Инструкция по применению AMVERSIO
Содержание инструкции
Amversio 1 g oral powder
betaine anhydrous
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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
- 1. What Amversio is and what it is used for
- 2. What you need to know before you take Amversio
- 3. How to take Amversio
- 4. Possible side effects
- 5. How to store Amversio
- 6. Contents of the pack and other information
1. What is Amversio and what is it used for
Amversio contains betaine anhydrous intended to be an additional treatment for homocystinuria, a
hereditary (genetic) disease in which the amino acid methionine is not completely transformed
by the human body.
Methionine is present in normal dietary proteins (such as meat, fish, milk, cheese, eggs).
It is transformed into homocysteine, which is then normally transformed in turn into cysteine during
digestion. Homocystinuria is a disease caused by the accumulation of homocysteine, which is not
transformed into cysteine, and is characterized by the formation of blood clots in the veins, bone weakness and
anomalies of the skeleton and lens. The use of Amversio, together with other treatments, such as vitamin
B6, vitamin B12, folate and a specific diet, is intended to reduce high levels of homocysteine
in the body.
2. What you need to know before taking Amversio
Do not take Amversio
If you are allergic to betaine anhydrous.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amversio.
- If you notice undesirable effects such as headache, vomiting or changes in vision and you suffer from the type of homocystinuria called CBS (cystathionine beta-synthetase deficiency), contact your doctor immediately as these may be signs of swelling in the brain (cerebral edema). In such cases, your doctor will monitor methionine levels in your body and may revise your diet. It may be necessary to stop treatment with Amversio.
- If you are undergoing treatment with Amversio and a mixture of amino acids and need to take other medicines at the same time, allow 30 minutes between administrations (see “Other medicines and Amversio”).
Other medicines and Amversio
Tell your doctor if you are taking, have recently taken or might take any other
medicinal product.
Tell your doctor if you are taking amino acid mixtures or medicines such as vigabatrin or GABA analogues (medicines used to treat epilepsy), as these may interact with treatment with
Amversio.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine. The doctor will decide whether the
medicine can be used during pregnancy and breastfeeding.
Driving and using machines
Amversio does not alter or alters negligibly the ability to drive vehicles and use machines.
3. How to take Amversio
The use of this medicine will be monitored by a doctor experienced in the treatment of patients with
homocystinuria.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose in children and adults is 100 mg/kg/day divided into 2 daily doses. In some
patients, doses higher than 200 mg/kg/day have been necessary to achieve therapeutic goals. The
doctor may adjust the dose based on your laboratory values.
It may therefore be necessary for you to undergo periodic blood tests to establish the correct
daily dose.
Instructions for use
You must take Amversio orally (by mouth).
To measure the dose:
- shake the bottle gently before opening
- take the correct measuring spoon:
- the green measuring spoon delivers 100 mg.
- the blue measuring spoon delivers 150 mg.
- the purple measuring spoon delivers 1 g.
- take one heaped spoonful of powder from the bottle
- pass the back of a knife over the spoon
- the remaining powder corresponds to one spoonful
- take the exact number of spoonfuls of powder from the bottle
Mix the measured dose of powder with water, juice, milk, infant formula or food, until
completely dissolved and ingest immediately after mixing.
If you take more Amversio than you should
If you accidentally take too much Amversio, inform your doctor or pharmacist immediately.
If you forget to take Amversio
Do not take a double dose to make up for a missed dose. If you forget to take a
dose, take it as soon as you remember and continue with the next dose as planned.
If you stop taking Amversio
Do not stop treatment without consulting your doctor. Before stopping it, consult your doctor or
pharmacist.
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.
The level of methionine may be linked to brain swelling (cerebral edema) which may
affect up to 1 in 100 people (uncommon frequency). If you experience morning headache with vomiting
and/or vision disturbances, contact your doctor immediately (these may be signs of cerebral
edema).
Other side effects include:
Very common: may affect more than 1 in 10
- increased levels of methionine in the blood
Uncommon: may affect up to 1 in 100
- gastrointestinal disorders such as diarrhea, nausea, vomiting, stomach discomfort and inflammation of the tongue,
- decreased appetite (anorexia),
- agitation,
- irritability,
- hair loss,
- urticaria (hives),
- abnormal skin odor,
- loss of bladder control (urinary incontinence).
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 detailed in Appendix V. By reporting side effects you can help to provide more information on the safety of this medicine.
5. How to store Amversio
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 label of the bottle and on the carton
after Exp. The expiry date refers to the last day of that month.
Store in the original packaging.
Keep the bottle tightly closed to protect the medicine from moisture.
This medicine does not require any particular storage temperature.
After the first opening of the bottle, the medicine must be used within 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Amversio contains
- The active ingredient is betaine anhydrous. 1 g of oral powder contains 1 g of betaine anhydrous.
- There are no excipients.
Description of the appearance of Amversio and contents of the pack
Amversio is a flowing crystalline powder of white color. It is presented in a bottle with a
child-resistant closure. Each bottle contains 180 g of powder. Each box contains one bottle and three
measuring spoons.
The green measuring spoon delivers 100 mg.
The blue measuring spoon delivers 150 mg.
The purple measuring spoon delivers 1 g.
Marketing Authorisation Holder
SERB S.A
Avenue Louise 480
1050 Brussels
Belgium
Manufacturer
MoNo Chem-Pharm Produkte GmbH
Leystraβe 129
1200 Vienna
Austria
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/ . Furthermore, links to other websites on rare diseases and
related therapeutic treatments are provided.

- Страна регистрации
- Форма выпускаOral powder, 1 g
- Код АТХA16AA06
- 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 AMVERSIOФорма выпуска: Oral powder, 1 GДействующее вещество: betaineПроизводитель: RECORDATI RARE DISEASES SARLОтпускается по рецептуФорма выпуска: Dispersible tablet, 200 MGДействующее вещество: Карглюмиковая кислотаПроизводитель: WAYMADE B.V.Отпускается по рецептуФорма выпуска: Dispersible tablet, 200 MGДействующее вещество: Карглюмиковая кислотаПроизводитель: RECORDATI RARE DISEASES SARLОтпускается по рецепту
Аналоги AMVERSIO в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог AMVERSIO в Испания
Аналог AMVERSIO в Украина
Врачи онлайн по AMVERSIO
Обсудите применение AMVERSIO и возможные следующие шаги — по оценке врача.
Получите рецепт на AMVERSIO 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
AMVERSIO требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество AMVERSIO — betaine. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
AMVERSIO производится компанией SERB S.A.. 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 AMVERSIO 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 AMVERSIO 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 (betaine) включают KYSTADANE, AKIDO KARLUMIKO WAYMADE, KARBALU. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















