Silicinar

Package Leaflet: Information for the Patient

SYLICYNAR 140 mg + 28.6 mg coated tablets
Cynarae herbae extractum+ Silybi mariani fructus extractum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Sylicynar and what is it used for
• 2. Important information before taking Sylicynar
• 3. How to take Sylicynar
• 4. Possible side effects
• 5. How to store Sylicynar
• 6. Package contents and other information

1. What is Sylicynar and what is it used for

Sylicynar is a traditional herbal medicinal product, the effectiveness of which is based solely on long-standing use and experience.
Sylicynar contains an extract of artichoke leaf and a dry extract of milk thistle fruit in its composition.
Sylicynar is used in conditions after toxic liver damage caused by, among other things, toxic factors (e.g., alcohol, plant protection agents). It is also used to support liver function disorders and elevated cholesterol and triglyceride levels in blood serum while maintaining a low-fat diet.

2. Important information before taking Sylicynar

When not to take Sylicynar:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to plants of the Asteraceaefamily (formerly Compositae),
• if the patient has bile duct obstruction

Warnings and precautions

A contraindication to the use of Sylicynar is bile duct obstruction.
In the case of gallstones, a doctor should be consulted before use. During and after therapy, substances harmful to the liver should be avoided.

Children

Due to the lack of data confirming the safety of use, it is not recommended to use Sylicynar in children under 12 years of age.

Sylicynar and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines have been reported so far

Pregnancy and breastfeeding

No controlled clinical trials have been conducted in pregnant women and breastfeeding women.
The medicine may be used after prior consultation with a doctor.

Driving and operating machinery

Sylicynar does not affect the ability to drive and operate machinery.
Sylicynar contains 0.06 mg of sodium benzoate E211 in each tablet, which corresponds to 0.16 mg/g.
Sodium benzoate E211 may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

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

Sylicynar contains brilliant black E151 and cosin Y E124. The medicine may cause allergic reactions.

3. How to take Sylicynar

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. In case of doubt, a doctor or pharmacist should be consulted.
Adults and adolescents over 12 years of age
3 times a day, 2 tablets after meals, unless otherwise directed by a doctor. The product requires systematic use. The duration of therapy should be consulted with a doctor.

Use in children

Due to the lack of data confirming the safety of use, it is not recommended to use Sylicynar in children under 12 years of age.

Taking a higher dose of Sylicynar than recommended

There are no reports of overdose.

Missing a dose of Sylicynar

A double dose should not be taken to make up for a missed dose.

Stopping Sylicynar treatment

In case of any further doubts about the use of this medicine, a doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported so far after the use of Sylicynar.
However, during use, there is a possibility of gastrointestinal disorders and mild laxative effects.
An allergic reaction may also be caused by the presence of other ingredients in the product, such as brilliant black.
If any side effects occur, including any possible side effects not listed in the leaflet, a doctor, pharmacist, or nurse should be consulted.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, a doctor, pharmacist, or nurse should be informed. 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 181C, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Sylicynar

The medicine should be stored at a temperature not exceeding 25°C.
The medicine should be stored out of sight and reach of children.
Sylicynar should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Sylicynar contains

One coated tablet contains:
Active substances:

140 mg of dry extract of artichoke leaf (Cynarae herbae extractum, DER 3-7:1, extractant: water),

28.6 mg of dry extract of milk thistle fruit (Silybi mariani fructus extractum, DER 20-34:1, extractant: 90% methanol),
Excipients: sodium benzoate E211 (added to the extract),
Core: microcrystalline cellulose, sodium starch glycolate, povidone, talc, magnesium stearate,
Coating: hypromellose, macrogol 6000, brilliant black E151, quinoline yellow E104, cosin Y E124.

What Sylicynar looks like and what the package contains

Sylicynar is in the form of coated tablets.
Available packages: 2 or 4 blisters of PVC/Al foil with 15 coated tablets in a cardboard box.
For more detailed information on this medicine, the marketing authorization holder should be contacted.

Marketing authorization holder and manufacturer

Poznańskie Zakłady Zielarskie "Herbapol" S.A.
ul. Towarowa 47-51, 61-896 Poznań, Poland
tel. +48 61 886 18 00

Date of the last update of the leaflet: