Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Warnings:
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 hypomania is present.

Extrapyramidal reactions, principally akathisia and tremor have been reported in a small number of cases. If warranted, reduction in dosage or anti-parkinsonian medication may be necessary.

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.

Modal Capsules and Modal Forte Tablets induce slight electroencephalogram (EEG) modifications. Neuroleptics may lower the epileptogenic threshold and some cases of convulsions, sometimes in patients with no previous history, have been reported with sulpiride (see section 4.8). Therefore, caution is advised in prescribing it for patients with unstable epilepsy, and patients with a history of epilepsy should be closely monitored during sulpiride therapy.

In patients requiring Modal Capsules or Modal Forte Tablets who are receiving anti- convulsant therapy, the dose of the anti-convulsant should not be changed.

In elderly patients, as with other neuroleptics, sulpiride should be used with particular caution (see section 4.2). Elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects.

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).


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.

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.

Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including sulpiride. 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.

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.

As hyperglycaemia has been reported in patients treated with atypical antipsychotic agents, patients with diagnosed diabetes mellitus or with risk factors for diabetes who have started treatment with sulpiride, should get appropriate glycaemic monitoring.

Avoid concomitant prescription of other antipsychotics.

QT prolongation:
Sulpiride can induce QT prolongation (see section 4.8). It is known that this effect may potentiate the risk of serious ventricular arrhythmias such as torsade de pointes.
Before any administration, and if possible taking into account the clinical condition of the patient, it is advisable to monitor factors which could favour the occurrence of this rhythm disorder, such as:
- bradycardia less than 55 bpm,
- electrolyte imbalance, particularly hypokalaemia,
- congenital QT prolongation,
- ongoing treatment with medicines that may produce pronounced bradycardia (< 55 bpm),
- hypokalaemia,
- decreased intracardiac conduction,
- or QT prolongation (see section 4.5)

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 for this increased risk is not known. An increase in the risk with other antipsychotic drugs or in other patient populations cannot be excluded. Sulpiride should be used with caution in patients with risk factors for stroke.

Increased mortality in elderly patients with dementia:

Elderly patients with dementia-related psychosis, who are treated with antipsychotic drugs, are at increased risk of death. Data from two large observational studies showed that elderly patients with dementia who are treated with antipsychotics are at 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. Sulpiride is not licenced for the treatment of dementia-related behavioural disturbances.

Venous thromboembolism:
There have been reports of venous thromboembolism (VTE), sometimes fatal, 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 Modal Capsules or Modal Forte Tablets and preventative measures undertaken.

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).

Neuroleptic Malignant Syndrome:
A Neuroleptic Malignant Syndrome (NMS), a potentially fatal complication, reported to occur with antipsychotics is characterised by hyperthermia, muscle rigidity, rhabdomyolysis, 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.

Modal Forte tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines
The medicine may cause drowsiness, dizziness, visual disturbances and impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a vehicle. Caution should be used while driving or operating machinery, especially because the particular sensitivity of each patient to the medicine has not been established.