Package Insert: Information for the Patient

Legalon 150 mg Capsules

(Silimarina)

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See Section 4

Licaron150 mg capsules belongs to a group of medications called “Liver therapy, lipotropic agents” with therapeutic activity on liver damage, and whose active ingredient is silimarina.

Licaron150 mg capsules is indicated for the treatment of liver damage such as that caused by chronic alcohol consumption and hepatotoxic drugs, hepatic steatosis (fatty liver), alcoholic hepatitis, and liver cirrhosis.

Do not take Legalon 150 mg capsules

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

Warnings and precautions

Treatment with dry extract of milk thistle fruit does not replace abstinence from liver-damaging causes (for example, alcohol).

In case of jaundice (yellowish discoloration of the skin from light to dark, yellowish discoloration of the white of the eye) consult your doctor.

The use of this medication over long periods of time should be controlled by your doctor.

Consult your doctor or pharmacist before starting to take Legalon 150 mg capsules.

Other medications and Legalon 150 mg capsules:

Inform your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

Taking Legalon 150 mg capsules with food and drinks:

No interactions have been described between the use of this medication and the consumption of food and drinks.

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Since there are no studies in pregnant women, this medication will only be used during pregnancy when strictly medical criteria justify the potential risks.

Breastfeeding:

The passage of silimarina into breast milk is unknown, so this medication will only be used during breastfeeding when strictly medical criteria justify the potential risks.

Driving and operating machines

The influence of Legalon 150 mg capsules on the ability to drive and operate machines is negligible.

Legalon 150 mg capsules contain sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again if you have any questions.

Adults

The recommended oral dose is 1 capsule (150 mg) three times a day, after the main meals.

The treatment period is established at 4 to 6 weeks and as a maintenance dose 1 capsule 2 times a day, unless otherwise indicated by a medical criterion.

Use in children and adolescents

No data is available for this age group.

Use in the elderly

No specific problems have been described for this age group.

Administration form

Swallow the capsules with a little liquid after the main meals.

If you take more Legalon 150 mg capsules than you should:

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Legalon 150 mg capsules

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Legalon 150 mg capsules

Consult your doctor.

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

Like all medications, Legalon 150 mg can produce adverse effects, although not all people will experience them.

Adverse reactions to Legalon 150 mg are infrequent.

Infrequent(affecting between 1 and 10 of every 1000 patients)

Gastrointestinal disorders: stomach pain and diarrhea.

Very Rare(affecting fewer than one patient in every 10,000)

Immunological system disorders: allergic reactions.

Respiratory, thoracic, and mediastinal disorders: dyspnea.

Skin and subcutaneous tissue disorders: skin rash.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Adverse Effect Reporting

If you experience any type of adverse effect, consult with 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 Human Medicines, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep this medication out of the sight and reach of children. Store in the outer packaging.

Do not use Legalon 150 mg capsules after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Legalon 150 mg capsules:

The active ingredient is silimarina. Each capsule contains 196 mg of silimarina extract equivalent to 150 mg of silibinina.

The other components are: Mannitol (E-421), Polysorbate 80, Polyvinylpyrrolidone, Anhydrous Colloidal Silica, Magnesium Stearate, and Sodium Carboxymethylcellulose Type A.

The capsule is composed of: Iron Oxides Red and Yellow (E-172), Erythrosine (E-127), and Titanium Dioxide (E-171).

Appearance of the product and contents of the packaging

Legalon 150 mg Capsules are presented in blisters containing 30 hard red capsules.

Holder of the marketing authorization:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing:

Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares – Spain

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

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

Last review date of this leaflet: February 2025

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