Silimarol Vita 150

Package Leaflet: Information for the Patient

Sylimarol Vita 150

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 according to the doctor's or pharmacist's instructions.

• 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 150 and what is it 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. Package contents and other information

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

Sylimarol Vita 150 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 heavy foods. Supportively in ailments 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:

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

Warnings and precautions

In case of jaundice symptoms (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 150 and other medicines

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

Pregnancy and breastfeeding

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

Driving and operating machinery

Sylimarol Vita 150 does not affect the ability to drive vehicles and operate machinery.

Sylimarol Vita 150 contains 0.43 mg of sodium benzoate (E211) in each tablet, which corresponds to 1.16 mg/g.

Sylimarol Vita 150 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 it is considered "sodium-free".

3. How to take Sylimarol Vita 150

This medicine should always be taken exactly as described in the package leaflet for the patient, or according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist. Adults and adolescents over 12 years oldshould take 2 capsules twice a day after meals, 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 substances harmful to the liver.

Use in children

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

Taking a higher dose of Sylimarol Vita 150 than recommended

There is no data on overdose symptoms.

Missing a dose of Sylimarol Vita 150

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

Stopping Sylimarol Vita 150 treatment

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, Sylimarol Vita 150 can cause side effects, although not everybody gets them. During use, gastrointestinal disorders may occur. Mild laxative effects are occasionally 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Sylimarol Vita 150

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 150 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 150 contains

The active substances of the medicine are: One capsule contains: dry extract of milk thistle fruit ( Silybi mariani fructusextractum siccum (20-34:1), extractant – methanol 90%, auxiliary substance – sodium benzoate (<0.2%)) 214.3 mg thiamine hydrochloride (vitamin B1) 10 mg riboflavin (vitamin B2) 4 mg pyridoxine hydrochloride (vitamin B6) 10 mg niacinamide (vitamin PP) 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 shell consists of: titanium dioxide (E171), indigo carmine (E132), quinoline yellow (E104), and bovine gelatin.

What Sylimarol Vita 150 looks like and what the package contains

Sylimarol Vita 150 is in the form of hard capsules. The available package contains 30 capsules in Al/PVC blisters in a cardboard box. For 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: