Coaxil

Package Leaflet: Information for the Patient

COAXIL

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

1. What is Coaxil and what is it used for

Coaxil, whose active substance is tianeptine, is an antidepressant.
Tianeptine has antidepressant and anxiolytic effects. It does not affect sleep and alertness.

2. Important information before taking Coaxil

When not to take Coaxil:

• 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 Coaxil, consult your doctor or pharmacist.

• Suicidal thoughts, worsening of depression or anxiety disorders Patients 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 drugs usually start working after 2 weeks, sometimes later. The occurrence of suicidal thoughts, self-harm, or suicidal behavior 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 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 to tell you if they notice that your depression or anxiety has worsened or if there are any worrying changes in your behavior.

• Avoid consuming alcohol during treatment with Coaxil.
• If general anesthesia is necessary, inform your anesthesiologist about taking Coaxil. You should stop taking the medicine 24-48 hours before the planned surgical procedure.
• Do not stop treatment abruptly; the dose should be gradually reduced over 7 to 14 days. 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 failure, tell your doctor.
• 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 "Coaxil and other medicines" in section 2), which you will change to tianeptine, you should start taking tianeptine 14 days after stopping the MAOI medicine. When changing from tianeptine treatment to MAOI therapy, stop taking tianeptine 24 hours in advance.

Children and adolescents

Coaxil is not intended for use in children and adolescents (under 18 years of age); Coaxil is contraindicated in children under 15 years of age.

Coaxil and other medicines

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

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 become pregnant, consult your doctor, who will decide whether to continue or change treatment.
During pregnancy and breastfeeding, avoid taking Coaxil.

Driving and using machines

Some patients may experience impaired psychomotor performance. Drivers and machine operators should be aware of the possibility of drowsiness while taking Coaxil.

Coaxil contains sucrose

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Coaxil

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 strictly.
The recommended dose is 1 tablet (12.5 mg) taken 3 times a day (morning, mid-day, and evening), before meals.
In patients with kidney or liver dysfunction and 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 Coaxil

After taking too many Coaxil tablets, mainly in combination with alcohol, the following subjective and objective symptoms have been reported: confusion (disorientation), seizures, drowsiness, dryness of the oral mucosa, and breathing difficulties.
In case of overdose, contact your doctor immediately.
In case of overdose, the patient should be closely monitored. Gastric lavage should be performed, and heart rate, respiratory function, kidney function, and metabolic parameters should be monitored.

Missed dose of Coaxil

Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take two doses at the same time or with a short time interval. If you are not sure, consult your doctor.

Stopping Coaxil treatment

Do not stop taking Coaxil abruptly. The dose should be gradually reduced over 7 to 14 days.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coaxil can cause side effects, although not everybody gets them.
Side effects reported during treatment with Coaxil are usually mild. They are mainly nausea, constipation, abdominal pain, drowsiness, headaches, dryness of the oral mucosa, and dizziness.
The frequency of possible side effects listed below is defined as follows:

• very common (affects more than 1 in 10 people);
• common (affects 1 to 10 people in 100);
• uncommon (affects 1 to 10 people in 1,000);
• rare (affects 1 to 10 people in 10,000);
• very rare (affects less than 1 in 10,000 people);
• not known (frequency cannot be estimated from the available data).

Side effects are as follows:
Common side effects:

• loss of appetite;
• nightmares, difficulty falling asleep, drowsiness, dizziness, headache, fainting, tremors;
• palpitations, abnormal heart rhythm, chest pain, hot flushes, breathing difficulties;
• stomach pain, abdominal pain, dryness of the oral mucosa, nausea, vomiting, constipation, bloating;
• muscle pain, back pain;
• weakness, feeling of a tight throat.

Uncommon side effects:

• rash, itching, urticaria, dependence on the medicine.

Side effects of unknown frequency:

• suicidal thoughts or behaviors;
• feeling of disorientation, seeing, feeling, or hearing things that do not exist (hallucinations);
• acne, in rare cases blisters and skin inflammation (bullous dermatitis);
• increased liver enzyme activity, liver inflammation, which may 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 Drug Safety Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Coaxil

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP" (the expiry date is the last day of the month shown). The batch number is stated on the packaging as "Lot".
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 Coaxil contains

• The active substance is tianeptine sodium. One coated tablet contains 12.5 mg of tianeptine sodium.
• The other excipients are: corn starch, mannitol, magnesium stearate, talc; coating ingredients: ethylcellulose, glycerol monooleate, povidone, sodium carboxymethylcellulose, colloidal anhydrous silica, talc, sucrose, polysorbate 80, titanium dioxide (E171), sodium bicarbonate, white beeswax.

What Coaxil looks like and contents of the pack

Coated tablets in packs of 30, 60, 90, or 108 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France

Manufacturer

ANPHARM Pharmaceutical Company S.A. Annopol 6B 03-236 Warsaw or Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy France For more information, contact the representative of the marketing authorization holder: Servier Polska Sp. z o.o. Phone: (22) 594-90-00

Date of last revision of the leaflet: