Инструкция по применению AVERBET
Содержание инструкции
- What is Betaistina TecniGen and what is it used for
- What you need to know before taking Betaistina TecniGen
- How to take Betaistina TecniGen
- Possible side effects
- How to store Betaistina TecniGen
- Package Contents and Other Information
Betaistina TecniGen, 8 mg, tablets
Betaistina TecniGen, 16 mg, tablets
Betaistina TecniGen, 24 mg, tablets
Betaistine dihydrochloride
Read this leaflet carefully before you start 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 pass it on to others, even if their
symptoms are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
What is in this leaflet
- 1. What Betaistina TecniGen is and what it is used for
- 2. What you need to know before you take Betaistina TecniGen
- 3. How to take Betaistina TecniGen
- 4. Possible side effects
- 5. How to store Betaistina TecniGen
- 6. Contents of the pack and other information
1. What is Betaistina TecniGen and what is it used for
Betaistina TecniGen contains betaistine (dihydrochloride). Betaistine is a type of medicine called a "histamine
analog".
Betaistina TecniGen is used to treat:
Ménière's Disease whose symptoms include:
- Sensation of dizziness and feeling unwell (nausea or vomiting)
- hearing loss or difficulty hearing
- ringing in the ears (tinnitus)
How Betaistina TecniGen works
The medicine works by improving blood flow to the inner ear. This reduces the increase in
pressure.
2. What you need to know before taking Betaistina TecniGen
Do not take Betaistina TecniGen:
- if you are allergic to betaistine or any of the other ingredients of this medicine (listed in section 6)
- If you have high blood pressure due to a tumor of the adrenal gland (called "pheochromocytoma").
If any of these situations apply to you, do not take this medicine and consult your doctor or pharmacist before taking Betaistina TecniGen.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Betaistina TecniGen
- if you have ever had a stomach ulcer
- if you suffer from asthma.
If any of these situations apply to you (or you are not sure), talk to your doctor before taking this medicine.
Your doctor may want to monitor you closely while you take Betaistina TecniGen.
Children and adolescents
The use of BETAISTINA DOC is not recommended in children and adolescents under 18 years of age.
Other medicines and Betaistina TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. These may increase exposure to Betaistina TecniGen.
- Antihistamines: may (in theory) reduce the effect of Betaistina TecniGen. Also, Betaistina TecniGen may reduce the effect of antihistamines.
If any of the above conditions apply to you (or you are not sure), talk to your doctor or pharmacist
before taking Betaistina TecniGen.
Betaistina TecniGen with food and drink
You can take Betaistina TecniGen during or away from meals. However, Betaistina TecniGen may cause
mild stomach discomfort (listed in section 4). Taking Betaistina TecniGen during meals may
help to reduce these discomforts.
Pregnancy and breastfeeding
It is not known whether Betaistina TecniGen has a sulfated effect:
- Stop taking Betaistina TecniGen and ask your doctor for advice if you are pregnant, suspect you may be pregnant or are planning a pregnancy
- Do not take Betaistina TecniGen if you are pregnant unless your doctor has decided it is necessary.
It is not known whether Betaistina TecniGen passes into breast milk:
- Do not breastfeed while taking Betaistina TecniGen unless your doctor tells you to do so.
Driving and using machines
Clinical studies show that Betaistina TecniGen does not appear to have effects on the ability to drive
vehicles or use machines. However, keep in mind that the condition you are being treated for (i.e. the
Ménière's Syndrome) with Betaistina TecniGen may cause you to feel dizzy or unwell.
Betaistina TecniGen contains mannitol
It may have a mild laxative effect.
3. How to take Betaistina TecniGen
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
- Swallow the tablet with water.
- You can take the tablet with or without food. However, Betaistina TecniGen may cause mild stomach problems (listed in section 4). Taking Betaistina TecniGen with food may help to reduce stomach problems.
How much to take
The recommended daily dose is 24 mg of betaistine per day in 2 or 3 single doses and may be
increased on prescription up to 48 mg per day. Betaistina TecniGen 24 mg has been specifically
developed for the higher daily dose of 48 mg per day.
The recommended starting dose is:
One to two tablets, three times a day.
Half to one tablet, three times a day.
The tablet can be divided into equal doses.
Half to one tablet, twice a day.
The tablet can be divided into equal doses.
