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PACKAGE LEAFLET: INFORMATION FOR USERS
LIVOSIL 140 mg hard capsules
Silymarin
Read the whole leaflet carefully before you start taking this medicine.
Livosil can purchased without a prescription, but it should be taken exactly as specified that effect would be the best.
• Keep the leaflet for later reference, when necessary.
• If you have more questions about the product, consult your pharmacist.
• If symptoms worsen or during 4 weeks of treatment don’t facilited, consult your doctor.
• If you experienced a severe side effect or had a side effect that is not specified in this leaflet, inform your doctor or pharmacist about it.
In this leaflet:
1. What Livosil is and what it is used for
2. What you should know before you take Livosil
3. How to take Livosil
4. Possible side effects
5. How to store Livosil
6. Further information
1. WHAT LIVOSIL IS AND WHAT IT IS USED FOR Livosil capsules is a medicine product of plant origin. The active component of Livosil is silymarin derived from the seeds of Milk thistle (Silybum marianum). Silymarin has hepatoprotective activity.
Studies have indicated that silymarin has strong antioxidative properties and acts as a free radical scavenger reducing free radicals. Silymarin may have possitive effect on regulating glutathione levels in the cell, promotes liver regeneration and inhibits of collagen fiber accumulation in the liver. Such disorders occur during liver cirrhosis.
Livosil capsules, as an additional medicine, is used by adults to treat liver toxic injury. Livosil, with other drugs, also can be used for chronic hepatitis and liver cirrhosis treatment.
2. WHAT YOU SHOULD KNOW BEFORE TAKING LIVOSIL
Do not take Livosil:
- if you are allergic (hypersensitive) to silymarin or any of the other ingredients.
- if you are allergic (hypersensitive) to shellfish, as the active substance is obtained from shellfish.
Take special care with Livosil:
- if you have diabetes or low glucose level in the blood or taking medicines, food supplements or other products that influence glucose levels in the blood. Livosil can reduce glucose levels in the blood.
Taking other medicines
Tell your doctor or pharmacist, if you are taking or have been taking other medicines lately, including
the ones purchased over-the-counter.
It is undetermined that Livosil capsules interact with other drugs.
Taking Livosil with food and drink
Livosil capsules can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development.
There are no data with pregnant and nursing mothers, therefore it is not recommended to use this medicinal product during pregnancy and breast-feeding.
Driving and using machines
Livosil capsules don’t affect ability to drive and use machines.
3. HOW TO USE LIVOSIL
Take Livosil exactly as instructed. In case of doubt, please consult your doctor or pharmacist.
The usual dose for adults is 280 - 420 mg per day. You can take one 140 mg capsule twice daily or 140 mg capsule three times daily.
It is recommended to take this medical product longer than 3 months.
Dose adjustment is not required in patients with renal dysfunction.
Not recommended for children younger than 18 years of age.
If you take more Livosil than you should
Contact your doctor or emergency unit if you have taken more Livosil than stated in this leaflet.
If you forget to take Livosil
Do not take a double dose of medicine to make up for a forgotten dose.
If you have any questions about the use of this medicine consult your physician or pharmacist.
4. POSSIBLE SIDE EFFECTS
Livosil, as any other medicine, can cause side effects, although not in all patients.
The following side effects have been reported:
Frequency unknown: headache, dizziness, abdominal discomfort, diarrhoea, itchiness and hives.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
5. HOW TO STORE LIVOSIL
Keep out of reach and out of sight of children.
Do not store above 25 C.
Do not use Livosil after the expiry date which is stated on the label. The expiry date refers to the last date of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Livosil contains
- The active substance is silymarine. Each capsule contains 232,75 mg – 257,25 mg of Silybum marianum (L.) Gaertn, fructus refined and standardized dry extract (24-27:1), equivalent to 140 mg silymarin, calculated as silibin.
Solvent extraction: acetone: water (95:5).
- Excipients – capsule content: calcium hydrogen phosphate, anhydrous, sodium starch glycolate (type A), talc, magnesium stearate, colloidal anhydrous silicon dioxide; body of the capsule - gelatin, titanium dioxide (E171), indigo carmine (E132), iron oxide, yellow (E172).
What Livosil looks like and content of the pack
Livosil capsules are green cylindrical capsules filled with yellow powder.
Livosil is packed in blister packages of 15 capsules. Blister packages are packed in carton box containing 30 or 45 capsules.
Not all the sizes of carton box may be available for supply.
Marketing authorization holder and manufacturer
Manufacturer
UAB Aconitum
Taikos av.102
LT-51195 Kaunas
Lithuania
Tel.: +370 37 328008
Fax.: +370 37 338487
E.mail:
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
www.aconitum.lt
Consult Marketing Authorization Holder, if you want more information about the medicine.
The latest date of approval of this package information leaflet was 2010-05-12 The latest review of the package information leaflet is available online at the website of State Medicines Control Agency (SMCA) under the Ministry of Health of the Republic of Lithuania http://www.vvkt.lt/
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