Source: Υπουργείο Υγείας (CY) Publisher: Lundbeck Hellas A.E., Spyrou Kyprianou, 20 CHAPO CENTRAL, 3rd floor P.C 1075, Nicosia, Cyprus
Hypersensitivity to flupentixol and melitracen or to any of the excipients listed in section 6.1.
Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma, blood disorders, phaeochromocytoma.
Recent myocardial infarction. Any degree of atrioventricular block or disorders of cardiac rhythm and coronary artery insufficiency.
Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contraindicated (see section 4.5).
Simultaneous administration of melitracen and MAO inhibitors may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia).
As with other tricyclic antidepressants, melitracen should not be given to patients receiving monoamine oxidase inhibitors (MAOIs). Treatment with Deanxit may be instituted 14 days after discontinuation of non-selective MAOIs and minimum one day after discontinuation of moclobemide and selegiline. Treatment with MAOIs may be introduced 14 days after discontinuation of Deanxit.
Deanxit should not be administered together with MAOIs (see section 4.3 and section 4.5).
Deanxit should be used with caution in patients with organic brain syndrome, convulsion, urinary retention, hyperthyroidism and advanced hepatic or cardiovascular disease.
Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics. If the patient has previously been treated with tranquillizers or neuroleptics with sedative effect, these should be withdrawn gradually.
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission 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 experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
As described for other psychotropics Deanxit may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.
In patients with the rare condition ofThe tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked.
Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. If possible, discontinue Deanxit several days before surgery; if emergency surgery is unavoidable, the anaesthetist should be informed that the patient is being so treated.
Deanxit should be used with caution in patients receiving SSRIs.
Deanxit is not recommended for use in children and adolescents due to lack of data on efficacy and safety.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Deanxit and preventive measures undertaken.
An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics.The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Deanxit should be used with caution in patients with risk factors for stroke.
Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Deanxit is not licensed for the treatment of dementia-related behavioural disturbances.
The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3).
Sympathomimetic agents: Melitracen may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (e.g. as contained in local and general anaesthetics and nasal decongestants).
Adrenergic neurone blockers: Deanxit may counteract the antihypertensive effects of guanethidine, betanidine, reserpine, clonidine and methyldopa. It is advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants.
Anticholinergic agents: Tricyclic antidepressants may potentiate the effects of these drugs on the eye, central nervous system, bowel and bladder; concomitant use of these should be avoided due to an increased risk of paralytic ileus, hyperpyrexia, etc.
CNS depressants: Deanxit may enhance the effects of alcohol, barbiturates and other CNS depressants.
Lithium: Concomitant use of Deanxit and lithium increases the risk of neurotoxicity.
Levodopa: Deanxit may reduce the effect of levodopa and increase the risk of cardiac side effects.
Deanxit should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Due to the risk of neonatal withdrawal symptoms it is recommended that Deanxit treatment is stopped about 14 days before delivery by tapering off the dosage.
Neonates exposed to antipsychotics (including Deanxit) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Animal studies have shown reproductive toxicity (see section 5.3.).
As flupentixol is found in breast milk in low concentrations it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 0.5% of the weight related maternal dose (in mg/kg).
It is not known whether melitracen is excreted in breast milk. However, another tricyclic antidepressant, amitriptyline, is found in breast milk in low concentrations and it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is about 2% of the weight related maternal daily dose (in mg/kg). As melitracen has the same lipophilic properties as amitriptyline, it is assumed that it occurs in breast milk in similar concentrations.
Breast-feeding can be continued during Deanxit therapy if considered of clinical importance but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.
In humans, adverse events have been reported that may have a negative impact on female and/or male sexual function and fertility. If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered.
The effect is reversible on discontinuation.
In preclinical fertility studies in rats, where flupentixol and melitracen were administered separately slight effects on fertility were noted. Flupentixol slightly affected the pregnancy rate of female rats, whereas melitracen slightly repressed fertility and fecundity of male rats. Effects were seen at doses well in access of those applied during clinical use.
Deanxit is a non-sedating drug in the recommended dosage range.
However, patients who are prescribed psychotropic medication may be expected to have some impairment in general attention and concentration and should be cautioned about their ability to drive or operate machinery.
There are few and mild adverse effects. Insomnia (in 6%) is the most frequent adverse effect.
In the listing below the following convention is used:
MedDRA system organ class / preferred term
Frequencies are defined as: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000) or not known (cannot be estimated from available data).
The following frequencies have been reported in clinical trials:
| MedDRA SOC | Frequency | Preferred Term |
|---|---|---|
| Psychiatric disorders | Common (>1/100, <1/10) | Insomnia, restlessness, agitation. |
| Rare (>1/10,000, <1/1,000 | Suicidal thoughts or behaviour* | |
| Nervous system disorders | Common (>1/100, <1/10) | Dizziness, tremor |
| Gastrointestinal disorders | Common (>1/100, <1/10) | Dry mouth, constipation |
| Eye disorder | Common (>1/100, <1/10) | Accommodation disorder |
| General disorders and administration site conditions | Common (>1/100, <1/10) | Fatigue |
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown.
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs Fax: +357 22608649.
Isolated cases of cholestatic hepatitis have been reported.
Not applicable.
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