Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Legalon 140
140 mg, hard capsules
Silybi mariani fructus extractum siccum
Please read this 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 patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your symptoms do not improve or if you feel worse, consult your doctor.

Table of Contents

What Legalon 140 is and what it is used for
What you need to know before taking Legalon 140
How to take Legalon 140
Possible side effects
How to store Legalon 140
Contents of the pack and other information

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

Legalon 140 is available as hard capsules containing a dry extract of milk thistle fruit. The active constituent of milk thistle fruit is a flavonolignan complex called silymarin, which includes, among others, silybinin.
The medicine is used in the treatment of liver disorders.
Indications:

Treatment of conditions following toxic liver damage;
As supportive therapy in patients suffering from chronic inflammatory liver diseases and liver cirrhosis.

2. Important information before using Legalon 140

When not to use Legalon 140

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

Warnings and precautions
Before starting treatment with Legalon 140, consult your doctor or pharmacist.
This medicine should not be used for the treatment of acute poisoning.
During treatment, avoid factors harmful to the liver.
If symptoms of jaundice occur (light to dark yellow discoloration of the skin, yellowing of the whites of the eyes, or changes in the colour of urine or stool), consult a doctor immediately.

Children and adolescents
Due to lack of data, do not use this medicine in children under 12 years of age.

Legalon 140 and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
To date, no interactions with other medicines have been reported.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Due to lack of available data, this medicine should not be used during pregnancy and breastfeeding.

Driving and operating machinery
There are no data regarding contraindications to driving vehicles or operating machinery while using Legalon 140.

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

3. How to use Legalon 140

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
At the beginning of treatment, the recommended dose is 1 capsule three times daily (corresponding to 420 mg of silymarin). For maintenance therapy, the dose is 1 capsule twice daily (corresponding to 280 mg of silymarin).
If symptoms worsen during treatment, the patient should consult a doctor.
If symptoms persist for longer than 2 weeks, medical advice should be sought.
The duration of therapy should be determined by a doctor.
Oral administration. Swallow the capsules whole, before meals, with a small amount of liquid.
Use in children and adolescents
Do not use this medicine in children under 12 years of age.
Accidental overdose of Legalon 140
Increased adverse effects may occur. In such a case, consult a doctor.
Missed dose of Legalon 140
Do not take a double dose to make up for a missed capsule.
Stopping Legalon 140
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of Legalon 140:
Rare (less than 1 in 1,000 people):
Gastrointestinal disorders: loose stools.
Very rare (less than 1 in 10,000 people):
Immune system disorders: hypersensitivity reactions
Respiratory, thoracic and mediastinal disorders: dyspnoea
Skin and subcutaneous tissue disorders: rash.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Legalon 140

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Legalon 140 contains

The active substance is: dried extract of milk thistle fruit (Silybi mariani fructus extractum siccum) 173.0 – 186.7 mg (standardised extract DER 36-44:1, extraction solvent: ethyl acetate), corresponding to 58.0 – 62.5% silymarin calculated as silibinin.
Other ingredients: sodium carboxymethyl starch (type A), magnesium stearate, maize starch, microcrystalline cellulose, sodium lauryl sulphate (see section 2 “Sodium content”). Capsule shell composition: iron oxide red (E 172), iron oxide black (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulphate (see section 2 “Sodium content”).

What the medicine looks like and contents of the pack
The medicine is in the form of brown hard gelatin capsules.
Pack sizes: 20 or 100 capsules in blister packs contained in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Hungary, 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
Hungarian Marketing Authorisation numbers, country of export: OGYI-T-1843/01
OGYI-T-1843/02
Parallel Import Authorisation number: 291/15