Legalon 70 Capsules

This data sheet conforms in all essential parts with the user information as prescribed by law in Germany.

A medicine acting on the liver - Reinforces the regenerative capacity and functional efficiency of the liver.

Active ingredient

Extract of milk thistle fruits


Composition

1 capsule contains: 86.5 - 93.3 mg dry extract from milk thistle fruits (36-44:1) equivalent to 70 mg silymarin, calculated as silibinin (extractant: ethyl acetate > 96.7%)

Other ingredients: mannitol, sodium carboxymethyl starch, polysorbate 80, polyvidone, magnesium stearate, gelatin, titanium dioxide E171, ferric oxide E172, dodecyl sodium sulphate.

Original packs of 30, 60, 100 and 400 capsules.
Hospital packs of 2000 capsules (20 x 100 capsules).


Uses

Toxic liver damage; for supportive treatment in cases of chronic inflammatory liver disease or hepatic cirrhosis.
Drug therapy does not replace the need to avoid factors harmful to the liver, e.g. alcohol.

Should jaundice become apparent (pale to dark yellow coloration of the skin, yellow coloration of the whites of the eyes) a doctor should be consulted.

Note: this medicine is not suitable for treating cases of acute poisoning.


Contraindications

When must you not use Legalon 70?
No restrictions.

What must be remembered when dealing with children?
There have been no adequate investigations of the use of this medicine in children. It should therefore not be used in children under 12 years of age.

What must you remember in connection with pregnancy and lactation?
No results are available regarding the use of Legalon 70 during pregnancy or lactation. It should therefore be used only after consultation with your doctor.

If symptoms persist for any length of time you should consult your doctor.


Side effects

What side effects may occur while taking Legalon 70?
A mild laxative effect has occasionally been observed.
Should you observe any side effects which are not listed in this package insert, please report them to your doctor or pharmacist.

M. No. 211 908/5.96


Can doctors prescribe Legalon® and will the health insurers pay for it?

The efficacy, adverse effects and pharmaceutical quality of Legalon® have been extensively investigated and documented, and it has accordingly been released for therapeutic use by the highest German health authorities. This is shown by the Licence Number on every Legalon® pack. Doctors can therefore prescribe Legalon®, and the health insurers have to pay for it.


How should Legalon® be taken?

Legalon® 70 Capsules, unless your doctor has directed otherwise, should be taken in a dose of 2 capsules 3 times daily when starting treatment and also in serious cases. A maintenance dose of 1 capsule 3 times daily is recommended. The capsules should be swallowed whole with a small amount of liquid.

Legalon® 140 Capsules, unless your doctor has directed otherwise, should be taken in a dose of 1 capsule 3 times daily when starting treatment and also in serious cases. A maintenance dose of 1 capsule twice daily is recommended. The capsules should be swallowed whole with a small amount of liquid.


Has Legalon® any side effects, and if so what are they?

Legalon® is a medicine of plant origin. Its active ingredient is extracted from the milk thistle (Silybum marianum). Medicines of plant origin are in general well tolerated, and this is certainly true of Legalon®. It has been employed for the treatment of liver diseases for almost 30 years. As regards side effects, a mild laxative action has occasionally been noted.


Is it better to take Legalon® before or after meals?

Legalon® is a medicine of plant origin and is very well tolerated. You can therefore take Legalon® before meals. This has the advantage that the active agent, known as silymarin, is more quickly absorbed into the body and can act more rapidly and effectively. Should any gastrointestinal problems occur, however, you can take Legalon® during or after meals.


For how long should Legalon® be taken?

The duration of treatment will be decided by the doctor in charge. As a rule, the doctor will be guided by the progress of your condition as assessed by your symptoms and by objective evidence such as laboratory results.


Is Legalon® a medicine of plant origin?

Legalon® is the outcome of several decades of intensive research by MADAUS. It is entirely of plant origin and is manufactured in the form of a dry extract from the fruits of the milk thistle. The active ingredient is silymarin, with its principal active component silibinin. As a manufacturer of medicines from natural sour-ces, MADAUS guarantees that every Legalon® capsule contains a fixed and consistent minimum quantity of silibinin (dry extract standardised in terms of silibinin).