LEGALON 150 mg CAPSULES

Introduction

Package Leaflet: Information for the Patient

Legalon 150 mg Capsules

(Silymarin)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Legalon 150 mg Capsules and what is it used for
2. What you need to know before taking Legalon 150 mg Capsules
3. How to take Legalon 150 mg Capsules
4. Possible side effects
5. Storage of Legalon 150 mg Capsules
6. Package Contents and Additional Information

1. What is Legalon 150 mg Capsules and what is it used for

Legalon 150 mg Capsules belongs to a group of medications called "Hepatic Therapy, Lipotropics" with therapeutic activity on liver lesions, and its active ingredient is silymarin.

Legalon 150 mg Capsules is indicated for the treatment of liver lesions such as those caused by chronic alcohol consumption and hepatotoxic medications, hepatic steatosis (fatty liver), alcoholic hepatitis, and hepatic cirrhosis.

2. What you need to know before taking Legalon 150 mg Capsules

Do not take Legalon 150 mg Capsules

If you are allergic to the active ingredient, silymarin, or to 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 the causes of liver damage (e.g., alcohol).

In case of jaundice (yellowish discoloration of the skin, yellowish discoloration of the whites of the eyes), consult your doctor.

The use of this medication for long periods of time should be monitored by your doctor.

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

Other Medications and Legalon 150 mg Capsules:

Tell 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 interaction has 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 plan 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, in the strict medical opinion, the benefits justify the potential risks.

Breastfeeding:

It is unknown whether silymarin passes into breast milk, so it will only be used during breastfeeding when, in the strict medical opinion, the benefits justify the potential risks.

Driving and Using Machines

The influence of Legalon 150 mg Capsules on the ability to drive and use machines is nil.

Legalon 150 mg Capsules contains Sodium

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

3. How to take Legalon 150 mg Capsules

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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 medically indicated.

Use in Children and Adolescents

No data are available for this age group.

Use in the Elderly

No specific problems have been described in this age group.

Method of Administration

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 Toxicology Information Service. Phone 91 562 04 20.

If you forget to take Legalon 150 mg Capsules

Do not take a double dose to make up for the forgotten doses.

If you interrupt 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.

4. Possible Side Effects

Like all medications, Legalon 150 mg may cause side effects, although not everyone will experience them.

The adverse reactions of Legalon 150 mg are infrequent.

Uncommon (affecting 1 to 10 out of 1000 patients)

Gastrointestinal disorders: stomach pain and diarrhea.

Very rare (affecting less than 1 patient in 10,000)

Immune system disorders: allergic reactions.

Respiratory, thoracic, and mediastinal disorders: dyspnea.

Skin and subcutaneous tissue disorders: skin rash.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Legalon 150 mg Capsules

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Legalon 150 mg Capsules:

The active ingredient is silymarin. Each capsule contains 196 mg of silymarin extract equivalent to 150 mg of silybinin.

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

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer:

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

Date of Last Revision of this Package Leaflet: February 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.es/