Silimax

SILIMAX,
70 mg, hard capsules
Silymarin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• 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 or pharmacist. See section 4.
• If there is no improvement after 4 weeks, or if your condition worsens, consult your doctor.

Table of contents

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

1. What Silimax is and what it is used for

Silimax is a herbal medicinal product used traditionally. Its efficacy in the indications listed below is based solely on long-standing use and experience.
The active substance in Silimax is silymarin — an extract from milk thistle fruit, which contains flavonolignan derivatives (silibinin, silydianin, and silychristin).

Indications for use
Silimax is used:

• traditionally in conditions following liver damage caused by toxic agents such as alcohol, pesticides, consumption of hard-to-digest foods, or damage caused by drug therapy;
• as supportive treatment in complaints occurring after acute and chronic liver diseases.

2. Important information before using Silimax

When not to use Silimax

• if the patient is allergic to any of the ingredients of the medicine or to plants from the Asteraceae (= Compositae) family.
• the medicine should not be used in the treatment of acute poisoning.

Warnings and precautions
The medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
If symptoms of jaundice occur (yellowing of the skin, yellow discoloration of the whites of the eyes), medical advice should be sought.
During treatment, avoid substances toxic to the liver, e.g., alcohol.
Studies on the use of silymarin in children have not been conducted; therefore, use in children under 12 years of age is not recommended.
Other medicines and Silimax
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
To date, no interactions with other medicines have been reported.
Pregnancy, breastfeeding and fertility
Due to lack of data confirming the safety of silymarin use, the medicine is not intended for use during pregnancy and breastfeeding.
Driving and operating machinery
When used according to recommendations, the medicine does not affect the ability to drive mechanical vehicles, operate machinery or psycho-physical performance.

3. How to use Silimax

The medicine should be used according to the doctor's instructions. In case of doubts, consult your doctor again.
The medicine is usually used as described below.
Adults and adolescents over 12 years of age:
The usual dose is one capsule taken orally three times a day (210 mg of silymarin per day). In case of increased symptoms, the dose may be increased to two capsules twice daily (280 mg of silymarin per day).
Unless otherwise directed by a physician, the medicine should be taken after meals with water.
Silimax is effective when used systematically. The duration of treatment should be discussed with a doctor. Treatment should last 4 weeks, and in chronic conditions up to 6 months.
If you feel that the effect of Silimax is too strong or too weak, consult your doctor or pharmacist.
Elderly patients
There is no need to change the method of administration or dosage in elderly patients.
If you feel that the effect of Silimax is too strong or too weak, consult your doctor.
In case of taking more Silimax than recommended
If you have taken more than the recommended dose, seek medical advice immediately from your doctor or pharmacist.
Symptoms of overdose: transient diarrhoea, which resolves upon dose reduction.
Treatment: symptomatic.
Missed dose of Silimax
Do not take a double dose to make up for a missed dose.
Stopping Silimax treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Silimax may cause adverse reactions, although not everyone experiences them.
When high doses of the medicine are used, a mild laxative effect may occur.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
In some individuals, other adverse reactions may occur during treatment with Silimax. If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist.
Reporting adverse reactions
If any adverse reactions occur, including those 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
Tel: +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 the medicine.

5. How to store Silimax
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

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

What Silimax looks like and contents of the pack
Silimax is hard, colorless, transparent oral capsules.
The cardboard box contains:
30 capsules – 3 blisters with 10 capsules each, or
36 capsules – 2 blisters with 18 capsules each.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz
For further information, please contact the Marketing Authorisation Holder:
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz
tel.: 52 342 67 88