Sulpiride is indicated for the treatment of:
- Schizophrenia:
with positive and negative symptoms.
- Depression:
treatment of psychotic depression and severe forms of antidepressant-resistant depression.
- Dizziness:
treatment of dizziness in the case of inappropriate treatment.
The preparation is for adults only.

Acute and chronic psychosis:
Negative symptomatology: doses range from 200 to 600 mg / day. It is recommended to start the treatment with a 200 mg dose three times daily and adjust the dose according to the clinical response.
Positive symptomatology: an initial dose of 600 - 1000 mg / day divided in 3 daily doses is recommended.
The dose can be increased to a maximum of 1600 mg / day. According to the clinical response, it is recommended to reduce the amount of sulpiride administered to the minimum effective dose.
Depression: Dosages range from 150 to 300 mg / day. It is recommended to start treatment with a 50 mg dose three times a day and adjust the dose according to the clinical response.
Dizziness: doses range from 150 to 300 mg / day. It is recommended to start the treatment with 50 mg three times daily and according to the clinical response to adjust the dose.
Special populations
Elderly patients: an increase in sulpiride plasma concentration may occur in the elderly. Therefore, these patients should start with a lower starting dose and gradually increasing the dose.
Functional impairment: in case of renal impairment, the dose should be adjusted depending on creatinine clearance. The dose should be reduced to 35% to 70% of the usual dose.
Clearance from 30 to 60 ml / min: Reduce the dose to 50 to 70% of the usual dose.
Clearance from 10 to 30 ml / min: Reduce the dose to 35 to 50% of the usual dose.
Clearance less than 10 ml / min: Reduce the dose to a maximum of 35% of the usual dose.
(See point 5.2)
The use of Genprid in the pediatric population is not relevant.

Prolonged QT interval tightening:
Sulpiride may cause a dose-dependent prolongation of the QT interval (see section 4.8). This effect is known to increase the risk of severe ventricular arrhythmias, such as torsade de pointes.
Prior to treatment, and if possible according to the patient's clinical condition, it is recommended to monitor the factors that may increase the incidence of these rhythm disorders, such as:
- bradycardia with a heart rate of less than 55 beats per minute,
- electrolyte imbalance, especially hypokalemia,
- congenital QT prolongation,
- Concomitant treatment with agents that can cause bradycardia (<55 / min), hypokalaemia, decreased intra-cardiac conductivity, or prolongation of the QT interval (see section 4.5).
Stroke:
In randomized, placebo-controlled clinical trials in the dementia population and treated with some atypical antipsychotics, a 3-fold increase in the risk of cerebrovascular events was observed. The mechanism of such an increase in risk is unknown. The increase in risk associated with other antipsychotics or other patient populations cannot be ruled out. Sulpirid should be administered with particular caution in patients at risk of stroke.
As with other neuroleptics, neuroleptic malignant syndrome may occur, which may be a potentially fatal complication characterized by hyperthermia, muscle rigidity and autonomic dysfunction. If hyperthermia of unknown origin occurs, sulpiride should be discontinued.
If neuroleptics are necessary for patients with Parkinson's disease, sulpiride may be taken, but caution should be exercised.
Concomitant administration with other antipsychotics should be avoided. In children, the safety and efficacy of sulpiride has not been thoroughly investigated.
Tardive dyskinesia:
As with other neuroleptics, it has been reported for longer than 3 months after administration;
antiparkinsonian drugs are ineffective or may even aggravate symptoms.
Elderly patients with dementia:
Elderly patients with dementia-related psychoses who are being treated with antipsychotics have a higher risk of death. Based on the results from 17 placebo-controlled clinical trials (median duration of 10 weeks), the risk of death was higher primarily in patients taking atypical psychology, 1.6 to 1.7 times as compared to patients in the placebo group. During a typical 10-week controlled clinical trial, the number of deaths in treated patients was approximately 4.5%, compared with 2.6% in the placebo group. Although the causes of death in clinical studies with atypical antipsychotics were different, most of them were associated with cardiovascular failure (eg heart failure, sudden death) or infection (eg pneumonia). Observational studies
suggest that treatment with conventional antipsychotics may increase mortality similar to treatment with atypical antipsychotics.
It is unclear to what extent the increased mortality observed in the observational studies can be attributed to the effects of antipsychotics or other characteristics of patients.
Venous Thromboembolism:

