Amversio
ItalyTable of Contents
Patient Information Leaflet
Amversio 1 g oral powder
anhydrous betaine
Read this leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
- What Amversio is and what it is used for
- What you need to know before taking Amversio
- How to take Amversio
- Possible side effects
- How to store Amversio
- Contents of the pack and other information
1. What Amversio is and what it is used for
Amversio contains anhydrous betaine intended as an adjunctive treatment for homocystinuria, a
hereditary (genetic) disease in which the amino acid methionine is not completely metabolized
by the human body.
Methionine is present in normal dietary proteins (such as meat, fish, milk, cheese, eggs).
It is converted into homocysteine, which is then normally transformed into cysteine during digestion. Homocystinuria is a disease caused by the accumulation of homocysteine, which fails to be converted into cysteine, and is characterized by the formation of blood clots in veins, bone weakness, and skeletal and lens abnormalities. The use of Amversio, together with other treatments such as vitamin B6, vitamin B12, folate, and a specific diet, aims to reduce elevated levels of homocysteine in the body.
2. What you need to know before taking Amversio
Do not take Amversio
If you are allergic to anhydrous betaine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amversio.
- If you experience side effects such as headache, vomiting, or vision disturbances and you have the type of homocystinuria known as CBS (cystathionine beta-synthase deficiency), contact your doctor immediately, as these may be signs of brain swelling (cerebral edema). In such cases, your doctor will monitor your methionine levels and may review your diet. It may be necessary to discontinue treatment with Amversio.
- If you are being treated with Amversio and an amino acid mixture and need to take other medicines at the same time, leave a 30-minute interval 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 medicine.
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 may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Your doctor will decide whether this medicine can be used during pregnancy and breastfeeding.
Driving and using machines
Amversio has no effect or has a negligible effect on the ability to drive vehicles and use machinery.
3. How to take Amversio
Your use of this medicine will be monitored by a doctor experienced in treating patients with homocystinuria.
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for children and adults is 100 mg/kg/day, divided into two daily doses. In some patients, doses higher than 200 mg/kg/day have been required to achieve therapeutic goals. Your doctor may adjust the dose based on your laboratory values.
Therefore, you may need to undergo periodic blood tests to determine the correct daily dose.
Instructions for use
You must take Amversio by mouth (orally).
To measure the dose:
- Gently shake the bottle before opening it.
- Select the correct dosing spoon:
- The green dosing spoon delivers 100 mg.
- The blue dosing spoon delivers 150 mg.
- The purple dosing spoon delivers 1 g.
- Take a full spoonful of powder from the bottle.
- Run the back of a knife across the spoon.
- The remaining powder corresponds to one spoonful.
- Take the exact number of spoonfuls of powder from the bottle as prescribed.
Mix the measured dose of powder with water, juice, milk, infant formula, or food, stirring until completely dissolved, and take 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 forgotten dose. If you forget to take a dose, take it as soon as you remember, then continue with your next scheduled dose as planned.
If you stop taking Amversio
Do not stop treatment without consulting your doctor. Before stopping, consult your doctor or pharmacist.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience 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 visual disturbances, contact your doctor immediately (these could be signs of cerebral edema).
Other side effects include:
Very common: may affect more than 1 in 10 people
- increased levels of methionine in the blood
Uncommon: may affect up to 1 in 100 people
- gastrointestinal disorders such as diarrhoea, nausea, vomiting, stomach discomfort and inflammation of the tongue,
- decreased appetite (anorexia),
- restlessness,
- irritability,
- hair loss,
- urticaria,
- abnormal skin odour,
- loss of bladder control (urinary incontinence).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help 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 stated on the label of the bottle and on the carton.
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 special storage temperature.
After first opening the bottle, the medicine should be used within 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Amversio contains
- The active substance is anhydrous betaine. 1 g of oral powder contains 1 g of anhydrous betaine.
- There are no excipients.
Description of the appearance of Amversio and contents of the pack
Amversio is a white, free-flowing crystalline powder. It is supplied in a bottle with a child-resistant cap. Each bottle contains 180 g of powder. Each carton contains one bottle and three dosing spoons.
The green dosing spoon delivers 100 mg.
The blue dosing spoon delivers 150 mg.
The purple dosing spoon delivers 1 g.
Marketing Authorisation Holder
SERB S.A
Avenue Louise 480
1050 Brussels
Belgium
Manufacturer
MoNo Chem-Pharm Produkte GmbH
Leystraße 129
1200 Vienna
Austria
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.