Package leaflet: Information for the user

SYLIMAROL 35 mg
Silybi mariani fructus extractum siccum
film-coated tablets
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
If there is no improvement or if you feel worse after 2 weeks, you should contact your doctor.

Leaflet contents

What Sylimarol 35 mg is and what it is used for
Important information before taking Sylimarol 35 mg
How to take Sylimarol 35 mg
Possible side effects
How to store Sylimarol 35 mg
Contents of the pack and other information

1. What Sylimarol 35 mg is and what it is used for

Traditional herbal medicinal product for use in specific indications based exclusively on long-standing use.
Sylimarol 35 mg is used as an adjunctive treatment in convalescence following toxic-metabolic liver damage caused, among others, by toxic factors (e.g. alcohol, pesticides) and in dyspepsia (bloating, belching) after consumption of hard-to-digest foods. Also used as an adjunctive treatment for symptoms following acute and chronic liver diseases.

2. Important information before taking Sylimarol 35 mg

When not to take Sylimarol 35 mg

if the patient is allergic to the active substances present in milk thistle or to plants from the family Asteraceae (formerly Compositae) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

If symptoms of jaundice (yellowing of the skin, yellow discoloration of the eyes) or changes in the colour of urine or faeces occur, consult a doctor immediately.
This medicine is not intended for the treatment of acute liver poisoning.
Children and adolescents
Studies on the use of silymarin in children and adolescents have not been conducted; therefore, the use of this medicine is not recommended in children and adolescents under 18 years of age.
Sylimarol 35 mg and other medicines
Inform your doctor about all medicines you are currently taking, including those available without a prescription. To date, no interactions with other medicines have been reported.
Pregnancy and breastfeeding
Due to insufficient data confirming safety, the use of this medicine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Studies on the influence of Sylimarol 35 mg on the ability to drive and operate machinery have not been conducted.
Warnings regarding excipients with known effects
Sylimarol 35 mg contains 0.1 mg of sodium benzoate (E211) in each tablet, equivalent to
0.32 mg/g.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Sylimarol 35 mg contains 72.9 mg of glucose and 125 mg of sucrose in each tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Sylimarol 35 mg

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Orally, 2 tablets three times daily after meals, unless otherwise prescribed by a doctor. The medicine requires regular use for approximately 2 to 4 weeks. If symptoms worsen or do not improve, contact your doctor, who may extend the treatment, for example, up to 6 months. During therapy, avoid substances harmful to the liver.
Use in children and adolescents
Due to lack of data confirming safety, the use of this medicine is not recommended in children and adolescents under 18 years of age.
If you take more Sylimarol 35 mg than recommended
No cases of overdose have been reported.
If you forget to take Sylimarol 35 mg
Do not take a double dose to make up for the missed tablet.
Stopping Sylimarol 35 mg
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
During use, mild gastrointestinal symptoms may occur, such as dry mouth,
nausea, stomach discomfort, gastric irritation, and diarrhoea; headache; allergic reactions may also occur (skin inflammation, urticaria, skin rash, itching, anaphylactic shock, asthma).
Frequency is unknown.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. 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 181C, 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Sylimarol 35 mg

The medicine should be stored at a temperature not exceeding 25°C.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Sylimarol 35 mg contains
The active substance is:
Each tablet contains 50 mg of dry extract (DER 20-34:1) from Silybum marianum L., fructus (milk thistle fruit), extracted with 90% methanol, corresponding to not less than 37.8 mg of silymarin expressed as silybin.
The other ingredients (excipients) are: sodium benzoate (E211) (added to the extract), 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 Sylimarol 35 mg looks like and contents of the pack
Sylimarol 35 mg is a green, round, biconvex coated tablet with a beige-yellow breakline.
Available pack sizes contain 30 or 60 tablets in PVC/Al blister packs, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47/51, 61-896 Poznań, Poland
tel. +48 61 886 18 00