Інструкція із застосування EBASTINA SANDOTS
Зміст інструкції
Ebastina Sandoz 10 mg orodispersible tablets, 20 mg orodispersible 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 Ebastina Sandoz is and what it is used for
- 2. What you need to know before you take Ebastina Sandoz
- 3. How to take Ebastina Sandoz
- 4. Possible side effects
- 5. How to store Ebastina Sandoz
- 6. Contents of the pack and other information
1. What is Ebastina Sandoz and what is it used for
Ebastina is an antihistamine that helps to relieve allergy symptoms such as sneezing, runny nose,
watery eyes and itchy skin rashes.
In adults and children aged 12 years and over, Ebastina Sandoz is used to relieve the
symptoms of seasonal and perennial allergic rhinitis (hay fever), including cases with allergic
conjunctivitis.
In adults over 18 years of age, Ebastina Sandoz 10 mg is used to relieve itching and the
development of wheals (urticaria).
2. What you need to know before taking Ebastina Sandoz
DO NOT take Ebastina Sandoz
- if you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Ebastina Sandoz if:
you are already taking certain antibiotics or medicines used to treat fungal infections: see
“Other medicines and Ebastina Sandoz”below;
you have severely impaired liver function (hepatic insufficiency).
Children and adolescents
This medicine should only be used in children aged 12 years and over. Do not give
this medicine to children under 12 years, as safety and efficacy have not been established in
this age group.
Other medicines and Ebastina Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Taking Ebastina Sandoz and erythromycin (antibiotic) or ketoconazole, itraconazole (active substances for the treatment of fungal infections) at the same time may lead to higher levels of ebastine
in the blood. Concomitant administration of ebastine with rifampicin (antituberculosis agent) may cause low blood levels of ebastine and therefore reduce its effects. The simultaneous use of Ebastina Sandoz with clarithromycin or josamycin (antibiotics) is not recommended.
Ebastina Sandoz with food and drink
You can take Ebastina Sandoz independently of meal times.
Pregnancy, breastfeeding and fertility
To date, experience regarding safety in humans for the fetus is limited. Therefore, you may take Ebastina
Sandoz during pregnancy only if your doctor considers that the expected benefit outweighs the possible risks.
Do not take Ebastina Sandoz if you are breastfeeding a newborn baby, as it is not known whether the active
substance passes into breast milk.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
Most patients treated with Ebastina Sandoz can drive or perform other activities that
require good reaction ability. However, as with all medicines, you should
check your individual reaction after taking Ebastina Sandoz before driving or
performing complicated tasks, as some patients may experience drowsiness or dizziness.
Ebastina Sandoz contains lactose, aspartame and sodium
This medicine contains lactose. If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
The 10 mg orodispersible tablets contain 2.5 mg of aspartame (E 951) and the 20 mg orodispersible tablets contain 5 mg of aspartame (E 951). Aspartame is a source of phenylalanine.
It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder
that causes a build-up of phenylalanine because the body cannot process it properly.
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet, i.e.
essentially ‘sodium-free’.
3. How to take Ebastina Sandoz
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
| A Indication | Age | Dose |
| Indication | Age | Dose | |||
| Allergic rhinitis In case of severe symptoms | Children aged 12 years and over and adults | One tablet of Ebastina Sandoz 10 mg (10 mg or of ebastine) per day c Two tablets of Ebastina Sandoz 10 mg or one tablet of Ebastina Sandoz 20 mg (20 mg of ebastine) once a day | |||
| Urticaria | Adults over 18 years of age | a One tablet of Ebastina Sandoz 10 mg (10 mg of ebastine) once a day | |||
In patients with impaired renal function, no dose adjustment is necessary.
In patients with mild to moderate hepatic impairment, no dose adjustment is necessary.
There is no experience with doses higher than 10 mg in patients with severe hepatic insufficiency, therefore in
these patients the dose should not exceed 10 mg.
Do not push the tablet out of its compartment to avoid it from crumbling.
Each blister contains tablets separated into compartments by perforations. Detach one compartment
along the dotted lines (figure 1).

Carefully remove the protective film, starting from the corner indicated by the arrow (figures 2 and
3).


