Tialera

Leaflet attached to the packaging: patient information

Tialera, 12.5 mg, coated tablets

Tianeptine sodium

Read the leaflet carefully before taking the medicine, 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 medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tialera and what is it used for
• 2. Important information before taking Tialera
• 3. How to take Tialera
• 4. Possible side effects
• 5. How to store Tialera
• 6. Package contents and other information

1. What is Tialera and what is it used for

Tialera contains the active substance tianeptine and is an antidepressant.
Tianeptine has antidepressant and anxiolytic effects. It does not affect sleep and alertness.

2. Important information before taking Tialera

When not to take Tialera

• if the patient is allergic to tianeptine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Tialera, the patient should discuss it with their doctor or pharmacist.

• Suicidal thoughts and worsening of depression or anxiety disorders

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start to work after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders who are being treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask relatives or friends to inform them if they notice that depression or anxiety has worsened or if there are any disturbing changes in behavior.
The patient should consult their doctor if any of the following conditions apply:

• If general anesthesia is necessary, the patient should inform the anesthesiologist about taking Tialera. The medicine should be discontinued 24-48 hours before the planned surgical procedure.
• The patient should inform their doctor about kidney or liver function disorders.
• If the patient is addicted to opioid drugs or alcohol.
• If the patient has experienced a manic episode.

Additional warnings

• Tialera should not be stopped abruptly. The dose should be gradually reduced over 7-14 days under medical supervision. The patient should be aware that after stopping treatment with tianeptine, they may experience certain side effects, such as anxiety, muscle pain, abdominal pain, insomnia, or joint pain.
• If the patient is currently taking an MAOI antidepressant (see also "Tialera and other medicines" in section 2), which will be replaced with tianeptine, they should start taking tianeptine 14 days after discontinuing the MAOI. When switching from tianeptine to MAOI therapy, tianeptine should be discontinued 24 hours in advance.
• Long-term use of high doses of the medicine may lead to dependence.
• The recommended doses should not be exceeded.
• Tialera is not recommended for use in children and adolescents under 18 years of age. Children and adolescents are more susceptible to side effects, such as suicidal attempts, suicidal thoughts, and hostile behavior (mainly aggression, opposition, and anger). However, the doctor may decide to prescribe Tialera to patients under 18 years of age if they consider it appropriate. Due to the above side effects, children and adolescents taking Tialera should be closely monitored. The doctor should be informed if any of the above side effects occur in patients under 18 years of age or if symptoms worsen. The long-term impact on growth, maturation, and development of perception, as well as thinking and behavior in children and adolescents under 18 years of age, has not been established.
• Alcohol should be avoided during treatment with Tialera.

Children and adolescents

Tialera is not intended for use in children and adolescents under 18 years of age.

Tialera and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking this medicine in combination with certain MAOIs (prescribed for depression) may have serious consequences, such as high blood pressure, very high body temperature, seizures, or death. After treatment with MAOIs, the patient should wait two weeks before starting to take Tialera.

Tialera with food, drinks, and alcohol

This medicine should be taken before or during a meal.

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 medicine.
If the patient becomes pregnant, they should consult their doctor, who will decide whether to continue or change treatment.
Tialera should be avoided during pregnancy and breastfeeding.

Driving and using machines

Some patients may experience impaired psychomotor function. Drivers and machine operators should be aware of the possibility of drowsiness while taking Tialera.

Tialera contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per daily dose, which means that the medicine is considered "sodium-free".

3. How to take Tialera

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should strictly follow the doctor's instructions.
The recommended dose is 1 tablet (12.5 mg) taken three times a day (morning, mid-day, and evening), before meals.
In patients with kidney or liver function disorders, as well as in elderly patients, the dose of the medicine will be determined by the doctor.
Treatment should not be discontinued without consulting a doctor.

Use in children and adolescents

Tianeptine is not recommended for use in children and adolescents under 18 years of age.

Overdose of Tialera

In case of taking too many Tialera tablets, especially in combination with alcohol, the following symptoms have been reported: confusion (disorientation), seizures, drowsiness, dry mouth, and respiratory failure.
In case of overdose, the patient should immediately contact their doctor.
In case of overdose, the patient should be closely monitored. Gastric lavage should be performed, and heart rate, respiratory function, kidney function, and metabolic parameters should be monitored.

Missed dose of Tialera

The patient should take the missed dose as soon as possible, except when the next dose is approaching. The patient should not take a double dose to make up for the missed tablet.
In case of doubts, the patient should consult their doctor.

Discontinuation of Tialera:

Tialera should not be stopped abruptly. The dose should be gradually reduced over 7-14 days.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tialera can cause side effects, although not everybody gets them.
Side effects reported during treatment with Tialera are mild and severe. They are mainly: nausea, constipation, abdominal pain, drowsiness, headaches, dry mouth, and dizziness.
The side effects are as follows:

• Loss of appetite;
• nightmares, difficulty falling asleep, drowsiness, dizziness, headache, fainting, tremors;
• palpitations, abnormal heart rhythm, chest pain, hot flashes, breathing difficulties;
• stomach pain, abdominal pain, dry mouth, nausea, vomiting, constipation, bloating;
• muscle pain, back pain;
• weakness, feeling of a tight throat.

Uncommon side effects (may affect up to 1 in 100 people):

• rash, itching, hives, drug dependence.

Side effects of unknown frequency (cannot be estimated from the available data):

• suicidal thoughts or suicidal behavior;
• feeling of disorientation, seeing, feeling, or hearing things that do not exist (hallucinations);
• acne, blisters, and skin inflammation (in single cases) - bullous dermatitis;
• increased liver enzyme activity, liver inflammation, which can be severe (in single cases);
• uncontrolled movements, uncontrolled tremors, reflexes, or convulsions;
• low sodium levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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 gather more information on the safety of the medicine.

5. How to store Tialera

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
For PVC/PVdC/Aluminum blisters:
Do not store above 25°C.
For Aluminum/Aluminum blisters:
No special storage precautions are required.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tialera contains

• The active substance of the medicine is tianeptine sodium. Each coated tablet contains 12.5 mg of tianeptine sodium.
• The other ingredients are:

Tablet core:
mannitol (E421)
corn starch
hydroxypropyl cellulose (E463)
magnesium stearate
Tablet coating:
hypromellose (E464)
microcrystalline cellulose (E460)
stearic acid (E570)
methacrylic acid copolymer
talc (E553b)
titanium dioxide (E 171)
triethyl citrate (E1505)
silica, colloidal anhydrous
sodium bicarbonate (E500ii)
yellow iron oxide (E172)
sodium lauryl sulfate

What Tialera looks like and what the pack contains:

Tialera is a pale yellow, coated, round, biconvex tablet with a diameter of 7 mm.
Tialera is available in PVC/PVdC/Aluminum or Aluminum/Aluminum blisters.
Package sizes:
15, 28, 30, 60, 90, 100, or 300 coated tablets
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Laboratorios Liconsa, S.A.
Avenida Miralcampo, 7 Polígono Industrial Miralcampo
19200 Azuqueca de Henares,
Guadalajara – Spain

For more information about the medicine, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:July 2022