Legalon 70 Capsules/Legalon 140 Capsules

Legalon 70 Capsules/Legalon 140 Capsules

silymarin

Manufacturer:

Madaus

Distributor:

DKSH

Marketer:

Meda Pharma
Full Prescribing Info
Contents
Dried extract of milk thistle fruits.
Description
Legalon 70 Capsules/Legalon 140 Capsules contains dried extract of milk thistle fruits.
Legalon 70: Each capsule contains dry extract of milk thistle fruits 86.5-93.35 mg equivalent to silymarin 70 mg (calculated as silibinin).
Legalon 140: 1 capsule contains 173.0 mg - 186.7 mg of dried extract of milk thistle fruits (36-44:1), corresponding to 140 mg of silymarin (DNPH), corresponding to 108.2 mg of silymarin (HPLC) calculated as silibinin (solvent: ethyl acetate > 96.7%).
Excipients/Inactive Ingredients: Legalon 70: Mannitol, sodium carboxymethyl starch, polysorbate 80, polyvidone, magnesium stearate, gelatin, titanium dioxide E171, ferric oxide E172 and dodecyl sodium sulphate.
Legalon 140: Sodium starch glycollate (Type A), Magnesium Stearate, Microcrystalline cellulose, Maize starch, Sodium lauryl sulphate, Iron oxide, red E172, Iron oxide, Black E172, Titanium dioxide E171, Gelatin.
Action
Pharmacotherapeutic group: Medicinal products for liver therapy. ATC Code: A05BA03.
Pharmacology: Pharmacodynamics: The antitoxic efficacy of silymarin has been demonstrated in animal experiments in numerous models of liver damage, e.g. with poisons of the death cap fungus phalloidin and alpha-amantin, with lanthinides, carbon tetrachloride, galactosamine, thiocetamine and the hepatotoxic frog virus FV3.
The therapeutic effect of silymarin is attributable to the fact that it has several sites of mechanisms of action: Because of its radical capturing powers, silymarin possesses antiperoxidative activity. The pathophysiological process of lipid peroxidation which is responsible for the destruction of cell membranes, is interrupted or prevented. Furthermore, in liver cells, which have already sustained damage, silymarin stimulates protein synthesis and normalises phospholipid metabolism. The overall outcome is that the cell membrane is stabilised and loss of dissolved cell constituents (e.g. transaminases) from the liver cell is restricted or prevented.
Silymarin restricts certain hepatotoxic substances (poisons of the death cap fungus) from gaining entry to the cell.
The enhancement of protein synthesis by silymarin is due to its stimulation of RNA polymerase I, an enzyme which is located in the nucleus. This leads to increased formation of ribosomal RNA and structure and function proteins (enzymes) are therefore synthetised in greater amounts. The outcome is an increase in the repair capacity and the regenerative powers of the liver.
Pharmacokinetics: The principal constituent of silymarin is silibinin. Clinical investigations show that after its absorption in the digestive tract, it is excreted mainly in the bile (> 80 percent of the amount absorbed).
As metabolites, glucoronides and sulphates have been demonstrated in the bile, silibinin is assumed to be reabsorbed after being deconjugated, and then enters into an enterohepatic circulation, as has been shown in experimental animals. As might be expected from its predominantly biliary elimination (site of action: liver), blood levels are low and renal elimination is small. The absorption half-life is 2.2 h and the elimination half-life 6.3 h.
When LEGALON is given in therapeutic doses (140 mg silymarin 3 times daily), the levels of silibinin found in human bile are the same after repeated doses and after a single dose. The results show that silibinin does not accumulate in the body.
After repeated administration of silymarin in doses of 140 mg 3 times daily biliary elimination reaches a steady state.
Toxicology: Preclinical safety data: Since silymarin is characterized by exceptionally low toxicity, it can be administered safely in the recommended doses for long periods.
Acute toxicity: Given in single doses by mouth to rats and mice, silymarin proved to be practically non toxic, and the LD50 can be stated as > 2000 mg/kg.
Chronic toxicity: In long-term trials extending up to 12 months, rats and dogs were given silymarin by mouth in maximum doses of 2500 or 1200 mg/kg respectively. Neither the laboratory results nor the autopsy findings showed any evidence of toxic effects.
Reproduction toxicity: Fertility studies in rats and rabbits, together with studies of prenatal, perinatal and postnatal toxicity, did not reveal any adverse effects at any of the stages of reproduction (maximum dose tested: 2500 mg/kg). In particular, silymarin showed no evidence of any teratogenic potential.
Mutagenicity: In vitro and in vivo investigations with silymarin yielded negative results.
Carcinogenicity: Appropriate in vivo studies in rodents have not yet been carried out.
Indications/Uses
Toxic liver damage: for supportive treatment in patients with chronic inflammatory diseases of the liver or hepatic cirrhosis.
Note: The treatment with this medicinal product does not serve as a substitute for the abstention from the cause of liver damage (e.g. alcohol).
Dosage/Direction for Use
Severe Cases: Unless otherwise directed, 2 Legalon 70 caps or 1 Legalon 140 cap should be taken 3 times daily before meals.
Moderate Cases: Maintenance/Initial Dose: 1 Legalon 70 cap 3 times daily before meals or 1 Legalon 140 cap 2 times daily before meals.
Legalon 140: Unless otherwise prescribed, for initial treatment and in severe cases: 1 capsule 3 times daily, corresponding to 420 mg (324.6 mg /HPLC) of silymarin daily.
Maintenance dose: 1 capsule 2 times daily, corresponding to 280 mg (216.4 mg /HPLC) of silymarin daily.
Method of administration: The capsules are to be swallowed whole and unchewed with an appropriate amount of liquid.
The doctor will decide on the duration of the treatment.
Overdosage
Legalon 70: No cases so far reported.
Legalon 140: Signs or symptoms of overdosage or poisoning have not hitherto been observed. The undesirable effects described in Adverse Reactions can be amplified.
A special antidote is not known. If necessary, symptomatic measures are recommended.
Contraindications
Legalon should not be administered in cases of known hypersensitivity against milk thistle fruits, other composites or any of the excipients.
Warnings
Legalon 70: None.
Special Precautions
Legalon 140: This medicine is not suitable for treating cases of acute poisoning.
If icterus (light to dark yellow tinge of the skin, yellow discoloration of the white of the eye) occurs the doctor is to be consulted.
If hypersensitivity reactions occur, the administration should be discontinued.
Effects on the ability to drive and use machines: Not relevant.
Use in Children: There are no sufficient data available concerning the use of this medicine in children. Therefore, it should not be used in children under the age of 12 years.
Use In Pregnancy & Lactation
Legalon 140: There are no adequate data from the use of LEGALON in pregnant or lactating women. Therefore, in these circumstances LEGALON should not be administered.
Adverse Reactions
Legalon 140: Like all medicinal products, LEGALON can have undesirable effects.
For the evaluation of undesirable effects, the following terms of frequency are used: very common: ≥ 1/10; common: ≥ 1/100 - < 1/10; uncommon: ≥ 1/1,000 - < 1/100; rare: ≥ 1/10,000 - < 1/1,000; very rare: < 1/10,000 including isolated reports.
In rare cases gastrointestinal disorders, as e.g. a mild laxative effect, have been observed. Very rarely hypersensitivity reactions, like rash or dyspnoea, can occur.
Side Effects
A mild laxative action has been observed in rare cases. Very rarely, hypersensitivity reactions eg, rash or dyspnoea, can occur. Inform the physician or pharmacist about any adverse reactions that might be observed and which are not mentioned in these instructions.
Drug Interactions
None known.
Caution For Usage
Legalon 140: Incompatibilities: Not applicable.
Instructions for use and handling: No special requirements.
Storage
Legalon 70: Store below 30°C in a dry place.
Legalon 140: Store below 30°C.
Shelf-life: Legalon 70: 5 years.
Legalon 140: 4 years.
ATC Classification
A05BA03 - silymarin ; Belongs to the class of drugs used in liver therapy.
Presentation/Packing
Legalon 70 cap: 70 mg (brown hard gelatin, with yellow powder) x 10 x 10's.
Legalon 140 cap: 140 mg (brown hard gelatin, with yellow powder) x 4 x 10's.
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