With dry hands, remove the tablet from the strip.
Place the tablet on your tongue where it will dissolve in a few seconds: no water or
other liquids are necessary.
Ebastina Sandoz can be taken regardless of meal times.
The doctor will determine the duration of use.
If you take more Ebastina Sandoz than you should
There is no specific antidote for the active ingredient ebastine.
If you suspect an overdose with Ebastina Sandoz, inform your doctor. Depending on the severity
of the intoxication, the doctor will take appropriate measures (monitoring of vital functions,
including monitoring via ECG for at least 24 hours, symptomatic treatment and gastric lavage),
if necessary.
If you forget to take Ebastina Sandoz
Do not take a double dose to make up for a missed dose.
If you have any doubts about using 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.
Stop taking Ebastina Sandoz and contact your doctor immediately or go to the nearest
hospital if you experience the following:
severe allergic reaction causing itching and swelling of the face, tongue or throat which may cause
difficulty swallowing or breathing. Severe allergic reactions to Ebastina Sandoz are rare
(may affect up to 1 in 1,000 people).
Other side effects include:
Very common side effectsmay affect more than 1 in 10 people:
Headache
Common side effectsmay affect up to 1 in 10 people:
Drowsiness
Dry mouth
Rare side effectsmay affect up to 1 in 1,000 people:
Nervousness, insomnia
Dizziness, decreased sense of touch, taste alterations
Palpitations, increased heart rate
Abdominal pain, vomiting, nausea, indigestion
Inflammation of the liver (hepatitis), problems with the elimination of bile (cholestasis),
alterations in liver function tests
Skin rash, urticaria, skin inflammation
Menstrual disorders
Edema (fluid retention), weakness (asthenia)
Frequency not known:the frequency cannot be estimated from the available data
Weight gain
Increased appetite.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 Ebastina Sandoz
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 package after
“Exp”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
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. Package contents and other information
What Ebastina Sandoz contains
- The active ingredient is ebastine. Each orodispersible tablet contains 10 mg of ebastine. Each orodispersible tablet contains 20 mg of ebastine.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, corn starch, sodium croscarmellose, aspartame (E951), peppermint flavour, anhydrous colloidal silica and magnesium stearate.
Description of the appearance of Ebastina Sandoz and package contents
Orodispersible tablets 10 mg
White, biconvex, round tablets, with a diameter of approximately 6.7 mm, with the inscription ‘E10’
engraved on one side, smooth on the other side.
Orodispersible tablets 20 mg
White, biconvex, round tablets, with a diameter of approximately 9.2 mm, with the inscription ‘E20’ engraved on
one side, smooth on the other side.
The orodispersible tablets are packaged in OPA/Al/PVC/Al blisters and inserted into a carton.
Pack sizes:
Orodispersible tablets 10 mg:
10, 20, 30, 40, 50, 90, 98 and 100 orodispersible tablets.
Orodispersible tablets 20 mg:
10, 15, 20, 30, 40, 50, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)
Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen, Hungary
Teva Pharma, S.L.U.
C/C, n° 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
Lek Pharmaceuticals d.d.
Verovskova 57, SI-1526, Ljubljana, Slovenia
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Sweden Ebastine Sandoz
Spain Ebastina Sandoz 10 mg bucodispersable tablets EFG
Ebastina Sandoz 20 mg bucodispersable tablets EFG
Italy Ebastina Sandoz
Belgium Ebastine Sandoz 10 mg orodispergeerbare tabletten
Ebastine Sandoz 20 mg orodispergeerbare tabletten

- Країна реєстрації
- Лікарська формаOrodispersible tablet, 10 MG
- Код АТХR06AX22
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до EBASTINA SANDOTSЛікарська форма: Film-coated tablet, 10 MGДіюча речовина: ЭбастинВиробник: ALMIRALL S.A.Потрібен рецептЛікарська форма: Orodispersible tablet, 10 MGДіюча речовина: ЭбастинПотрібен рецептЛікарська форма: Orodispersible tablet, 10 MGДіюча речовина: ЭбастинВиробник: ARISTO PHARMA GMBHПотрібен рецепт
Аналоги EBASTINA SANDOTS в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог EBASTINA SANDOTS у Іспанія
Аналог EBASTINA SANDOTS у Польща
Аналог EBASTINA SANDOTS у Україна
Лікарі онлайн щодо EBASTINA SANDOTS
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на EBASTINA SANDOTS 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
EBASTINA SANDOTS потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у EBASTINA SANDOTS — Эбастин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
EBASTINA SANDOTS виробляється компанією SANDOZ S.P.A.. 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 EBASTINA SANDOTS 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 EBASTINA SANDOTS 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 (Эбастин) включають KLEVER, DEKASTIN, EBARIK. 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.
















