Legalon 140

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Legalon 140

140 mg, hard capsules

Silybi mariani fructus extractum siccum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the 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 using Legalon 140
• 3. How to use 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 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; as an auxiliary treatment for patients suffering from chronic inflammatory liver diseases and liver cirrhosis.

2. Important information before using Legalon 140

When not to use Legalon 140

Warnings and precautions

Before starting to take Legalon 140, you should discuss it with your doctor or pharmacist. The medicine should not be used to treat acute poisonings. During treatment, you should avoid factors that are 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 a change in the color of urine or stool) occur, you should consult a 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

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, as well as any medicines you plan to take. So far, no interactions have been found during use with other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using 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 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 use Legalon 140

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your 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, you should consult your doctor. The duration of therapy should be decided by the doctor. Oral administration. 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, you should consult your doctor.

Missing a dose of Legalon 140

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

Stopping the use of Legalon 140

If you have any further doubts about the use of this medicine, you should consult your 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 you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your 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 By reporting side effects, you can help provide more information 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 specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your 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 a dry extract of milk thistle fruit (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.
• The excipients are: microcrystalline cellulose, corn starch, sodium carboxymethyl cellulose (type A), sodium lauryl sulfate, 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 pack contains

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

Marketing authorization holder in Hungary, the country of export:

Mylan EPD Kft 1138 Budapest Váci út 150. Hungary

Manufacturer:

Madaus GmbH 51101 Cologne Germany

Parallel importer:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warsaw Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warsaw Laboratorium Galenowe Olsztyn Sp. z o.o. ul. Spółdzielcza 25A 11-001 Dywity Synoptis Industrial Sp. z o.o. ul. Szosa Bydgoska 58 87-100 Toruń Authorization number in Hungary, the country of export: OGYI-T-1843/01 OGYI-T-1843/02 Parallel import authorization number: 272/19

Date of approval of the leaflet: 17.07.2024

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