Hepadetox Intense

Package Leaflet: Information for the Patient

Hepadetox Intense, 200 mg, Tablets

Timonacicum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Hepadetox Intense and what is it used for
• 2. Important information before taking Hepadetox Intense
• 3. How to take Hepadetox Intense
• 4. Possible side effects
• 5. How to store Hepadetox Intense
• 6. Contents of the pack and other information

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

Hepadetox Intense contains the active substance timonacicum. It supports the breakdown of toxic compounds, thus protecting the liver tissue from the damaging effects of bacterial, viral, and industrial toxins, as well as medications and alcohol. It stimulates the secretion of bile by the liver.
Hepadetox Intense 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 chemical substances.

2. Important information before taking Hepadetox Intense

When not to take Hepadetox Intense:

• if you are allergic to timonacicum or any of the other ingredients of this medicine (listed in section 6);
• in children under 6 years of age.

Warnings and precautions

Before taking Hepadetox Intense, discuss it with your doctor or pharmacist. To monitor the progress of treatment, it is recommended to perform liver function tests every 4 weeks.

Children

Hepadetox Intense should not be used in children and adolescents under 15 years of age (see section 3).

Hepadetox Intense and other medicines

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

Hepadetox Intense with food and drink

Take Hepadetox Intense before a meal.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Hepadetox Intense if you are pregnant or breastfeeding, due to the lack of data confirming safety.

Driving and using machines

Hepadetox Intense has no or negligible influence on the ability to drive and use machines.

Hepadetox Intense contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Hepadetox Intense

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Adults

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

Use in children and adolescents

Adolescents over 15 years of age:
Initially, 200 mg (1 tablet) 2 or 3 times a day.
Then, after the acute symptoms have subsided, the dose can be reduced to 100 mg (half a tablet) 2 times a day.
The tablet can be divided into two equal doses.
Hepadetox Intense should not be used in children and adolescents between 6 and 15 years of age due to the inability to administer the correct dose.
Hepadetox Intense is contraindicated in children under 6 years of age (see section 2).
If you feel that the effect of Hepadetox Intense is too strong or too weak, consult your doctor.

Taking a higher dose of Hepadetox Intense than recommended

If you have taken more than the recommended dose of Hepadetox Intense, contact your doctor or pharmacist immediately.
Taking a higher dose of Hepadetox Intense than recommended can lead to changes in the central nervous system. The risk is higher in children due to the easier penetration of the medicine through the blood-brain barrier. Within 15-60 minutes after ingestion of an excessive dose, a convulsive state (a life-threatening condition during which the patient experiences continuous seizures lasting over 30 minutes or a series of seizures between which the patient does not regain consciousness) and coma may develop. Central nervous system disorders can 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 treatment with Hepadetox Intense

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hepadetox Intense can cause side effects, although not everybody gets them.
Gastrointestinal disorders: frequency not known:nausea.
Skin and subcutaneous tissue disorders: frequency not known:skin reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Hepadetox Intense

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hepadetox Intense contains

• The active substance is timonacicum. 1 tablet contains 200 mg of timonacicum.
• The other ingredients are: lactose monohydrate, 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, oblong, biconvex, with a dividing line.
The tablet can be divided into two equal doses.
The medicine is available in PVC/Aluminum blisters in a cardboard box.
The pack contains 30, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: