Coaxil

Package leaflet: Information for the patient

COAXIL
12.5 mg
coated tablets
Tianeptinum natricum
Please read all of this leaflet carefully before taking this medicine, as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

Coaxil is an antidepressant medicine containing tianeptine as the active substance.
Tianeptine has antidepressant activity.

2. Important information before using Coaxil

When not to use Coaxil:

• 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 Coaxil, consult a doctor or pharmacist.

• Suicidal thoughts, worsening of depression
  Patients suffering from depression 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 start to work after about 2 weeks, sometimes later. The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:
  • the patient has previously experienced suicidal thoughts or self-harm;
  • 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 being treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately
contact a doctor or go to hospital.
It may be helpful to inform family members or friends about the depression and ask them to
read this leaflet. The patient may ask family or friends to inform them if they notice that the depression has worsened or if there are disturbing changes
in behaviour.

• During treatment with Coaxil, alcohol consumption should be avoided.
• If general anaesthesia is required, the anaesthetist must be informed about the use of Coaxil. The medicine should be discontinued 24–48 hours before a planned surgical procedure.
• Do not stop treatment abruptly; the dose should be gradually reduced over 7 to 14 days. The patient should be aware that after discontinuation of tianeptine treatment, certain adverse effects may occur, such as: anxiety, muscle pain, abdominal pain, insomnia, joint pain.
• If the patient has kidney impairment, they should inform their doctor.
• Long-term use of high doses of the medicine may lead to dependence.
• Do not exceed the recommended doses.
• If the patient is currently taking an antidepressant from the MAO inhibitor group (see also "Coaxil and other medicines" in section 2), which will be switched to tianeptine, treatment with tianeptine should be started 14 days after discontinuation of the MAO inhibitor. When switching from tianeptine to treatment with an MAO inhibitor, tianeptine should be discontinued 24 hours earlier.

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
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking this medicine together with certain MAO inhibitors (used in the treatment of depression) may lead to very serious consequences, such as high blood pressure, very high body temperature, seizures, or death; a period of two weeks must elapse after treatment with MAO inhibitors before starting Coaxil.
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 be continued or changed.
Coaxil should be avoided during pregnancy and breastfeeding.
Driving and operating machinery
Some patients may experience impaired psychomotor performance. Drivers and machine operators should be aware of the possibility of drowsiness during treatment with Coaxil.
Coaxil contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their 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 the medicine is considered "sodium-free".

3. How to use Coaxil

This medicine should always be used as directed by a physician or pharmacist.
If in doubt, consult a doctor or pharmacist.
Always follow your doctor's instructions exactly.
The recommended dose is 1 tablet (12.5 mg) taken 3 times daily (in the morning, at midday,
and in the evening), before meals.
Dosage for patients with impaired kidney or liver function, 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 Coaxil than recommended
After ingestion of excessive amounts of Coaxil tablets, particularly in combination with alcohol,
the following signs and symptoms have been reported: confusion (disorientation), seizures, drowsiness,
dryness of the oral mucosa, and breathing difficulties.
In case of overdose, seek immediate medical advice.
If overdose occurs, the patient should be closely observed. Gastric lavage should be performed,
and cardiac function, 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 a double dose or two doses in quick succession.
If in doubt, consult your doctor.

Stopping Coaxil
Do not stop taking Coaxil 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 reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions reported during the use of Coaxil have been mild in intensity. These include
nausea, constipation, abdominal pain, drowsiness, headache, dryness of the oral mucosa, and dizziness.

The frequency of possible adverse reactions listed below is defined according to the following classification:

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

The adverse reactions are as follows:
Common adverse reactions:

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

Uncommon adverse reactions:

• rash, itching, urticaria, drug dependence.

Adverse reactions with unknown frequency:

• suicidal thoughts or suicidal behaviour;
• feeling of disorientation, seeing, feeling or hearing non-existent things (hallucinations);
• acne, in exceptional cases blisters and skin inflammation (bullous dermatitis);
• increased liver enzyme activity, hepatitis, which may exceptionally be severe;
• uncontrolled movements, uncontrolled jerking, reflexes or convulsive 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, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Coaxil

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP" (abbreviation used to describe the expiry date). The expiry date refers to the last day
of the stated month. The abbreviation "Lot" on the packaging 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. This will help protect
the environment.

6. Contents of the pack and other information

What Coaxil contains

• The active substance is sodium tianeptine. One coated tablet contains 12.5 mg of sodium tianeptine.
• The other ingredients are: corn starch, mannitol, magnesium stearate, talc; coating components: 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6B
03-236 Warsaw
Poland
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France

For further information, please contact the Marketing Authorisation Holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594-90-00