SYLIMAROL PLUS

Patient Information Leaflet

SYLIMAROL PLUS
complex of silymarin-phospholipids
film-coated tablets
100 mg
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed
by your doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• 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 your symptoms do not improve or if you feel worse, you should consult your doctor.

Contents of the leaflet:

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

1. What Sylimarol Plus is and what it is used for

Sylimarol Plus contains in its composition a silymarin-phospholipid complex with 30% flavonolignans expressed as silybin. It is traditionally used in the recommended indications, and its efficacy is based solely on long-term use and experience.
Indications:
The medicine is used as supportive treatment in liver function disorders.

2. Important information before using Sylimarol Plus

When not to use Sylimarol Plus:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If symptoms of jaundice occur (yellowing of the skin or yellowing of the eyeball), consult a doctor.
If other symptoms worsen or do not resolve, medical advice should be sought. The doctor may recommend continuing treatment.

Children and adolescents
Studies on the safety of use in children and adolescents have not been conducted. The use of the medicine is not recommended in children under 12 years of age. In adolescents under 18 years of age, use only after prior consultation with a doctor.

Sylimarol Plus and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to lack of data confirming safety, the use of this preparation is not recommended during pregnancy and breastfeeding.

Driving and operating machinery
The effect on the ability to drive vehicles and operate machinery has not been studied.

3. How to use Sylimarol Plus

This medicine should always be used exactly as described in the patient leaflet, or as directed by a
physician, pharmacist, or nurse. If in doubt, consult a physician or pharmacist.
The usual recommended dose for adults: 1 tablet three times daily in chronic conditions; 2
tablets three times daily in acute conditions, unless otherwise directed by a physician.
The medicine should be taken after meals.
Taking more Sylimarol Plus than recommended
There are no reports regarding overdose of this medicine.
Missing a dose of Sylimarol Plus
Do not take a double dose to make up for a missed dose.
Stopping Sylimarol Plus
If you have any further questions about the use of this medicine, consult your
physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicinal products, this medicine may cause adverse reactions, although not everybody experiences them.
To date, no adverse reactions have been reported with Sylimarol Plus.
Gastrointestinal disturbances may occur during use. Mild laxative effect may occasionally occur.

Reporting suspected 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 provide more information on the safety of this medicine.

5. How to store Sylimarol Plus

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicinal product contains Sylimarol Plus: 1 tablet contains 100 mg of silymarin-phospholipid complex with
30% flavonolignans calculated as silybin and 1.5% phosphorus.
Other components (excipients): microcrystalline cellulose with 2% colloidal silicon dioxide,
sodium croscarmellose, hypromellose, macrogol 6000, titanium dioxide, indigo carmine (E 132),
quinoline yellow lake (E 104).
What Sylimarol Plus looks like and contents of the pack
Sylimarol Plus is available as film-coated tablets. The pack contains: 20, 40 or 45 tablets in blisters made of PVC/Al foil in a cardboard box.
For more detailed information, please contact the marketing authorization holder.
Marketing authorization holder and manufacturer
Poznańskie Zakłady Zielarskie Herbapol S.A.
Towarowa 47/51, 61-896 Poznań, Poland
tel. + 48 61 886 18 00