Package leaflet: Information for the user

Sylifar
140 mg silymarin calculated as silibinin, hard capsules
Silybi mariani extractum siccum raffinatum et normatum
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 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, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 weeks of treatment, or if you feel worse, consult your doctor.

Table of contents

What Sylifar is and what it is used for
What you need to know before taking Sylifar
How to take Sylifar
Possible side effects
How to store Sylifar
Contents of the pack and other information

1. What Sylifar is and what it is used for

Sylifar is a traditional herbal medicinal product used for specific indications based solely on its long-standing use.
Sylifar contains in its formulation a dried extract of milk thistle (Silybum marianum) fruits. The active constituent of milk thistle fruits is a flavonolignan complex called silymarin, which includes, among others, silibinin.
Traditional herbal medicinal product used symptomatically for digestive disturbances, sensation of fullness and dyspepsia, as well as supportive treatment for liver function, after exclusion of serious diseases by a physician.
If there is no improvement after 2 weeks of use, or if you feel worse, consult your doctor.

2. Important information before using Sylifar

When not to use Sylifar:

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

Warnings and precautions
Before starting to use Sylifar, consult your doctor or pharmacist.
This medicine should not be used for the treatment of acute poisoning.
Avoid factors harmful to the liver (e.g. alcohol).
If symptoms of jaundice occur (light to dark yellow discoloration of the skin, yellowing of the eyes), consult a doctor.
If symptoms worsen during treatment with this medicinal product, consult a doctor.

Children and adolescents
Due to lack of data confirming safety of use, Sylifar is not recommended for children under 18 years of age.

Sylifar and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions have been reported so far when used with other medicines.

Sylifar with food, drink and alcohol
It is recommended to take the medicine before meals.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
The safety of using this medicinal product during pregnancy and breastfeeding has not been established.
Use of this medicine during pregnancy and breastfeeding is not recommended due to insufficient data.

Driving and operating machinery
Studies on the influence of sylimaryn on the ability to drive vehicles and operate machinery have not been conducted.

Sylifar contains Sunset Yellow FCF (E110) and Azorubine (E122).
This medicine may cause allergic reactions.
The product contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning the medicine is considered "sodium-free".

3. How to use Sylifar
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

At the beginning of treatment, the recommended dose is 1 capsule three times daily (corresponding to 420 mg of sylimaryn). For maintenance therapy, the recommended dose is 1 capsule twice daily (corresponding to 280 mg of sylimaryn).
It is recommended to take the capsules whole, without chewing or crushing, before meals, with a small amount of liquid.

Consult your doctor if symptoms persist for more than 2 weeks after starting treatment.

Use in children
Due to lack of data confirming safety of use, Sylifar is not recommended for children under 18 years of age.

Overdose of Sylifar
There is no available data on symptoms of overdose.

Missed dose of Sylifar
Do not take a double dose to make up for a missed dose.

Stopping treatment with Sylifar
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 everyone will experience them.
During use, mild gastrointestinal disturbances may occur, such as dry mouth, nausea, upset stomach,
gastric irritation, diarrhoea. Headache and allergic reactions (dermatitis, urticaria, rash, itching, anaphylaxis,
asthma) have also been observed. The frequency of the aforementioned reactions is unknown.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel. 48 22 49 21 301
fax 48 22 49 21 309
e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Sylifar
Store below 30°C.
Keep out of sight and reach of children.
Do not use Sylifar after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Sylifar contains
The active substance in Sylifar is a dry, purified and standardized extract from milk thistle fruits
(Silybi mariani extractum siccum raffinatum et normatum).

Each capsule contains 241.35 mg of extract (in the form of a dry extract, purified from Silybum marianum (L.) Gaertn., fructus (milk thistle fruits) (22-27:1)), equivalent to 140 mg of silymarin calculated as silybin. Extraction solvent: 95% (V/V) acetone.

The nominal silymarin content, expressed as silybin, in the extract is 58% (m/m).

Other ingredients: Capsule contents: microcrystalline cellulose, colloidal anhydrous silica, meglumine, sodium carboxymethyl starch type A, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), quinoline yellow (E104), azorubine (E122), patent blue V (E131), sunset yellow FCF (E110).

What Sylifar looks like and contents of the pack
Sylifar consists of hard capsules with a red cap and a dark green body, containing a brownish mixture.
The hard capsules are packed in PVC/PVDC/Aluminium blisters, placed together with the patient leaflet in a cardboard box.
Pack sizes contain 10, 20, 30, 60 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500