Package leaflet: Information for the patient

Hepadetox Intense, 200 mg, tablets
Timonacicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Hepadetox Intense is and what it is used for

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

2. Important information before using Hepadetox Intense

When not to use Hepadetox Intense:

if the patient is allergic to timonacic 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 Hepadetox Intense, consult your doctor or pharmacist.
To monitor treatment progress, periodic liver function tests are recommended every 4 weeks.
Children
Hepadetox Intense should not be used in children and adolescents aged 15 years and younger (see section 3).
Hepadetox Intense with other medicines
Inform your doctor about all medicines currently used, recently used, or planned to be used.
Hepadetox Intense with food and drink
Hepadetox Intense should be taken before meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Hepadetox Intense should not be used in pregnant women or during breastfeeding due to lack of data confirming safety of use.
Driving and operating machinery
Hepadetox Intense has no effect or has a negligible effect on the ability to drive and operate machinery.
Hepadetox Intense 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 Hepadetox Intense
This medicine should always be used according to the doctor's instructions. In case of doubt, consult your doctor.
Adults
Initially, 200 mg (1 tablet) 2 or 3 times daily.
After acute symptoms subside, the dose may be reduced to 100 mg (half a tablet) twice daily.
Use in children and adolescents
Adolescents over 15 years of age
Initially, 200 mg (1 tablet) 2 or 3 times daily.
After acute symptoms subside, the dose may be reduced to 100 mg (half a tablet) twice daily.
The tablet may be divided into two equal doses.
Hepadetox Intense must not be used in children and adolescents aged 6 to 15 years due to the inability to administer the appropriate dose.
Hepadetox Intense is contraindicated in children under 6 years of age (see section 2).
If the effect of Hepadetox Intense seems too strong or too weak, consult your doctor.
Taking more than the recommended dose of Hepadetox Intense
In case of overdose, seek immediate medical advice from a doctor or pharmacist.
An overdose of Hepadetox Intense primarily poses a risk of central nervous system disturbances. The risk is higher 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, status epilepticus (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.
Missing a dose of Hepadetox Intense
Do not take a double dose to make up for a missed dose.
Stopping Hepadetox Intense
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 will experience them.
Gastrointestinal disorders: frequency unknown: nausea.
Skin and subcutaneous tissue disorders: frequency unknown: skin reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform 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.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hepadetox Intense
Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the blister or carton (after EXP). The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Hepadetox Intense contains

The active substance is thymonacil. Each tablet contains 200 mg of thymonacil.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, corn starch, talc, colloidal anhydrous silica, magnesium stearate.

What Hepadetox Intense looks like and contents of the pack
Hepadetox Intense tablets are white, elongated, biconvex, with a dividing score line.
The tablet can be divided into two equal doses.
The medicine is available in blisters made of PVC/Aluminum foil, packed in a cardboard box.
The pack contains 30, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel.: +48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice