Sanohepatic

Leaflet attached to the packaging: information for the user

SanoHepatic, coated tablets

Silybi mariani extractum siccum raffinatum et normatum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is SanoHepatic and what is it used for
• 2. Important information before using SanoHepatic
• 3. How to use SanoHepatic
• 4. Possible side effects
• 5. How to store SanoHepatic
• 6. Contents of the packaging and other information

1. What is SanoHepatic and what is it used for

SanoHepatic is a traditional herbal medicinal product for use in specified indications, resulting solely from its long-term use.
SanoHepatic contains dry extract of milk thistle fruit in its composition.
The traditional herbal medicinal product is used for the symptomatic treatment of digestive disorders, feelings of fullness and indigestion, as well as to support liver function, after serious diseases have been ruled out by a doctor.
If after 2 weeks there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using SanoHepatic

When not to use SanoHepatic:

Asteraceaefamily (composites, formerly Compositae) or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Before starting to use SanoHepatic, you should discuss it with your doctor or pharmacist.
The medicine should not be recommended for the treatment of acute poisonings.
In case of symptoms of jaundice (light to dark yellow discoloration of the skin, yellow discoloration of the eyes) or changes in the color of urine or stool, you should consult a doctor.
If symptoms worsen or new symptoms appear during the use of the medicine, you should consult a doctor.

Children and adolescents

Due to the lack of data confirming the safety of use, it is not recommended to use the medicine in children and adolescents under 18 years of age.

SanoHepatic and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions have been found during use with other medicines.

Using SanoHepatic with food and drink

It is recommended to use the medicine before a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
The safety of using this medicine during pregnancy and breastfeeding has not been established. It is not recommended to use the medicine during pregnancy and breastfeeding due to the lack of sufficient data.

Driving and using machines

No studies have been conducted on the effect of silymarin on the ability to drive and use machines.

SanoHepatic contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit (2 tablets), which means the medicine is considered "sodium-free".

3. How to use SanoHepatic

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
At the beginning of treatment, it is recommended to use 2 coated tablets, three times a day (which corresponds to 140 mg of silymarin in a single dose and 420 mg of silymarin in a daily dose). As a maintenance dose, it is recommended to use 2 coated tablets 2 times a day (which corresponds to 280 mg of silymarin).
The medicine should be taken whole, without chewing or crushing, before a meal, with a small amount of liquid.
You should consult your doctor if symptoms persist after 2 weeks of using the medicine.

Use in children and adolescents

Due to the lack of data confirming the safety of use, it is not recommended to use the medicine in children and adolescents under 18 years of age.

Overdose of SanoHepatic

No cases of overdose have been reported.

Missed dose of SanoHepatic

You should not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During use, mild gastrointestinal disorders, such as dry mouth, nausea, stomach upset, stomach irritation, diarrhea, may occur. Headache, allergic reactions (skin inflammation, hives, rash, itching, anaphylaxis - a severe allergic reaction, asthma) have also been observed. The frequency of these side effects is unknown.
If new symptoms not listed above appear during the use of the medicine, you should consult your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store SanoHepatic

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date (EXP). The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What SanoHepatic contains

• The active substance of the medicine is a dry, purified, and standardized extract from milk thistle fruit (Silybi mariani extractum siccum raffinatum et normatum). One coated tablet contains 120.07 mg of the extract (as a dry, purified, and standardized extract) from Silybum marianum(L.) Gaertner, fructus(milk thistle fruit) DER 20-35:1, which corresponds to 70 mg of silymarin calculated as silybinin, extraction solvent: acetone 96% (V/V).
• The other ingredients are: Tablet core: siliconized microcrystalline cellulose (microcrystalline cellulose, colloidal silica), croscarmellose sodium, magnesium stearate. Tablet coating: Aqua Polish D green 674.05 PVA (copolymer of macrogol and poly(vinyl alcohol), hydroxypropyl cellulose, glycerol, talc, hydrated silica,

titanium dioxide (E171), black iron oxide (E 172), yellow iron oxide (E 172), brilliant blue FCF, lake (E 133), indigo carmine, lake (E 132).

What SanoHepatic looks like and what the packaging contains

SanoHepatic is a dark green, round, biconvex, coated tablet with a diameter of about 8.5 mm.
The coated tablets are packaged in PVC/PVDC/Aluminum blisters, along with the patient leaflet, in a cardboard box.
The packaging contains 30, 60, 90, 120 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Natur Produkt Pharma Sp. z o. o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Poland
Tel.: +48 29 644 29 00

Date of last revision of the leaflet: