Package leaflet: Information for the patient

Tialera, 12.5 mg, coated tablets
Tianeptinum natricum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Leaflet contents

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

1. What Tialera is and what it is used for

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

2. Important information before using Tialera

When not to use 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 treatment with Tialera, discuss this with your doctor or pharmacist.

Suicidal thoughts and worsening of depression or anxiety disorders

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

the patient has previously experienced suicidal thoughts or self-harm;
the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who are being treated with antidepressant medications.

If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends to inform them if they notice worsening of depression or anxiety, or concerning changes in behaviour.
Consult a doctor if any of the following situations apply to the patient:

If general anaesthesia is required, inform the anaesthetist that the patient is taking Tialera. The medicine should be discontinued 24–48 hours before a planned surgical procedure.
Inform the doctor about any kidney or liver function disorders.
If the patient is dependent on opioid drugs or alcohol.
If the patient has experienced a manic episode.

Additional warnings

Tialera must not be stopped abruptly. The dose should be gradually reduced under medical supervision over 7 to 14 days. The patient should be aware that after stopping treatment with tianeptine, they may experience certain withdrawal symptoms such as anxiety, muscle pain, abdominal pain, insomnia, and joint pain.
If the patient is currently taking an antidepressant belonging to the MAO inhibitor group (see also "Tialera and other medicines" in section 2), and treatment is to be switched to tianeptine, tianeptine should be started 14 days after discontinuing the MAO inhibitor. When switching from tianeptine to an MAO inhibitor, tianeptine should be discontinued 24 hours beforehand.
Long-term use of high doses of this medicine may lead to dependence.
Recommended doses must not be exceeded.
Tialera is not recommended for use in children and adolescents under 18 years of age. Children and adolescents are at higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostile behaviours (mainly aggression, defiance, and anger). However, a doctor may decide to prescribe Tialera to patients under 18 years of age if they consider it appropriate. Due to the adverse effects described above, children and adolescents taking Tialera must be closely monitored. Inform the doctor if any of the above-mentioned adverse effects occur in a patient under 18 years of age, or if symptoms worsen. The long-term impact on growth, puberty, and cognitive and behavioural development in children and adolescents under 18 years of age has not been established.
Alcohol should be avoided while taking Tialera.

Children and adolescents
Tialera is not intended for use in children and adolescents under 18 years of age.
Tialera with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking this medicine together with certain MAO inhibitors (used in the treatment of depression) may lead to very serious consequences, such as high blood pressure, very high body temperature, seizures, and death. A two-week interval must be observed after stopping MAO inhibitors before starting Tialera.
Tialera with food, drink and alcohol
This medicine should be taken before or during a meal.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
If the patient discovers she is pregnant, she should consult her doctor, who will decide whether treatment should continue or be changed.
Tialera should be avoided during pregnancy and breastfeeding.
Driving and operating machinery
Some patients may experience impaired psychomotor performance. 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, meaning the medicine is considered "sodium-free".

3. How to use Tialera

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Always follow your doctor's instructions carefully.
The recommended dose is 1 tablet (12.5 mg) taken three times daily (in the morning, at midday, and
in the evening), before meals.
Dosage for patients with impaired renal or hepatic function, as well as for elderly patients, will be
determined by the doctor.
Do not discontinue treatment without consulting your doctor.

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

Taking more Tialera than recommended
In cases of overdose, especially when combined with alcohol, the following symptoms have been
reported: confusion (disorientation), seizures, drowsiness, dry mouth, and respiratory failure.
In case of overdose, seek immediate medical advice.
The patient should be closely observed. Gastric lavage should be performed, and cardiac function,
respiratory function, renal function, and metabolic parameters should be monitored.

Missed dose of Tialera
Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a
double dose to make up for a missed tablet.
If in doubt, consult your doctor.

Stopping Tialera
Do not stop taking Tialera suddenly. The dose should be gradually reduced over a period of 7–14 days.
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.
Adverse reactions reported during the use of Tialera have been mild to severe in intensity. These are
mainly: nausea, constipation, abdominal pain, drowsiness, headaches, dry mouth, and dizziness.

The adverse reactions are as follows:

Common adverse reactions (may affect 1 in 10 patients):

loss of appetite;
nightmares, difficulty falling asleep, drowsiness, dizziness, headache, fainting, tremor;
palpitations, unusual awareness of heartbeat, chest pain, hot flushes, shortness of breath;
stomach pain, abdominal pain, dry mouth, nausea, vomiting, constipation, bloating;
muscle pain, back pain;
weakness, sensation of tightness in the throat.

Uncommon adverse reactions (may affect 1 in 100 patients):

rash, itching, urticaria, drug dependence.

Adverse reactions with unknown frequency (cannot be estimated from available data):

suicidal thoughts or suicidal behaviour;
feeling disoriented, seeing, feeling or hearing non-existent things (hallucinations);
acne, blisters and skin inflammation (in isolated cases) – bullous dermatitis;
increased liver enzyme activity, hepatitis which may be severe (in isolated cases);
uncontrolled movements, uncontrolled tremors, reflexes or clonic movements;
low blood sodium levels.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
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 helps to provide more information on the safety of the medicine.

5. How to store Tialera

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP. The expiry date refers to the last day of the stated month.
For PVC/PVdC/Aluminium blisters:
Do not store above 25°C.
For Aluminium/Aluminium blisters:
No special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tialera contains

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

Tablet core:
Mannitol (E421)
Corn starch
Hydroxypropylcellulose (E463)
Magnesium stearate
Tablet coating:
Hypromellose (E464)
Microcrystalline cellulose (E460)
Stearic acid (E570)
Methacrylic acid copolymer
Talc (E553b)
Titanium dioxide (E171)
Triethyl citrate (E1505)
Colloidal anhydrous silica
Sodium bicarbonate (E500ii)
Iron oxide yellow (E172)
Sodium lauryl sulfate

What Tialera looks like and contents of the pack:
Tialera is pale yellow, coated, round, biconvex tablets with a diameter of 7 mm.
Tialera is available in PVC/PVdC/Aluminium or Aluminium/Aluminium blisters.
Pack sizes:
15, 28, 30, 60, 90, 100 or 300 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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 further information about this medicinal product, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: + 48 22 375 92 00