FEXOFENADINE MYLAN GENERICS

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Fexofenadine Mylan Generics 120 mg film-coated tablets, 180 mg film-coated tablets

Fexofenadine hydrochloride
EQUIVALENT MEDICINE
Please read this leaflet carefully before using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT FEXOFENADINE MYLAN GENERICS IS AND WHAT IT IS USED FOR

Fexofenadine Mylan Generics contains fexofenadine hydrochloride, which is an antihistamine.
Fexofenadine Mylan Generics 120 mg tablets are used in adults and adolescents over 12 years of age to relieve symptoms of hay fever (seasonal allergic rhinitis), such as sneezing, itching, runny or blocked nose, and red, itchy, watery eyes.
Fexofenadine Mylan Generics 180 mg tablets are used in adults and adolescents over 12 years of age to relieve symptoms of long-term allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and skin rashes.

2. WHAT YOU SHOULD KNOW BEFORE TAKING FEXOFENADINE MYLAN GENERICS

Do not take Fexofenadine Mylan Generics 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 Fexofenadine Mylan Generics if:

• you have liver or kidney problems
• you have or have ever had heart disease, as this type of medicine may cause rapid or irregular heartbeat
• you are an elderly person

If any of these conditions apply to you, inform your doctor before taking Fexofenadine Mylan Generics.

Other medicines and Fexofenadine Mylan Generics
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines.
Antacids containing aluminium or magnesium may interfere with the action of Fexofenadine Mylan Generics, reducing the amount of drug absorbed. It is recommended to leave a 2-hour interval between taking Fexofenadine Mylan Generics and such medicines.
Animal studies have shown that the increase in plasma levels of fexofenadine observed after concomitant administration of erythromycin or ketoconazole appears to be due to increased gastrointestinal absorption and, respectively, decreased biliary excretion or gastrointestinal secretion.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Fexofenadine Mylan Generics during pregnancy unless strictly necessary.
Fexofenadine Mylan Generics is not recommended during breastfeeding.

Driving and using machines:
It is unlikely that Fexofenadine Mylan Generics 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.

3. HOW TO TAKE FEXOFENADINE MYLAN GENERICS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

For adults and adolescents over 12 years of age:

Fexofenadine Mylan Generics 120 mg tablets: The recommended dose is one tablet (120 mg) once daily. Take your tablet with water before a meal.

Fexofenadine Mylan Generics 180 mg tablets: The recommended dose is one tablet (180 mg) once daily. Take your tablet with water before a meal.

If you take more Fexofenadine Mylan Generics 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 Generics

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 Fexofenadine Mylan Generics

Inform your doctor if you wish to stop taking Fexofenadine Mylan Generics before completing the treatment course.

If you stop treatment with Fexofenadine Mylan Generics earlier than planned, symptoms may return.

If you have any questions about how to use 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 Generics if you experience:

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

Common side effects (may affect up to 1 in 10 people):

• headache
• drowsiness
• malaise (nausea)
• dizziness

Uncommon side effects (may affect up to 1 in 100 people):

• fatigue

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

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

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 the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FEXOFENADINE MYLAN GENERICS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. 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. PACKAGING CONTENTS AND OTHER INFORMATION

What Fexofenadine Mylan Generics contains
The active substance is fexofenadine hydrochloride.
Each Fexofenadine Mylan Generics 120 mg tablet contains 120 mg of fexofenadine hydrochloride.
The excipients are:
o Tablet core: microcrystalline cellulose, sodium croscarmellose, maize starch, povidone, magnesium stearate.
o Tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, macrogol 4000, yellow iron oxide (E 172) and red iron oxide (E 172).

Each Fexofenadine Mylan Generics 180 mg tablet contains 180 mg of fexofenadine hydrochloride.
The excipients are: microcrystalline cellulose, sodium croscarmellose, maize starch, povidone, magnesium stearate.
The coating contains hypromellose (E 464), titanium dioxide (E 171), macrogol 400, macrogol 4000, and yellow iron oxide (E 172).

Description of the appearance of Fexofenadine Mylan Generics and packaging contents
Fexofenadine Mylan Generics 120 mg tablets: peach-colored, biconvex, oblong, film-coated tablets without score lines on either side.
Fexofenadine Mylan Generics 180 mg tablets: yellow, biconvex, oblong, film-coated tablets with a central score line on one side.

Fexofenadine Mylan Generics is available in packages containing 2, 7, 10, 15, 20, 30, 50, 100 or 200 tablets.
Not all pack sizes may be marketed.

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

Responsible producer for batch release:
Chanelle Medical Loughrea, Co. Galway, Ireland

This medicinal product is authorized in EEA member states under the following names:
Denmark: Alterfast 120 mg, film-coated tablets
Alterfast 180 mg, film-coated tablets
Belgium: Doc Fexofenadine 120 mg
Doc Fexofenadine 180 mg
Bulgaria: Ewofex 120 mg
Ewofex 180 mg
Cyprus: Fexonad 120 mg
Fexonad 180 mg
Finland: Alterfast 120 mg
Alterfast 180 mg
France: Fexofenadine Mylan 120 mg, film-coated tablet
Fexofenadine Mylan 180 mg, film-coated tablet
Italy: Fexofenadine Mylan Generics 120 mg
Fexofenadine Mylan Generics 180 mg
Luxembourg: Doc Fexofenadine 120 mg
Doc Fexofenadine 180 mg
Norway: Fexofenadine Docpharma 120 mg
Fexofenadine Docpharma 180 mg
Netherlands: Fexofenadine 120 A
Fexofenadine 180 A
Poland: Ewofex 120 mg tabletki powlekane
Ewofex 180 mg tabletki powlekane
Czech Republic: Ewofex 120 mg potahovane tablety
Ewofex 180 mg potahovane tablety
Romania: Ewofex 120 mg comprimate filmate
Ewofex 180 mg comprimate filmate
Sweden: Fexofenadine Docpharma 120 mg
Fexofenadine Docpharma 180 mg
Slovenia: Ewofex 120 mg
Ewofex 180 mg
Slovakia: Ewofex 120 mg
Ewofex 180 mg
Hungary: Ewofex 120 mg
Ewofex 180 mg

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