Legalon 140

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Legalon 140

140 mg, hard capsules

Silybi mariani fructus extractum siccum

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Legalon 140 and what is it used for
• 2. Important information before taking Legalon 140
• 3. How to take Legalon 140
• 4. Possible side effects
• 5. How to store Legalon 140
• 6. Contents of the packaging and other information

1. What is Legalon 140 and what is it used for

Legalon 140 is manufactured in the form of hard capsules, which contain a dry extract of milk thistle fruits. The active substance of milk thistle fruits is a complex of flavonolignans called silymarin, which includes, among others, silybinin. The medicine is used to treat liver diseases.

Indications for use:

• treatment of conditions after toxic liver damage;
• auxiliary treatment in patients suffering from chronic inflammatory liver diseases and liver cirrhosis.

2. Important information before taking Legalon 140

When not to take Legalon 140

• if the patient is allergic to the active substance, milk thistle, and (or) other plants of the Asteraceae family (formerly Compositae), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Legalon 140, the patient should discuss it with their doctor or pharmacist. The medicine should not be used to treat acute poisonings. During treatment, the patient should avoid harmful factors for the liver. If symptoms of jaundice (light to dark yellow discoloration of the skin, yellow discoloration of the whites of the eyes, or change in the color of urine or stool) occur, the patient should immediately consult their doctor.

Children and adolescents

Due to the lack of data, the medicine should not be used in children under 12 years of age.

Legalon 140 and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. So far, no interactions have been found when used with other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Due to the lack of available data, the medicine should not be used during pregnancy and breastfeeding.

Driving and using machines

There is no data on contraindications for driving and using machines while taking Legalon 140.

Sodium content

Legalon 140 contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Legalon 140

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. At the beginning of treatment, it is recommended to take 1 capsule 3 times a day (which corresponds to 420 mg of silymarin). As a maintenance dose, 1 capsule is taken 2 times a day (which corresponds to 280 mg of silymarin). If the patient experiences an exacerbation of symptoms, they should consult their doctor. If the symptoms persist for more than 2 weeks, the patient should consult their doctor. The duration of therapy should be decided by the doctor. The capsules should be taken orally, whole, before meals, with a small amount of liquid.

Use in children and adolescents

The medicine should not be used in children under 12 years of age.

Taking a higher dose of Legalon 140 than recommended

Enhanced side effects may occur. In such a case, the patient should consult their doctor.

Missing a dose of Legalon 140

The patient should not take a double dose to make up for a missed capsule.

Stopping the use of Legalon 140

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. During the use of Legalon 140, the following side effects have been observed:

Rare(less than 1 in 1000 people):

Gastrointestinal disorders: loose stools.

Very rare(less than 1 in 10,000 people):

Immune system disorders: hypersensitivity reactions

Respiratory, thoracic, and mediastinal disorders: dyspnea

Skin and subcutaneous tissue disorders: rash.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Legalon 140

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Legalon 140 contains

• The active substance of the medicine is: dry extract of milk thistle fruits (Silybi mariani fructus extractum siccum) 173.0 - 186.7 mg (standardized extract DER 36-44:1, extractant: ethyl acetate) which corresponds to 58.0 - 62.5% of silymarin calculated as silybinin.
• Excipients: sodium carboxymethylcellulose (type A), magnesium stearate, corn starch, microcrystalline cellulose, sodium lauryl sulfate (see section 2 "Sodium content"). Capsule shell: red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate (see section 2 "Sodium content").

What Legalon 140 looks like and contents of the pack

The medicine is in the form of brown, hard gelatin capsules. The cardboard box contains 20 or 100 capsules in blisters. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, in the country of export:

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

Manufacturer:

Madaus GmbH, 51101 Cologne, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Hungary, in the country of export: OGYI-T-1843/01, OGYI-T-1843/02

Parallel import authorization number: 291/15

Date of approval of the leaflet: 21.05.2025

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