Sanohepatic
Poland
Table of Contents
Package leaflet: Information for the user
SanoHepatic, coated tablets
Silybi mariani extractum siccum raffinatum et normatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.
- Keep this leaflet, so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 2 weeks, or if the patient feels worse, consult a doctor.
Contents of the leaflet
- What SanoHepatic is and what it is used for
- Important information before taking SanoHepatic
- How to take SanoHepatic
- Possible adverse reactions
- How to store SanoHepatic
- Contents of the package and other information
1. What SanoHepatic is and what it is used for
SanoHepatic is a traditional herbal medicinal product used based on its long-standing use for specific indications.
SanoHepatic contains dried extract of milk thistle (Silybi mariani) fruit.
This traditional herbal medicinal product is used symptomatically for digestive disorders, sensation of fullness and dyspepsia, as well as to support liver function, after exclusion of serious diseases by a physician.
If there is no improvement after 2 weeks, or if the patient feels worse, consult a doctor.
2. Important information before using SanoHepatic
When not to use SanoHepatic:
- if the patient is allergic to milk thistle, silymarin, plants from the Asteraceae family (daisy family, formerly known as Compositae), or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Before starting treatment with SanoHepatic, consult your doctor or pharmacist.
This medicine should not be recommended for the treatment of acute poisoning.
If symptoms of jaundice occur (light to dark yellow discoloration of the skin, yellowing of the eyes) or if there is a change in the color of urine or stool, consult a doctor.
If symptoms worsen or new symptoms appear during treatment, consult a doctor.
Children and adolescents
Due to lack of data confirming safety, use of the medicine is not recommended in children and adolescents under 18 years of age.
SanoHepatic and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
No interactions with other medicines have been reported to date.
Taking SanoHepatic with food and drink
It is recommended to take the medicine before meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The safety of this medicine during pregnancy and breastfeeding has not been established. Use during pregnancy and breastfeeding is not recommended due to insufficient data.
Driving and operating machinery
No studies have been conducted on the effect of silymarin on the ability to drive vehicles or operate machinery.
SanoHepatic contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit (2 tablets), meaning the medicine is considered "sodium-free".
3. How to use SanoHepatic
This medicine should always be taken exactly as described in the patient leaflet or as advised by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
At the beginning of treatment, it is recommended to take 2 coated tablets three times daily (corresponding to a single dose of 140 mg
of silymarin and a daily dose of 420 mg of silymarin). For maintenance, it is recommended to take 2 coated tablets twice daily (corresponding to 280 mg of silymarin).
The tablets should be taken whole, without chewing or crushing, before meals, with a small amount of liquid.
Consult a physician if symptoms persist after 2 weeks of treatment.
Use in children and adolescents
Due to lack of data confirming safety, SanoHepatic should not be used in children and adolescents under 18 years of age.
Overdose of SanoHepatic
No cases of overdose have been reported.
Missed dose of SanoHepatic
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult a physician or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Mild gastrointestinal disturbances may occur during use, such as dry mouth, nausea, upset stomach, stomach irritation, diarrhoea. Headache and allergic reactions (skin inflammation, urticaria, rash, itching, anaphylaxis – severe allergic reaction, asthma) have also been observed. The frequency of these adverse reactions is unknown.
If new symptoms not listed above occur during treatment, consult a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl . Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store SanoHepatic
Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
(EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the packaging and other information
What SanoHepatic contains
- The active substance in the medicinal product is a dry, purified and standardized extract obtained from milk thistle fruits (Silybi mariani extractum siccum raffinatum et normatum). One coated tablet contains 120.07 mg of the extract (as dry, purified and standardized extract) from Silybum marianum (L.) Gaertner, fructus (milk thistle fruit), DER 20-35:1, corresponding to 70 mg of silymarin expressed as silibinin, with the extraction solvent: 96% (V/V) acetone.
- Other ingredients are:
Tablet core: microcrystalline cellulose with silica (microcrystalline cellulose, colloidal anhydrous silica), sodium croscarmellose, magnesium stearate.
Tablet coating: Aqua Polish D green 674.05 PVA (polyvinyl alcohol-polyethylene glycol grafted copolymer, hydroxypropylcellulose, glycerol, talc, hydrated colloidal silica,
titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172), brilliant blue
FCF, lac (E133), indigocarmine, lac (E132).
What SanoHepatic looks like and contents of the pack
SanoHepatic is dark green, round, biconvex coated tablets with bevelled edges, approximately 8.5 mm in diameter.
The coated tablets are packed in PVC/PVDC/Aluminium blisters, placed together with the patient leaflet in a cardboard box.
Pack sizes contain 30, 60, 90 or 120 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Poland
Tel.: +48 29 644 29 00