Stablon Special Precautions

If general anaesthesia is necessary, the anaesthetist should be informed of the treatment, and the drug discontinued 24 or 48 hours prior to surgery.
In an emergency, surgery may be performed without an intervening wash-out period; peroperative monitoring should be performed.
As with any psychotropic drug, this medicinal product should not be taken with alcoholic beverages or medicines containing alcohol.
As with all psychotropic agents, if the treatment is to be interrupted, the dosage should be gradually reduced over a period of 7 to 14 days.
If there is a history of drug dependence or alcohol dependence, the patients must be kept under very close surveillance in order to avoid any increase in dosage.
Do not exceed the recommended doses.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicidal behaviour). This risk persists until a significant remission has been obtained. Clinical improvement may not be obtained until after several weeks of treatment, so patients must be closely monitored until this improvement has been achieved. Clinical experience shows that the risk of suicide can increase during the very early stages of recovery.
Patients with a history of suicidal behaviour or those expressing significant suicidal thoughts before starting the treatment face a higher risk of the onset of suicidal thoughts or suicidal behaviour, and must be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of the use of antidepressants in adults displaying psychiatric disorders has revealed an increase in the risk of suicidal behaviour in patients under 25 years of age who were being treated with antidepressants compared to those receiving a placebo. Careful monitoring of patients, and particularly of high-risk patients, must accompany use of this medication, particularly at the beginning of treatment and at times of dose changes.
The patients (and their family and friends) must be alerted to the need to monitor for the onset of clinical worsening, the appearance of suicidal thoughts/behaviour and any abnormal change of behaviour, and to seek medical advice immediately if such symptoms present.
Effects on ability to drive and use machines: Some patients may experience diminished alertness. The attention of drivers and machine-operators in particular should thus be drawn to the risk of somnolence with this product.
Use in Children: STABLON is contraindicated in children and adolescents under 15 years of age (see Contraindications) and should not be used in adolescents between 15 and 18 years of age. Suicidal type (suicide attempts and suicidal thoughts) and hostile type (mainly aggressiveness, opposition behaviour and anger) behaviours have been observed more frequently during clinical studies in children and adolescents treated with antidepressants compared to those treated with placebo. However, if treatment is clinically necessary, the patient must be closely monitored to detect the appearance of suicidal symptoms. Furthermore, there is no long term safety data in children and adolescents concerning the effects on growth, sexual maturation and cognitive and behavioural development.