Инструкция по применению EBASTINA DOK
Содержание инструкции
EBASTINA DOC 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 DOC is and what it is used for
2. What you need to know before you take EBASTINA DOC
3. How to take EBASTINA DOC
4. Possible side effects
5. How to store EBASTINA DOC
6. Contents of the pack and other information
1. What EBASTINA DOC is and what it is used for
Ebastine 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 DOC is used to relieve the symptoms of seasonal (hay fever) and perennial allergic rhinitis, including cases with
allergic conjunctivitis.
In adults over the age of 18, EBASTINA DOC 10 mg is used to relieve itching and the
development of wheals in urticaria.
2. What you need to know before taking EBASTINA DOC
Do not take EBASTINA DOC
- 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 DOC:
- if you have low potassium levels in your blood;
- if you are already taking certain antibiotics or medicines used to treat fungal infections: see below “ Other medicines andEBASTINA DOC”;
- if you have severely impaired liver function (hepatic insufficiency).
EBASTINA DOC may cause dry mouth. Therefore, with long-term treatment it is
important to have good oral hygiene (teeth should be brushed twice a day with
fluoride toothpaste) to reduce the risk of tooth decay.
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 of age as safety and
efficacy have not been established in this age group.
Other medicines and EBASTINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The concurrent use of EBASTINA DOC and erythromycin (antibiotic) or ketoconazole, itraconazole
(active ingredients for the treatment of fungal infections) may lead to elevated blood levels of
ebastine. The concomitant administration of ebastine with rifampicin (antitubercular agent) may
cause low blood levels of ebastine and therefore reduced effects. The concomitant use of EBASTINA
DOC with clarithromycin or josamycin (antibiotics) is not recommended.
EBASTINA DOC with food and drink
You can take EBASTINA DOC independently of mealtimes.
Pregnancy, breastfeeding and fertility
Currently there are limited data in humans on safety for the fetus. Therefore, you should take
EBASTINA DOC during pregnancy only if the doctor considers that the expected benefit outweighs the possible
risks.
Do not take EBASTINA DOC if you are breastfeeding a newborn, as it is not known whether the
active ingredient 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 DOC can drive or perform other activities that
require good reaction ability. However, as with all medicines, you need to
check your individual reaction after taking EBASTINA DOC before driving or
performing complicated activities, as some patients experience drowsiness or dizziness.
EBASTINA DOC contains aspartame
EBASTINA DOC 10 mg contains 2.5 mg per tablet .EBASTINA DOC 20 mg contains 5
mg per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have
phenylketonuria, a rare genetic disorder that causes phenylalanine to build up because the body cannot
process it correctly.
EBASTINA DOC contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.
EBASTINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.
3. How to take EBASTINA DOC
Take EBASTINA DOC following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is:
Indication Age Dose
Allergic rhinitis
In case of severe symptoms
One EBASTINA DOC 10 mg tablet (10 mg
of ebastine) per day
Two EBASTINA DOC 10 mg tablets or one
EBASTINA DOC 20 mg tablet (20 mg of
ebastine) once a day
Urticaria Adults over 18 years One EBASTINA DOC 10 mg tablet (10 mg
Children aged 12 years and
over and
adults
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.
In patients with severe hepatic insufficiency, there is no experience with doses higher than 10 mg;
therefore, in these patients, the dose should not exceed 10 mg.
Do not push the tablet out of its compartment to avoid breakage.
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: no water or other liquids are necessary.
EBASTINA DOC can be taken regardless of meal times.
The doctor will determine the duration of use.
If you take more EBASTINA DOC than you should
There is no specific antidote for the active ingredient ebastine.
If you suspect an overdose with EBASTINA DOC, 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 DOC
Do not take a double dose to make up for a missed dose.
If you have any doubts about 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.
Stop taking EBASTINA DOC and contact your doctor immediately or go to the nearest
hospital if the following condition occurs:
severe allergic reaction that causes swelling of the face, tongue or throat which can cause
difficulty swallowing or breathing.
Other side effects include:
Very common side effectscan affect more than 1 in 10 people :
headache,
Common side effectscan affect up to 1 in 10 people :
drowsiness
dry mouth
Uncommon side effectscan affect up to 1 in 100 people
sore throat (pharyngitis), runny nose (rhinitis), nosebleeds
Rare side effectscan affect up to 1 in 1,000 people
nervousness, insomnia
altered sense of touch, reduced sense of touch
altered sense of taste
dizziness
palpitations, fast heartbeat
abdominal pain, nausea, indigestion
vomiting
abnormal liver function tests
liver inflammation
problems with the elimination of bile causing itching, yellowing of the skin and
eyes
skin rash, hives, skin inflammation
menstrual disorders
edema (fluid retention in the tissues)
weakness (asthenia).
Very rare side effectscan affect up to 1 in 10,000 people
widespread skin rash, eczema
painful menstruation
Frequency not known: the frequency cannot be estimated based on available data
increased weight
increased appetite.
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 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 DOC
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.
Store in the original package to protect the medicine from light.
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. Contents of the pack and other information
What EBASTINA DOC contains
The active ingredient is ebastine.
EBASTINA DOC 10 mg: each orodispersible tablet contains 10 mg of ebastine.
EBASTINA DOC 20 mg: 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 DOC and contents of the pack
Orodispersible tablet
Ebastine 10 mg: white, biconvex, round tablets, with the inscription ‘E10’ on one side,
smooth on the other side.
Ebastine 20 mg: white, biconvex, round tablets, with the inscription ‘E20’ on one side,
smooth on the other side.
Available in packs of:
10 mg: 10, 20, 30, 40, 50, 90, 98 and 100 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 and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l.
Via Turati, 40
20121 Milano
Italy
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
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Sweden: Ebateva
Spain: Ebastina ratiopharm
Italy: EBASTINA DOC
- Страна регистрации
- Форма выпускаOrodispersible tablet, 10 MG
- Код АТХR06AX22
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги EBASTINA DOKФорма выпуска: Film-coated tablet, 10 MGДействующее вещество: ЭбастинПроизводитель: ALMIRALL S.A.Отпускается по рецептуФорма выпуска: Orodispersible tablet, 10 MGДействующее вещество: ЭбастинПроизводитель: LABORATORIO CHIMICO DECA DR.CAPUANI S.R.L.Отпускается по рецептуФорма выпуска: Orodispersible tablet, 10 MGДействующее вещество: ЭбастинПроизводитель: ARISTO PHARMA GMBHОтпускается по рецепту
Аналоги EBASTINA DOK в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог EBASTINA DOK в Испания
Аналог EBASTINA DOK в Польша
Аналог EBASTINA DOK в Украина
Врачи онлайн по EBASTINA DOK
Обсудите применение EBASTINA DOK и возможные следующие шаги — по оценке врача.
Получите рецепт на EBASTINA DOK онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
EBASTINA DOK требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество EBASTINA DOK — Эбастин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
EBASTINA DOK производится компанией DOC GENERICI SRL. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения EBASTINA DOK с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить EBASTINA DOK в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Эбастин) включают KLEVER, DEKASTIN, EBARIK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















