FEXOFENADINA 120 mg Tabletki Powlekane

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

Fexofenadina Aurobindo 120 mg film-coated tablets

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

1. What is Fexofenadina Aurobindo and what is it used for

Fexofenadina Aurobindo contains fexofenadine hydrochloride, which is a non-drowsy antihistamine.
Fexofenadina Aurobindo 120 mg is used in adults and adolescents aged 12 years and over
to relieve the symptoms of allergic rhinitis (for example, hay fever) such as sneezing, itching
nose, runny or blocked nose and itching, redness and watery eyes.

2. What you need to know before you take Fexofenadina Aurobindo

Do not take Fexofenadina Aurobindo

• 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 Aurobindo if:

• you suffer from liver or kidney problems;
• you have or have had heart disease, as this type of medicine can cause a fast or irregular heartbeat;
• you are elderly.

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

Children and adolescents
Fexofenadina Aurobindo is not recommended for children under 12 years of age.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablets is the formulation
appropriate for administration and dosage in this population.

Other medicines and Fexofenadina Aurobindo
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.
It is particularly important to talk to your doctor before taking fexofenadine if you are also taking
any of the following medicines:

• an antibiotic used to treat certain types of bacterial infections (erythromycin);
• an antifungal medicine used to treat fungal infections (ketoconazole).

These medicines increase the amount of fexofenadine absorbed.
Remedies for digestive problems containing aluminium and magnesium can affect
the action of Fexofenadina Aurobindo, decreasing the amount of medicine absorbed.
It is recommended to observe an interval of about 2 hours between taking Fexofenadina Aurobindo and the
remedy 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 Aurobindo during pregnancy unless necessary.
Fexofenadina Aurobindo is not recommended during breastfeeding.

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

Fexofenadina Aurobindo 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 Aurobindo 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 Fexofenadina Aurobindo

Dosage
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.

For 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 Fexofenadina Aurobindo 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 Fexofenadina Aurobindo
Do not take a double dose to make up for a missed dose.
Take the next dose at the same time you usually take it, as prescribed by your
doctor.

If you stop taking Fexofenadina Aurobindo
Contact your doctor if you intend to stop taking Fexofenadina Aurobindo before
completing the treatment cycle.
If you stop taking Fexofenadina Aurobindo prematurely, symptoms may reappear.
If you have any further questions about 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 treatment with Fexofenadina Aurobindo if you
experience:

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

The following side effects have been reported in clinical studies, with a frequency 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)

• Fatigue.
• Sleepiness.

Additional side effects(frequency not known: cannot be estimated based on the available
data) that may occur are:

• Difficulty falling asleep (insomnia).
• Sleep disturbances.
• Nightmares.
• Nervousness.
• Blurred vision.
• Fast or irregular heartbeat.
• Diarrhea.
• Skin rash and itching.
• Hives.
• Serious 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, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 Fexofenadina Aurobindo

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 blister and the carton 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 in waste water or household waste. Return any unused medicines to the
pharmacist. This will help protect the environment.

6. Package Contents and Other Information

What Fexofenadina Aurobindo contains

• The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, equivalent to 112 mg of fexofenadine.
• The other ingredients are: - Tablet core:Sodium croscarmellose, lactose, lactose monohydrate, corn starch, anhydrous colloidal silica, pregelatinized starch, stearic acid. Tablet coating:Red iron oxide (E172), yellow iron oxide (E172), hypromellose type 2910 6 mPas (E464), macrogol 400 (E1521), titanium dioxide (E171). Description of the appearance of Fexofenadina Aurobindo and package contentsFilm-coated tablet.

Film-coated tablets, biconvex, peach-colored, capsule-shaped, with a beveled edge of approximately 15
x 6.5 mm, with “FE” imprinted on one side and “120” on the other side.
Fexofenadina Aurobindo 120 mg film-coated tablets are available in blister packs
containing 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Fexofenadina Aurobindo
Portugal: Fexofenadina Generis Phar

Fexofenadina Aurobindo 180 mg film-coated tablets

Generic medicine
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 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

• 7. What Fexofenadina Aurobindo is and what it is used for
• 8. What you need to know before you take Fexofenadina Aurobindo
• 9. How to take Fexofenadina Aurobindo
• 10. Possible side effects
• 11. How to store Fexofenadina Aurobindo
• 12. Contents of the pack and other information

7. What is Fexofenadina Aurobindo and what is it used for

Fexofenadina Aurobindo contains fexofenadine hydrochloride, which is an antihistamine that does not cause drowsiness.
Fexofenadina Aurobindo 180 mg is used in adults and adolescents aged 12 years and over
to relieve the symptoms of chronic allergic skin reactions (chronic idiopathic urticaria)
such as itching, swelling and rash.

8. What you need to know before you take Fexofenadina Aurobindo

Do not take Fexofenadina Aurobindo

• 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 Aurobindo if:

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

If any of these conditions apply to you, or if you are unsure, tell your doctor before taking
Fexofenadina Aurobindo.

Children and adolescents
Fexofenadina Aurobindo is not recommended for children under 12 years of age.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablets is the appropriate
formulation for administration and dosage in this population.

Other medicines and Fexofenadina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
If you are taking apalutamide (a medicine for the treatment of prostate cancer), as the effect
of fexofenadine may be reduced.
It is particularly important to talk to your doctor before taking fexofenadine if you are also taking
any of the following medicines:

• an antibiotic used to treat certain types of bacterial infections (erythromycin);
• an antifungal medicine used to treat fungal infections (ketoconazole).

These medicines increase the amount of fexofenadine absorbed.
Antacids containing aluminium and magnesium may affect
the action of Fexofenadina Aurobindo, decreasing the amount of medicine absorbed.
It is recommended to observe an interval of about 2 hours between taking Fexofenadina Aurobindo and the
antacid.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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 Aurobindo during pregnancy unless necessary.
Fexofenadina Aurobindo is not recommended during breastfeeding.

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

Fexofenadina Aurobindo 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 Aurobindo contains sodium:
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
“sodium-free”.

9. How to take Fexofenadina Aurobindo

Dosage
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.

For 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 Fexofenadina Aurobindo 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 Fexofenadina Aurobindo
Do not take a double dose to make up for a missed dose.
Take the next dose at the same time as you usually take it, as prescribed by your
doctor.

If you stop taking Fexofenadina Aurobindo
Consult your doctor if you intend to stop taking Fexofenadina Aurobindo before
completing the treatment cycle.
If you stop taking Fexofenadina Aurobindo prematurely, the symptoms may reappear.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

10. 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 Fexofenadina Aurobindo if you experience:

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

The following side effects have been reported in clinical studies, with a frequency 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)

• Fatigue.
• Sleepiness.

Additional side effects(frequency not known: cannot be estimated based on available data) that may occur are:

• Difficulty falling asleep (insomnia).
• Sleep disturbances.
• Nightmares.
• Nervousness.
• Blurred vision.
• Fast or irregular heartbeat.
• Diarrhea.
• Skin rash and itching.
• Hives.
• Serious 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, talk to 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.

11. How to store Fexofenadina Aurobindo

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 blister and the box 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. Return any unused medicines to the
pharmacist. This will help protect the environment. 

12. Package contents and other information

What Fexofenadina Aurobindo contains

• The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 180 mg of fexofenadine hydrochloride, equivalent to 168 mg of fexofenadine.
• The other ingredients are: - Tablet core:Sodium croscarmellose, lactose, lactose monohydrate, corn starch, anhydrous colloidal silica, pregelatinized starch, stearic acid. Tablet coating:Red iron oxide (E172), yellow iron oxide (E172), hypromellose type 2910 6 mPas (E464), macrogol 400 (E1521), titanium dioxide (E171). Description of the appearance of Fexofenadina Aurobindo and package contentsFilm-coated tablet.

Film-coated tablets, biconvex, peach-colored, capsule-shaped, with a beveled edge of approximately 15
x 6.5 mm, with “FE” imprinted on one side and “180” on the other side.
Fexofenadina Aurobindo 180 mg film-coated tablets are available in blister packs
containing 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19
Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Fexofenadina Aurobindo
Portugal: Fexofenadina Generis Phar