Heparegen

Package Leaflet: Information for the Patient

Heparegen, 100 mg, Tablets

Timonacicum

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Heparegen and What is it Used For
• 2. Important Information Before Taking Heparegen
• 3. How to Take Heparegen
• 4. Possible Side Effects
• 5. How to Store Heparegen
• 6. Package Contents and Other Information

1. What is Heparegen and What is it Used For

Heparegen contains thiazolidinecarboxylic acid as the active substance. It aids in the breakdown of toxic compounds, thereby protecting the liver tissue from the damaging effects of bacterial, viral, and industrial toxins, as well as medications and alcohol. It stimulates bile secretion by the liver. Heparegen is used as an auxiliary medication in acute and chronic liver diseases of various origins, as well as in toxic liver damage caused by alcohol, medications, or chemicals.

2. Important Information Before Taking Heparegen

When Not to Take Heparegen:

• in children under 6 years of age.

Warnings and Precautions

Before starting to take Heparegen, discuss it with your doctor or pharmacist. To monitor treatment progress, it is recommended to perform liver function tests every 4 weeks.

Children

Do not use this medication in children under 6 years of age.

Heparegen and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Heparegen with Food and Drink

Heparegen should be taken before meals.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication. Do not use Heparegen in pregnant or breastfeeding women due to the lack of data confirming its safety.

Driving and Operating Machinery

The medication does not affect psychophysical abilities and does not impair the ability to drive vehicles or operate machinery.

Heparegen Contains Lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medication.

3. How to Take Heparegen

This medication should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor.

Adults

Initially, 200 mg (2 tablets) 2 or 3 times a day. Then, after the acute symptoms have subsided, the dose can be reduced to 100 mg (1 tablet) 2 times a day.

Use in Children and Adolescents

Children over 15 years of age: Initially, 200 mg (2 tablets) 2 or 3 times a day. Then, after the acute symptoms have subsided, the dose can be reduced to 100 mg (1 tablet) 2 times a day. Children between 6 and 15 years of age: 50 mg (1/2 tablet) per 10 kg of body weight per day, divided into 2 or 3 doses. Children under 6 years of age: Heparegen is not recommended for 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 than the Recommended Dose of Heparegen

In case of taking more than the recommended dose, immediately consult a doctor or pharmacist. Taking more than the recommended dose of Heparegen can lead to changes in the central nervous system. The risk is higher in children due to the easier penetration of the medication through the blood-brain barrier. Within 15-60 minutes after taking an excessive dose, a life-threatening condition (status epilepticus) and coma may develop, as well as central nervous system disorders that can last for several weeks or even months. Hearing impairment and deafness may also occur.

Missing a Dose of Heparegen

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

Stopping Heparegen Treatment

In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Heparegen can cause side effects, although not everybody gets them. Gastrointestinal disorders: frequency unknown:nausea. Skin and subcutaneous tissue disorders: frequency unknown:skin reactions.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Heparegen

Store the medication out of sight and reach of children. Store at a temperature below 25°C. Do not use this medication after the expiration date stated on the packaging after {EXP:}. The expiration date refers to the last day of the specified month.

6. Package Contents and Other Information

What Heparegen Contains

• The active substance of Heparegen is thiazolidinecarboxylic acid.
• Other ingredients are: lactose monohydrate, microcrystalline cellulose, corn starch, talc, colloidal silicon dioxide, magnesium stearate.

What Heparegen Looks Like and What the Package Contains

Heparegen tablets are white, round, flat on both sides, with a dividing groove. Package sizes: 30 tablets, 90 tablets, 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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.

Date of the Last Update of the Leaflet: