditions apply to you, or if you are unsure, inform 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking apalutamide (a medicine used to treat prostate cancer), as the effect of fexofenadine may be reduced.
Indigestion medicines containing aluminium or magnesium may interfere with the action of Fexofenadina Mylan Italia, reducing the amount of medicine absorbed. It is recommended to leave a 2-hour interval between taking Fexofenadina Mylan Italia and the indigestion medicine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take Fexofenadina Mylan Italia during pregnancy 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 use machinery.
However, you should check whether the tablets cause you drowsiness or dizziness before driving or operating machinery.
Fexofenadina Mylan Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her 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 Fexofenadine Mylan Italia
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
For adults and adolescents aged 12 years and older
The recommended dose is one tablet (180 mg) daily.
Take your tablet with water before a meal.
This medicine starts relieving symptoms within 1 hour and its effect lasts for 24 hours.
If you take more Fexofenadine Mylan Italia 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 Fexofenadine Mylan Italia
Do not take a double dose to make up for the forgotten tablet.
Take the next dose at the usual time, as prescribed by your doctor.
If you stop taking Fexofenadine Mylan Italia
If you stop treatment with Fexofenadine Mylan Italia earlier than planned, symptoms may return.
If you have any doubts about using 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 Fexofenadine Mylan Italia if you experience:
- swelling of the face, lips, tongue or throat and breathing difficulties, as these may be signs of a severe allergic reaction.
The following side effects were reported in clinical studies, with an incidence 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.
Other side effects (frequency not known: cannot be estimated from the available data) that
may occur include:
- difficulty sleeping (insomnia)
- sleep disturbances
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhoea
- skin rash and itching
- hives (urticaria)
- severe allergic reaction which may cause swelling of the face, lips, tongue or throat, redness, chest tightness and breathing difficulties
- blurred vision.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via
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 Fexofenadine Mylan Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, and bottle 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 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. Package contents and other information
What Fexofenadine Mylan Italia contains
- The active substance is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride.
- The other components are:
- Tablet core: monohydrate lactose, 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 Fexofenadine Mylan Italia and contents of the pack
Film-coated capsule-shaped tablets, peach-colored, 17.1 mm x 7.6 mm, with "180" engraved on one side and "FX" on the other side.
Available in:
Blister packs: 10, 15, 20, 30 or 100 film-coated tablets
HDPE bottles: 500 or 1000 film-coated tablets
Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
This leaflet has been updated