Package leaflet: Information for the patient

SYLIMAROL 70 mg
Silybi mariani fructus extractum siccum
film-coated tablets
Please read carefully all the information in this leaflet before taking the medicine, as 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 physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects 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, consult your doctor.

Table of contents

What Sylimarol 70 mg is and what it is used for
Important information before taking Sylimarol 70 mg
How to take Sylimarol 70 mg
Possible side effects
How to store Sylimarol 70 mg
Contents of the pack and other information

1. What Sylimarol 70 mg is and what it is used for

Traditional herbal medicinal product used for specific indications based exclusively on long-standing use.
Sylimarol 70 mg is used as an adjunctive treatment in convalescence following toxic-metabolic liver damage caused, among others, by toxic agents (e.g. alcohol, pesticides) and in dyspepsia (bloating, belching) after consuming hard-to-digest foods. Also used as an adjunctive treatment in symptoms following acute and chronic liver diseases.

2. Important information before taking Sylimarol 70 mg

When not to take Sylimarol 70 mg:

if the patient is allergic to the active substance present in milk thistle or to plants from the family Asteraceae (formerly Compositae) or to any of the other ingredients 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 urine or stool color occur, consult a doctor immediately.
The 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 the medicine is not recommended in children and adolescents under 18 years of age.
Sylimarol 70 mg and other medicines
Inform your doctor about all medicines you are currently taking, including those obtained 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 the medicine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Studies on the effect of Sylimarol 70 mg on the ability to drive and operate machinery have not been conducted.
Warnings regarding excipients with known effects
Sylimarol 70 mg contains 0.21 mg of sodium benzoate (E211) per tablet, equivalent to 0.66 mg/g.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.
Sylimarol 70 mg contains 51.6 mg of glucose and 125.6 mg of sucrose per tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Sylimarol 70 mg

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Orally, 1 tablet three times daily after meals, unless otherwise directed by a physician. The medicine requires regular use for approximately 2 to 4 weeks. If symptoms worsen or do not improve, consult your doctor, who may extend 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, Sylimarol 70 mg is not recommended for use in children and adolescents under 18 years of age.
Taking more Sylimarol 70 mg than recommended
No cases of overdose have been reported.
Missed dose of Sylimarol 70 mg
Do not take a double dose to make up for a missed tablet.
Stopping Sylimarol 70 mg
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
During use, mild gastrointestinal symptoms may occur, such as dry mouth, nausea, stomach upset,
gastric irritation, and diarrhoea; headache; allergic reactions may occur (skin inflammation, urticaria, skin rash, itching, anaphylactic shock, asthma).
Frequency of occurrence is not known.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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, tel. +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.
By reporting adverse reactions, additional information on the medicine's safety can be collected.

5. How to store Sylimarol 70 mg

The medicine should be stored at a temperature not exceeding 25°C.
Keep the medicine 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 measures help protect the environment.

6. Contents of the pack and other information

What Sylimarol 70 mg contains
The active substance is:
Each tablet contains 100 mg of dry extract (DER 20-34:1) from Silybum marianum L., fructus
(milk thistle fruit), with 90% methanol as the extraction solvent, corresponding to not less than
77 mg of silymarin expressed as silibinin.
The other ingredients (excipients) are: sodium benzoate (E211) (added to the extract),
glucose, potato starch, sucrose, talc, magnesium stearate, arabic gum, and a mixture of white beeswax and Carnauba wax (Capol 1295).
What Sylimarol 70 mg looks like and contents of the pack
Sylimarol 70 mg is a white-grey, round, biconvex coated tablet with a beige-yellow breakline.
The available pack contains 30 tablets in a blister made of PVC/Al foil, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
Towarowa 47/51 Street, 61-896 Poznań, Poland
tel. +48 61 886 18 00