Fexofenadine Oppella Healthcare
Italy
Table of Contents
Package leaflet: Information for the user
Fexofenadina Opella Healthcare 180 mg film-coated tablets
fexofenadine hydrochloride
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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Fexofenadina Opella Healthcare is and what it is used for
- What you need to know before taking Fexofenadina Opella Healthcare
- How to take Fexofenadina Opella Healthcare
- Possible side effects
- How to store Fexofenadina Opella Healthcare
- Contents of the pack and other information
1. What Fexofenadine Opella Healthcare is and what it is used for
Fexofenadine Opella Healthcare contains fexofenadine hydrochloride, which is a non-sedating antihistamine.
Fexofenadine Opella Healthcare 180 mg is used in adults and adolescents aged 12 years and older to relieve symptoms associated with chronic allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and skin rash.
2. What you should know before taking Fexofenadina Opella Healthcare
Do not take Fexofenadina Opella Healthcare
- 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 Opella Healthcare if:
- you have liver or kidney problems;
- you currently have or have previously had heart problems, as this type of medicine may cause a fast or irregular heartbeat;
- you are elderly.
If any of the above conditions apply to you or if you have any doubts, inform your doctor before taking Fexofenadina Opella Healthcare.
Other medicines and Fexofenadina Opella Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines used to treat digestive problems containing aluminium and magnesium may affect the action of Fexofenadina Opella Healthcare by reducing the amount of medicine absorbed.
It is recommended to leave an interval of approximately 2 hours between taking Fexofenadina Opella Healthcare and taking the medicine for digestive problems.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Fexofenadina Opella Healthcare during pregnancy unless clearly necessary.
The use of Fexofenadina Opella Healthcare is not recommended during breastfeeding.
Driving and using machines
It is unlikely that Fexofenadina Opella Healthcare will affect your ability to drive or operate machinery. However, make sure that the tablets do not cause you drowsiness or dizziness before driving or operating machinery.
3. How to take FEXOFENADINE OPELLA HEALTHCARE
Take this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
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.
The medicine starts relieving symptoms within 1 hour and lasts for 24 hours.
If you take more Fexofenadine Opella Healthcare 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 Opella Healthcare
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 Opella Healthcare
Consult your doctor if you intend to stop taking Fexofenadine Opella Healthcare before completing the treatment course. If you stop taking Fexofenadine Opella Healthcare too early, symptoms may return.
If you would like more information 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 everyone gets them.
Immediately inform your doctor and stop treatment with Fexofenadine Opella Healthcare if you experience:
- swelling of the face, lips, tongue or throat and breathing difficulties, as these signs may indicate a serious allergic reaction.
The following side effects were reported in clinical studies conducted in adults and occurred 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
- numbness
- feeling unwell (nausea)
- dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
- tiredness
- drowsiness.
The following side effects have been reported during post-marketing surveillance:
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
- rapid or irregular heartbeat
- diarrhoea
- skin rash and itching
- hives
- 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 Opella Healthcare
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after (Exp.). The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Fexofenadine Opella Healthcare 180 mg contains
The active substance of Fexofenadine Opella Healthcare is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride.
The other components are:
- Tablet core: microcrystalline cellulose, pregelatinized corn starch, croscarmellose sodium, magnesium stearate.
- Film coating: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol 400, and iron oxide (E172).
Description of the appearance of Fexofenadine Opella Healthcare 180 mg and pack contents
The film-coated tablets of Fexofenadine Opella Healthcare 180 mg are peach-coloured, capsule-shaped, with the code “018” engraved on one side and “e” on the other side.
Fexofenadine Opella Healthcare is supplied in blister packs. Each tablet is individually packed in a blister.
Fexofenadine Opella Healthcare is available in packs containing 2 (sample), 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale Luigi Bodio
n. 37/B - 20158 Milan (Italy).
Manufacturer
SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel - 37100 Tours (France)
Sanofi Winthrop Industrie
56, route de Choisy-au-bac
60205 Compiègne (France)
Package leaflet: Information for the user
Fexofenadine Opella Healthcare 120 mg film-coated tablets
fexofenadine hydrochloride
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms 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 Opella Healthcare is and what it is used for
- What you need to know before taking Fexofenadine Opella Healthcare
- How to take Fexofenadine Opella Healthcare
- Possible side effects
- How to store Fexofenadine Opella Healthcare
- Contents of the pack and other information
1. What Fexofenadina Opella Healthcare is and what it is used for
Fexofenadina Opella Healthcare contains fexofenadine hydrochloride, which is a non-sedating antihistamine.
Fexofenadina Opella Healthcare 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, itchy nose, runny or blocked nose, and itchy, red or watery eyes.
2. What you need to know before taking Fexofenadine Opella Healthcare
Do not take Fexofenadine Opella Healthcare
- 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 Opella Healthcare 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 the conditions listed above apply to you, or if you have any doubts, inform your doctor before taking Fexofenadine Opella Healthcare.
Other medicines and Fexofenadine Opella Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines used to treat digestive problems that contain aluminium and magnesium may affect the action of Fexofenadine Opella Healthcare by reducing the amount of medicine absorbed.
It is recommended to leave an interval of about 2 hours between taking Fexofenadine Opella Healthcare and the medicine for digestive problems.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Fexofenadine Opella Healthcare during pregnancy unless absolutely necessary.
The use of Fexofenadine Opella Healthcare is not recommended during breastfeeding.
Driving and using machines
It is unlikely that Fexofenadine Opella Healthcare will affect your ability to drive or use machines. However, make sure that the tablets do not cause you drowsiness or dizziness before driving or operating machinery.
3. How to take Fexofenadina Opella Healthcare
Take this medicine exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
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.
The medicine starts relieving symptoms within 1 hour and lasts for 24 hours.
If you take more Fexofenadina Opella Healthcare 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 Fexofenadina Opella Healthcare
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 Opella Healthcare
Consult your doctor if you intend to stop taking Fexofenadina Opella Healthcare before completing the treatment course. If you stop taking Fexofenadina Opella Healthcare prematurely, symptoms may return.
If you would like more information 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 Opella Healthcare
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 conducted in adults and occurred with a frequency similar to that observed in patients who did not receive the medicine (placebo):
Common side effects (may affect up to 1 in 10 people):
- headache
- numbness
- feeling unwell (nausea)
- dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
- tiredness
- sleepiness.
The following side effects have been reported during post-marketing surveillance:
Additional side effects (frequency not known: cannot be estimated based on available data) which may occur include:
- difficulty falling asleep (insomnia)
- sleep disturbances
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhoea
- skin rash and itching
- hives
- 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 Opella Healthcare
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after (Exp.). The expiry date refers to the last day of the 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 Fexofenadina Opella Healthcare 120 mg contains
The active substance in Fexofenadina Opella Healthcare is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
The other components are:
- Tablet core: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.
- Film coating: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol 400, iron oxide (E172).
Description of the appearance of Fexofenadina Opella Healthcare 120 mg and package contents
Fexofenadina Opella Healthcare 120 mg film-coated tablets are peach-coloured, capsule-shaped tablets with the imprint “012” on one side and “e” on the other side.
Fexofenadina Opella Healthcare is supplied in blister packs. Each tablet is individually packaged in a blister.
Fexofenadina Opella Healthcare is available in pack sizes of 2 (sample), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per box.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale Luigi Bodio
n. 37/B - 20158 Milano (Italy)
Manufacturer
SANOFI WINTHROP INDUSTRIES
30-36 Avenue Gustave Eiffel - 37100 Tours (France)
Sanofi Winthrop Industrie
56, route de Choisy-au-bac
60205 Compiègne