How quickly does Tianeptine work

TIANEURAX 12.5 MG

Patient information for TIANEURAX 12.5 MG

1. What is TIANEURAX 12.5 MG and what is it used for?

1.1 What are the properties of the medicinal product?

TIANEURAX 12.5 MG contains the active ingredient tianeptine, a drug from the group of so-called antidepressants.

Tianeptine is effective for mild, moderate, or severe depression.

It is commonly used in salt form as tianeptine sodium.

Tianeptine requires a prescription and should only be used on medical advice.

1.2 Effective strength and dosage form of TIANEURAX 12.5 MG

Tianeptine is commonly available as

- Film-coated tablets containing 12.5 mg tianeptine sodium.

Your doctor will determine whether this strength and dosage form are suitable for your treatment.

1.3 Tianeptine is used for

Treatment of depression in adults.

2. What you need to know before you take TIANEURAX 12.5 MG?

2.1 TIANEURAX 12.5 MG must not be taken

- if you are hypersensitive (allergic) to tianeptine sodium or any of the other ingredients of TIANEURAX 12.5 MG,

- if you are taking other medicines for depression, such as monoamine oxidase (MAO) inhibitors.

2.2 Special care is required when taking TIANEURAX 12.5 MG

When you are depressed and / or have anxiety disorders you may at times have thoughts of harming or killing yourself. These thoughts may be aggravated the first time you use antidepressants because all of these medicines take some time to work, usually about two weeks, sometimes longer.

Such thoughts are more likely to occur

- if you have had thoughts of killing or harming yourself in the past

- if you are a young adult.

Results from clinical trials have shown an increased risk of suicidal behavior in young adults aged 25 and under who have had a psychiatric illness and have been treated with an antidepressant.

Contact your doctor or go to a hospital straight away if you have thoughts of harming or killing yourself at any time. It can be helpful to tell a friend or relative that you are depressed or have an anxiety disorder. Ask them to read this leaflet. Ask them to let you know if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

If you start to have a manic phase (overactive behavior or thoughts), you should stop taking TIANEURAX 12.5 MG. Ask your doctor for advice.

If you have to undergo an operation that requires general anesthesia, treatment with TIANEURAX 12.5 MG should be interrupted 24 to 48 hours before the anesthesia. However, if an emergency procedure has to be carried out, it can be carried out without interrupting the treatment beforehand. However, appropriate monitoring must take place during the intervention.

If you have impaired liver or kidney function, your doctor may need to adjust your dose.

Note on other ingredients: Oral medicinal products may contain different types of sugar. Therefore, please only take this after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

2.2.a) Children

TIANEURAX 12.5 MG should generally not be used in children and adolescents.

2.2.b) Elderly patients

In patients over 70 years of age, the dose should be reduced to 12.5 mg tianeptine sodium twice daily.

2.2.c) Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. Unless otherwise instructed by the doctor, TIANEURAX 12.5 MG should not be taken during pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

2.2.d) Breastfeeding

Unless otherwise instructed by the doctor, TIANEURAX 12.5 MG should not be taken during breastfeeding.

Ask your doctor or pharmacist for advice before taking / using any medicine.

2.2.e) Ability to drive and use machines

In some patients, this medicine can have negative effects on activities that require increased alertness, coordination of movements or quick decisions (such as driving a vehicle, using machines, working at height, etc.). These activities should only be carried out with the consent of the doctor.

2.3 Which interactions with other medicinal products have to be considered?

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

TIANEURAX 12.5 MG and the simultaneous use of other drugs can cause interactions.

TIANEURAX 12.5 MG must not be used together with monoamine oxidase (MAO) inhibitors that are used, for example, for the treatment of depression or Parkinson's disease (such as selegiline or moclobemide). There must be at least two weeks between the use of monoamine oxidase inhibitors and treatment with TIANEURAX 12.5 MG.

Reduced efficacy has been reported when mianserin (an antidepressant) is used at the same time.

2.4 What should I think of when taking TIANEURAX 12.5 MG together with food, beverages and tobacco?

TIANEURAX 12.5 MG can be taken with food. Alcohol should be avoided while taking TIANEURAX 12.5 MG.

3. How to take TIANEURAX 12.5 MG?

Always take TIANEURAX 12.5 MG exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

Tablets should be swallowed whole and with water. You can take this medicine with meals.

It may take several weeks before you feel better. You should therefore continue to take TIANEURAX 12.5 MG, even if it takes some time before you feel an improvement in your condition. Do not change the dose without first talking to your doctor. Take the tablets for as long as your doctor has told you to. If you stop treatment too early, your symptoms could return.

It is recommended that you continue treatment for at least 6 months after you feel better. In any case, always strictly follow the instructions of your doctor.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Adults

12.5 mg tianeptine sodium 3 times a day (equivalent to 3 tablets with 12.5 mg / day), 1 in the morning, 1 at noon and 1 in the evening.

It is not necessary to change the dose in persons with alcohol dependence with or without cirrhosis.

3.2.b) Elderly patients and patients with impaired liver or kidney function

In patients over 70 years of age and in patients with impaired renal function, the dose should be reduced to 12.5 mg twice a day.

3.3 If you take more TIANEURAX 12.5 MG than you should

In the event of an overdose or accidental ingestion by a child, seek advice from your doctor immediately. In such a case, treatment must be stopped immediately; gastric lavage is performed and vital functions are checked. Contact your doctor immediately or go to the emergency department of the nearest hospital. Show the packaging of TIANEURAX 12.5 MG.

3.4 If you forget to take TIANEURAX 12.5 MG

Do not take a double dose to make up for a forgotten dose. If you forget to take a tablet, take it as soon as you remember. If it is soon time for the next tablet, just take it at the usual time.

3.5 Effects if treatment with TIANEURAX 12.5 MG is discontinued

Treatment with TIANEURAX 12.5 MG should not be stopped abruptly; the dose should be reduced over 7 to 14 days. Do not stop taking the tablets even if you feel well unless your doctor tells you to.

4. What are the possible side effects?

Like all medicines, TIANEURAX 12.5 MG can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100 but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

4.1.a) Often

Anorexia (eating disorders), nightmares, insomnia, drowsiness, drowsiness, headache, circulatory collapse, tremors, impaired vision, hot flashes, fast or unnatural heart palpitations, chest pain, difficulty breathing, dry mouth, constipation, stomach pain, nausea, vomiting, back pain, diarrhea, heartache , Muscle pain, feeling weak, feeling like you have a lump in your throat.

4.1.b) Occasionally

Itching, hives (rash).

4.1.c) Rarely

Drug abuse and addiction, especially in patients under 50 years of age, a history of alcohol or drug abuse.

4.1.d) Not known

Suicide and suicidal behavior.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert.

5. How should TIANEURAX 12.5 MG be stored?

Store TIANEURAX 12.5 MG at normal room temperature and keep the medicine in the original packaging protected from light and moisture.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; October 2012