Package Leaflet

SILMAR 200 MG HARD CAPSULES 30 CAPSULES, 200 MG EFFERVESCENT GRANULES

silymarin
PHARMACOTHERAPEUTIC CATEGORY
Hepatoprotective agent.
THERAPEUTIC INDICATIONS
Acute liver diseases, organic impairment of hepatic parenchyma. Adjuvant in chronic liver diseases,
steatotic conditions and pre-cirrhotic states.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Mechanical obstruction of the biliary tract.
PRECAUTIONS FOR USE
No cases of habituation or dependence are known.
No special precautions for use are required.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those
without a prescription.
No interactions with other drugs have been demonstrated; however, it has been observed that silymarin
reduces the activity of cytochrome P450, UDP-glucuronosyltransferase (UGT), and decreases P-gp activity.
SPECIAL WARNINGS
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
The drug has no teratogenic effect; however, its administration during pregnancy is not recommended
unless strictly necessary.
Effects on the ability to drive and use machines
SILMAR does not affect or affects only negligibly the ability to drive vehicles or operate machinery.
Important information about certain excipients:
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Initial treatment lasting 4-6 weeks
1 capsule or 1 sachet twice daily, after meals or as directed by the physician.
Maintenance therapy
1 capsule or 1 sachet 1-2 times daily after meals or as directed by the physician.
Treatment with Silmar may be prolonged and dosage increased according to the physician's judgment and
severity of the condition.
Instructions for use
The contents of the sachets must be dissolved in half a glass of water, stirring well to aid dissolution.
OVERDOSE
No cases of overdose have been reported.
In case of accidental ingestion or administration of an excessive dose of Silmar, contact your doctor
immediately or go to the nearest hospital.
If you have any doubts about the use of Silmar, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Silmar can cause adverse reactions, although not everybody experiences them.
Silymarin is generally well tolerated. Occasionally, laxative, diuretic effects and headache have been
reported.
Following the instructions in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or
pharmacist. Adverse reactions can also be reported directly via the national reporting system at
“www.agenziafarmaco.gov.it/it/responsabili”. Reporting adverse reactions helps provide more information
on the safety of this medicine.
Expiry and storage
Expiry date: see the date printed on the packaging
The expiry date refers to the product stored correctly in its original intact packaging.
Warning: do not use the medicine after the expiry date stated on the packaging
Store in a dry place.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
COMPOSITION
Hard capsules
One capsule contains:
Active substance: Milk thistle extract containing not less than 200 mg of flavonoids expressed as
Silymarin
Excipients: lactose, maize starch, polyvinylpyrrolidone, talc, magnesium stearate, gelatin, titanium dioxide.
Effervescent granules
One sachet contains:
Active substance: Milk thistle extract containing not less than 200 mg of flavonoids expressed as
Silymarin
Excipients: sodium bicarbonate, tartaric acid, citric acid, sodium chloride, trisodium citrate,
sodium saccharin, lemon flavor, sucrose, lactose.
PHARMACEUTICAL FORM AND CONTENT
Hard capsules, 30 capsules
Effervescent granules, 30 sachets
MARKETING AUTHORIZATION HOLDER
PHARMABER S.r.l.
Corso Magenta, 32 – 20123 Milano
MANUFACTURER
Hard capsules
Special Product’s Line S.p.A. - Via Campobello, 15 - 00040 Pomezia (Roma)
Effervescent granules
LA.FA.RE. S.r.l. - Via Sac. Benedetto Cozzolino, 77 – 80056 Ercolano (Napoli)