Silimax

PATIENT INFORMATION LEAFLET: PATIENT INFORMATION

SILIMAX,

70 mg, hard capsules

Silymarin

Read the contents of the 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 patient information leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Silimax and what is it used for
• 2. Important information before taking Silimax
• 3. How to take Silimax
• 4. Possible side effects
• 5. How to store Silimax
• 6. Other information

1. What is Silimax and what is it used for

Silimax is a herbal medicinal product used traditionally. Its effectiveness, in the indications listed, is based solely on a long period of use and experience. The active substance of the medicine is silymarin - an extract from the fruit of the milk thistle, which contains flavonoid derivatives (silybin, silydianin, and silycristin).

Indications for use

Silimax is used:

• traditionally in conditions after liver damage caused by toxic factors, such as alcohol, pesticides, after consuming hard-to-digest foods, as well as after damage caused by medications.
• supportively in ailments occurring after acute and chronic liver diseases.

2. Important information before taking Silimax

When not to take Silimax

• if the patient is allergic to any of the medicine's ingredients or to plants of the Asteraceae (= Compositae) family.
• the medicine should not be used to treat acute poisonings.

Warnings and precautions
The medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
If symptoms of jaundice (yellowing of the skin, yellowing of the whites of the eyes) occur, medical advice should be sought.
During treatment, toxic substances for the liver, such as alcohol, should be avoided.
No studies have been conducted on the use of silymarin in children, so it is not recommended for use in children under 12 years of age.
Other medicines and Silimax
The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines have been found.

Pregnancy, breastfeeding, and fertility

Due to the lack of data confirming the safety of silymarin, the medicine is not intended for use during pregnancy and breastfeeding.

Driving and using machines

The medicine, when used as directed, does not affect the ability to drive vehicles, operate machinery, or mental and physical performance.

3. How to take Silimax

The medicine should be taken as directed by the doctor. In case of doubts, the doctor should be consulted again.
Usually, the medicine is taken as described below.

Adults and adolescents over 12 years:

Usually, 1 capsule is taken orally three times a day (210 mg of silymarin per day). In case of worsening symptoms, the dose can be increased to 2 capsules twice a day (280 mg of silymarin per day).
If the doctor does not recommend otherwise, the medicine should be taken after a meal, with water.
Silimax is effective when used systematically. The duration of treatment should be consulted with a doctor. The treatment should last 4 weeks, and in chronic conditions, up to 6 months.
If the patient feels that the effect of the Silimax medicine is too strong or too weak, they should consult their doctor or pharmacist.
Elderly patients
There is no need to change the method of administration or dosage of the medicine in elderly patients.
If the patient feels that the effect of the Silimax medicine is too strong or too weak, they should consult their doctor.

In case of taking a larger dose of Silimax than recommended

In case of taking a larger dose of the medicine than recommended, the doctor or pharmacist should be consulted immediately.
Symptoms of overdose: transient diarrhea after reducing the dose.
Treatment: symptomatic.

Missing a dose of Silimax

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

Stopping Silimax treatment

In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Silimax can cause side effects, although not everybody gets them.
When taking large doses of the medicine, a mild laxative effect may occur.
If any of the side effects worsen or any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.
In some people, other side effects may occur during the use of Silimax. If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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
Phone: +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 Silimax

The medicine should be stored in a place inaccessible and invisible to children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date means the last day of the given month.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Silimax contains

The active substance of the medicine is silymarin.
1 capsule contains: 70 mg of silymarin.
Excipients: lactose, magnesium stearate, capsule shell
Capsule shell composition: Lower part of the capsule (body): hydrolyzed gelatin. Upper part of the capsule (cap): hydrolyzed gelatin.

What Silimax looks like and what the packaging contains

Silimax is a hard oral capsule, colorless, and transparent.
A cardboard box contains:
30 pieces - 3 blisters of 10 pieces each or
36 pieces - 2 blisters of 18 pieces each.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz
To obtain more detailed information, the representative of the marketing authorization holder should be contacted:
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz
phone: 52 342 67 88

Date of the last update of the leaflet: