SYLIMAROL VITA 150

Package leaflet: Information for the patient

Sylimarol Vita 150
Hard capsules
Please read the entire leaflet carefully before using this 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 a doctor or pharmacist.

• Keep this leaflet for possible future reference.
• If advice or additional information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

1. What Sylimarol Vita 150 is and what it is used for
2. Important information before taking Sylimarol Vita 150
3. How to take Sylimarol Vita 150
4. Possible side effects
5. How to store Sylimarol Vita 150
6. Contents of the pack and other information

1. What Sylimarol Vita 150 is and what it is used for

Sylimarol Vita 150 is a traditional herbal medicinal product used for specific indications based solely on its long-standing use.
It is used as supportive treatment in convalescence following toxic-metabolic liver damage caused, among others, by toxic agents (e.g. alcohol, pesticides) and in indigestion (bloating, belching) after consumption of hard-to-digest foods.
Supportively in symptoms occurring after acute and chronic liver diseases.
Pharmacotherapeutic group (ATC code): A 05 BA 03

2. Important information before taking Sylimarol Vita 150

When not to take Sylimarol Vita 150:

• if the patient is allergic to the active substances, 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). If any of the adverse reactions worsen or if any adverse reactions not listed in the leaflet occur, inform your doctor or pharmacist.

Warnings and precautions
If symptoms of jaundice occur (yellowing of the skin, yellow discoloration of the eyes),
consult a doctor. This medicine should not be used for the treatment of acute poisoning.
Sylimarol Vita 150 and other medicines
Inform your doctor about all medicines you have recently taken, including those
available without a prescription. To date, no interactions with other medicines have been observed.
Pregnancy and breastfeeding
Due to lack of data confirming safety of use, this product should not be used during
pregnancy and breastfeeding.
Driving and operating machinery
Sylimarol Vita 150 has no influence on the ability to drive or operate machinery.
Sylimarol Vita 150 contains 0.43 mg of sodium benzoate (E211) per tablet,
equivalent to 1.16 mg/g.
Sylimarol Vita 150 contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Sylimarol Vita 150

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years of age
Take 1 capsule twice daily after meals, unless otherwise advised by a physician. The medicine should be taken regularly for approximately 2–4 weeks. If symptoms worsen or do not improve, consult a doctor, who may extend treatment, for example up to 6 months. During therapy, avoid substances harmful to the liver.
Use in children
Due to lack of data confirming safety, the use of this medicine is not recommended in children under 12 years of age.
Taking more Sylimarol Vita 150 than recommended
There is no data available on symptoms of overdose.
Missed dose of Sylimarol Vita 150
Do not take a double dose to make up for a missed capsule.
Stopping Sylimarol Vita 150
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 experience them.
Gastrointestinal disturbances may occur during use.
A mild laxative effect has been observed occasionally.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 Vita 150

The medicine should be stored at a temperature not exceeding 25°C.
The medicine should be kept out of the reach and sight of children.
Do not use Sylimarol Vita 150 after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sylimarol Vita 150 contains
The active substances are:
One capsule contains:
Dry extract of milk thistle fruit ( Silybi mariani fructus
extractum siccum (20-34:1), extraction solvent – methanol 90%, excipient – sodium benzoate (<0.2%) ) 214.3 mg
Vitamin B (thiamine hydrochloride) 10 mg
Vitamin B (riboflavin) 4 mg
Vitamin B (pyridoxine hydrochloride) 10 mg
Vitamin PP (nicotinamide) 10 mg
Calcium pantothenate 4 mg
The other ingredients (excipients) are: sodium benzoate (E211) (added to the extract),
a mixture of monohydrate lactose, povidone and crospovidone.
The capsule shell consists of: titanium dioxide (E171), indigo carmine (E132), quinoline yellow (E104)
and bovine gelatin.

What Sylimarol Vita 150 looks like and contents of the pack
Sylimarol Vita 150 is a hard capsule.
The available pack contains 30 capsules in Al/PVC blisters in a cardboard box.
For more detailed information, please contact the marketing authorisation holder.

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, fax +48 61 853 60 58