Label: information for the user

Silibinina Viatris 350 mg lyophilized for infusion solution

Read this label carefully before starting to take this medicine, as it contains important information for you.

−Keep this label as you may need to refer to it again.

−If you have any questions, consult your doctor or pharmacist.

−This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

−If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Silibinina is an antidote to amatoxina (the main toxin of the poisonous mushroom Amanita phalloides), and it acts by blocking the uptake of amatoxina 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.

Do not use Silibinina Viatris

-If you are allergic to the active ingredient silibinina or to any of the other components of this medication (listed in section 6).

Warnings and precautions

• You must maintain strict control of the electrolyte and acid-base balance, as well as the fluid balance of patients being treated with silibinina.
• 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 silibinina.

Other medications and Silibinina Viatris

No interactions with other medications have been described.

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

No clinical data are available with silibinina in pregnant women. Animal studies do not show direct or indirect harmful effects on pregnancy, embryonic/fetal development, delivery, or postnatal development. If silibinina is considered necessary for a pregnant woman, it is recommended to administer with caution.

Silibinina Viatris contains sodium

This medication contains 34 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.7% of the maximum daily sodium intake recommended for an adult.

Driving and operating machines

No effects on driving and operating machines have been described.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication will be administered by a healthcare professional at all times.

The administration of this medication will be performed by intravenous infusion.

Recommended Dose:

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

Treatment Duration:

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• Feeling of heat (flush) during infusion.

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

• Fever.
• Increased bilirubin in blood.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

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

Composition of Silibinina Viatris

A vial for infusion with 598.5 mg of lyophilized product contains:

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

The other components are inulin.

Appearance of the product and contents of the package

Silibinina Viatris is presented in packages with 4 vials for infusion containing 598.5 mg of lyophilized product.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

MADAUS GmbH

Lütticher Strasse, 5

53842 –Troisdorf

Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:October 2023

This information is intended solely for healthcare professionals:

• Intravenous infusions with silibinina should be initiated as soon as possible after intoxication, even without waiting for confirmation of the diagnosis of mushroom poisoning.
• The recommended dose is20 mg of silibinina per kg of body weight per day, divided into 4 intravenous infusions of 2 hours each, with 4 hours of intervalbetween them, 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, a vial (350 mg of silibinina) would 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 (sodium chloride 0.9% solution or 5% glucose solution).
• The amount of reconstituted solution (1 ml = 10 mg silibinina) necessary, depending on the patient's weight, is added to the remaining saline or glucose solution.
• Once reconstituted, the solution is stable within 6 hours at 30°C and 24 hours at 2-8°C.
• The administration of the preparation should be carried out by intravenous infusion over 2 hours.
• After a 4-hour interval, another infusion similar to the previous one (2 hours of duration) should be performed, so that in 24 hours, 4 infusions are performed. This regimen should be continued until the complete disappearance of the symptoms of intoxication.

• Precautions:

• A strict control of the electrolyte balance and acid-base balance, as well as fluid balance, should be maintained in patients undergoing treatment with this medication.
• According to the recommended daily dose of 20 mg of silibinina per kg of body weight and the corresponding amount of saline solution necessary for its dissolution, approximately 0.36 mmol of sodium per kg of body weight/day are administered.
• Extracorporeal detoxification measures, such as hemoperfusion or hemodialysis, should be performed during the intervals in which the infusion is not being administered in order to avoid, as far as possible, the elimination of silibinina from the bloodstream.
• The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Further detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es