Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Phaeochromocytoma 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 sulpiride may aggravate symptoms. Care should be exercised where mania or hypomania is present.
Extrapyramidal reactions, principally akathisia have been reported in a small number of cases. If warranted, reduction in dosage or anti-parkinsonian medication may be necessary.
As with other neuroleptics, neuroleptic malignant syndrome, a potentially fatal complication, which is characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK levels, has been reported. In such an event, or in the event of hyperthermia of undiagnosed origin, all antipsychotic drugs, including sulpiride, should be discontinued.
Elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects.
In patients with aggressive behaviour or agitation with impulsiveness, sulpiride could be given with a sedative.
Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) have been reported. Therefore, gradual withdrawal is advisable.
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.
Sulpiride is not licenced for the treatment of dementia-related behavioural disturbances.
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 Sulpiride and preventive measures undertaken.
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.
In elderly patients, as with other neuroleptics, sulpiride should be used with particular caution (see section 4.2).
In children, efficacy and safety of sulpiride have not been thoroughly investigated. Therefore, caution should be exercised when prescribing to children (see section 4.2).
When neuroleptic treatment is absolutely necessary in a patient with Parkinson’s disease, sulpiride can be used, although caution is in order.
Neuroleptics may lower the epileptogenic threshold. Cases of convulsions, sometimes in patients with no previous history, have been reported with sulpiride. Caution is advised in prescribing it for patients with unstable epilepsy, and patients with a history of epilepsy should be closely monitored during therapy with sulpiride.
In patients requiring sulpiride 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.
Sulpiride should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate.
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.
Sulpiride induces 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, 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.
Avoid concomitant treatment with other neuroleptics (see section 4.5).
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.
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including sulpiride. Unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8) and requires immediate haematological investigation.
Sulpiride 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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Levodopa, antiparkinsonian drugs (including ropinirole): reciprocal antagonism of effects between levodopa or antiparkinsonian drugs (including ropinirole) and neuroleptics.
Alcohol: Enhances the sedative effects of neuroleptics. Avoid the consumption of alcoholic beverages and drugs containing alcohol.
Combination with the following medications could induce torsades de pointes or prolong the QT interval (see section 4.4):
Electrolyte imbalance should be corrected:
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: Increased risk of extrapyramidal effects. Discontinuation of both drugs is recommended at first signs of neurotoxicity.
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 Sulpiride 200mg Film-Coated Tablets) 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.
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 breast-feeding 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 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 including urticaria, dyspnoea, hypotension and anaphylactic shock
Common: Hyperprolactinaemia
Common: Insomnia
Not known: Confusion
Common: Sedation or drowsiness, extrapyramidal disorder (these symptoms are generally reversible upon administration of antiparkinsonian medication), Parkinsonism, tremor, akathisia
Uncommon: Hypertonia, dyskinesia, and 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 three 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 arrhythmia, 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
Common: Maculo-papular rash
Not known: Torticollis, trismus
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
Reporting of 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
None known.
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