Source: Medicines Authority (MT) Revision Year: 2022 Publisher: Ferrer Internacional, S.A., Gran Via Carlos III, 94 Barcelona, 08028, Spain
Hypersensitivity to the active substance and to any of the excipients listed in paragraph 6.1. Dislep 25 mg should not be used in epilepsy, manic states, manic phases of manic-depressive psychosis.
Dislep is contraindicated in patients with pheochromocytoma as it can cause a hypertensive crisis probably due to the release of catecholamines from the tumour. These hypertensive crises can be controlled with phentolamine.
In relation to the supposed correlations between the hyperprolactinaemia effect of most psychotropic drugs and breast dysplasia, Dislep 25 mg should not be used in subjects who are already carriers of malignant mastopathy. Dislep 25 mg should not be used when stimulation of gastrointestinal motility may be harmful, for example in the presence of gastrointestinal bleeding, mechanical obstructions or perforations.
Dislep 25 mg is contraindicated in pregnancy and breastfeeding (see section 4.6).
An approximately three-fold increase in the risk of cerebrovascular events has been observed in randomised clinical trials versus placebo in a population of patients with dementia treated with some atypical antipsychotics. The mechanism of this increased risk is not known. An increased risk for other antipsychotics or other patient populations cannot be excluded. Levosulpiride should be used with caution in patients with risk factors for stroke.
A potentially fatal symptom complex called Neuroleptic Malignant Syndrome (N.M.S.) has been reported with the use of neuroleptics (usually during antipsychotic treatment). Clinical manifestations of this syndrome are: hyperpyrexia, muscle stiffness, akinesia, vegetative disorders (irregularities in the pulse and blood pressure, sweating, tachycardia, arrhythmias), alterations in the state of consciousness that can progress to stupor and coma.
The treatment of N.M.S. consists in immediately suspending the administration of antipsychotic drugs and other non-essential drugs and in instituting intensive symptomatic therapy (particular care must be taken to reduce hyperthermia and correct dehydration). If the resumption of antipsychotic treatment is deemed essential, the patient should be carefully monitored. Avoid concomitant therapy with other neuroleptics.
The effects of levosulpiride on gastrointestinal motility can be antagonised by anticholinergic, narcotic and analgesic drugs. Use with caution in patients with cardiovascular disease or a family history of QT prolongation.
Cases of venous thromboembolism (VTE) have been reported with the use of antipsychotic drugs. Since patients treated with antipsychotics often have acquired risk factors for VTE, these factors must be identified before and during treatment with Dislep to take appropriate preventive measures.
Data from two large observational studies have shown that elderly patients with dementia treated with antipsychotics have a slightly increased risk of mortality compared to untreated patients. The available data are insufficient to safely estimate the precise extent of the risk and the cause of the increased risk is not known.
Dislep is not indicated for the treatment of the behavioural disorders of dementia. Simultaneous use of alcohol must be avoided.
Dislep 25 mg Solution for injection/infusion contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.
The association with other psychotropic drugs requires particular caution and vigilance on the part of the doctor to avoid unexpected undesirable effects from interaction.
When neuroleptics are administered concomitantly with QT prolonging drugs, the risk of developing cardiac arrhythmias increases.
Do not administer concomitantly with drugs that cause electrolyte imbalances.
The effects of levosulpiride on gastrointestinal motility can be antagonised by anticholinergic, narcotic and analgesic drugs.
There are no adequate and well-controlled studies on pregnant women. Patients should be advised of the need to inform their doctor in the event of an existing or planned pregnancy while being treated with levosulpiride. Therefore, Dislep should not be used used in confirmed or suspected pregnancy.
Infants who have been exposed to conventional or atypical antipsychotics, including Dislep, during the third trimester of pregnancy are at risk for side effects, including extrapyramidal symptoms or withdrawal symptoms, which may vary in severity and duration after delivery. Agitation, hypertonus, hypotonus, tremors, somnolence, respiratory distress and nutritional disorders have been reported. Therefore, newborns need to be carefully monitored. Breastfeeding There are no adequate and well-controlled studies on breastfeeding women. Therefore, Dislep must not be used during breastfeeding period.
High dosages may cause somnolence, drowsiness and dyskinesia; patients under treatment must be cautioned of this so that they avoid driving vehicles and carrying out operations requiring their full attention due to the possible danger.
According to the MedDRA system organ classification, the frequency groupings use the following convention: 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), not known (frequency cannot be estimated from the available data).
| Very common | Common | Uncommon | Rare | Very rare | Not known |
|---|---|---|---|---|---|
| Nervous system disorders | |||||
| Somnolence, Parkinsonism1, dyskinesia1, tremors1, dystonia1, neuroleptic malignant syndrome (see section 4.4) | |||||
| Diseases of the reproductive system and breast | |||||
| Amenorrhoea2, gynaecomastia2, galactorrhoea2, breast tenderness2 libido changes2 | |||||
| Cardiac pathologies | |||||
| QT prolongation3, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation3, cardiac arrest3 | Sudden death3 | ||||
| Vascular pathologies | |||||
| Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section 4.4)3 | |||||
| Pregnancy, puerperium and perinatal conditions | |||||
| Neonatal withdrawal syndrome, extrapyramidal symptoms (see section 4.6) | |||||
| Diagnostic tests | |||||
| Hyperprolactinaemia2 | |||||
1 observed in case of prolonged administration and/or with other drugs of the same class
2 observed in special cases, for prolonged administration and attributable to a reversible effect of levosulpiride on the function of the hypothalamuspituitary-gonadal axis, similar to that known for many neuroleptics
3 observed with other drugs of the same class
Reporting of suspected adverse reactions after the authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via ADR Reporting Website:www.medicinesauthority.gov.mt/adrportal.
No data are known in this regard.
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