Distribute the tablets evenly throughout the day. For example, take one tablet in the
morning and one in the evening.
Try to take the tablet every day at the same time. This will ensure that there is a constant amount of
medicine in your body. Taking it at the same time will also help you remember to take the
tablets.
Use in children and adolescents
The safety and efficacy of Betaistina TecniGen in children and adolescents have not yet been
established.
Duration of treatment
Continue to take the medicine. The medicine may take some time to start working.
The doctor will adjust the dose, depending on the improvements.
If you take more Betaistina TecniGen than you should
If you or someone else takes too much Betaistina TecniGen (an overdose), talk to your doctor or go
immediately to hospital. Bring the medicine packaging with you. The following effects may occur:
- Feeling unwell (nausea)
- Feeling sleepy
- Stomach ache.
If you forget to take Betaistina TecniGen
- Wait until it is time to take your next dose. Take your next dose at the usual time.
- Do not take a double dose to make up for a missed dose.
If you stop taking Betaistina TecniGen
Do not stop taking Betaistina TecniGen without talking to your doctor, even if you start to feel
better.
If you have any further questions 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.
The following side effects may occur with this medicine:
Allergic reactions
If you have an allergic reaction, stop taking Betaistina TecniGen and consult your doctor or go
immediately to hospital. The signs may include:
- Skin rash with redness or blisters or inflamed and itchy skin
- swelling of the face, lips, tongue or throat
- a drop in blood pressure
- loss of consciousness
- difficulty breathing.
Stop taking Betaistina TecniGen and consult a doctor or go immediately to hospital,
if you notice any of the above signs.
Other side effects include:
Common:may affect up to 1 in 10 people
- feeling unwell (nausea)
- indigestion (dyspepsia)
- headache.
Other side effects that have been reported with the use of Betaistina TecniGen
- Mild stomach problems such as nausea (vomiting), stomach pain, bloating (abdominal distension) and swelling.
Taking Betaistina TecniGen with food may help to reduce stomach problems.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any side effects not listed in this leaflet.
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 to provide more information on the safety of
this medicine.
5. How to store Betaistina TecniGen
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 box and on the blister. The expiry date refers to the last day of that month.
Store at a temperature below 30 ºC.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Package Contents and Other Information
What Betaistina TecniGen contains
The active ingredient is betahistine dihydrochloride.
Each tablet contains 8 mg of betahistine dihydrochloride.
Each tablet contains 16 mg of betahistine dihydrochloride.
Each tablet contains 24 mg of betahistine dihydrochloride.
The other ingredients are: anhydrous citric acid, microcrystalline cellulose, mannitol (E421), colloidal
anhydrous silica, talc.
Description of the appearance of Betaistina TecniGen and package contents
Betaistina TecniGen 8 mg tablets are white, round and flat, uncoated, smooth on
both sides.
Betaistina TecniGen 16 mg tablets are uncoated white, round and
biconvex tablets with an embossed "I" on one side and smooth on the other side.
Betaistina TecniGen 24 mg tablets are uncoated white, round and
biconvex tablets with an embossed "II" on one side on both sides of the score line and smooth
on the other side.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
S.C. SANTA S.A.
Str. Carpatilor nr. 60, obj. Nr. 47, 48, 58, 133, 156
Brasov, jud. Brasov
Cod 500269
Romania
S.C. POLISANO PHAMRACEUTICALS S.A.
Sos. Alba Iulia nr. 156,
Cod 550052.
Sibiu Jud.
Sibiu
Romania
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2 Abrunheira,
2710-089 Sintra
Portugal
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy: Beta-histina Tecnigen
Portugal: Beta-histina Tecnigen
Spain: Betahistina TecniGen 8 mg comprimidos EFG
Betahistina TecniGen 16 mg comprimidos EFG
Betahistina TecniGen 24 mg comprimidos EFG
- Страна регистрации
- Форма выпускаCoated tablet, 8 MG
- Код АТХN07CA01
- 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 AVERBETФорма выпуска: Coated tablet, 8 MGДействующее вещество: betahistineПроизводитель: ACCORD HEALTHCARE, S.L.U.Отпускается по рецептуФорма выпуска: Coated tablet, 8 MGДействующее вещество: betahistineПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецептуФорма выпуска: Tablet, 8 MGДействующее вещество: betahistineПроизводитель: DOC GENERICI SRLОтпускается по рецепту
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