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About the medicine

How to use AMVERSIO 1 G ORAL POWDER

Contents of the leaflet

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

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

Not sure if this medicine is right for you?

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 whether a prescription is appropriate, subject to medical assessment and local regulations.

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5.0(21)

Nuno Tavares Lopes

General medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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Jorge Correa Bellido

General medicine7 years of experience
Licence no. 464626297

Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

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General medicine21 years of experience

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Anastasiia Shalko

General medicine13 years of experience
Licence no. 52891

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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Chikeluo Okeke

General medicine4 years of experience

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

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Common reasons for consultation:

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5.0(8)

Lizaveta Trafimchuk Takhvaniuk

DermatologyGeneral medicine10 years of experience
Licence no. 58788

Dr. Lizaveta Trafimchuk Takhvaniuk graduated in Medicine and subsequently specialized in Dermatology and Venereology. She has more than 10 years of clinical experience and is licensed to practice in Spain, where she focuses on the comprehensive diagnosis and treatment of dermatological conditions.

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She has developed a particular interest in trichology, treating various types of alopecia, chronic hair loss, and scalp disorders. In addition, she has experience in managing infectious dermatoses of fungal, viral, and bacterial origin, as well as in evaluating benign and suspicious skin lesions, with referral to specialized care when necessary.

With a strong interest in a comprehensive approach to skin health, she also treats scars, post-procedural skin changes, and conditions related to hormonal factors and aging, including those associated with pregnancy, menopause, and age-related skin changes.

Thanks to her experience and continuous professional development, Dr. Trafimchuk provides high-quality medical care that is professional, confidential, and aligned with modern dermatology standards.

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€72
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5.0(1)

Cristina Andrada Brazo

General medicineSleep medicine16 years of experience
Licence no. 264505958

Dr. Cristina Andrada Brazo is a highly experienced Spanish physician with more than 15 years of clinical practice in emergency medicine, urgent care, and clinical neurophysiology. She provides professional online medical consultations for patients across Spain, helping both residents and international visitors receive timely medical advice, diagnosis, treatment recommendations, and electronic prescriptions when clinically appropriate.

As a licensed physician fully integrated with the Spanish electronic prescription system, Dr. Andrada can issue legally valid e-prescriptions following a medical assessment during an online consultation. Whether you need help with an acute illness, prescription renewal, neurological symptoms, or travel-related healthcare, she offers convenient, patient-centered medical care without the need to visit a clinic.

Dr. Andrada combines extensive emergency medicine experience with advanced expertise in neurology, epilepsy, sleep medicine, and headache disorders. Her international clinical background includes several years working in Switzerland, where she collaborated with multidisciplinary teams in emergency departments and neurology services. This experience strengthened her commitment to evidence-based medicine, compassionate communication, and high-quality patient care.

She graduated in Medicine from the University of Seville and completed her residency in Clinical Neurophysiology at Hospital Virgen de la Salud and the National Hospital for Paraplegics in Toledo. She currently works as a Clinical Neurophysiology Specialist at Hospital San Pedro in Logroño.

To further expand her expertise, Dr. Andrada completed several postgraduate qualifications, including Master's degrees in Sleep Physiology and Medicine, Medical Professionalism and Clinical Practice, Epilepsy, and Clinical Management.

Patients appreciate her thorough consultations, practical treatment recommendations, and empathetic approach. She speaks Spanish, French, and Portuguese, allowing her to communicate comfortably with patients from different backgrounds.

Conditions Dr. Cristina Andrada Treats Online

Dr. Andrada provides online consultations for a wide range of common medical conditions, including:

  • Fever, flu, COVID-19 symptoms, sore throat and respiratory infections
  • Sinusitis, bronchitis, cough and seasonal allergies
  • Urinary tract infections (UTIs)
  • Migraine and tension headaches
  • Dizziness and vertigo
  • Epilepsy and seizure follow-up
  • Sleep disorders, including insomnia and circadian rhythm disturbances
  • Heartburn, gastritis, diarrhea and constipation
  • Back pain, muscle injuries and joint pain
  • Minor skin infections and allergic reactions
  • Fatigue and general medical assessment
  • Prescription renewals for appropriate chronic treatments
  • Follow-up consultations after surgery or previous medical treatment
  • Travel medicine advice and preventive healthcare
  • Interpretation of laboratory results and medical reports

If your condition requires urgent in-person assessment or emergency care, Dr. Andrada will advise you on the most appropriate next steps.

Book an Online Consultation

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Book a video appointment
€56

Frequently Asked Questions

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.

The active ingredient in AMVERSIO 1 G ORAL POWDER is betaine. This information helps identify medicines with the same composition but different brand names.

AMVERSIO 1 G ORAL POWDER is manufactured by Serb Sa. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Family doctors, Endocrinologists, Gastroenterologists, Oncologists, Sports medicine specialists, General medicine doctors, Lactation medicine doctors, Intensive care physicians 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.

The prescription is issued by a doctor after assessing your health. In Spain, AMVERSIO 1 G ORAL POWDER is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

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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