Amversio – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Amversio, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
ℹ️ 1. What Amversio is and what it is used for
Amversio contains betaine anhydrous which is intended to be an adjunctive treatment of homocystinuria, an inherited (genetic) disease where the amino a cid methionine cannot be broken down completely by the body.
Methionine is present in regular food prote in (such as meat, fish, milk, cheese, eggs). It is converted into homocysteine which is then normally converted into cysteine during digestion. Homocys tinuria is a disease caused by the accumulation of homocysteine which is not converted to cysteine and is characterised by formation of clots in the veins, bone weakness, and skeletal and crystalline lens abnormalities. The use of Amversio together with ot her treatments such as vitamin B6, vitamin B12, folate and a specific diet aims to reduce the elevated ho mocysteine levels in your body.
⚠️ 2. What you need to know before you take Amversio
Do not take Amversio
- if you are allergic to betaine anhydrous.
Warnings and precautions
Talk to yo ur doctor or pharmacist before taking Amversio .
- If you notice side effects like headaches, vomiting or a change in your vision and you are of the homocystinuria subtype called CBS (cystathionine beta -synthase deficiency ), please contact your doctor immediately, they could be signs of a swelling in the b rain (cerebral oedema). In that case your doctor will monitor your methionine level in your body and may review your diet. Your treatment with Amversio may need to be inte rrupted.
- If you are treated with Amversio and with an amino -acid mixture and if you need to take other medic ines at the same time, leave 30 minutes between the intake (see “section “Other medicines and Amversio ).
18 Other medicines and Amversio Tell your d octor if you are taking, have recently taken or might take any other medicines.
If you are taking amino -acid mixture or medicines such as vigabatrin or Gaba analogues (medicine used to treat epilepsy), please tell your doctor as they might inte ract with y our treatment with Amversio .
Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if you can use this medicine during pregnancy and breast -feeding.
Driving and using machines
Amversio has no or negligible influence on the ability to drive and use machines.
💊 3. How to t ake Amversio
The use of this medicine will be supervised by a doctor expe rienced in th e treatment of patients with homocystinuria.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose in children and adults is 100 mg/kg/day divided in 2 doses per day. In some patients doses above 200 mg/kg/day were needed to reach therapeutic goals. Your doctor may adapt the dose depending on your laboratory values.
You will theref ore need regular blood tests to determine the correct daily dose.
Instruc tions for use You should take Amversio orally (by mouth).
To measure the dose:
- shake the bottle lightly before opening
- take the correct measuring spoon:
- the green measuring spoon dispenses 100 mg;
- the blue measuring spoon dispenses 150 mg;
- the purple measuring spoon dispenses 1 g.
- take a heaped spoonful of powder out of the bottle
- pass the flat back of a knife over the top of the spoon
- the powder left in the spoon is one spoonful
- take the correct number of spoonfuls of powder from the bottle Mix the measured dose of powder with water, juice, milk, 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 , talk to a doctor or pharmacist immed iately.
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 it and continue the next dose as planned.
If you stop taking Amversio
Do not stop the treatment without consulting your doctor. Contact your doctor or pharmacist before stopping.
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 e ffects, although not everybody gets them.
Methionine level can be related to swelling in the brain (cerebral swelling), which may affect up to 1 in 100 people (frequency uncommon). If you experience morning headaches with vomiting and/or visual changes, contact i mmediately your doctor (they could be signs of a swelling in the brain) .
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 )
- gastroint estinal disorders like diarrhoea, nausea, vomiting, stomach discomfort and inflammation of the tongue ,
- decreased appetite (anorexia),
- agitation,
- irritability,
- hair loss,
- hives,
- abnormal skin odour,
- lack of control over passing urine (urinary inconti nence).
Reporting of side effects
If you get 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 via 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. How to store Amversio
Keep this med icine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle label and the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package.
Keep the bott le tightly closed in order to protect from moisture.
This medicin e does not require any special temperature storage conditions After the first opening of the bottle, the m edicine should be used within 3 months.
Do not throw away any medicines via wastew ater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures wil l help protect the environment.
📦 6. Contents of the pack and other information
What Amversio contains
- The active substance is betaine anhydrous. 1 g of oral powder contains 1 g of betaine anhydrous .
- There is no other ingredient .
20 What Amversio looks like and contents of the pack Amversio is a white crystalline free flowing powder. It is presented in a bottle with a child resistant closure. 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 dispense s 1 g.
Marketing Authorisation Holder
SERB S.A.
Avenue Louise 480 1050 Brussels Belgium
Manufacturer
MoNo Chem -Pharm Produkte GmbH, Leystraße 129, 1200 Wien, Austria
This leaflet was last revised i n
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Amversio (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1640).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.