Livosil 140 mg hard capsules

Package leaflet: information for the user

Silymarin

Read all this leaflet carefully before you start taking this medicinal product because it contains important information for you.

•          Keep this leaflet; you may need to read it again.
•          If you have any further questions, consult your doctor or a pharmacist.
•          This medicinal product is prescribed specifically for you so do not give it to other people, the medicinal product could cause harm (even though the symptoms are the same as yours).
•          If you experience a side effect (even though it is not listed in this leaflet), consult your doctor or a pharmacist. See chapter 4.

Content of the leaflet
1. What LIVOSIL is and what it is used for
2. What do you need to know before you use LIVOSIL
3. How to use LIVOSIL
4. Possible side effects
5. How to store LIVOSIL
6. Content of the package and other information

1. What LIVOSIL is and what it is used for
LIVOSIL’s active substance is silymarin – an active substance of plant origin extracted from the seeds of milk thistle (Silybum marianum). Silymarin has a protective effect on the liver. Studies have shown that silymarin has a strong antioxidant action and controls the level of glutathione inside the cell, neutralises free radicals, stops the access of harmful substances to liver cells, promotes liver renewal and inhibit the accumulation of collagen fibres in the liver. These disorders occur in the case of cirrhosis of the liver.
LIVOSIL hard capsules, as an additional measure, are used for the treatment of adult liver toxicity. This medicinal product can also be used together with other medication for the treatment of chronic hepatitis and cirrhosis of the liver.

2. What do you need to know before you use LIVOSIL
Do not use LIVOSIL:
if you are allergic (hypersensitive) to silymarin or any excipient of LIVOSIL (they are listed in chapter 6).

Warnings and precautions

Consult your doctor or a pharmacist before you start taking LIVOSIL.
If you have diabetes, low levels of glucose or take medicinal products, food supplements or other products that influence levels of glucose, LIVOSIL might reduce glucose levels.

Children and adolescents
Use of LIVOSIL is not recommended for children and adolescents under 18 years of age.

Other medicinal products and LIVOSIL
If you take or recently took other medicinal products or you are not sure about this, inform a doctor or a pharmacist.
There is no evidence that LIVOSIL interacts with other medicinal products.

LIVOSIL use with food and beverages
LIVOSIL can be taken during a meal or on an empty stomach.

Pregnancy and breastfeeding
If you are (possibly) pregnant, breastfeeding or wish to get pregnant, consult your doctor or a pharmacist before you start taking this medicinal product.
Animal studies do not indicate direct or indirect harmful effect to pregnancy, embryo or foetus development, parturition or after. There are no studies on pregnant or breastfeeding women so it is not recommended to take this medicinal product during these periods.

Driving and using machines
LIVOSIL does not influence the ability to drive and use machines.

3. How to use LIVOSIL
Always take this medicinal product exactly as directed by your doctor or a pharmacist. If in doubt, consult your doctor or a pharmacist.

The recommended daily dose of LIVOSIL for adults is 280–420 mg. You can take one capsule of 140 mg twice a day or one capsule of 140 mg three times a day.
It is recommended to use this medicinal product for more than 3 months.
No dose adjustment in elderly patients with impaired renal function is needed.

Children and adolescents
Use of LIVOSIL is not recommended for children and adolescents under 18 years of age.

What to do in case of LIVOSIL overdose?
In the event of an overdose, consult your doctor or the nearest hospital emergency department.

If you forget to take LIVOSIL 
If you forget to take a dose at the usual time, take it as soon as you remember. If it is almost time to take another dose, skip the forgotten one and continue using the medication normally. Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicinal product, consult your doctor or a pharmacist.

4. Possible side effects
This medicinal product, like all medicinal products, can cause side effects, although, not everybody experiences them.
LIVOSIL can cause the following side effects:
disorders of unknown frequency (cannot be estimated from available data): headache, dizziness, unpleasant feeling in the middle of the abdomen, diarrhoea, itchiness and hives.

If you experience a serious side effect or you notice an effect that is not indicated in this leaflet, tell your doctor or a pharmacist.

Reporting side effects

If you experience a side effect, including the effect not indicated in this leaflet, tell your doctor or a pharmacist. You can also report a side effect to the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania via free phone: 8 800 73568, via the form on www.vvkt.lt website, and submit it: send in writing to the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, Žirmūnų str. 139A, LT 09120 Vilnius, via free fax: 8 800 20131, via email: NepageidaujamaR@vvkt.lt, via the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania website (http://www.vvkt.lt). By reporting a side effect, you can help us get more information about the safety of this medicinal product.

5. How to store LIVOSIL
Keep out of the reach and sight of children.
Do not store above 25 °C.
Do not use this medicinal product after the expiry date stated on the carton and blister pack. This medicinal product is suitable for use until the last day of the indicated month.

Medicinal products should not be disposed to drainage or with household waste. Ask a pharmacist how to dispose of unnecessary medicinal products. These measures will help protect the environment.

6. Content of the package and other information
LIVOSIL composition
– The active substance is silymarin. Each hard capsule contains 215.38–350 mg of refined and standardised dry extract of Silybum marianum (L.) Gaertn., fructus (milk thistle fruit) (24-27:1) that corresponds to 140 mg of silymarin, based on silibinin.
Extraction solvent: acetone : water (95:5);

Or

Each hard capsule contains 215.38–350 mg of refined and standardised dry extract of Silybum marianum (L.) Gaertn., fructus (milk thistle fruit) (36-44:1) that corresponds to 140 mg of silymarin, based on silibinin.

Extraction solvent: ethyl acetate.
– Excipients in the content of the capsule: anhydrous calcium-hydrogen phosphate, carboxymethyl starch sodium salt, talc, magnesium stearate, anhydrous colloidal silicon dioxide, the coating of the capsule contains: gelatine, titanium dioxide, (E171), red iron oxide (E172).

LIVOSIL appearance and amount in the pack
 LIVOSIL hard capsules are chestnut brown, cylindrical, filled with yellow powder.
LIVOSIL is packed in blister packs of 15 capsules. Blister packs are packed in cartons of 15, 30, 45 or 60 capsules.
Not all package sizes might be available.

Registrant and producer
UAB Aconitum
Inovaciju str. 4
Biruliskes village
Kaunas district municipality
Lithuania
Phone: +370 37 328008
Fax: +370 37 338487
info@aconitum.lt

If you want more information about this medicinal product, contact the registrant.

This package leaflet was last reviewed: 12/07/2017

Detailed information on this medicinal product is provided on the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania website https://www.vvkt.lt/.