Legalon 140
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Legalon 140
140 mg, hard capsules
Silybi mariani fructus extractum siccum
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement 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 manufactured in the form of hard capsules containing a dry extract of milk thistle fruit. The active constituent of milk thistle fruit is a group of flavonolignans 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 an adjunctive 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, 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 change 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 with 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 intends to take. No interactions with other medicines have been reported to date.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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 is no data on contraindications regarding driving and operating machinery during use of 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 information 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 3 times daily (corresponding to 420 mg of silymarin). For maintenance therapy, the dose is 1 capsule 2 times 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.
Taking more Legalon 140 than recommended
Increased adverse effects may occur. In such a case, consult a doctor immediately.
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 effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed during the use of Legalon 140:
Rare (less than 1 in 1,000 people):
Gastrointestinal disorders: loose stool.
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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.
5. How to store Legalon 140
Keep the 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 in use. Such measures help protect the environment.
6. Contents of the pack and other information
What Legalon 140 contains
- The active substance is dry extract of milk thistle fruit ( Silybi mariani fructus extractum siccum) 173.0 - 186.7 mg (standardized extract DER 36-44:1, extraction solvent: ethyl acetate), corresponding to 58.0 - 62.5% silymarin calculated as silybinin.
- The excipients are: microcrystalline cellulose, maize starch, sodium carboxymethyl starch (type A), sodium lauryl sulfate, magnesium stearate.
- Capsule coating composition: iron oxide red (E 172), iron oxide black (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate (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.
Each cardboard box contains 20 capsules in blisters.
For more detailed information, please 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.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A Street
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
Hungary marketing authorization number: OGYI-T-1843/01
OGYI-T-1843/02
Parallel import authorization number: 272/19