Active ingredients: Silymarin
LEGALON 70 mg coated tablets
LEGALON 140 mg coated tablets
LEGALON 200 mg effervescent granules
Why is Legalon used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antitoxic
THERAPEUTIC INDICATIONS
Treatment of poisoning from ethyl alcohol, psychotropic drugs, antiblastics, paracetamol.
Contraindications When Legalon should not be used
Individual ascertained hypersensitivity to the product. Severe biliary obstruction.
Precautions for use What you need to know before taking Legalon
They are not necessary. There are no known cases of addiction or dependence.
Interactions Which drugs or foods can modify the effect of Legalon
No interactions with other drugs have been reported.
Dose, Method and Time of Administration How to use Legalon: Posology
Sachets: Start treatment with one sachet 2 times a day after main meals for 4-6 weeks. Then continue with one sachet 1-2 times a day even for long periods. The contents of the sachets must be dissolved in half a glass of water, shaking well to facilitate dissolution.
70 mg coated tablets: Start treatment with 2 tablets 3 times a day after main meals for 4-6 weeks. Then continue with one tablet 3 times a day even for long periods.
140 mg coated tablets: Start treatment with 1 tablet 3 times a day after main meals for 4-6 weeks. Then continue with one tablet 2 times a day even for long periods.
Overdose What to do if you have taken too much Legalon
There are no known cases of overdose
Side Effects What are the side effects of Legalon
LEGALON is usually well tolerated. Occasionally a moderate laxative effect has been reported. In the event of any other side effect occurring, this must be reported to your doctor or pharmacist.
Expiry and Retention
The expiry date indicated refers to the product in intact packaging, correctly stored.
CAUTION: DO NOT USE THE MEDICINAL PRODUCT AFTER THE EXPIRY DATE INDICATED ON THE PACKAGE.
Keep this medicine out of the reach of children.
COMPOSITION
Each 200 mg sachet contains:
Active principle:
milk thistle extract containing 200 mg of flavonoids expressed as silymarin.
Excipients: sodium bicarbonate, tartaric acid, citric acid, sodium chloride, tribasic sodium citrate, sodium saccharinate, quinoline yellow color E104, lemon flavor, sucrose, lactose.
Each 70 mg coated tablet contains:
Active ingredient:
milk thistle extract containing 70 mg of flavonoids expressed as silymarin.
Excipients: lactose, dextrose, polysorbitan monoleate, polyvinylpyrrolidone, rice starch, stearin, crospovidone, gum arabic, talc, sucrose, precipitated silica, calcium carbonate, titanium dioxide, E110, kepal wax.
Each 140 mg coated tablet contains
Active principle:
milk thistle extract containing 140 mg of flavonoids expressed as silymarin.
Excipients: lactose, dextrose, polysorbitan monoleate, polyvinylpyrrolidone, rice starch, stearin, crospovidone, gum arabic, talc, sucrose, precipitated silica, calcium carbonate, titanium dioxide, E127, E110, kepal wax
PHARMACEUTICAL FORM AND PACKAGING
Effervescent granules, coated tablets.
Box of 30 sachets of 200 mg effervescent granules
Box of 30 coated tablets of 140 mg
Box of 40 coated tablets of 70 mg
Box of 20 coated tablets of 70 mg
Legalon is also present in 1% syrup
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
LEGALON
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 70 mg coated tablet contains: active principle: milk thistle extract containing flavonoids expressed as silymarin 70 mg.
Each 140 mg coated tablet contains: active principle: milk thistle extract containing flavonoids expressed as silymarin 140 mg.
Each 200 mg sachet contains: active principle: milk thistle extract containing flavonoids expressed as silymarin 200 mg.
100 ml of syrup contain: active principle: milk thistle extract containing flavonoids expressed as silymarin g 1.
03.0 PHARMACEUTICAL FORM
Coated tablets, effervescent granules, syrup.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of poisoning from ethyl alcohol, psychotropic drugs, antiblastics, paracetamol.
04.2 Posology and method of administration
Adults: Legalon 70 mg: start treatment with 2 tablets 3 times a day after main meals for 4-6 weeks; therefore continue with 1 tablet 3 times a day even for long periods.
Legalon 140 mg: start treatment with 1 tablet 3 times a day after main meals for 4-6 weeks; therefore continue with 1 tablet 2 times a day even for long periods.
Legalon 200 mg: start treatment with one sachet twice a day after main meals for 4-6 weeks. Then continue with a sachet 1-2 times a day even for long periods. The contents of the sachets must be dissolved in 1 glass of water, shaking well to facilitate dissolution.
Legalon syrup: 10 ml 3 times a day, after meals. Shake before use to obtain a uniform suspension.
Children:
Legalon syrup: from 2 to 4 years: 2.5 ml 3 times a day after meals: from 5 to 10 years: 5 ml 3 times a day after meals; 11 to 14 years: 7.5 ml 3 times a day after meals; over 14 years: 10 ml 3 times a day after meals. 10 ml of Legalon syrup contain 100 mg of active ingredient.
04.3 Contraindications
Individual ascertained hypersensitivity to the product. Severe biliary obstruction.
04.4 Special warnings and appropriate precautions for use
There are no known cases of addiction or dependence.
No special precautions are necessary for use.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions with other drugs have been reported.
04.6 Pregnancy and lactation
The drug is devoid of teratogenic effect; however, its administration during pregnancy is not recommended except in cases of absolute necessity.
04.7 Effects on ability to drive and use machines
Legalon does not interfere with those capabilities.
04.8 Undesirable effects
Legalon is usually well tolerated. Occasionally a moderate laxative effect has been reported.
04.9 Overdose
There are no known cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
The liver is the target organ of many of the most common food and environmental toxicants. Silymarin, the active ingredient of the Legalon specialty, has been shown to be able to antagonize the effects of various hepatotoxins. The drug's activity is attributable to the its property of interfering with the pathogenetic mechanisms triggered by the hepatotoxins themselves. The mechanism of action is complex. For most toxicants it is due to an inhibition of their metabolic activation, through the ability of silymarin to interfere with membrane events, exerting anti-lipoperoxidative and free radical scavenger actions at this level. added silymarin interferes with the transport systems, at the level of cell membranes, common to many exogenous substances (carbon tetrachloride, rifampicin, fusidic acid, amanitin, etc.) thus causing a reduced uptake of these substances by the liver cells. Furthermore, the drug, in ethanol poisoning, has been shown to inhibit the conversion of ethanol itself to acetaldehyde and to prevent the decrease in intracellular concentrations of glutathione, induced by exogenous toxic agents such as alcohol and paracetamol, thus determining a greater availability of this molecule for the inactivation of the toxic agents themselves and theirs metabolites.
05.2 Pharmacokinetic properties
Pharmacokinetic studies have shown that the drug is well absorbed orally and that absorption is proportional to the administered dose. Elimination through the renal emunctory is very low, occurring mainly via the biliary route (80-90% of administered) with the existence of an enterohepatic circulation. The highest concentrations are in fact found in the liver and blood, to a modest extent in other organs. Following repeated administration, biliary excretion reaches a steady-state at the end of the second day, with exclusion therefore of accumulation phenomena.
05.3 Preclinical safety data
The active ingredient of Legalon, administered orally in experimental animals, has a very low toxicity, practically undocumented. Long-term toxicity studies in various animal species have demonstrated the perfect tolerability of the product even at doses of 1.2 g / kg / day. No teratogenic or foetotoxic effects were detected.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
70 mg coated tablets:
Lactose, dextrose, polysorbitan monooleate, polyvinylpyrrolidone, rice starch, stearin, crospovidone, gum arabic, talc, sucrose, precipitated silica, calcium carbonate, titanium dioxide, color E110, kepal wax.
140 mg coated tablets:
Lactose, dextrose, polysorbitan monooleate, polyvinylpyrrolidone, rice starch, stearin, crospovidone, gum arabic, talc, sucrose, precipitated silica, calcium carbonate, titanium dioxide, color E127, color E110, kepal wax.
200 mg sachets:
Sodium bicarbonate, tartaric acid, citric acid, sodium chloride, tribasic sodium citrate, sodium saccharinate, quinoline yellow color E104, lemon flavor, sucrose, lactose.
Syrup: Carboxymethylcellulose, bentonite, microgranular cellulose, potassium sorbate, sodium benzoate, ascorbic acid, citric acid, sorbitol, sodium saccharin, Somal Jordan flavor, Givaudan sweet flavor, Nougat E flavor, water to taste.
06.2 Incompatibility
No incompatibilities were highlighted.
06.3 Period of validity
With intact packaging:
Coated tablets 5 years.
Sachets 5 years.
Syrup 3 years.
06.4 Special precautions for storage
They are not necessary.
06.5 Nature of the immediate packaging and contents of the package
Box containing 20 coated tablets of 70 mg
Box containing 40 coated tablets of 70 mg
Box containing 30 coated tablets of 140 mg
Box containing 30 sachets of 200 mg effervescent granules
Syrup bottle containing 150 ml
06.6 Instructions for use and handling
See point 4.2
07.0 MARKETING AUTHORIZATION HOLDER
Madaus S.r.l. - Riviera Francia, 3 / A - Padua
08.0 MARKETING AUTHORIZATION NUMBER
LEGALON 70 mg coated tablets - 20 tablets n. 022258026
LEGALON 70 mg coated tablets - 40 tablets n. 022258040
LEGALON 140 mg coated tablets - 30 tablets n. 022258014
LEGALON 200 mg effervescent granules - 30 sachets n. 022258091
LEGALON 1% syrup - 150 ml bottle n. 022258053
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: June 2005
10.0 DATE OF REVISION OF THE TEXT
01/12/2003
