Legalon 150 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Legalon 150 mg capsules

(silymarin)

Read the entire leaflet carefully before you start taking 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Legalon 150 mg capsules are and what they are used for
2. What you need to know before taking Legalon 150 mg capsules
3. How to take Legalon 150 mg capsules
4. Possible adverse effects
5. How to store Legalon 150 mg capsules
6. Contents of the pack and other information

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

Legalon 150 mg capsules belong to a group of medicines called "Hepatic therapy, lipotropic agents" with therapeutic activity on liver damage, and whose active ingredient is silymarin.

Legalon 150 mg capsules are indicated for the treatment of liver injuries such as those caused by chronic intake of alcohol and hepatotoxic drugs, 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 substance, silymarin, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Treatment with the dried extract of milk thistle fruit does not replace avoiding the causes of liver damage (for example, alcohol).

If jaundice occurs (skin turning from light to dark yellow, yellowing of the whites of the eyes), you should consult your doctor.

Long-term use of this medicine should be monitored by a doctor.

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

Other medicines and Legalon 150 mg capsules:

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

Taking Legalon 150 mg capsules with food and drinks:

No interaction between the use of this medicine and food or drink has been reported.

Pregnancy, breastfeeding and fertility

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

Pregnancy:

As there are no studies available in pregnant women, this medicine should only be used during pregnancy when, in the strict judgment of the physician, the benefit outweighs the potential risks.

Breastfeeding:

It is unknown whether silymarin passes into breast milk; therefore, this medicine should only be used during breastfeeding when, in the strict judgment of the physician, the benefit outweighs the potential risks.

Driving and using machines

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

Legalon 150 mg capsules contains sodium

This medicine 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 exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

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

The treatment period is typically 4 to 6 weeks, followed by a maintenance dose of 1 capsule twice daily, unless otherwise directed by a physician.

Use in children and adolescents

No data are available in this age group.

Use in elderly

No specific problems have been reported in this age group.

Method of administration

Swallow the capsules with a little liquid after main meals.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Legalon 150 mg capsules

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

If you stop treatment with Legalon 150 mg capsules

Consult your doctor.

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

4. Possible adverse effects

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

Adverse reactions to Legalon 150 mg are uncommon.

Uncommon (affecting between 1 and 10 out of 1,000 patients):

Gastrointestinal disorders: stomach pain and diarrhoea.

Very rare (affecting less than 1 out of 10,000 patients):

Immune system disorders: allergic reactions.

Respiratory, thoracic and mediastinal disorders: dyspnoea.

Skin and subcutaneous tissue disorders: skin rash.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through 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 Legalon 150 mg capsules

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

Do not use Legalon 150 mg capsules after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Pack contents and additional information

Composition of Legalon 150 mg capsules:

The active substance is silymarin. Each capsule contains 196 mg of silymarin extract equivalent to 150 mg of silibinin.

The other components are: Mannitol (E-421), Polysorbate 80, Polyvinylpyrrolidone, Anhydrous colloidal silica, Magnesium stearate and Sodium carboxymethylstarch type A.

The capsule shell contains: Red and yellow iron oxides (E-172), erythrosine (E-127) and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Legalon 150 mg Capsules are presented in blister packs containing 30 red, hard capsules.

Marketing Authorization Holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The Netherlands

Manufacturer:

Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares – Spain

Further information on this medicinal product is available 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 latest review of this leaflet: February 2025

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