Source: Υπουργείο Υγείας (CY) Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Pheochromocytoma and acute porphyria.
Hypersensitivity to sulpiride or to any of the excipients listed in section 6.1.
Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer (see section 4.8 Undesirable effects).
Association with levodopa or antiparkinsonian drugs (including ropinirole) (see section 4.5 Interactions with other medicinal products and other forms of interaction).
Increased motor agitation has been reported at high dosage in a small number of patients:
In aggressive, agitated or excited phases of the disease process, low doses of Devodil may aggravate symptoms. Care should be exercised where hypomania is present.
Extrapyramidal reactions, principally akathisia and tremor have been reported in a small number of cases.
A Neuroleptic Malignant Syndrome (NMS), a potentially fatal complication, reported to occur with antipsychotics is characterised by hyperthermia, muscle rigidity, rhabdomyolisis, elevated serum creatine phosphokinase levels and autonomic dysfunction. Cases with atypical features, such as hyperthermia without muscle rigidity or hypertonia, have been observed. In case of hyperthermia of undiagnosed origin, which may be considered either as an early sign/symptom of NMS or as an atypical NMS, sulpiride and all other antipsychotics should be discontinued promptly under medical supervision.
Devodil induces slight EEG modifications. Neuroleptics may lower the epileptogenic threshold and some cases of convulsions have been reported with sulpiride (see section 4.8 Undesirable Effects). Therefore, patients with a history of epilepsy should be closely monitored during sulpiride therapy.
In elderly patients, as with other neuroleptics, sulpiride should be used with particular caution (see 4.2 Posology and method of administration).
In children, efficacy and safety of sulpiride have not been thoroughly investigated. Therefore, caution should be exercised when prescribing to children (see 4.2 Posology and method of administration).
In patients with aggressive behaviour or agitation with impulsiveness, sulpiride could be given with a sedative.
When neuroleptic treatment is absolutely necessary in a patient with Parkinson’s disease, sulpiride can be used, although caution is in order.
In patients requiring Devodil who are receiving anti-convulsant therapy, the dose of the anti-convulsant should not be changed. Cases of convulsions, sometimes in patients with no previous history, have been reported.
As with all drugs for which the kidney is the major elimination pathway, the dose should be reduced and titrated in small steps in cases of renal insufficiency.
Initiation of treatment in schizophrenia should only be undertaken by a specialist under whose regular supervision the patients should remain.
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Devodil. Unexplained sore throat, lymphadenopathy, infections or fever may be evidence of blood dyscrasia (see section 4.8) and requires immediate haematological investigation.
Sulpiride has an anticholinergic effect and, therefore, should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate.
Devodil should be used with caution in hypertensive patients, especially in the elderly population, due to the risk of hypertensive crisis. Patients should be adequately monitored.
Increased Mortality in Elderly people with dementia:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 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. Although the causes of death in clinical trials with atypical antipsychotics were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Devodil is not licenced for the treatment of dementia-related behavioural disturbances.
Venous thromboembolism:
Cases of venous thromboembolism (VTE), sometimes fatal 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 Devodil and preventive measures taken.
Breast cancer:
Sulpiride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during sulpiride therapy (see section 4.3).
As hyperglycaemia has been reported in patients treated with atypical antipsychotic agents, patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are started on sulpiride, should get appropriate glycaemic monitoring.
Avoid concomitant prescription of other antipsychotics.
Prolongation of the QT interval:
Sulpiride may reduce a prolongation of the QT interval (see section 4.8). This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes.
Before any administration, and if possible according to the patient’s clinical status, it is recommended to monitor factors which could favour the occurrence of this rhythm disorder, such as for example:
Sulpiride should be prescribed with caution in patients presenting with these factors and patients with cardiovascular disorders which may predispose to prolongation of the QT interval.
Stroke:
In randomised clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Sulpiride should be used with caution in patients with stroke risk factors.
Dolmatil should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate.
Devodil tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Levodopa, antiparkinsonian drugs (including ropinirole): reciprocal antagonism of effects between levopoda or antiparkinsonian drugs (including ropinirole) and neuroleptics.
Alcohol: alcohol enhances the sedative effects of neuroleptics.
Avoid the consumption of alcoholic beverages and drugs containing alcohol.
Combination with the following medications which could induce torsades de pointes or prolong the QT interval (see section 4.4):
Antihypertensive agents: antihypertensive effect and possibility of enhanced postural hypotension (additive effect).
CNS depressants including narcotics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytics, clonidine and derivatives.
Antacids or sucralfate: The absorption of sulpiride is decreased after co-administration. Therefore, sulpiride should be administered two hours before these drugs.
Lithium: lithium increases the risk of extrapyramidal side effects. Discontinuation of both drugs is recommended at first signs of neurotoxicity.
Devodil may modify response to metoclopramide therapy.
There are only very limited data available from the use of sulpiride in pregnant women. The safety of sulpiride during human pregnancy has not been established.
Sulpiride crosses the placenta. Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3).
The use of sulpiride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks.
Neonates exposed to antipsychotics (including Devodil) 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 (see section 4.8). There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Sulpiride is excreted into breastmilk in rather large amounts, far above the accepted value of 10% of the maternal weight-adjusted dosage in some cases, but blood concentrations in breastfed infants have not been evaluated. There is insufficient information on the effects of sulpiride in newborns/infants. A decision must be made whether to discontinue breast-feeding or to abstain from sulpiride therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed in treated animals.
Even used as recommended, sulpiride may cause sedation so that the ability to drive vehicles or operate machinery can be impaired (see section 4.8).
The following CIOMS frequency rating is used, when applicable: 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 (cannot be estimated from the available data).
Uncommon: leukopenia.
Not known: neutropenia, agranulocytosis.
Not known: anaphylactic reactions; urticaria, dyspnea, hypotension and anaphylactic shock.
Common: hyperprolactinaemia.
Common: insomnia.
Not known: confusion.
Common: sedation or drowsiness, extrapyramidal disorder, Parkinsonism, tremor, akathisia.
Uncommon: hypertonia, dyskinesia, dystonia.
Rare: oculogyric crisis.
Not known: neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia (have been reported, as with all neuroleptics, after a neuroleptic administration of more than 3 months. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms), convulsion.
Not known: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Rare: ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia
Not known: electrocardiogram QT prolonged, cardiac arrest, torsade de pointes, sudden death (see section 4.4).
Uncommon: orthostatic hypotension.
Not known: venous embolism, pulmonary embolism, deep vein thrombosis (see section 4.4).
Not known: pneumonia aspiration (mainly in association with other CNS depressants).
Common: constipation.
Uncommon: salivary hypersecretion.
Common: hepatic enzyme increased.
Not known: hepatocellular, cholestatic or mixed liver injury.
Common: maculo-papular rash.
Not known: torticollis, trismus, rhabdomyolysis.
Not known: extrapyramidal symptoms, drug withdrawal syndrome neonatal (see section 4.6).
Common: breast pain, galactorrhoea.
Uncommon: breast enlargement, amenorrhoea, orgasm abnormal, erectile dysfunction.
Not known: gynaecomastia.
Common: weight gain
Not known: hyperthermia (see section 4.4)
Not known: blood creatine phosphokinase increased.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.
Not applicable.
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