EBASTINA 10 mg Ородисперсная Таблетка
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Инструкция по применению EBASTINA AUROBINDO
Содержание инструкции
Ebastina Aurobindo 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 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 Ebastina Aurobindo is and what it is used for
- 2. What you need to know before you take Ebastina Aurobindo
- 3. How to take Ebastina Aurobindo
- 4. Possible side effects
- 5. How to store Ebastina Aurobindo
- 6. Contents of the pack and other information
1. What is Ebastina Aurobindo 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 eyes.
In adults and children aged 12 years and over, Ebastina Aurobindo is used to relieve the
symptoms of seasonal rhinitis (hay fever) and perennial allergic rhinitis, including cases of
allergic conjunctivitis.
In adults over 18 years of age, Ebastina Aurobindo 10 mg is also used to relieve itching and
the development of wheals in urticaria (hives rash).
2. What you need to know before taking Ebastina Aurobindo
Do not take Ebastina Aurobindo
- If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor before taking Ebastina Aurobindo if:
- you have low levels of potassium in your blood;
- you have an abnormal heart tracing (known prolongation of the QTc interval on ECG), which can occur in some forms of heart disease;
- you are already taking certain antibiotics or medicines used to treat fungal infections: see “Othermedicines and Ebastina Aurobindo” below;
- you have severe impairment of 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 of age as safety and efficacy have not
been established in this age group.
Other medicines and Ebastina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Ebastina Aurobindo can affect or be affected by certain medicines that contain the following
active ingredients:
- ketoconazole, itraconazole (medicines used to treat fungal infections).
- erythromycin (antibiotic).
- rifampicin (medicine used to treat tuberculosis).
Ebastina Aurobindo with food and alcohol
Ebastina Aurobindo can be taken independently of meals.
Pregnancy, breastfeeding and fertility
There is limited experience to date on safety in humans for the fetus. For this reason, you should
only take Ebastina Aurobindo during pregnancy if your doctor considers that the expected benefits outweigh the
possible risks.
Do not take Ebastina Aurobindo if you are breastfeeding a baby, 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 Aurobindo can drive or perform other activities that
require good reaction ability. As with all other medicines, however, you should check your individual reaction after taking Ebastina
Aurobindo before driving or performing complicated tasks, as some patients experience drowsiness or dizziness.
Ebastina Aurobindo 10 mg contains2.5 mg of aspartame per tablet.
Ebastina Aurobindo 20 mg contains5 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic
disorder in which phenylalanine builds up because the body cannot process it properly.
3. How to take Ebastina Aurobindo
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
| Symptom | z Age | Dosage | |||
| n Allergic rhinitis and In case of severe symptoms | Children 12 years of age and over, and adults | One tablet of Ebastina Aurobindo 10 mg (10 mg of ebastina) per day Two tablets of Ebastina Aurobindo 10 mg or one tablet of Ebastina Aurobindo 20 mg (20 mg of ebastina) once a day | |||
| g Urticaria | Adults over 18 years | One tablet of Ebastina Aurobindo 10 mg (10 mg of ebastina) once a day | |||
In patients with impaired renal function, no dose adjustment is necessary.
In patients with mild or 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 the dose
should not exceed 10 mg in these patients.
Ebastina Aurobindo can be taken independently of meals.
The doctor will decide the duration of treatment.
If you take more Ebastina Aurobindo than you should
There is no specific antidote for the active substance ebastina.
If you suspect an overdose of Ebastina Aurobindo, inform your doctor. Depending on the severity
of the intoxication, he/she will initiate appropriate measures (monitoring of vital functions, including
ECG monitoring for at least 24 hours, treatment of symptoms and gastric lavage), if necessary.
If you forget to take Ebastina Aurobindo
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.
manifest.
Stop taking Ebastina Aurobindo and contact your doctor immediately or go to the
nearest hospital if the following occurs:
- Itching, hives and swelling of the face, tongue or throat that can cause difficulty swallowing or breathing. This may be a sign of a hypersensitivity reaction to Ebastina Aurobindo such as anaphylaxis and angioedema, which are rare side effects (may affect up to 1 in 1,000 people). Other side effects include:Very common side effects, which can affect more than 1 in 10 people
- Headache. Common side effects, which can affect up to 1 in 10 people
- Drowsiness.
- Dry mouth.
Uncommon side effects, which can affect up to 1 in 100 people
- Nosebleed.
- Sore throat (pharyngitis).
- Runny nose (rhinitis). Rare side effects, which can affect up to 1 in 1,000 people
- Nervousness.
- Insomnia.
- Drowsiness.
- Dizziness.
- Reduced sense of touch.
- Altered sense of taste.
- Palpitations (fast heartbeat, irregular heartbeat).
- Increased pulse.
- Abdominal pain.
- Vomiting.
- Nausea.
- Indigestion.
- Hepatitis (inflammation of the liver).
- Cholestasis (altered bile flow).
- Abnormal liver function tests.
- Rash, hives, widespread rash.
- Menstrual disorders.
- Edema (fluid retention in the tissues).
- Weakness (asthenia). Very rare side effects, which can affect up to 1 in 10,000 people
- Altered sense of touch.
- Eczema, skin inflammation.
- Menstrual pain.
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 Ebastina Aurobindo
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 packaging after Exp.
The expiry date refers to the last day of that 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. Package contents and other information
What Ebastina Aurobindo 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 (grade-102), mannitol, crospovidone (type-A), aspartame, colloidal anhydrous silica, magnesium stearate, peppermint aroma. Description of the appearance of Ebastina Aurobindo and package contentsOrodispersible tablets
Ebastina Aurobindo 10 mg orodispersible tablets [size 6.7 mm]:
Uncoated, circular, biconvex tablets, from white to almost white in colour, with “E 10” imprinted on one
side and smooth on the other side.
Ebastina Aurobindo 20 mg orodispersible tablets [size 9.2 mm]:
Uncoated, circular, biconvex tablets, from white to almost white in colour, with “E 20” imprinted on one
side and smooth on the other side.
Ebastina Aurobindo 10 mg and 20 mg orodispersible tablets are available in blister packs.
Packs:
10, 20 and 30 orodispersible tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Ebastina Aurobindo
Portugal: Ebastina Aurobindo
Spain: Ebastina Aurobindo 10mg / 20mg bucodispersable tablets EFG
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- 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 AUROBINDOФорма 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
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Действующее вещество EBASTINA AUROBINDO — Эбастин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
EBASTINA AUROBINDO производится компанией AUROBINDO PHARMA (ITALIA) S.R.L.. 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 AUROBINDO 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 AUROBINDO в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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