Legalon 140

Package Leaflet: Information for the Patient

LEGALON 140, hard capsules

Silybi mariani fructus extractum siccum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• This 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 those not listed in this leaflet, they should inform their doctor or pharmacist. 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. Package contents 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 fruit in their composition. The active substance of milk thistle fruit 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 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 factors harmful to the liver. If symptoms of jaundice (light to dark yellow discoloration of the skin, yellow discoloration of the whites of the eyes, or changes in the color of urine or stool) occur, the patient should consult their doctor immediately.

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 tell 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 during use 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 operating machines during the use of 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 package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, 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 medicine should be taken orally. The capsules should be taken 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 about the use of this medicine, the patient should consult their doctor or pharmacist. 4.

Possible side effects

Like all medicines, Legalon 140 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 the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. 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 Side effects can also be reported to the marketing authorization holder. 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. It should be stored at a temperature below 25°C .The medicine should not be used after the expiry date stated on the carton and blister after: EXP. The expiry date (EXP) means 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. Package contents and other information

What Legalon 140 contains

• The active substance of the medicine is Silybi mariani fructus extractum siccum173.0 - 186.7 mg (standardized extract 36-44:1, extractant: ethyl acetate 98% V/V) which corresponds to 58.0 - 62.5% of silymarin calculated as silybinin.
• The excipients are: microcrystalline cellulose, corn starch, sodium carboxymethylcellulose (type A), sodium lauryl sulfate (see section 2 "Sodium content"), magnesium stearate.
• The composition of the capsule shell is: red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate (see section 2 "Sodium content").

What the medicine looks like and what the package contains

The medicine is in the form of brown gelatin hard capsules. The carton contains 20 or 100 capsules in blisters.

Marketing authorization holder:

Viatris Healthcare Sp. z o.o. ul. Postępu 21B 02-676 Warsaw

Manufacturer:

Madaus GmbH Lütticher Str. 5 53842 Troisdorf Germany

To obtain more detailed information about this medicine, please contact:

Viatris Healthcare Sp. z o.o. tel.: 22 546 64 00

Date of the last revision of the leaflet: 11/2024