SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Silibinina Viatris 350 mg Powder for Solution for Infusion

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 signs of illness are the same as yours.
• If you get 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 Silibinina Viatris and what is it used for
2. What you need to know before you use Silibinina Viatris
3. How to use Silibinina Viatris
4. Possible side effects
5. Storage of Silibinina Viatris
6. Contents of the pack and further information

1. What is Silibinina Viatris and what is it used for

Silibinina is an antidote for amatoxin (the main toxin of the poisonous mushroom Amanita phalloides), and it works by blocking the uptake of amatoxin by liver cells (hepatocytes), thus interrupting the enterohepatic circulation of the toxin and promoting its elimination.

Silibinina Viatris is indicated for the treatment of Amanita phalloides poisoning.

2. What you need to know before you use Silibinina Viatris

Do not use Silibinina Viatris

• If you are allergic to the active substance silibinina or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• A strict control of the electrolyte and acid-base balance, as well as the fluid balance of patients undergoing treatment with silibinina, must be maintained.
• If you are on a low-sodium diet, inform your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take silibinina.

Other medicines and Silibinina Viatris

No interactions with other medicines have been reported.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no clinical data on the use of silibinina in pregnant women. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition, or postnatal development. If silibinina is considered necessary in a pregnant woman, it should be administered with caution.

Silibinina Viatris contains sodium

This medicine contains 34 mg of sodium (a major component of table/cooking salt) per vial. This is equivalent to 1.7% of the maximum recommended daily intake of sodium for an adult.

Driving and using machines

No effects on driving or using machines have been reported.

3. How to use Silibinina Viatris

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

This medicine will always be administered by a healthcare professional.

The administration of this medicine will be by intravenous infusion.

Recommended dose:

Unless your doctor indicates otherwise, the recommended dose is 4 intravenous infusions of 2 hours each, with a 4-hour interval between them, while controlling fluid balance.

Duration of treatment:

The infusions should continue for several days until the complete disappearance of symptoms.

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 effects, although not everybody gets them.

Very rare side effects (may affect up to 1 in 10,000 people):

• Feeling of heat (flush) during infusion.

Side effects of unknown frequency (cannot be estimated from the available data):

• Fever.
• Increased bilirubin in the blood.

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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Silibinina Viatris

No special storage conditions are required.

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 carton after EXP. The expiry date refers to the last day of the month shown.

Once reconstituted, the solution is stable for 6 hours at 30°C and 24 hours at 2-8°C.

6. Contents of the pack and further information

Composition of Silibinina Viatris

One vial for infusion contains 598.5 mg of lyophilized product:

The active substance is 528.5 mg of silibinina-C-2',3-dihydrogensuccinate disodium, equivalent to 350 mg of silibinina.

The other ingredients are inulin.

Appearance and pack contents

Silibinina Viatris is presented in packs containing 4 vials for infusion, each containing 598.5 mg of lyophilized product.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

MADAUS GmbH

Lütticher Strasse, 5

53842 – Troisdorf

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of last revision of this leaflet:March 2025

This information is intended only for healthcare professionals:

• Infusions with silibinina should be started as soon as possible after poisoning, even without waiting for the diagnosis of mushroom poisoning to be confirmed.
• The recommended dose is 20 mg of silibinina per kg of body weight and day, divided into 4 intravenous infusions of 2 hours each, with a 4-hour interval between them, while controlling fluid balance. In each infusion, 5 mg of silibinina per kg of body weight will be administered. Thus, for the treatment of a 70 kg patient, one vial (350 mg of silibinina) will be needed for each infusion.

• Instructions for reconstitution:

• The contents of the vial are dissolved with a minimum of 35 ml of the infusion solution to be administered (0.9% sodium chloride solution or 5% glucose solution).
• The required amount of reconstituted solution (1 ml = 10 mg silibinina) is added to the rest of the saline or glucose solution, depending on the patient's weight.
• Once reconstituted, the solution is stable for 6 hours at 30°C and 24 hours at 2-8°C.
• The administration of the preparation should be by intravenous infusion over 2 hours.
• After an interval of 4 hours, another infusion of the same duration (2 hours) will be performed, so that in 24 hours, 4 infusions will be carried out. This regimen should be continued until the complete disappearance of symptoms of poisoning.

• Precautions:

• A strict control of the electrolyte and acid-base balance, as well as the fluid balance of patients undergoing treatment with this medicine, must be maintained.
• According to the recommended daily dose of 20 mg of silibinina per kg of body weight and the corresponding amount of saline solution needed for its dissolution, up to approximately 0.39 mmol of sodium per kg of body weight/day will be administered.
• Extracorporeal detoxification measures, such as hemoperfusion or hemodialysis, should be performed during the intervals when the infusion is not being administered, in order to avoid the elimination of silibinina from the bloodstream as much as possible.
• The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es