Silimarol 35 mg

PATIENT INFORMATION LEAFLET: USER INFORMATION

SYLIMAROL 35 mg

Silybi mariani fructus extractumsiccum
coated tablet
Product intended for adolescents over 12 years of age and adults.
Package size: 30 or 60 pieces
Read the entire leaflet carefully, as it contains important information for the patient.
This medicinal product is available without a prescription. However, to achieve the best treatment result, the medicinal product
Sylimarol 35mg should be used cautiously.

• This leaflet should be kept in case it needs to be read again.
• A pharmacist should be consulted if advice or additional information is needed.
• If symptoms worsen or do not improve, a doctor should be contacted.
• If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor or pharmacist should be informed.

Table of contents of the leaflet:

• 1. What is Sylimarol 35mg and what is it used for
• 2. Important information before using Sylimarol 35mg
• 3. How to use Sylimarol 35mg
• 4. Possible side effects
• 5. How to store Sylimarol 35mg
• 6. Other information
• 1. What is Sylimarol 35mg and what is it used forSylimarol 35mg is a traditional herbal medicinal product for use in specific indications, resulting solely from its long-term use. It is used as a supportive treatment in conditions of convalescence after toxic-metabolic liver damage caused by, among other things, toxic factors (e.g., alcohol, plant protection agents) and in indigestion (bloating, belching) after consuming hard-to-digest foods. Supportively in ailments occurring after acute and chronic liver diseases. Pharmacotherapeutic group (ATC code): A 05 BA 03
• 2. Important information before using Sylimarol 35mgWhen not to use Sylimarol 35mgThe medicinal product should not be used if there is hypersensitivity to any of the ingredients or hypersensitivity to Compositae/Asteraceaeplants. When to exercise special caution when using Sylimarol 35mgIf symptoms of jaundice (yellowing of the skin, yellowing of the eyes) occur, a doctor should be consulted. The medicinal product is not intended for the treatment of acute liver poisoning. Use of other medicinal productsThe doctor should be informed about all medicinal products taken recently, even those that are available without a prescription. No interactions with other medicinal products have been found so far. Pregnancy and breastfeedingDue to the lack of data confirming safety, the preparation should not be used during pregnancy and breastfeeding. Driving and using machinesThe use of the preparation does not affect the ability to drive vehicles and operate machines. Important information about some ingredients of Sylimarol 35mgIf intolerance to some sugars is found, a doctor should be consulted before using this product.

• 3. How to use Sylimarol 35mgAdults and adolescents over 12 years of age: 3 times a day, 2 tablets after meals, unless otherwise prescribed by a doctor. The medicinal product requires systematic use for about 2-4 weeks. If symptoms worsen or do not improve, a doctor should be contacted, who may extend the treatment to, for example, 6 months. During therapy, agents harmful to the liver should be avoided. Use in childrenDue to the lack of data confirming safety, the use of the medicinal product is not recommended in children under 12 years of age. Using a higher dose of Sylimarol 35mg than recommendedThere are no data on symptoms of overdose. Missing a dose of Sylimarol 35mgA double dose should not be used to make up for a missed tablet. Stopping the use of Sylimarol 35mgIn case of any further doubts related to the use of the medicinal product, a doctor or pharmacist should be consulted.
• 4. Possible side effectsLike all medicinal products, Sylimarol 35mg can cause side effects, although they may not occur in everyone. During use, gastrointestinal disorders are possible. Mild laxative effects are occasionally observed.

Reporting side effects

If any side effects occur, including any side effects not mentioned in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel. 48 22 49 21 301, fax 48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, more information can be collected on the safety of the medicinal product.
.

• 5. How to store Sylimarol 35mgStore at a temperature not exceeding 25°C. Store in a place inaccessible and invisible to children. The medicinal product Sylimarol 35mg should not be used after the expiry date stated on the packaging. Medicinal products should not be disposed of via wastewater or household waste. A pharmacist should be asked what to do with unused medicinal products. This will help protect the environment.
• 6. Other informationWhat does Sylimarol 35mgcontainThe active substances of the medicinal product are: 50 mg of dry extract from the fruit of Silybi mariani fructus extractum siccum DER20-34:1, extractant - 90% methanol. The auxiliary substance added to the extract is sodium benzoate. The medicinal product also contains auxiliary substances: glucose, potato starch, sucrose, talc, magnesium stearate, arabic gum, a mixture of white beeswax and carnauba wax (Capol 1295), indigo carmine E132, and quinoline yellow E104.

What does Sylimarol 35mglook like and what does the packaging contain
Sylimarol 35mg is in the form of coated tablets.
The available packaging contains 30 or 60 tablets in an Al/PVC blister pack and a carton.

Marketing authorisation holder and manufacturer

Poland
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47-51, 61-896 Poznań
tel. + 48 61 886 18 00, fax +48 61 853 60 58

Date of the last update of the leaflet:

Label text on the immediate packaging (blister).

SYLIMAROL 35 mg

Silybi mariani fructus extractum siccum
coated tablet
Batch:
EXP:
Poznańskie Zakłady Zielarskie „Herbapol” S.A.

Label text on the outer packaging (carton for blisters).

SYLIMAROL 35mg

Silybi mariani fructus extractumsiccum
coated tablet
Product intended for adolescents over 12 years of age and adults.
30 pieces
Sylimarol 35mg is a traditional herbal medicinal product for use in specific indications, resulting solely from its long-term use. If any side effects occur, the doctor or pharmacist should be informed.

Composition:

Active substances: 50 mg of dry extract from the fruit of Silybi mariani fructusextractum siccum. The product contains glucose and sucrose.

Method of administration and route of administration:

Adults and adolescents over 12 years of age: 3 times a day, 2 tablets after meals, unless otherwise prescribed by a doctor. The medicinal product requires systematic use for about 2-4 weeks. If symptoms worsen or do not improve, a doctor should be contacted, who may extend the treatment to, for example, 6 months. During therapy, agents harmful to the liver should be avoided.
The medicinal product is available without a prescription – OTC.
The medicinal product should be stored in a place inaccessible and invisible to children.
Store at a temperature not exceeding 25°C.
Expiry date (EXP):

Marketing authorisation holder:

Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47-51, 61-896 Poznań
Batch number (Lot):
Authorisation number R/3788
EAN UCC code:
Name of the medicinal product in Braille

Label text on the outer packaging (carton for blisters).

SYLIMAROL 35mg

Silybi mariani fructus extractumsiccum
coated tablet
Product intended for adolescents over 12 years of age and adults.
60 pieces
Sylimarol 35mg is a traditional herbal medicinal product for use in specific indications, resulting solely from its long-term use. If any side effects occur, the doctor or pharmacist should be informed.

Composition:

Active substances: 50 mg of dry extract from the fruit of Silybi mariani fructusextractum siccum. The product contains glucose and sucrose.

Method of administration and route of administration:

Adults and adolescents over 12 years of age: 3 times a day, 2 tablets after meals, unless otherwise prescribed by a doctor. The medicinal product requires systematic use for about 2-4 weeks. If symptoms worsen or do not improve, a doctor should be contacted, who may extend the treatment to, for example, 6 months. During therapy, agents harmful to the liver should be avoided.
The medicinal product is available without a prescription – OTC.
The medicinal product should be stored in a place inaccessible and invisible to children.
Store at a temperature not exceeding 25°C.
Expiry date (EXP): .....................................

Marketing authorisation holder:

Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47-51, 61-896 Poznań
Batch number (Lot): ....................................
Authorisation number R/3788
EAN UCC code:
Name of the medicinal product in Braille