Sylimarol vita 80
PolandTable of Contents
Package leaflet: Information for the user
Sylimarol Vita 80
Hard capsules
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 information leaflet or as directed by the doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, 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 symptoms persist or worsen, consult your doctor.
Table of contents
- What Sylimarol Vita 80 is and what it is used for
- Important information before taking Sylimarol Vita 80
- How to take Sylimarol Vita 80
- Possible side effects
- How to store Sylimarol Vita 80
- Contents of the pack and other information
1. What Sylimarol Vita 80 is and what it is used for
Sylimarol Vita 80 is a traditional herbal medicinal product intended for use in specific indications based exclusively on long-standing use.
It is used as an adjunct in convalescence following toxic-metabolic liver damage caused, among others, by toxic agents (e.g. alcohol, pesticides), and in dyspepsia (bloating, belching) after consumption of hard-to-digest foods.
Also used as supportive treatment in complaints occurring after acute and chronic liver diseases.
Pharmacotherapeutic group (ATC code): A 05 BA 03
2. Information before taking Sylimarol Vita 80
When not to take Sylimarol Vita 80:
- if the patient is allergic to the active substances, to plants present in milk thistle, to plants from the family Asteraceae (formerly Compositae), or to any of the other ingredients 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.
The medicine should not be used for the treatment of acute poisonings.
Sylimarol Vita 80 with other medicines
Inform your doctor about all medicines you have recently taken, including those available without a prescription.
No interactions with other medicines have been reported to date.
Pregnancy and breastfeeding
Due to lack of data confirming safety, the product should not be used during pregnancy and breastfeeding.
Driving and operating machinery
Sylimarol Vita 80 has no influence on the ability to drive and operate machinery.
Sylimarol Vita 80 contains 0.23 mg of sodium benzoate (E211) in each tablet, corresponding to 0.97 mg/g.
Sylimarol Vita 80 contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The 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 80
This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age
1 to 2 capsules three times daily after meals, unless otherwise directed by a physician. The medicine requires regular use for approximately 2–4 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
Due to lack of data confirming safety, Sylimarol Vita 80 is not recommended for children under 12 years of age.
Taking more Sylimarol Vita 80 than recommended
There is no available data on symptoms of overdose.
Missed dose of Sylimarol Vita 80
Do not take a double dose to make up for a missed capsule.
Stopping Sylimarol Vita 80
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicinal products, this medicine can cause adverse reactions, although not everybody will experience them.
Gastrointestinal disturbances may occur during treatment.
Mild laxative effect has been observed occasionally.
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 at 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 Vita 80
Keep this medicine below 25°C.
Keep this medicine out of the sight and reach of 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. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the packaging and other information
What Sylimarol Vita 80 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%, substance
114.3 mg
auxiliary – sodium benzoate (<0.2%) )
Vitamin B(_1) (thiamine hydrochloride) 2 mg
Vitamin B(_2) (riboflavin) 2 mg
Vitamin B(_6) (pyridoxine hydrochloride) 2 mg
Vitamin PP (nicotinamide) 10 mg
calcium pantothenate 4 mg
Other ingredients (excipients): sodium benzoate (E211) (added to the extract),
a mixture of monohydrate lactose, povidone and crospovidone.
The capsule shell consists of: titanium dioxide (E171), indigotine (E132), quinoline yellow (E104)
and bovine gelatin.
What Sylimarol Vita 80 looks like and contents of the pack
Sylimarol Vita 80 is in the form of hard capsules.
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.
Towarowa 47/51, 61-896 Poznań, Poland
Tel. +48 61 886 18 00, Fax +48 61 853 60 58