Package leaflet: Information for the patient

Heparegen, 100 mg, tablets
Timonacicum
Please read this leaflet carefully before using the medicine, because
it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Heparegen is and what it is used for
Important information before taking Heparegen
How to take Heparegen
Possible side effects
How to store Heparegen
Contents of the pack and other information

1. What Heparegen is and what it is used for

Heparegen contains thioproctic acid as the active substance. It supports the breakdown of toxic compounds, thereby protecting the liver parenchyma against damaging effects of bacterial, viral, and industrial toxins, as well as drugs and alcohol. It stimulates bile secretion by the liver.
Heparegen is used as an adjunctive treatment in acute and chronic liver disorders of various origins, as well as in toxic liver damage caused by alcohol, drugs, or chemical substances.

2. Important information before using Heparegen

When not to use Heparegen:

if the patient is allergic to thioglycolic acid or to any of the other ingredients of this medicine (listed in section 6);
in children under 6 years of age.

Warnings and precautions
Before starting treatment with Heparegen, consult your doctor or pharmacist.
To monitor treatment progress, it is recommended to perform periodic liver function tests every 4 weeks.
Children
Do not use this medicine in children under 6 years of age.
Heparegen and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines planned for future use.
Heparegen with food and drink
Heparegen should be taken before meals.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Heparegen should not be used during pregnancy and breastfeeding due to lack of data confirming safety of use.
Driving and operating machinery
This medicine does not impair psycho-physical abilities and does not affect the ability to drive vehicles or operate machinery.
Heparegen contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to use Heparegen

This medicine should always be used according to the doctor's instructions. In case of doubt, consult your doctor.

Adults
Initially: 200 mg (2 tablets) 2 or 3 times daily.
After acute symptoms subside, the dose may be reduced to 100 mg (1 tablet) twice daily.

Use in children and adolescents
Children over 15 years of age
Initially: 200 mg (2 tablets) 2 or 3 times daily.
After acute symptoms subside, the dose may be reduced to 100 mg (1 tablet) twice daily.

Children aged 6–15 years
50 mg ( / tablets) per 10 kg body weight daily, divided into 2 or 3 doses.

Children under 6 years of age
Use of Heparegen is not recommended in children under 6 years of age.

If you feel that the effect of Heparegen is too strong or too weak, consult your doctor.

Taking more Heparegen than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
Overdose of Heparegen primarily poses a risk of central nervous system disturbances. The risk is greater in children due to easier penetration of the drug through the blood-brain barrier. Within 15–60 minutes after oral ingestion of an excessive dose, epileptic status (a life-threatening condition characterized by continuous seizures lasting more than 30 minutes or a series of seizures without regaining consciousness between them) and coma may develop. Central nervous system disturbances may persist for several weeks or even months. Hearing impairment and deafness may also occur.

Missed dose of Heparegen
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Gastrointestinal disorders:
Frequency unknown: nausea.
Skin and subcutaneous tissue disorders:
Frequency unknown: skin reactions.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions
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,
tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
5. How to store Heparegen
Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the packaging after {EXP:}.
The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Heparegen contains

The active substance is thiazolidinecarboxylic acid.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, maize starch, talc, colloidal anhydrous silica, magnesium stearate.

What Heparegen looks like and contents of the pack
Heparegen tablets are white, round, flat on both sides, with a score line dividing them.
Pack sizes:
30 tablets
90 tablets
100 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland