Silimarol Vita 80

Package Leaflet: Information for the Patient

Sylimarol Vita 80

Hard capsules

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 the package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• 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 Sylimarol Vita 80 and what is it used for
• 2. Important information before taking Sylimarol Vita 80
• 3. How to take Sylimarol Vita 80
• 4. Possible side effects
• 5. How to store Sylimarol Vita 80
• 6. Package contents and other information

1. What is Sylimarol Vita 80 and what is it used for

Sylimarol Vita 80 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 suffering from acute and chronic liver diseases.
Pharmacotherapeutic group (ATC code): A 05 BA 03

2. Important information before taking Sylimarol Vita 80

When not to take Sylimarol Vita 80:

Asteraceaefamily (formerly Compositae) or any of the other ingredients of this medicine (listed in section 6). If any of the side effects worsen or any side effects not listed in the leaflet occur, the patient should inform their doctor or pharmacist.

Warnings and precautions

In case of symptoms of jaundice (yellowing of the skin, yellowing of the eyes), the patient should consult a doctor. The medicine should not be recommended for the treatment of acute poisonings.

Sylimarol Vita 80 and other medicines

The patient should inform their doctor about all medicines taken recently, even those that are available without a prescription. So far, no interactions with other medicines have been found.

Pregnancy and breastfeeding

Due to the lack of data confirming the safety of use, the preparation should not be used during pregnancy and breastfeeding.

Driving and operating machinery

Sylimarol Vita 80 does not affect the ability to drive and operate machinery.

Sylimarol Vita 80 contains 0.23 mg of sodium benzoate (E211) in each tablet, which corresponds to

0.97 mg/g.

Sylimarol Vita 80 contains lactose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodiumper dose, which means the medicine is considered "sodium-free".

3. How to take Sylimarol Vita 80

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Adults and adolescents over 12 years old
3 times a day, 1 to 2 capsules after eating, unless the doctor recommends otherwise. The medicine requires systematic use for about 2-4 weeks. If the symptoms worsen or do not improve, the patient should contact their doctor, who may extend the treatment to, for example, 6 months. During therapy, the patient should avoid harmful substances for the liver.

Use in children

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

Taking a higher dose of Sylimarol Vita 80 than recommended

There is no data on symptoms of overdose.

Missing a dose of Sylimarol Vita 80

The patient should not take a double dose to make up for a missed capsule.

Stopping Sylimarol Vita 80

In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During use, gastrointestinal disorders may occur.
Rarely, a mild laxative effect is observed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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 allow for more information to be collected on the safety of the medicine.

5. How to store Sylimarol Vita 80

The medicine should be stored at a temperature not exceeding 25°C.
The medicine should be stored in a place inaccessible and invisible to children.
Do not use Sylimarol Vita 80 after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sylimarol Vita 80 contains

The active substances of the medicine are:
One capsule contains:
dry extract of milk thistle fruit ( Silybi mariani fructus
extractum siccum (20-34:1), extractant – methanol 90%, auxiliary substance – sodium benzoate (<0.2%))
114.3 mg
vitamin B (thiamine hydrochloride)
2 mg
vitamin B (riboflavin)
2 mg
vitamin B (pyridoxine hydrochloride)
2 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 lactose monohydrate, povidone, and crospovidone.
The capsule consists of: titanium dioxide (E171), indigo carmine (E132), quinoline yellow (E104),
and bovine gelatin.

What Sylimarol Vita 80 looks like and what the package contains

Sylimarol Vita 80 is in the form of hard capsules.
The available package contains 30 capsules in Al/PVC blisters and a cardboard box.
To obtain more detailed information, the patient should contact the marketing authorization holder.

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, fax +48 61 853 60 58

Date of the last update of the leaflet: