Tianeptine

Pregnancy Pregnancy: Tianeptine should not be used during pregnancy. Breast-feeding Breast-feeding: Tianeptine should not be used during breast-feeding. Driving Driving: In some patients, this medicinal product may adversely affect activities requiring heightened attention, motor coordination, and rapid decision-making (such as driving vehicles, operating machinery, working at heights, etc.). Suicide/suicidal ideation/clinical worsening: Depression is associated with an increased risk of suicidal ideation, self-harm, and suicide (suicide-related thoughts/behaviours). This risk persists until significant remission of symptoms occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical practice that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-relat‍‍‍‍‍‍​​​‍​​​​​​ed thoughts/behaviours, who exhibit a significant degree of these symptoms before the start of treatment, are also at greater risk of suicidal ideation or suicide attempt and should therefore be carefully monitored during treatment. A meta-analysis of placebo-controlled clinical trials in adults with psychiatric disorders demonstrated an increased risk of suicidal behaviour in patients under 25 years of age taking antidepressants compared with those taking placebo. Drug therapy should be accompanied by close monitoring, particularly in higher-risk patients, especially in the early phase of treatment or following dose changes. Patients, and their caregivers, should be alerted to the need for monitoring for any clinical worsening, suicide-related thoughts/behaviours, and to seek medical attention immediately should these occur. If the patient requires general anaesthesia, the anaesthetist should be informed of the treatment, and the medicinal product should be discontinued 24 to 48 hours before the procedure. In an emergency, the procedure may be carried out without prior discontinuation; preoperative monitoring should be performed. As with all psychotropic medicinal products, if treatment is to be discontinued, the dosage should be gradually reduced over a period of 7 to 14 days. Patients with a history of drug or alcohol dependence must be kept under close surveillance to prevent dose escalation. Do not exceed the recommended doses. Tianeptine must not be administered with monoamine oxidase (MAO) inhibitors used, for example, for the treatment of depression or Parkinson's disease (such as selegiline or moclobemide). At least two weeks should elapse between the administration of monoamine oxidase inhibitors and treatment with Tianeptine. Concomitant administration with mianserin (an antidepressant) has been shown to reduce efficacy.