Tianesal

Package leaflet: Information for the patient

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

• 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 you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Tianesal is and what it is used for
2. What you need to know 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 Tianesal is and what it is used for

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

2. Important information before using Tianesal

When not to use Tianesal:

• if the patient is 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 treatment with Tianesal, discuss this with your doctor or pharmacist.

• Suicidal thoughts or worsening of depression or anxiety disorders

Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm
or suicide. These symptoms or behaviors may worsen at the beginning of treatment with
antidepressants, as these medicines usually start to work after about 2 weeks of treatment, and sometimes even later.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicide attempts may be more likely if:

• the patient has previously experienced suicidal thoughts or thoughts of self-harm.
• the patient is a young adult. Clinical trials have shown an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact their doctor immediately or go to a hospital.
The patient may seek help by informing relatives or friends about their depression or anxiety disorders and asking them to read this leaflet. The patient may ask them to inform them if they notice worsening of depression or anxiety, or any concerning changes in their behavior.

• During treatment with Tianesal, alcohol consumption should be avoided.
• If general anesthesia is required, the anesthesiologist must be informed about the use of Tianesal. The medicine should be discontinued 24–48 hours before a planned surgical procedure.
• Do not abruptly stop treatment; dosage should be gradually reduced over 7 to 14 days under medical supervision. The patient should be aware that after discontinuation of tianeptine, certain withdrawal symptoms may occur. These include: anxiety, muscle pain, abdominal pain, insomnia, joint pain.
• If the patient has impaired kidney function, this should be reported to the doctor.
• Long-term use of high doses may lead to dependence.
• Recommended doses should not be exceeded. If the patient is currently taking an antidepressant from the MAO inhibitor group (see also "Tianesal and other medicines" in section 2), which is to be changed to tianeptine, tianeptine treatment should be started 14 days after discontinuation of the MAO inhibitor. When switching from tianeptine to MAO inhibitor 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
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Concomitant use of this medicine with certain medicines belonging to the MAO inhibitor group (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 should be observed after discontinuation of MAO inhibitors before starting treatment with Tianesal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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.
Tianesal should be avoided during pregnancy and breastfeeding.
Driving and operating machinery
Some patients may experience impaired psychomotor performance. Individuals who drive vehicles or operate machinery should consider the possibility of drowsiness occurring during treatment with Tianesal.
Tianesal 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 Tianesal

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
You must strictly follow your doctor's instructions.
The recommended dose is 1 coated tablet (12.5 mg) taken 3 times daily (in the morning, at midday,
and in the evening), before meals.
Dosage for patients with renal or hepatic impairment, 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
The use of tianeptine is not recommended in children and adolescents under 18 years of age.
Taking more Tianesal than recommended
When excessive amounts of Tianesal tablets have been taken, particularly 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 the event of an overdose, the patient should be placed under close observation. Gastric lavage
should be performed, and cardiac function, respiratory function, renal function, and metabolic parameters
should be monitored.
Missed dose of Tianesal
If you miss a dose, take it 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 one.
If in doubt, consult your doctor.
Stopping Tianesal treatment
Do not stop taking Tianesal suddenly. The dose should be gradually reduced over a period of 7 to 14 days.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects reported during the use of tianeptine are generally mild in intensity. These include
mainly nausea, constipation, abdominal pain, drowsiness, headache, dry mouth, and dizziness.

The following adverse effects may occur:

Common adverse effects (may affect up to 1 in 10 people):

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

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

• rash, itching, urticaria, drug dependence.

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

• suicidal thoughts or behaviour;
• feeling of disorientation, seeing, feeling, or hearing non-existent things (hallucinations);
• acne, in exceptional cases, bullous dermatitis;
• increased liver enzyme activity, hepatitis (in exceptional cases), even severe;
• involuntary movements, uncontrollable tremors, reflexes or convulsive movements;
• low blood sodium levels.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Tianesal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer cardboard
box, 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 the medicine.
Medicines must not be disposed of via wastewater 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 Tianesal contains:
The active substance is sodium tianeptine. Each coated tablet contains 12.5 mg of sodium tianeptine.
The other ingredients are:
Tablet core:
Mannitol (E421)
Corn starch
Hydroxypropylcellulose (E463)
Magnesium stearate
Coating composition:
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)
Yellow iron oxide (E172)
Sodium lauryl sulfate

What Tianesal looks like and contents of the pack
Tianesal is pale yellow, round, biconvex, coated tablets with a diameter of 7 mm.
Tianesal is available in PVC/PVdC/Aluminium or Aluminium/Aluminium blister packs, packed in a cardboard box.
Pack sizes:
30 or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Tianesal
Greece: Tianeptine / Liconsa 12.5 mg Επικαλυμμένα με λεπτό υμένιο δισκία
Portugal: Tianeptine Generis