AMVERSIO 1 G ORAL POWDER

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.

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.

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.