Patient Information Leaflet: Information for the Patient

LEGALON

coated tablets
effervescent granules
silymarin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LEGALON is and what it is used for

LEGALON contains the active substance silymarin, derived from a plant (milk thistle), known for its liver-protecting (hepatoprotective) properties.
LEGALON is indicated as an adjunctive treatment for symptoms related to digestive disorders, sensation of fullness and indigestion, and as supportive treatment for liver function, after clinically excluding serious conditions.

2. What you need to know before taking LEGALON

Do not take LEGALON

if you are allergic to silymarin or to any of the other ingredients of this medicine (listed in section 6);
if you have a severe blockage of the ducts carrying bile to the intestine (severe biliary obstruction);
if you are allergic to plants of the Asteraceae (Compositae) family.

Warnings and precautions
Talk to your doctor or pharmacist before taking LEGALON.
In particular, consult your doctor immediately if, during treatment with this medicine, you develop a yellowish discoloration of the skin or eyes (jaundice) or a change in the colour of your urine or stools.
The efficacy and safety of use in children and adolescents under 18 years of age have not been established.

Other medicines and LEGALON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between LEGALON and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, the use of Legalon is not recommended.

Driving and using machines
There are no studies on the effects of LEGALON on the ability to drive vehicles or operate machinery.

LEGALON film-coated tablets contain lactose, dextrose, sucrose and the colouring agent orange-yellow (E110)
This medicine contains lactose, dextrose and sucrose, three types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains the colouring agent orange-yellow (E110) which may cause allergic reactions.

LEGALON effervescent granulate contains lactose, sucrose and sodium
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains 155 mg of sodium (a component of table salt) per dose (1 sachet).
This corresponds to 7.75% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take LEGALON

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take LEGALON after main meals.
LEGALON 70 mg coated tablets
Initial (attack) therapy: The recommended dose is 2 tablets, 3 times a day for 4–6
weeks.
Maintenance therapy: The recommended dose is 1 tablet, 3 times a day.
LEGALON 140 mg coated tablets
Initial (attack) therapy: The recommended dose is 1 tablet, 3 times a day for 4–6
weeks.
Maintenance therapy: The recommended dose is 1 tablet, 2 times a day.
LEGALON 200 mg effervescent granules
Initial (attack) therapy: The recommended dose is 1 sachet, 2 times a day for 4–6 weeks.
Maintenance therapy: The recommended dose is 1 sachet, 1 or 2 times a day.
Empty the contents of the sachet into half a glass of water and stir to ensure it dissolves properly.
If you take more LEGALON than you should
There are no known cases of overdose.
In case of accidental ingestion/overdose of LEGALON, contact your doctor immediately or go to the nearest hospital.
If you forget to take LEGALON
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 people)

Stomach and intestinal disturbances (gastrointestinal disorders);
Soft stools (laxative effect).

Very rare (may affect up to 1 in 10,000 people)

Changes in breathing rate and rhythm (dyspnoea);
Blistering rash accompanied by redness, itching, and pain (skin eruption);
Allergic reactions (hypersensitivity reactions).

Frequency not known (frequency cannot be estimated from the available data):

Dry mouth
Nausea
Stomach discomfort
Gastric irritation
Headache
Dermatitis
Urticaria
Itching
Anaphylaxis (sudden and severe allergic reaction with breathing difficulties, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness)
Asthma

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LEGALON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original packaging,
properly stored.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What LEGALON contains
LEGALON 70 mg coated tablets

The active substance is extract (as dry extract) from milk thistle fruit (36-44:1). Extraction solvent: 98% (v/v) ethyl acetate. Each tablet contains 70 mg of total flavonoids expressed as silymarin.
The other ingredients are: lactose, dextrose, polysorbate 80, polyvinylpyrrolidone, rice starch, stearic acid, crospovidone, gum arabic, talc, sucrose, precipitated silica, calcium carbonate, titanium dioxide, colour E110, cera kepal.

LEGALON 140 mg coated tablets

The active substance is extract (as dry extract) from milk thistle fruit (36-44:1). Extraction solvent: 98% (v/v) ethyl acetate. Each tablet contains milk thistle extract containing 140 mg of total flavonoids expressed as silymarin.
The other ingredients are: lactose, dextrose, polysorbate 80, polyvinylpyrrolidone, rice starch, stearic acid, crospovidone, gum arabic, talc, sucrose, precipitated silica, calcium carbonate, titanium dioxide, colour E127, colour E110, cera kepal.

LEGALON 200 mg effervescent granules

The active substance is extract (as dry extract) from milk thistle fruit (36-44:1). Extraction solvent: 98% (v/v) ethyl acetate. Each sachet contains milk thistle extract containing 200 mg of total flavonoids expressed as silymarin.
The other ingredients are: sodium bicarbonate, tartaric acid, citric acid, sodium chloride, trisodium citrate, sodium saccharin, quinoline yellow colour E104, lemon flavour, sucrose, lactose.

Description of the appearance of LEGALON and contents of the pack
LEGALON 70 mg coated tablets
70 mg coated tablets. Carton pack containing 20 or 40 tablets.
LEGALON 140 mg coated tablets
140 mg coated tablets. Carton pack containing 30 tablets.
LEGALON 200 mg effervescent granules
Effervescent granules 200 mg. Carton pack containing 30 sachets.

Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)

Manufacturers responsible for batch release
LEGALON coated tablets
Madaus GmbH - Luetticher Strasse, 5 - 53842 Troisdorf - Germany
LEGALON effervescent granules
Madaus GmbH - Luetticher Strasse, 5 - 53842 Troisdorf - Germany
Rottapharm Ltd – Damastown Industrial Park - Mulhuddart – Dublin 15 (Ireland)