Silifar

Leaflet attached to the packaging: information for the user

Sylifar

140 mg of silymarin in terms of silybin, hard capsules

Silybi mariani extractum siccum raffinatum et normatum

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Please keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should 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 or pharmacist. See section 4.
• If after 2 weeks of use, there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Sylifar and what is it used for
• 2. Important information before using Sylifar
• 3. How to use Sylifar
• 4. Possible side effects
• 5. How to store Sylifar
• 6. Contents of the packaging and other information

1. What is Sylifar and what is it used for

Sylifar is a traditional herbal medicinal product for use in specified indications, resulting solely from its long-term use.
Sylifar contains a dry extract of milk thistle fruit in its composition. The active substance of milk thistle fruit is a complex of flavonoids called silymarin, which includes, among others, silybin.
The traditional herbal medicinal product is used for the symptomatic treatment of digestive disorders, feelings of fullness and indigestion, as well as to support liver function, after excluding serious diseases by a doctor.
If after 2 weeks, there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Sylifar

When not to use Sylifar:

Warnings and precautions

Before starting to use Sylifar, the patient should discuss it with their doctor or pharmacist.
The medicine should not be used to treat acute poisonings.
Harmful factors for the liver (such as alcohol) should be avoided.
If symptoms of jaundice (light to dark yellow discoloration of the skin, yellow discoloration of the eyes) occur, the patient should consult their doctor.
If the symptoms worsen during the use of the medicinal product, the patient should consult their doctor.

Children and adolescents

Due to the lack of data confirming the safety of use, it is not recommended to use the medicine in children under 18 years of age.

Sylifar and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions have been found during use with other medicines.

Sylifar with food, drink, and alcohol

It is recommended to use the medicine before a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The safety of the medicinal product during pregnancy and breastfeeding has not been established.
The use of the medicine during pregnancy and breastfeeding is not recommended due to the lack of sufficient data.

Driving and using machines

No studies have been conducted on the effect of silymarin on the ability to drive and use machines.

Sylifar contains orange yellow (E110) and azorubine (E122).

The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, which means the medicine is considered "sodium-free".

3. How to use Sylifar

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
At the beginning of treatment, it is recommended to take 1 capsule 3 times a day (which corresponds to 420 mg of silymarin). As a maintenance dose, it is recommended to take 1 capsule 2 times a day (which corresponds to 280 mg of silymarin).
The medicine should be taken whole, without chewing or crushing, before a meal, with a small amount of liquid.
The patient should consult their doctor if the symptoms persist for more than 2 weeks after starting the use of the medicine.

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 18 years of age.

Overdose of Sylifar

There are no data on the symptoms of overdose.

Missed dose of Sylifar

A double dose should not be taken to make up for a missed dose.

Stopping the use of Sylifar

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

4. Possible side effects

Like all medicines, Sylifar can cause side effects, although not everybody gets them.
During use, mild gastrointestinal disorders, such as dry mouth, nausea, stomach upset, stomach irritation, and diarrhea, may occur. Headache, allergic reactions (skin inflammation, hives, rash, itching, anaphylaxis, asthma), have also been observed. The frequency of these side effects is unknown.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be gathered on the safety of the medicine.

5. How to store Sylifar

Store in a temperature below 30°C.
Store in a place 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 specified month.
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. Contents of the packaging and other information

What Sylifar contains

The active substance of Sylifar is a dry, purified, and standardized extract of milk thistle fruit (Silybi mariani extractum siccum raffinatum et normatum).

• One capsule contains 241.35 mg of extract (in the form of a dry, purified extract from Silybum marianum(L.) Gaertn., fructus (milk thistle fruit) (22-27:1), which corresponds to 140 mg of silymarin in terms of silybin. The extraction solvent is aceton 95% (V/V).

The nominal content of silymarin in terms of silybin in the extract is 58% (m/m).

• The other ingredients are: Capsule content: microcrystalline cellulose, colloidal anhydrous silica, meglumine, sodium carboxymethyl cellulose type A, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), quinoline yellow (E104), azorubine (E122), patent blue V (E131), orange yellow FCF (E110).

What Sylifar looks like and what the packaging contains

Sylifar are red and dark green hard capsules containing a brown mixture.
The hard capsules are packaged in PVC/PVDC/Aluminum blisters, together with the patient leaflet, in a cardboard box.
The packaging contains 10, 20, 30, 60, or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500

Date of the last update of the leaflet: