Tianesal

Package Leaflet: Information for the Patient

Tianesal, 12.5 mg, Coated Tablets

Tianeptine Sodium

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Tianesal and what is it used for

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

2. Important information before taking Tianesal

When not to take Tianesal:

• if you are allergic to tianeptine or any of the other ingredients of this medicine (listed in section 6);
• in children under 15 years of age;

Warnings and precautions

Before starting to take Tianesal, discuss it with your doctor or pharmacist.

• Suicidal thoughts or worsening of depression or anxiety disorders

Patient with depression and/or anxiety disorders may sometimes have thoughts of self-harm
or suicide. Such symptoms or behavior may worsen at the beginning of
antidepressant treatment, as these medicines usually start working after
2 weeks of treatment, and sometimes even later.
The occurrence of suicidal thoughts, self-harm thoughts, or suicide may be more likely if:

• you have had suicidal thoughts or self-harm thoughts in the past.
• you are a young adult. Clinical trials have shown an increased risk of suicidal behavior in people under 25 years of age with mental disorders treated with antidepressants.

If you have suicidal thoughts or thoughts of self-harm, contact your doctor or go to the hospital immediately.
You can seek help by informing your relatives or friends about your depression or anxiety disorders and asking them to read this leaflet. You can ask them to inform you if they notice that your depression or anxiety has worsened or if they notice any disturbing changes in your behavior.

• While taking Tianesal, avoid consuming alcohol.
• If general anesthesia is necessary, inform the anesthesiologist about taking Tianesal. The medicine should be discontinued 24-48 hours before the planned surgical procedure.
• Do not stop treatment abruptly, the dose should be gradually reduced over 7 to 14 days under medical supervision. You should know that after stopping tianeptine treatment, you may experience certain side effects. These are: anxiety, muscle pain, abdominal pain, insomnia, joint pain.
• If you have kidney function disorders, tell your doctor.
• Long-term use of high doses may lead to dependence.
• Do not exceed the recommended dose. If you are currently taking an antidepressant from the MAOI group (see also "Tianesal and other medicines" in section 2), which you want to change to tianeptine, you should start taking tianeptine 14 days after discontinuing the MAOI group medicine. When changing from tianeptine to MAOI therapy, tianeptine should be discontinued 24 hours earlier.

Children and adolescents

Tianesal is not intended for use in children and adolescents under 18 years of age. Its use in children and adolescents under 15 years of age is contraindicated.

Tianesal and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking this medicine at the same time as certain medicines from the MAOI group (prescribed for depression) may have very serious consequences, such as high blood pressure, very high body temperature, seizures, and death. After MAOI treatment, wait two weeks before starting to take Tianesal

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
If you find out you are pregnant, consult your doctor, who will decide whether to continue or change treatment.
It is recommended to avoid taking Tianesal during pregnancy and breastfeeding.

Driving and using machines

Some patients may experience impaired psychomotor performance. People driving vehicles or operating machines should consider the possibility of drowsiness while taking Tianesal.

Tianesal 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 Tianesal

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Follow the doctor's instructions carefully.
The recommended dose is 1 coated tablet (12.5 mg) taken 3 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 doctor will determine the dosage of the medicine.
Do not stop 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.

Overdose of Tianesal

In case of taking too many Tianesal tablets, especially in combination with alcohol, the following subjective and objective symptoms have been reported: confusion (disorientation), seizures, drowsiness, dry mouth, and breathing difficulties.
In case of overdose, contact your doctor immediately.
In case of overdose, the patient should be under close supervision. Gastric lavage should be performed, and heart rate, respiratory function, kidney function, and metabolic parameters should be monitored.

Missed dose of Tianesal

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 the missed dose.
In case of doubts, consult your doctor.

Stopping Tianesal treatment

Do not stop taking Tianesal abruptly. The dose should be gradually reduced over 7 to 14 days.
In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tianesal can cause side effects, although not everybody gets them.
Side effects reported during tianeptine treatment are usually mild. They mainly include nausea, constipation, abdominal pain, drowsiness, headache, dry mouth, and dizziness.
The side effects are as follows:
Common side effects (may affect up to 1 in 10 people):

• 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, dependence on the medicine

Side effects with frequency not known (cannot be estimated from the available data):

• suicidal thoughts or behaviors;
• feeling of disorientation, seeing, feeling, or hearing things that do not exist (hallucinations);
• acne, in rare cases, blistering skin rash;
• increased liver enzyme activity, liver inflammation (in rare cases, severe);
• involuntary movements, uncontrolled tremors, or convulsions;
• low sodium levels in the blood.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Tianesal

Keep the medicine out of the 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.

6. Contents of the pack and other information

What Tianesal contains:

The active substance of Tianesal is tianeptine sodium. Each coated tablet contains 12.5 mg of tianeptine sodium.
The other ingredients are:
Core:
Mannitol (E421)
Corn starch
Hydroxypropylcellulose (E463)
Magnesium stearate
Coating:
Hypromellose (E464)
Microcrystalline cellulose (E460)
Stearic acid (E570)
Methacrylic acid copolymer
Talc (E553b)
Titanium dioxide (E171)
Triethyl citrate (E1505)
Silica, colloidal anhydrous
Sodium bicarbonate (E500ii)
Yellow iron oxide (E172)
Sodium lauryl sulfate

What Tianesal looks like and contents of the pack

Tianesal is a pale yellow, round, biconvex, coated tablet with a diameter of 7mm.
Tianesal is available in PVC/PVdC/Aluminum or Aluminum/Aluminum blister packs, in a carton box.
Pack sizes:
30 or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer

Laboratorios Liconsa, S.A.
Avenida Miralcampo, 7 Polígono Industrial Miralcampo
19200 Azuqueca de Henares,
Guadalajara
Spain
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A,
05-152 Czosnów

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Poland:
Tianesal
Greece:
Tianeptine / Liconsa 12.5 mg film-coated tablets
Portugal:
Tianeptine Generis
Date of last revision of the leaflet: