Fexofenadine Aurobindo
Italy
Table of Contents
Package leaflet: Information for the user
Fexofenadine Aurobindo 120 mg film-coated tablets
Generic medicine
Please read all of 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 further 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 yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Fexofenadine Aurobindo is and what it is used for
- What you need to know before taking Fexofenadine Aurobindo
- How to take Fexofenadine Aurobindo
- Possible side effects
- How to store Fexofenadine Aurobindo
- Contents of the pack and other information
1. What Fexofenadine Aurobindo is and what it is used for
Fexofenadine Aurobindo contains fexofenadine hydrochloride, which is a non-sedating antihistamine.
Fexofenadine Aurobindo 120 mg is used in adults and adolescents aged 12 years and older to relieve symptoms of allergic rhinitis (for example, hay fever) such as sneezing, itching of the nose, runny or blocked nose, and itching, redness and watering of the eyes.
2. What you need to know before taking Fexofenadine Aurobindo
Do not take Fexofenadine Aurobindo
- 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 Aurobindo if:
- you have liver or kidney problems;
- you currently have or have previously had heart disease, as this type of medicine may cause an increased or irregular heartbeat;
- you are elderly.
If any of these conditions apply to you, or if you are unsure, inform your doctor before taking
Fexofenadine Aurobindo.
Children and adolescents
Fexofenadine Aurobindo is not recommended for children under 12 years of age.
For children aged 6 to 11 years: fexofenadine hydrochloride 30 mg tablets are the appropriate formulation
for administration and dosing in this population.
Other medicines and Fexofenadine 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 used to treat prostate cancer), 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 used to treat fungal infections (ketoconazole).
These medicines increase the amount of fexofenadine absorbed.
Antacids containing aluminium and magnesium may affect the action of Fexofenadine Aurobindo by reducing the amount of medicine absorbed.
It is recommended to leave an interval of approximately 2 hours between taking Fexofenadine Aurobindo and taking antacids.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fexofenadine Aurobindo during pregnancy unless clearly necessary.
Fexofenadine Aurobindo is not recommended during breastfeeding.
Driving and using machines
It is unlikely that Fexofenadine Aurobindo affects the ability to drive or operate machinery. However, make sure the tablets do not cause you to feel drowsy or dizzy before driving or operating machinery.
Fexofenadine Aurobindo contains lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Fexofenadine 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 Fexofenadine Aurobindo
Dosage
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For adults and children aged 12 years and older
The recommended dose is one tablet (120 mg) once daily.
Take the tablet with water before meals.
This medicine starts relieving symptoms within 1 hour and the effect lasts for 24 hours.
If you take more Fexofenadine Aurobindo than you should
If you take too many tablets, contact your doctor or the nearest emergency department immediately. Symptoms of overdose in adults include dizziness, drowsiness, fatigue, and dry mouth.
If you forget to take Fexofenadine Aurobindo
Do not take a double dose to make up for the missed dose.
Take the next dose at the same time as usual, according to your doctor's instructions.
If you stop taking Fexofenadine Aurobindo
Consult your doctor if you intend to stop taking Fexofenadine Aurobindo before completing the treatment course.
If you stop taking Fexofenadine Aurobindo too early, 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 treatment with Fexofenadine Aurobindo if
you experience:
- Swelling of the face, lips, tongue or throat and breathing difficulties, as these signs may indicate a severe allergic reaction.
The following side effects were 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)
- Tiredness.
- Sleepiness.
Additional side effects (frequency not known: cannot be estimated from the available data) which may occur are:
- Difficulty falling asleep (insomnia).
- Sleep disorders.
- Nightmares.
- Nervousness.
- Blurred vision.
- Increased or irregular heartbeat.
- Diarrhoea.
- Skin rash and itching.
- Hives (urticaria).
- Severe allergic reactions which may cause swelling of the face, lips, tongue or throat, hot flushes, chest tightness and breathing difficulties.
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 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 Aurobindo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and 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 medicines via wastewater or household waste. Return unused medicines to your pharmacist. This will help protect the environment.
6. Package contents and other information
What Fexofenadine Aurobindo contains
- The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, equivalent to 112 mg of fexofenadine.
- The other components are:
Tablet core: Croscarmellose sodium, lactose, monohydrate lactose, maize 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 Fexofenadine Aurobindo and pack contents
Film-coated tablet.
Film-coated, biconvex, peach-coloured, capsule-shaped tablets with bevelled edges, approximately 15 x 6.5 mm in size, marked “FE” on one side and “120” on the other side.
Fexofenadine Aurobindo 120 mg film-coated tablets are available in blister packs containing 20 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
Italy: Fexofenadina Aurobindo
Portugal: Fexofenadina Generis Phar
Package leaflet: Information for the user
Fexofenadine Aurobindo 180 mg film-coated tablets
Generic 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 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, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Fexofenadine Aurobindo is and what it is used for
- What you need to know before taking Fexofenadine Aurobindo
- How to take Fexofenadine Aurobindo
- Possible side effects
- How to store Fexofenadine Aurobindo
- Contents of the pack and other information
7. What is Fexofenadine Aurobindo and what is it used for?
Fexofenadine Aurobindo contains fexofenadine hydrochloride, which is a non-sedating antihistamine.
Fexofenadine Aurobindo 180 mg is used in adults and adolescents aged 12 years and older to relieve symptoms of chronic allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and skin rash.
8. What you need to know before taking Fexofenadina Aurobindo
Do not take Fexofenadina Aurobindo
- 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 Aurobindo if:
- you have liver or kidney problems;
- you currently have or have previously 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 Aurobindo.
Children and adolescents
Fexofenadina Aurobindo is not recommended for children under 12 years of age.
For children aged 6 to 11 years: fexofenadine hydrochloride 30 mg tablets are the appropriate formulation
for administration and dosing in this population.
Other medicines and Fexofenadina Aurobindo
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), 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 by reducing the amount of medicine absorbed.
It is recommended to leave an interval of approximately 2 hours between taking Fexofenadina Aurobindo and antacids.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fexofenadina Aurobindo during pregnancy unless clearly 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 your doctor has diagnosed you with an intolerance to certain 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”.
9. How to take Fexofenadine Aurobindo
Dosage
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For adults and children aged 12 years and older
The recommended dose is one tablet (180 mg) once daily.
Take the tablet with water before meals.
This medicine starts relieving symptoms within 1 hour and lasts for 24 hours.
If you take more Fexofenadine Aurobindo than you should
If you take too many tablets, contact your doctor or the nearest emergency department immediately. Symptoms of overdose in adults include dizziness, drowsiness, fatigue, and dry mouth.
If you forget to take Fexofenadine Aurobindo
Do not take a double dose to make up for the missed dose.
Take the next dose at the usual time, as prescribed by your doctor.
If you stop taking Fexofenadine Aurobindo
Consult your doctor if you intend to stop taking Fexofenadine Aurobindo before completing the treatment course.
If you stop taking Fexofenadine Aurobindo too early, symptoms may return.
If you have any questions 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 everyone experiences them.
Immediately contact your doctor and stop treatment with Fexofenadine Aurobindo if you experience:
- Swelling of the face, lips, tongue or throat, and breathing difficulties, as these signs may indicate a severe allergic reaction.
The following side effects were reported in clinical studies, with a frequency similar to that observed in patients who received placebo (inactive treatment):
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.
- Sleepiness.
Additional side effects (frequency not known: cannot be estimated based on available data) that may occur include:
- Difficulty falling asleep (insomnia).
- Sleep disorders.
- Nightmares.
- Nervousness.
- Blurred vision.
- Fast or irregular heartbeat.
- Diarrhea.
- Skin rash and itching.
- Hives.
- Severe allergic reactions that may cause swelling of the face, lips, tongue or throat, hot flushes, chest tightness, and breathing difficulties.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 Fexofenadine Aurobindo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack 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 medicines via wastewater or household waste. Return unused medicines to the pharmacist. This will help protect the environment.
12. Package contents and other information
What Fexofenadina Aurobindo contains
- The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 180 mg of fexofenadine hydrochloride, equivalent to 168 mg of fexofenadine.
- The other components are:
Tablet core: Crosscarmellose sodium, lactose, lactose monohydrate, maize starch, colloidal anhydrous silica, pregelatinized starch, stearic acid.
Tablet coating: Red iron oxide (E172), yellow iron oxide (E172), hypromellose type 2910 6 mPa·s (E464), macrogol 400 (E1521), titanium dioxide (E171).
Description of the appearance of Fexofenadina Aurobindo and package contents
Film-coated tablet.
Film-coated, biconvex, peach-coloured, capsule-shaped tablets with a bevelled edge, approximately 15 x 6.5 mm, marked “FE” 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 Authorization 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 authorized in the European Economic Area countries under the
following names:
Italy: Fexofenadina Aurobindo
Portugal: Fexofenadina Generis Phar