Atinepte

Package Leaflet: Information for the Patient

Atinepte, 12.5 mg, Coated Tablets

Tianeptine Sodium

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Leaflet

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

1. What is Atinepte and what is it used for

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

2. Important information before taking Atinepte

When not to take Atinepte

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

Warnings and precautions

Before starting treatment with Atinepte, discuss it with your doctor or pharmacist.

• Suicidal thoughts, worsening of depression or anxiety disorders People 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 working after 2 weeks, sometimes later. The occurrence of suicidal thoughts is more likely if:
• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; data from clinical trials indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants.

If you experience suicidal thoughts or thoughts of self-harm, contact your doctor or go to the hospital immediately.
It may be helpful to inform your relatives or friends about your depression or anxiety disorders and ask them to read this leaflet. You can ask your relatives or friends for help and ask them to inform you if they notice that your depression or anxiety has worsened or if there are any worrying changes in your behavior.

• During treatment with Atinepte, avoid consuming alcohol or medicines containing alcohol.
• If general anesthesia is necessary, inform your anesthesiologist about taking Atinepte. You should stop taking the medicine 24-48 hours before anesthesia.
• Do not stop treatment abruptly; the dose should be gradually reduced over 7 to 14 days. You should know that after stopping treatment with tianeptine, you may experience certain side effects. These are: anxiety, muscle pain, abdominal pain, insomnia, joint pain.
• Long-term use of high doses of the medicine may lead to dependence.
• Do not exceed the recommended dose.
• If you are currently taking an MAOI antidepressant (see also "Atinepte and other medicines" in section 2), which you will switch to tianeptine, you should start taking tianeptine 14 days after stopping the MAOI. When switching from tianeptine to MAOI therapy, stop taking tianeptine 24 hours in advance.

Children and adolescents

Atinepte should not be used in children and adolescents under 18 years of age.

Atinepte and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Taking this medicine in combination with certain MAOIs (prescribed for depression) can have very serious consequences, such as high blood pressure, very high body temperature, seizures, death; after MAOI treatment, wait two weeks before starting to take Atinepte.

Atinepte with food, drinks, and alcohol

Atinepte can be taken without food. Swallow the tablet whole, with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Atinepte during pregnancy and breastfeeding, unless your doctor decides otherwise.

Driving and using machines

Some patients may experience impaired attention. Drivers and machine operators should be aware of the possibility of drowsiness while taking Atinepte.

Atinepte contains carmoisine, lake (E124), and sodium

Carmoisine, lake may cause allergic reactions.
Atinepte contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Atinepte

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Follow the doctor's instructions carefully.
The recommended dose is 1 tablet (12.5 mg) 3 times a day (morning, noon, and evening), before main meals. Atinepte can be taken without food. Swallow the tablet whole, with a glass of water.
In patients with kidney or liver impairment, as well as in elderly patients, the doctor will determine the dose of the medicine.
Do not stop treatment without consulting your doctor.

Use in children and adolescents

Atinepte should 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.

Overdose of Atinepte

After taking too many Atinepte tablets, mainly in combination with alcohol, the following symptoms have been reported: confusion (disorientation), seizures, drowsiness, dryness of the mucous membranes, and difficulty breathing.
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 treatment with Atinepte

Do not stop taking the medicine unless your doctor tells you to. When stopping the medicine, the dose should be gradually reduced over 7 to 14 days.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atinepte can cause side effects, although not everybody gets them.
The following side effects have been reported:

Common(affects less than 1 in 10 people)

• vision disturbances
• nightmares, insomnia, drowsiness, dizziness, headaches, fainting, tremors
• rapid heartbeat, palpitations, occasional irregular heartbeat (extrasystoles), chest pain, hot flashes, shortness of breath
• abdominal pain, stomach pain, dry mouth, nausea, vomiting, indigestion, constipation, diarrhea, bloating
• back pain, muscle pain
• weakness, feeling of a foreign body in the throat.

Uncommon(affects less than 1 in 100 people)

• rash, itching, hives
• abuse and dependence, particularly in people under 50 years of age with a history of drug or alcohol dependence.

Frequency not known(cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 to gather more information on the safety of this medicine.

5. How to store Atinepte

Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister, after EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atinepte contains

• The active substance is tianeptine sodium. Each tablet contains 12.5 mg of tianeptine sodium.
• The other ingredients are: Tablet core: mannitol (E421), talc, corn starch, ethylcellulose (18-24 mPas), magnesium stearate. Tablet coating: polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), quinoline yellow, lake (E104), carmoisine, lake (E124), macrogol 3350, talc.

What Atinepte looks like and contents of the pack

Atinepte are yellow, round, biconvex, film-coated tablets, approximately 7 mm in diameter.
Atinepte tablets are available in packs of 28, 30, 56, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of last revision of the leaflet:November 2021