Legalon 140 mg x 20 capsules

LEGALON capsules 140 mg x 20
Leaflet: information for the user Legalon 140 mg hard capsules Dry refined and standardized extract Milk Thistle, (36-44:1)Legalon 140 mg capsules hardSilybi mariani extractum siccum raffinatum et norraatum (36-44:1)Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again. If you have any further questions, ask your pharmacist.This medicine has been prescribed for you personally. Do not pass it on to other people. It may harm them, even if their signs of illness are the same as yours.If you get any side effects, tell your pharmacist. This also includes any possible side effects not listed in this leaflet. See section 4.
What this leaflet contains: 1. What Legalon 140 mg is and what it is used for 2. What you need to know before you use it 3. How to take Legalon 140 mg 4. Possible side effects 5. How to store Legalon 140 mg 6. Contents of the pack and other information
1. What is Legalon 140 and what is it used for? Legalon 140 is a herbal medicinal product for the treatment of the liver. For the maintenance treatment of chronic inflammatory liver diseases or liver cirrhosis and for external toxic liver damage or metabolic disorders (caused by poisons affecting the liver).
Note: This medicinal product is not suitable for the treatment of acute poisoning.
2. What you need to know before you use Legalon 140 Taking the medicine does not mean that you should not avoid causes of liver damage (e.g. alcohol use).
Do not take Legalon 140: in case of hypersensitivity to milk thistle fruit, other plants of the Asteraceae family or to any of the excipients. Warnings and precautions: if jaundice occurs (light to dark yellow skin color, yellowing of the eyes), a doctor should be consulted. in children. There is insufficient clinical data for use in children. Therefore, Legalon 140 should not be used in children under 12 years of age!
This medicine contains less than 1 mmol sodium (23 mg) per three capsules, i.e. essentially ‘sodium-free’.
Other medicines and Legalon 140There are no known drug interactions.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, lactation and fertility Due to lack of sufficient data, Legalon 140 should not be used during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines No special precautions are required.
3. How to take Legalon 140 Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Unless otherwise instructed by your doctor, the usual dosage is: Adults and children over 12 years of age take 1 capsule 3 times daily (corresponding to 420 mg of silymarin).
Method of administration: The hard capsules are swallowed whole, unchewed, with a sufficient amount of liquid before meals.
Duration of use: If the complaints persist despite taking Legalon 140, you should consult a doctor.
Please talk to your doctor or pharmacist if you have the impression that the effect of this product is too strong or too weak.
If you take more Legalon 140 than you should: No symptoms of poisoning have been observed so far. In case of overdose, the side effects described in the "Side effects" section may be intensified. In such a case, you should consult a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects Like all medicines, Legalon 140 can cause side effects, although not everyone gets them. The following frequency information is used to estimate side effects:
Very common: more than 1 in 10 patientsCommon: 1 to 10 in 100 patientsUncommon: 1 to 10 in 1000 patientsRare: 1 to 10 in 10,000 patientsVery rare: less than 1 in 10,000 patientsNot known: frequency cannot be estimated from the available dataPossible side effects:In rare cases, gastrointestinal disturbances have been observed, such as a mild laxative effect. Very rarely, hypersensitivity reactions, such as rash or shortness of breath, may occur.If any of the listed drug reactions occur, inform your doctor, who can assess its severity and decide what measures should be taken. In the event of a hypersensitivity reaction, you should stop taking Legalon 140.
If any of the side effects mentioned become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects: If you get any side effects, please tell your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Bulgarian Medicines Agency, Damyan Gruev Str., 8, 1303 Sofia, tel.: +35 928903417, website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Legalon 140 Keep out of the reach of children.
Do not use the product after the expiry date stated on the blister and box.
Storage conditions:
No special storage requirements
6. Contents of the pack and additional information What Legalon 140 contains: Each 1 capsule contains 173.0 - 186.7 mg of dry refined and standardized milk thistle extract (36-44:1 (SiJybum marianum (.L.) Gaertnert jructus), equivalent to 108 mg silymarin (HPLC), equivalent to 140 mg silymarin (DNPH), expressed as silibinin. (Extractant-ethyl acetate) Excipients: corn starch, microcrystalline cellulose, sodium starch glycolate, sodium dodecyl sulfate, magnesium stearate, gelatin, titanium dioxide (E 171), iron oxides (E 172). What Legalon 140 looks like and what the package contains: Original packages of 20, 30, 60, 100 and 180 brown capsules in transparent blisters PVC/AL-foil» placed in a box together with the leaflet. (Not all packaging is on the market).
 
Marketing Authorisation Holder: Mylan EOOD, Bulgaria
 
Manufacturer of the medicinal product: Madaus GmbH, Germany