Silibinin Viatris 350 mg lyophilisate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Silibinin Viatris 350 mg lyophilisate for solution for infusion

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Silibinin Viatris is and what it is used for
2. What you need to know before using Silibinin Viatris
3. How to use Silibinin Viatris
4. Possible side effects
5. How to store Silibinin Viatris
6. Contents of the pack and other information

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

Silibinin is an antidote for amatoxin (the main toxin of the poisonous mushroom Amanita phalloides), and acts by blocking the uptake of amatoxin by liver cells (hepatocytes), thereby interrupting the enterohepatic circulation of this toxin and promoting its elimination.

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

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

Do not use Silibinina Viatris

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

Warnings and precautions

• Strict monitoring of the patient's electrolyte and acid-base balance, as well as fluid balance, must be maintained during treatment with silybinine.
• If you are on a low-sodium diet (low-salt diet), inform your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take silybinine.

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 need to take any other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no clinical data available on silybinine in pregnant women. Animal studies do not show any direct or indirect harmful effects on pregnancy, embryonal/fetal development, parturition or postnatal development. If administration of silybinine is considered necessary during pregnancy, it is recommended to administer it with caution.

Silibinina Viatris contains sodium

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

Driving and using machines

No effects on driving or using machines have been reported.

3. How to use Silibinin Viatris

Follow exactly the instructions for administration of this medicinal product as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine will always be administered by a healthcare professional.

Method of administration

This medicine is administered by intravenous infusion.

The contents of the vial should be dissolved in a minimum of 35 ml of infusion solution (0.9% sodium chloride solution or 5% glucose solution) to be administered (1 ml = 10 mg of silibinin).

Extracorporeal detoxification measures, such as hemoperfusion or hemodialysis, should be performed during intervals when the infusion is not being administered, in order to minimize the removal of silibinin from the bloodstream.

Strict monitoring of electrolyte and acid-base balance, as well as fluid balance, must be maintained in patients receiving treatment with this medicine.

According to the recommended daily dose of 20 mg of silibinin per kg of body weight and the corresponding amount of saline required for dissolution, up to approximately 0.39 mmol of sodium per kg of body weight/day is administered.

Recommended dose:

Unless otherwise directed by your doctor, the recommended dose is 4 intravenous infusions, each lasting 2 hours, with 4-hour intervals between them, while monitoring fluid balance.

Duration of treatment:

Infusions should be continued for several days until symptoms have completely disappeared.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Feeling of warmth (flush) during infusion.

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

• Fever.
• Increased bilirubin in blood.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Silibinin 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 stated on the container following CAD or EXP. The expiry date refers to the last day of the month indicated.

After reconstitution, the solution is stable for 6 hours if stored at 30 °C and for 24 hours if stored at 2–8 °C.

6. Contents of the pack and other information

Composition of Silibinina Viatris

One infusion vial containing 598.5 mg of lyophilized product includes:

The active substance is 528.5 mg of silibinin-C-2',3-dihydrogen succinate disodium, equivalent to 350 mg of silibinin.

The other component is inulin.

Presentation of the product and pack contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

MADAUS GmbH
Lütticher Strasse, 5
53842 – Troisdorf
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent revision of this summary: October 2025

This information is intended for healthcare professionals only:

• Silibinin infusions should be initiated as soon as possible after poisoning, even without waiting for confirmation of mushroom poisoning diagnosis.

• The recommended dose is 20 mg of silibinin per kg of body weight per day, divided into 4 intravenous infusions, each lasting 2 hours, with 4-hour intervals between them, while monitoring fluid balance. Thus, each infusion delivers 5 mg of silibinin per kg of body weight. For example, treating a 70 kg patient would require one vial (350 mg of silibinin) per infusion.

• Reconstitution instructions:

• Dissolve the contents of the vial with a minimum of 35 ml of the infusion solution to be administered (0.9% sodium chloride solution or 5% glucose solution).

• Add the required amount of reconstituted solution (1 ml = 10 mg silibinin), according to the patient's weight, to the remainder of the saline or glucose solution.

• Once reconstituted, the solution is stable for up to 6 hours at 30 °C or up to 24 hours at 2–8 °C.

• The prepared solution must be administered intravenously by 2-hour infusion.

• After a 4-hour interval, another identical infusion (2 hours duration) should be administered, so that 4 infusions are performed within 24 hours. This regimen should be continued until complete resolution of poisoning symptoms.

• Precautions:

• Strict monitoring of electrolyte and acid-base balance, as well as fluid balance, is required in patients receiving this medicinal product.

• Based on the recommended daily dose of 20 mg of silibinin per kg of body weight and the corresponding volume of diluent required, approximately 0.39 mmol of sodium per kg of body weight/day is administered.

• Extracorporeal detoxification procedures, such as hemoperfusion or hemodialysis, should be performed during intervals when the infusion is not being administered, in order to minimize the removal of silibinin from the bloodstream.

• Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es