Package leaflet: information for the patient

Atinepte, 12.5 mg, film-coated tablets
Tianeptinum natricum
Please read the entire leaflet carefully before using the medicine, as 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 identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Atinepte is and what it is used for

Atinepte contains the active substance tianeptine. Atinepte belongs to a group of medicines called antidepressants. It is used in the treatment of mild, moderate, and severe depression.

2. Important information before using Atinepte

When not to use Atinepte

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

Warnings and precautions
Before starting treatment with Atinepte, discuss this with your doctor or pharmacist.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients suffering from depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working. The occurrence of suicidal thoughts or thoughts of self-harm is more likely if:
- the patient has previously experienced suicidal thoughts or self-harming behaviour;
- 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 treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to a 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 for help and ask them to inform the patient if they notice worsening of depression or anxiety, or concerning changes in behaviour.

During treatment with Atinepte, alcohol or medicinal products containing alcohol should be avoided.
If general anaesthesia is required, the anaesthetist must be informed that the patient is taking Atinepte. The medicine should be discontinued 24–48 hours before administration of anaesthetic agents.
Treatment should not be stopped abruptly; the dose should be gradually reduced over 7 to 14 days. The patient should be aware that discontinuation of tianeptine treatment may lead to certain adverse effects, such as anxiety, muscle pain, abdominal pain, insomnia, and joint pain.
Prolonged use of high doses of this medicine may lead to dependence.
Recommended doses should not be exceeded.
If the patient is currently taking an antidepressant of the MAO inhibitor class (see also "Atinepte and other medicines" in section 2) and is to be switched to tianeptine, tianeptine treatment should be started 14 days after discontinuation of the MAO inhibitor. If switching from tianeptine to an MAO inhibitor, tianeptine should be discontinued 24 hours beforehand.

Children and adolescents
Atinepte should not be used in children and adolescents under 18 years of age.
Atinepte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Concomitant use of this medicine with certain MAO inhibitors (prescribed for depression) may lead to very serious consequences, such as high blood pressure, extremely high body temperature, seizures, and death. A two-week interval should be observed after treatment with MAO inhibitors before starting Atinepte.

Atinepte with food, drink and alcohol
Atinepte may be taken without food. The tablet should be swallowed whole with a glass of water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Atinepte should not be used during pregnancy or breastfeeding unless otherwise decided by the doctor.
Driving and operating machinery
Some patients may experience impaired attention. Drivers and machine operators should be aware of the possibility of drowsiness during treatment with Atinepte.
Atinepte contains carmine, cochineal red (E124) and sodium
Carmine, cochineal red (E124), may cause allergic reactions.
Atinepte contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Atinepte

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
You must strictly follow the doctor's instructions.
The recommended dose is 1 tablet (12.5 mg) three times daily (in the morning, at noon, and in the evening), before
main meals. Atinepte may be taken without food. Swallow the tablet whole with a glass of water.
Dosage for patients with renal or hepatic impairment and for elderly patients will be determined by the physician.
Do not discontinue treatment without consulting your doctor.
Use in children and adolescents
Atinepte must not be used in children and adolescents under 18 years of age.
Duration of treatment
Do not stop treatment abruptly; the dose should be gradually reduced over 7 to 14 days.
Taking more Atinepte than recommended
Following overdose ingestion of Atinepte tablets, particularly in combination with alcohol, the following symptoms have been reported: confusion (disorientation), seizures, drowsiness, dryness of the oral mucosa, and breathing difficulties.
In case of overdose, contact your doctor immediately.
Missed dose of Atinepte
Do not take a double dose to make up for a missed tablet.
Stopping Atinepte
Do not stop taking this medicine unless advised by your doctor. When discontinuing treatment, the dose should be gradually reduced over 7 to 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 everyone experiences them.
The following adverse reactions have been reported:

Common (occur in less than 1 in 10 patients)

Vision disturbances
Nightmares, insomnia, drowsiness, dizziness, headache, fainting, tremor
Rapid heartbeat, palpitations, transient irregular heartbeat (extrasystoles), chest pain, hot flushes, shortness of breath
Abdominal pain, stomach ache, dry mouth, nausea, vomiting, dyspepsia, constipation, diarrhoea, flatulence
Back pain, muscle pain
Weakness, sensation of a foreign body in the throat

Uncommon (occur in less than 1 in 100 patients)

Rash, itching, urticaria
Drug abuse and dependence, particularly in individuals under 50 years of age with a history of drug or alcohol dependence

Frequency not known (cannot be estimated from available data)

Suicidal thoughts or behaviour (see section “Warnings and precautions”), feeling disoriented, seeing, feeling or hearing things that are not there (hallucinations)
Acne, in rare cases blisters and skin inflammation (bullous dermatitis)
Increased liver enzyme activity, hepatitis, which may exceptionally be severe
Involuntary movements, uncontrollable tremors, reflexes or jerking 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 Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the medicine's safety and helps to provide more information on the safe use of the medicine.

5. How to store Atinepte

Do not store above 25°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister, following the abbreviation EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Atinepte contains

The active substance is sodium tianeptine. Each tablet contains 12.5 mg of sodium tianeptine.
Other ingredients are: Tablet core: mannitol (E421), talc, maize starch, ethylcellulose (18-24 mPas), magnesium stearate.
Tablet coating: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), quinoline yellow, lac (E104), carmine red, lac (E124), macrogol 3350, talc.

What Atinepte looks like and contents of the pack
Atinepte are yellow, round, biconvex coated tablets, approximately 7 mm in diameter.
Atinepte tablets are available in packs containing 28, 30, 56 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01