SILARINE 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Silarine 80 mg Hard Capsules

Silymarin

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Silarine is and what it is used for
2. What you need to know before taking Silarine
3. How to take Silarine
4. Possible side effects
5. Storage of Silarine
6. Package Contents and Additional Information

1. What Silarine is and what it is used for

Silarine is a preparation with antitoxic and hepatoprotective action due to its active ingredient silymarin present in the dry extract of milk thistle (Silybum marianum).

It is indicated for supportive treatment in adults of chronic liver lesions caused by chronic alcohol consumption or hepatotoxic medications, steatosis (fatty liver) or cirrhosis.

2. What you need to know before taking Silarine

Do not take Silarine

If you are allergic to silymarin or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Silarine.

Treatment with dry extract of milk thistle fruit does not replace abstinence from the causes of liver damage (e.g., alcohol).

In case of jaundice (yellowish discoloration of the skin, yellowish discoloration of the whites of the eyes), you should consult your doctor.

The use of this medication for long periods of time should be monitored by a doctor.

Cautions should be taken in patients with known sensitivity to plants of the Asteraceae/Compositae family (such as chrysanthemum, daisy, calendula, or ragweed).

Children

There is no experience with the use of this medication in children, so its administration is not recommended.

Other Medications and Silarine

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. In particular, inform them if you are taking:

• Metronidazole or losartan; special precautions may be required.
• Domperidone: its use with Silarine is not recommended.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

According to experience with Silarine, it is unlikely that your ability to drive vehicles or operate hazardous machinery will be impaired. However, at the start of treatment, be cautious when performing these tasks until you know how you tolerate the treatment.

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to take Silarine

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Silarine is presented in the form of hard capsules for oral administration. The capsules should be swallowed without chewing, with the help of a little water, and can be taken with or without food.

The recommended starting dose is 1 capsule 3 times a day, after meals, for 1 month, and then continue with 2 capsules per day.

If you take more Silarine than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. You may observe nausea, diarrhea, dyspepsia, flatulence, abdominal pain, or a feeling of fullness and anorexia.

If you forget to take Silarine

Do not take a double dose to make up for forgotten doses. Take your dose as soon as you remember and continue the treatment as before.

If you stop treatment with Silarine

Your doctor will indicate the duration of your treatment with this medication. Do not stop the treatment before, as your symptoms may worsen. If you think the effect of Silarine is too strong or too weak, tell your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects are mild and transient.

The following side effects* have been observed in products containing the active ingredient silymarin:

Uncommon (affecting 1 to 10 out of 1000 patients)

Gastrointestinal disorders: stomach pain and diarrhea.

Very rare (affecting less than 1 in 10,000 patients)

Immune system disorders: allergic reactions.

Respiratory, thoracic, and mediastinal disorders: dyspnea.

Skin and subcutaneous tissue disorders: skin rash.

• Side effects and their frequencies have been extrapolated from other medications containing the same active ingredient but at different doses. Due to the lack of clinical data specific to this medication, both side effects and frequencies should be interpreted with caution.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Silarine

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the blister pack and the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Silarine

The active ingredient is silymarin. Each capsule contains 100 mg of dry extract of milk thistle, equivalent to 80 mg of silymarin.

The other ingredients are lactose and magnesium stearate.

The capsule shell contains gelatin, indigo carmine (E-132), quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Hard gelatin capsules with a white opaque body and a green opaque cap, packaged in aluminum/PVC blister packs containing 30 hard capsules.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-68-70. Polígono Industria Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Package Leaflet:June 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS).