Package leaflet: Information for the patient

Timohep, 100 mg, tablets
Timonacicum
Please read all of this leaflet carefully before taking 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 questions, 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 another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Timohep is and what it is used for
Important information before taking Timohep
How to take Timohep
Possible adverse reactions
How to store Timohep
Contents of the pack and other information

1. What Timohep is and what it is used for

Timohep contains thiocarboxylic acid as the active substance. It supports the breakdown of toxic compounds, thereby protecting the liver parenchyma from damaging effects of bacterial, viral, industrial toxins, as well as drugs and alcohol. It stimulates bile secretion by the liver.
Timohep 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

When not to use Timohep:

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

Warnings and precautions
Before starting treatment with Timohep, discuss it with your doctor or pharmacist. To monitor treatment progress, periodic liver function tests are recommended every 4 weeks.
Children
Do not use this medicine in children under 15 years of age.
Timohep and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Timohep with food and drink
Timohep 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 baby, she should consult her doctor or pharmacist before using this medicine.
Timohep should not be used in pregnant women and during breastfeeding due to lack of data confirming safety of use.
Driving and operating machinery
Timohep has no effect or has negligible effect on the ability to drive and operate machinery.

3. How to take Timohep

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor.
Adults
Initially 200 mg (2 tablets) 2 or 3 times daily.
After acute symptoms have subsided, 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 have subsided, the dose may be reduced to 100 mg (1 tablet) twice daily.
If you feel that the effect of Timohep is too strong or too weak, consult your doctor.
Taking more Timohep than recommended
If you take more Timohep than recommended, seek immediate medical advice from a doctor or
pharmacist.
Taking an overdose of Timohep 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, 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
disorders may persist for several weeks or even months. Hearing impairment and deafness may also
occur.
Missed dose of Timohep
Do not take a double dose to make up for a missed dose.
Stopping Timohep
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.
Frequency unknown (cannot be estimated from 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 of Adverse Drug Reactions at 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
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 TIMOHEP

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 container.
The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Timohep contains

The active substance is thiazolidinecarboxylic acid (thymonacid). One tablet contains 100 mg of thiazolidinecarboxylic acid (thymonacid).
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, potato starch, magnesium stearate, colloidal anhydrous silica.

What Timohep looks like and contents of the pack
Timohep tablets are white, round, biconvex.
The pack contains 30, 90 or 100 tablets in aluminium/PVC/PVDC blisters, packed in a cardboard box.
Marketing Authorisation Holder
Solinea Sp. z o.o.
Elizówka, 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