Silimarin

Package leaflet: Information for the patient

SILIMARIN 200 mg film-coated tablets

Silimarina
Please read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SILIMARIN is and what it is used for
2. What you need to know before taking SILIMARIN
3. How to take SILIMARIN
4. Possible side effects
5. How to store SILIMARIN
6. Contents of the pack and other information

1. What SILIMARIN is and what it is used for

SILIMARIN contains the active substance silymarin, which belongs to the class of drugs
used for liver therapies.
SILIMARIN is used as an adjunctive treatment for symptoms related to digestive disorders,
such as a feeling of fullness and indigestion, and as a supportive treatment for liver
function after serious conditions have been clinically excluded.

2. What you need to know before taking SILIMARIN

Do not take SILIMARIN

• If you are allergic to silymarin or to any of the other ingredients of this medicine listed in section 6.
• If you are allergic to plants of the Asteraceae (Compositae) family.
• If there is a physical obstruction in the biliary tract.

Warnings and precautions
Talk to your doctor or pharmacist before taking SILIMARIN.
If your symptoms worsen during treatment with this medicine, consult your doctor. If jaundice occurs or if you notice a change in the colour of your urine or stools, you must consult your doctor immediately.
Children and adolescents
The efficacy and safety of use in children and adolescents under 18 years of age have not been established due to lack of adequate data.
SILIMARIN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
Other medicines and SILIMARIN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not prescribed by a doctor.
No interactions with other drugs have been reported; however, it has been observed that silymarin decreases the activity of cytochrome P450, UDP-glucuronosyltransferase (UGT), and reduces P-gp activity.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use SILIMARIN during pregnancy and breastfeeding unless absolutely necessary and only after consulting your doctor, who will assess whether the potential benefits outweigh the possible risks.
Driving and using machines
SILIMARIN does not affect or affects negligibly the ability to drive vehicles or operate machinery.

3. How to take SILIMARIN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 200 mg twice daily after meals, for 4-6 weeks.
Always inform your doctor during treatment, as administration and dosage are only indicative and may be increased at the doctor's discretion.
Once improvement is achieved, your doctor may reduce the dose to 200 mg per day.
If you take more SILIMARIN than you should
In case of accidental ingestion/overdose of Silimarin, immediately contact your doctor or go to the nearest hospital.
If you have any questions about the use of Silimarin, consult your doctor or pharmacist.
If you forget to take SILIMARIN
Do not take a double dose to make up for the missed tablet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking your tablets and inform your doctor immediately.

Rare (may affect up to 1 in 1,000 people)

• stomach and intestinal disorders (gastrointestinal disturbances);
• loose stools (laxative effect).

Very rare (may affect up to 1 in 10,000 people)

• changes in breathing rate and rhythm (dyspnoea);
• blistering rash accompanied by redness, itching, and pain (skin eruption);
• allergic reactions (hypersensitivity reactions).

Frequency not known (frequency cannot be estimated from the available data):

• dry mouth
• nausea
• stomach discomfort
• gastric irritation
• headache
• dermatitis
• urticaria
• pruritus
• anaphylaxis (sudden and severe allergic reaction with breathing difficulties, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness)
• asthma

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SILIMARIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original packaging, properly stored.
This medicine does not require any special storage precautions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SILIMARIN contains
The active substance is silymarin.
One coated tablet contains:
Active substance: extract (as dry extract) from the fruit of milk thistle (22-27:1).
Extraction solvent: 95% (v/v) acetone. Each tablet contains 200 mg of total flavonoids expressed as silymarin.
Excipients: maize starch, mannitol, microcrystalline cellulose, methylcellulose, magnesium stearate.
Excipients of the coating: cetyl alcohol, ethylcellulose, hypromellose, polyethylene glycol 400, polysorbate 80, sodium lauryl sulfate, titanium dioxide, triacetin (glyceryl triacetate).
Description of the appearance of SILIMARIN and contents of the pack
Coated tablets.
SILIMARIN is available in a carton containing 30 coated tablets of 200 mg in blisters.
Marketing Authorization Holder and Manufacturer
ELLEVA PHARMA S.r.l., Via San Francesco n. 5/7, 80034 Marigliano (NA)
MANUFACTURER
Special Product’s Line S.p.A.
Strada Paduni, 240
03012 Anagni (FR)
Italy
LACHIFARMA SRL, LABORATORIO CHIMICO FARMACEUTICO SALENTINO
S.S. 16 Zona Industriale
73010 Zollino (LE)
Italy