Silarine 80 mg hard capsules
SpainTable of Contents
- Package Leaflet: Information for the User
- Introduction
- 1. What Silarine is and what it is used for
- 2. What you need to know before taking Silarine
- **Driving and operating machinery**
- 3. How to take Silarine
- **If you forget to take Silarine**
- **If treatment with Silarine is interrupted**
- 4. Possible adverse effects
- 5. Storage of Silarine
- 6. Contents of the pack and other information
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
Silarine 80 mg Hard Capsules
Silymarin
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Silarine is and what it is used for
- What you need to know before taking Silarine
- How to take Silarine
- Possible side effects
- How to store Silarine
- Contents of the pack and other information
1. What Silarine is and what it is used for
Silarine is a preparation with detoxifying and hepatoprotective properties due to its active ingredient, silymarin, present in the dry extract of milk thistle (Silybum marianum).
It is indicated as supportive treatment in adults for chronic liver injuries caused by chronic alcohol intake or hepatotoxic drugs, 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 ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Silarine.
Treatment with the dried fruit extract of milk thistle does not replace abstaining from causes of liver damage (for example, alcohol).
If jaundice occurs (skin turning from light to dark yellow, yellowish discoloration of the whites of the eyes), you should consult your doctor.
Long-term use of this medicine should be monitored by a doctor.
Caution should be exercised in patients with known sensitivity to plants of the Asteraceae/Compositae family (such as chrysanthemum, daisy, calendula, or ragweed).
Children
There is no experience regarding the use of this medicine in children; therefore, administration is not recommended.
Other medicines and Silarine
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Based on experience with Silarine, it is unlikely that your ability to drive vehicles or operate heavy machinery will be affected. However, at the beginning of treatment, you should exercise caution when performing these activities until you know how you tolerate the treatment.
This medicine contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Silarine
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Silarine is available as hard capsules for oral administration. The capsules should be swallowed whole, without chewing, with a little water, and may be taken with or without food.
The recommended starting dose for treatment is 1 capsule three times a day, after meals, for 1 month, followed by 2 capsules per day.
If you take more Silarine than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Symptoms such as nausea, diarrhea, dyspepsia, flatulence, abdominal pain or sensation of fullness, and anorexia may occur.
If you forget to take Silarine
Do not take a double dose to make up for missed doses. Take your dose as soon as you remember and continue treatment as before.
If treatment with Silarine is interrupted
Your doctor will determine the duration of your treatment with this medicine. Do not stop the treatment earlier, as your symptoms may worsen. If you feel that the effect of Silarine is too strong or too weak, inform your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
The adverse effects are mild and transient.
The following adverse effects* have been observed in products containing the active substance silymarin:
Uncommon (affect between 1 and 10 in every 1,000 patients):
Gastrointestinal disorders: stomach pain and diarrhoea.
Very rare (affect less than 1 in every 10,000 patients):
Immune system disorders: allergic reactions.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Skin and subcutaneous tissue disorders: skin rash.
- The adverse effects and their frequencies have been extrapolated from other medicines containing the same active substance but at different doses. Due to the absence of specific clinical data for this medicine, both the adverse effects and their frequencies should be interpreted with caution.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Silarine
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the blister and packaging after "EXP". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Silarine
The active substance is silymarin. Each capsule contains 100 mg of dried extract of milk thistle, equivalent to 80 mg of silymarin.
The other components are lactose and magnesium stearate.
The capsule shell contains gelatin, indigotine (E-132), quinoline yellow (E-104), and titanium dioxide (E-171).
Appearance of the product and contents of the pack
Hard gelatin capsules with an opaque white body and an opaque green cap, packed 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 most recent revision of this leaflet: June 2025.
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)