LIPOCYNAR

Patient Information Leaflet

LIPOCYNAR 140 mg + 28.6 mg film-coated tablets
Cynarae herbae extractum + Silybi mariani fructus extractum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or if you feel worse, you should consult your doctor.

Table of Contents

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

1. What Lipocynar is and what it is used for

Lipocynar is a herbal medicinal product used traditionally, whose efficacy in the indicated conditions is based solely on long-standing use and experience.
Lipocynar contains an extract of artichoke herb and a dry extract of milk thistle fruit.
Lipocynar is used in conditions following toxic liver damage caused, for example, by toxic agents (e.g. alcohol, pesticides). It is also used as supportive treatment in liver function disorders and in elevated serum cholesterol and triglyceride levels, provided a low-fat diet is maintained.

2. Important information before taking Lipocynar

When not to take Lipocynar:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to plants of the Asteraceae family (formerly Compositae),
• if the patient has biliary tract obstruction, biliary inflammation, liver diseases, gallstones, or any other biliary disorders requiring medical supervision and advice.

Warnings and precautions
Biliary tract obstruction is a contraindication for the use of Lipocynar.
In case of gallstones, medical advice must be sought before use. During and after treatment, avoid substances harmful to the liver.
Children
Due to lack of data confirming safety, Lipocynar is not recommended for children under 12 years of age.
Lipocynar and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No interactions with other medicines have been reported to date.
Pregnancy, breastfeeding and fertility
Controlled clinical studies have not been conducted in pregnant or breastfeeding women.
Lipocynar may be used after prior consultation with a doctor.
There is no data available on the effect on fertility.
Driving and operating machinery
Lipocynar has no effect on the ability to drive or operate machinery.
Warnings regarding excipients with known effects
Lipocynar contains 0.06 mg of sodium benzoate (E211) per tablet, equivalent to 0.16 mg/g.
Sodium benzoate (E211) may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Lipocynar contains 0.21 mg of Brilliant Black (E151) and 1.2 mg of Carmoisine (E124) per tablet. The medicine may cause allergic reactions.

3. How to take Lipocynar

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.

Adults and adolescents over 12 years of age
Orally, 3 times daily, 2 tablets after meals, unless otherwise directed by a physician. The medicine requires regular use. The duration of therapy should be discussed with a doctor.

Use in children
Due to lack of data confirming safety, Lipocynar is not recommended for children under 12 years of age.

Taking more Lipocynar than recommended
There are no reports regarding overdose with this medicine.

If you forget to take Lipocynar
Do not take a double dose to make up for the missed dose.

Stopping Lipocynar
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Mild gastrointestinal symptoms may occur during use, such as dry mouth,
upper abdominal discomfort including nausea and heartburn, stomach upset, gastric irritation,
and diarrhoea, mild diarrhoea with abdominal cramps; headache; allergic reactions may also occur
(skin inflammation, urticaria, skin rash, itching, anaphylaxis, asthma). Frequency is unknown.
No adverse effects have been reported so far following the use of Lipocynar.
Allergic reactions may also be caused by the presence of other ingredients in the medicine, such as e.g.
brilliant black.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor, pharmacist or nurse.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone +48 22 49 21 301, fax +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lipocynar

Store the medicine at a temperature not exceeding 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.
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.

6. Contents of the packaging and other information

What Lipocynar contains
One coated tablet contains:
Active substances:
• 140 mg dry extract (DER 3-7:1) from Cynara scolymus, herba (artichoke herb),
extraction solvent: water;
• 28.6 mg dry extract (DER 20-34:1) from Silybum marianum L., fructus (fruit (husk)
of milk thistle), extraction solvent: 90% methanol, corresponding to not less than 20
mg of silymarin, expressed as silibinin.
Excipients: sodium benzoate (E211) (added to the extract),
Tablet core: microcrystalline cellulose, sodium starch glycolate, povidone, talc, magnesium stearate,
Coating: hypromellose, macrogol 6000, brilliant black (E151), quinoline yellow (E104), cochineal red (E124).

What Lipocynar looks like and contents of the pack
Lipocynar is a brown, round, biconvex coated tablet with a yellowish-brown cross-section.
Available pack sizes: 2 or 4 blisters made of PVC/Al foil, each containing 15 coated tablets, packed in a cardboard box.

For more detailed information about this medicinal product, please contact the marketing authorisation holder.

Marketing Authorisation Holder and Manufacturer
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47/51, 61-896 Poznań, Poland
tel. +48 61 886 18 00