Stablon Special Precautions





Zuellig Pharma
Full Prescribing Info
Special Precautions
Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harming and suicide (suicidal behaviour). This risk persists until a significant remission has been obtained. C
Patients with a history of suicidal type behaviour or those expressing significant suicidal thoughts before starting the treatment face a higher risk of the onset of suicidal thoughts or suicidal type 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 treated with antidepressants compared to those receiving a placebo. Careful monitoring of patients, and particularly of high-risk patients, must accompany the use of this drug treatment, particularly at the beginning of treatment and at times of dose changes.
The patients (and their family and friends) must be warned of the need to monitor 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 arise.
In case of general anaesthesia, the anaesthetist should be informed of the treatment, and the treatment discontinued 24 or 48 hours prior to surgery.
In case of emergency, surgery may still be performed without prior discontinuation; under peroperative monitoring.
As with any psychotropic treatment, the administration of this medicinal product with alcoholic beverages or medicinal products containing alcohol is inadvisable.
Do not exceed the recommended doses.
Abuse/dependence and withdrawal syndrome: In case of a history of drug-dependence or alcohol-dependence, the patients must be very closely monitored in order to avoid any increase in dosage.
After discontinuation of treatment with tianeptine, withdrawal symptoms have been observed in some patients. The following events have been observed: anxiety, muscle pain, abdominal pain, insomnia, joint pain. When the treatment is started, the patient should be informed on the risk of withdrawal syndrome at discontinuation.
If the treatment is to be interrupted, the dosage should be gradually reduced over a period of 7 to 14 days in order to reduce the risk of withdrawal reactions (see Dosage & Administration).
A combination with MAOI is inadvisable (see Interactions). It is necessary to allow a free interval: of two weeks when tianeptine is used as a replacement of MAOI, of 24 hours when a MAOI is used as a replacement of tianeptine.
Hyponatraemia: Hyponatraemia, probably due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH), has been reported with the use of tianeptine. The majority of cases were reported in the elderly, especially when coupled with a recent history of, or condition pre-disposing to, altered fluid balance. Caution should be exercised in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, or dehydrated patients or those treated with diuretics.
This medicinal product contains sucrose. Its use is inadvisable in patients with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare hereditary diseases).
Level of sodium: This medicine contains less than 1 mmol sodium (23 mg) per coated-tablet, i.e. essentially 'sodium-free'.
Effects on ability to drive and use machines: Diminished alertness could appear in some patients. Therefore, the attention of drivers and users of machines should be drawn to the risks of drowsiness attached to the use of this medicinal product.
Use in Children: STABLON is contraindicated in children and adolescents under 15 years old (see Contraindications) and should not be used in adolescents aged 15 to 18 years. Suicidal type behaviours (suicide attempts and suicidal thoughts) and hostile type behaviour (mainly aggressiveness, opposition behaviour and anger) have been observed more frequently during clinical studies in children and adolescents treated with antidepressants compared to those treated with placebo. If the decision to treat is nonetheless taken, in case of clinical need, 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 growth, sexual maturation and cognitive and behavioural development.
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