Package leaflet: Information for the patient

Timohep forte, 200 mg,
tablets
Timonacicum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Timohep forte is and what it is used for

Timohep forte contains thiopronine 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.
Timohep forte 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 Timohep forte

When not to use Timohep forte:

if the patient is allergic to thiazolidinecarboxylic acid or to any of the other components of this medicine (listed in section 6);
in children under 15 years of age.

Warnings and precautions
Before starting treatment with Timohep forte, consult your doctor or pharmacist.
To monitor the progress of treatment, it is recommended to perform periodic liver function tests every 4 weeks.

Children
Do not use this medicine in children under 15 years of age.

Timophep forte with other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Timophep forte with food and drink
Timophep forte should be taken before meals.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Timophep forte should not be used during pregnancy and breastfeeding due to lack of data confirming its safety.

Driving and operating machinery
Timophep forte has no effect or has negligible effect on the ability to drive and operate machinery.

3. How to use Timohep forte

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor.
Adults
Initially 200 mg (1 tablet) 2 or 3 times daily.
Subsequently, after acute symptoms subside, reduce the dose to 100 mg (1/2 tablet) twice
daily.
The tablet may be divided into two equal doses.
Use in children and adolescents
Children above 15 years of age
Initially 200 mg (1 tablet) 2 or 3 times daily.
Subsequently, after acute symptoms subside, reduce the dose to 100 mg (1/2 tablet) twice
daily.
If you feel that the effect of Timohep forte is too strong or too weak, consult your doctor.
Taking more Timohep forte than recommended
In case of taking more than the recommended dose, seek immediate medical advice from a doctor or
pharmacist.
Taking an overdose of Timohep forte 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, a seizure state (status epilepticus—a life-threatening condition characterized by continuous seizures lasting more than 30 minutes or a series of seizures between which the patient does not regain consciousness) 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 Timohep forte
Do not take a double dose to make up for a missed dose.
Stopping Timohep forte
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 everybody gets them.
Frequency unknown (cannot be estimated from the available data): nausea, skin reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 Authorisation Holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Timohep forte

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Timohep forte contains

The active substance is thiazolidinecarboxylic acid (timonacic). Each tablet contains 200 mg of thiazolidinecarboxylic acid (timonacic).
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, potato starch, magnesium stearate, anhydrous colloidal silicon dioxide.

What Timohep forte looks like and contents of the pack
Timohep forte tablets are white or almost white, capsule-shaped, 14.5 mm long and 7.25 mm wide, with a break line on both sides.
The pack contains 10, 30, 50, 90 or 100 tablets in blisters made of Aluminium/PVC/PVDC, packed in a cardboard box.
Marketing Authorisation Holder
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
tel.: +48 81 463 48 82
[logo Solinea ]
Manufacturer
Mako Pharma Sp. z o.o.
Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom