Інструкція із застосування FEXOFENADINA OPELLA EALTKARE
Зміст інструкції
- Fexofenadina Opella Healthcare 180 mg film-coated tablets
- Fexofenadina Opella Healthcare 120 mg film-coated tablets
Fexofenadina Opella Healthcare 180 mg film-coated tablets
fexofenadine hydrochloride
Read 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 Opella Healthcare is and what it is used for
- 2. What you need to know before you take Fexofenadina Opella Healthcare
- 3. How to take Fexofenadina Opella Healthcare
- 4. Possible side effects
- 5. How to store Fexofenadina Opella Healthcare
- 6. Contents of the pack and other information
1. What is Fexofenadina Opella Healthcare and what is it used for
Fexofenadina Opella Healthcare contains fexofenadine hydrochloride, which is an antihistamine that does not cause
drowsiness.
Fexofenadina Opella Healthcare 180 mg is used in adults and adolescents aged 12 years and over to relieve the symptoms that occur following chronic allergic skin reactions
(chronic idiopathic urticaria) such as itching, swelling and rash.
2. What you need to know before taking Fexofenadina Opella Healthcare
Do not take Fexofenadina Opella Healthcare
- 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 Opella Healthcare if:
- you have liver or kidney problems;
- you currently have or have previously had heart disease, as this type of medicine can cause a fast or irregular heartbeat;
- you are elderly. If any of the above conditions apply to you or if you have any doubts, tell 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 medicine.
Medicines used to treat digestive problems that contain aluminium and magnesium can
affect the action of Fexofenadina Opella Healthcare by decreasing the amount of medicinal product
absorbed.
It is recommended to observe an interval of about 2 hours between taking Fexofenadina 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 Fexofenadina Opella Healthcare during pregnancy unless necessary.
The use of Fexofenadina Opella Healthcare is not recommended during breastfeeding.
Driving and operating machinery
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 FEXOFENADINA OPELLA HEALTHCARE
Take this medicine following the instructions of your doctor exactly as prescribed.
If you have any doubts, consult your doctor or pharmacist.
Adults and children aged 12 years and over
The recommended dose is one tablet (180 mg) once a day.
Take the tablet with water before meals.
The medicine starts to relieve 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 room immediately. The
symptoms of overdose in adults are 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 same time as you usually take it, 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 course of treatment. If you stop taking Fexofenadina Opella
Healthcare prematurely, the symptoms may reappear.
If you would like more information on the use of 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.
Inform your doctor immediately and stop treatment with Fexofenadina Opella Healthcare 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 conducted on adults and 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.
The following side effects have been reported in the post-
marketing surveillance:
Additional side effects (frequency not known: cannot be estimated based on available
data) that may occur are:
- difficulty falling asleep (insomnia)
- sleep disorders
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhoea
- skin rash and itching
- urticaria
- 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, even those not listed in this leaflet, tell
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.
5. How to store Fexofenadina Opella Healthcare
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 packaging after (Expiry Date). The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 180 mg contains
The active ingredient of Fexofenadina Opella Healthcare is fexofenadine hydrochloride. Each tablet
contains 180 mg of fexofenadine hydrochloride.
The other ingredients are:
- Tablet core: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.
- Film coating: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol 400 and iron oxide (E172).
Description of the appearance of Fexofenadina Opella Healthcare 180 mg and package contents
The film-coated tablets of Fexofenadina Opella Healthcare 180 mg are peach-colored, capsule-shaped with the inscription “018” imprinted on one side and with “e” on the opposite side.
Fexofenadina Opella Healthcare is available in blister packs. Each tablet is packaged in
blisters.
Fexofenadina Opella Healthcare is available in packs of 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 Milano (Italy).
Manufacturer
SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel - 37100 Tours (France)
Sanofi Winthrop Industrie
56, route de Choisy-au-bac
60205 Compiègne
Fexofenadina Opella Healthcare 120 mg film-coated tablets
fexofenadine hydrochloride
Read 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 Opella Healthcare is and what it is used for
- 2. What you need to know before you take Fexofenadina Opella Healthcare
- 3. How to take Fexofenadina Opella Healthcare
- 4. Possible side effects
- 5. How to store Fexofenadina Opella Healthcare
- 6. Contents of the pack and other information
1. What is Fexofenadina Opella Healthcare and what is it used for
Fexofenadina Opella Healthcare contains fexofenadine hydrochloride, which is an antihistamine that does not cause
drowsiness.
Fexofenadina Opella Healthcare 120 mg is used in adults and adolescents aged 12 years and over to relieve symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, nasal itching, runny or blocked nose and itching, redness and
watery eyes.
2. What you need to 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 disease, as this type of medicine can cause a fast or irregular heartbeat;
- you are elderly. If any of the above conditions apply to you or if you have any doubts, tell 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 that contain aluminium and magnesium can
affect the action of Fexofenadina Opella Healthcare by decreasing the amount of medicinal product
absorbed.
It is recommended to observe an interval of about 2 hours between taking Fexofenadina 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 Fexofenadina Opella Healthcare during pregnancy unless 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 vehicles or
use machines. However, make sure that the tablets do not cause you drowsiness or dizziness
before driving vehicles or using machines.
3. How to take Fexofenadina Opella Healthcare
Take this medicine following exactly the instructions of your doctor.
If you have any doubts, consult your doctor or pharmacist.
Adults and children aged 12 years and over
The recommended dose is one tablet (120 mg) once a day.
Take the tablet with water before meals.
The medicine starts to relieve symptoms within 1 hour and lasts 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 room immediately. The
symptoms of overdose in adults are 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 same time you usually take it, 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 cycle. If you stop taking Fexofenadina Opella
Healthcare prematurely, the symptoms may reappear.
If you would like more information on 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 will experience them.
Immediately inform your doctor and stop treatment with Fexofenadina Opella
Healthcare 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 conducted on adults and 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.
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 are:
- difficulty falling asleep (insomnia)
- sleep disturbances
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhea
- skin rash and itching
- urticaria
- 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 experience any side effects, including those not listed in this leaflet, please inform
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.
5. How to store Fexofenadina Opella Healthcare
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 packaging after (Expiry Date). The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Fexofenadina Opella Healthcare 120 mg contains
The active ingredient of Fexofenadina Opella Healthcare is fexofenadine hydrochloride. Each tablet
contains 120 mg of fexofenadine hydrochloride.
The other ingredients are:
- Tablet core: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.
- Film coating: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silica, macrogol 400 and iron oxide (E172).
Description of the appearance of Fexofenadina Opella Healthcare 120 mg and contents of the pack
The film-coated tablets of Fexofenadina Opella Healthcare 120 mg are peach-colored, in a
capsule shape with the inscription “012” embossed on one side and with “e” on the opposite side.
Fexofenadina Opella Healthcare is available in blister packs. Each tablet is packaged in
blisters.
Fexofenadina Opella Healthcare is available in packs 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale Luigi Bodio
- n. 37/B - 20158 Milan (Italy). ManufacturerSANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel - 37100 Tours (France)
Sanofi Winthrop Industrie
56, route de Choisy-au-bac
60205 Compiègne
- Країна реєстрації
- Лікарська формаFilm-coated tablet, 180 MG
- Код АТХR06AX26
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до FEXOFENADINA OPELLA EALTKAREЛікарська форма: Film-coated tablet, 120 MGДіюча речовина: fexofenadineВиробник: OPELLA HEALTHCARE ITALY S.R.L.Рецепт не потрібенЛікарська форма: Film-coated tablet, 120 MGДіюча речовина: fexofenadineВиробник: AUROBINDO PHARMA (ITALIA) S.R.L.Потрібен рецептЛікарська форма: Film-coated tablet, 120 MGДіюча речовина: fexofenadineВиробник: MYLAN S.P.A.Потрібен рецепт
Аналоги FEXOFENADINA OPELLA EALTKARE в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог FEXOFENADINA OPELLA EALTKARE у Іспанія
Аналог FEXOFENADINA OPELLA EALTKARE у Польща
Аналог FEXOFENADINA OPELLA EALTKARE у Україна
Лікарі онлайн щодо FEXOFENADINA OPELLA EALTKARE
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на FEXOFENADINA OPELLA EALTKARE онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
FEXOFENADINA OPELLA EALTKARE потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у FEXOFENADINA OPELLA EALTKARE — fexofenadine. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
FEXOFENADINA OPELLA EALTKARE виробляється компанією OPELLA HEALTHCARE ITALY S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування FEXOFENADINA OPELLA EALTKARE з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати FEXOFENADINA OPELLA EALTKARE у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (fexofenadine) включають FEXALLEGRA, FEXOFENADINA AUROBINDO, FEXOFENADINA MYLAN JENERIKS. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















