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AMVERSIO 1 G ORAL POWDER

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About the medicine

How to use AMVERSIO 1 G ORAL POWDER

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Amversio 1 g Oral Powder

anhydrous betaine

Read all of 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 further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Amversio and what is it used for
  2. What you need to know before you take Amversio
  3. How to take Amversio
  4. Possible side effects
  5. Storage of Amversio
  6. Contents of the pack and further information

1. What is Amversio and what is it used for

Amversio contains anhydrous betaine, which is indicated as a supplement in the treatment of homocystinuria, a hereditary (genetic) disease in which the body is unable to break down the amino acid methionine completely.

Methionine is present in the proteins of normal foods (such as meat, fish, milk, cheese, eggs). It is converted into homocysteine, which is then usually converted into cysteine during digestion. Homocystinuria is a disease caused by the accumulation of homocysteine that is not converted into cysteine, and is characterized by the formation of blood clots in the veins, bone weakness, and skeletal and lens anomalies. The use of Amversio, along with other treatments such as vitamin B6, vitamin B12, folate, and a specific diet, aims to reduce high levels of homocysteine in your body.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Amversio

Do not take Amversio

if you are allergic to anhydrous betaine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amversio.

  • If you experience side effects such as headaches, vomiting, or changes in vision and you have the subtype of homocystinuria known as CBS (cystathionine beta-synthase deficiency), contact your doctor immediately, as they may be signs of brain inflammation (cerebral edema). In this case, your doctor will monitor the level of methionine in your body and may review your diet. It may be necessary to interrupt treatment with Amversio.
  • If you are being treated with Amversio and an amino acid mixture, and if you need to use other medicines at the same time, wait 30 minutes between doses (see section "Other medicines and Amversio").

Other medicines and Amversio

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

If you are using an amino acid mixture or medicines such as vigabatrin or GABA analogs (medicines used to treat epilepsy), inform your doctor, as they may interact with your Amversio treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can use the medicine during pregnancy and breastfeeding.

Driving and using machines

Amversio has no or negligible influence on the ability to drive and use machines.

3. How to take Amversio

The use of this medicine will be supervised by a doctor with experience in the treatment of patients with homocystinuria.

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose in children and adults is 100 mg/kg/day in two doses per day. In some patients, doses higher than 200 mg/kg/day may be necessary to achieve therapeutic goals. Your doctor may adjust the dose based on laboratory values.

Therefore, you will need to have blood tests periodically to determine the correct daily dose.

Instructions for use

You must take Amversio orally (by mouth).

To measure the dose:

  • shake the bottle slightly before opening it
  • take the appropriate measuring spoon:
  • the green measuring spoon dispenses 100 mg.
  • the blue measuring spoon dispenses 150 mg.
  • the purple measuring spoon dispenses 1 g.
  • remove a heaped spoonful of powder from the bottle
  • level the spoon with the flat side of a knife
  • the powder that remains in the spoon is one spoonful
  • remove the correct number of spoonfuls of powder from the bottle

Mix the measured dose of powder with water, juice, milk, infant formula, or food until it is completely dissolved, and take it 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 forgotten doses. If you forget to take a dose, take it as soon as you remember, and continue with the next dose as scheduled.

If you stop taking Amversio

Do not stop treatment without consulting your doctor. Consult your doctor or pharmacist before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The level of methionine may be related to brain inflammation (cerebral edema), which can affect up to 1 in 100 people (uncommon). If you experience morning headaches with vomiting and/or visual disturbances, consult your doctor immediately (they may be signs of cerebral inflammation).

Other side effects include:

Very common: may affect more than 1 in 10 people

  • high levels of methionine in the blood

Uncommon: may affect up to 1 in 100 people

  • gastrointestinal disorders such as diarrhea, nausea, vomiting, stomach discomfort, and tongue inflammation
  • decreased appetite (anorexia),
  • restlessness,
  • irritability,
  • hair loss,
  • hives,
  • abnormal skin odor,
  • loss of bladder control (urinary incontinence).

Reporting of side effects

If you experience 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 listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton after EXP. The expiry date is the last day of the month stated.

Store in the original package.

Keep the bottle tightly closed to protect it from moisture.

This medicine does not require any special storage temperature.

Once the bottle is opened, the medicine should be used within 3 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amversio

  • The active substance is anhydrous betaine. 1 g of oral powder contains 1 g of anhydrous betaine.
  • There are no other ingredients.

Appearance and pack contents

Amversio is a white crystalline powder that flows freely. It is presented in a child-resistant closure bottle. Each bottle contains 180 g of powder. Each carton contains one bottle and three measuring spoons.

The green measuring spoon dispenses 100 mg.

The blue measuring spoon dispenses 150 mg.

The purple measuring spoon dispenses 1 g

Marketing authorisation holder and manufacturer

Marketing authorisation holder

SERB S.A.

Avenue Louise 480

1050 Brussels

Belgium

Manufacturer

MoNo Chem-Pharm Produkte GmbH,

Leystraße 129,

1200 Vienna

Austria

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website http://www.emea.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

Online doctors for AMVERSIO 1 G ORAL POWDER

Discuss questions about AMVERSIO 1 G ORAL POWDER, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
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  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
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Endocrinology – Diabetes, thyroid, metabolism:
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  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Frequently Asked Questions

Is a prescription required for AMVERSIO 1 G ORAL POWDER?
AMVERSIO 1 G ORAL POWDER requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in AMVERSIO 1 G ORAL POWDER?
The active ingredient in AMVERSIO 1 G ORAL POWDER is betaine. This information helps identify medicines with the same composition but different brand names.
Who manufactures AMVERSIO 1 G ORAL POWDER?
AMVERSIO 1 G ORAL POWDER is manufactured by Serb Sa. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of AMVERSIO 1 G ORAL POWDER online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether AMVERSIO 1 G ORAL POWDER is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to AMVERSIO 1 G ORAL POWDER?
Other medicines with the same active substance (betaine) include CYSTADANE 1 g ORAL POWDER, CARGLUMIC ACID TILLOMED 200 mg DISPERSIBLE TABLETS, CARGLUMIC ACID WAYMADE 200 mg DISPERSIBLE TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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