There have been cases of venous thromboembolism (VTE) in association with the use of antipsychotics.
Since the risk factors for VTE are often present in patients treated with antipsychotics, these risk factors should be recognized before and during Genprid treatment and preventive measures should be taken.
Notice
Hyperglycaemia has been reported in patients treated with atypical antipsychotics, therefore glycemia should be monitored in patients diagnosed with diabetes mellitus or risk factors for diabetes, which is indicated for sulpiride.
In the case of renal insufficiency, the dose should be reduced (see section 4.2).
Neuroleptics may reduce the epileptogenic threshold, and several cases of convulsions have been reported (see section 4.8). Therefore, patients with a history of epilepsy should be carefully monitored during treatment with sulpiride.
In elderly patients, sulpiride, like other neuroleptics, should be used with extreme caution (see section 4.2).
In patients aggressive or agitated with impulsive behavior, sulpiride can be given together with sedatives.
Patients with a family history of breast carcinoma should be closely monitored by their physician.
Leukopenia, neutropenia have been reported with the administration of antipsychotics including Genprid and agranulocytosis. Symptoms of blood dyscrasias may be unexplained infections or fever requiring immediate haematological examination (see section 4.8).
Genprid has an anticholinergic effect and should therefore be used with caution in patients with glaucoma,
bowel obstruction, congenital gastrointestinal stenosis, urinary retention or prostate hyperplasia.
Genprid should be used with caution in hypertensive patients, particularly in elderly patients and in patients at risk of hypertension. These patients must be adequately monitored.
In patients with acute porphyria, Genprid should be used only if there is a serious indication for its use.
Abruptly discontinuing antipsychotic medications has reported symptoms that include nausea, vomiting,
increased sweating, or insomnia. Psychotic symptoms and involuntary movements (such as akathisia,
dystonia and dyskinesia) may also reappear. It is therefore advisable to plant the medicine gradually.
Hard capsules contain lactose monohydrate. Patients with rare hereditary problems
galactose intolerance, lack of lactase or glucose-galactose malabsorption should not be taken.

Contraindicated combinations:
Levodopa, dopaminergic receptor agonists: the effects of levodopa or dopaminergic agonists and neuroleptics antagonize each other.
If treatment with neuroleptics is absolutely necessary in patients with Parkinson's disease, sulpiride may be given.
In case of neuroleptic-induced extrapyramidal syndrome, do not treat dopaminergic agonists but anticholinergics.
Not recommended combinations:
Alcohol: alcohol intensifies the sedative effect of neuroleptics. Patients should avoid drinking alcohol and alcohol-containing medicines.
Concomitant administration with drugs that also cause QT prolongation or cause electrolyte imbalance should be avoided.
Combination with the following drugs, which may prolong QT interval or trigger torsade de pointes (see section 4.4):
- drug-inducing bradycardia such as beta-blockers, calcium channel blocker-inducing bradycardia such as diltiazem and verapamil, clonidine, guanfacine; digitalis.
- hypokalemia-inducing drugs: hypokalemia diuretics, stimulant laxatives, amphotericin B i.v., glucocorticoids, tetracosactides. Hypocalcaemia should be corrected.
- class Ia antiarrhythmics such as quinidine, disopyramide,
- class III antiarrhythmics such as amiodarone, sotalol.
- other medicines such as pimozide, sultopride, haloperidol, thioridazine, methadone, imipramine antidepressants, lithium, bepridil, cisapride, erythromycin i.v., vinkamin i.v., halofantrine, pentamidine, sparfloxacin.
Sultopride: increased risk of ventricular arrhythmias, especially torsade de pointes.
Combinations that need to be addressed:
Antihypertensive: Increase of antihypertensive effect and risk of postural hypotension (additive effect).
Other central nervous system depressants: total anesthetics, analgesics and cough suppressants, most H1 antagonists, barbiturates, benzodiazepines and other anxiolytics, clonidine and related substances.
Antacids and sucralfate: Sulfurized absorption is reduced during concomitant administration. Therefore, sulpiride should be given at least two hours prior to administration of these drugs.
Lithium: Increases the risk of undesirable extrapyramidal effects while lithium is given. At the first signs of neurotoxicity, it is recommended to discontinue both.

Pregnancy:
In animals, a decrease in fertility was observed associated with the pharmacological effects of sulpiride (a prolactin effect). Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryonal / fetal development and / or postnatal development. There is very little clinical data on the use of sulpiride in pregnant women. In most cases, fetal or neonatal disorders reported during the use of sulpiride during pregnancy may be other, more likely, explanations. However, the use of sulpiride is not recommended during pregnancy due to limited experience.
Newborns who have been exposed to antipsychotic medications (including Genprid) during the third trimester of pregnancy are at risk of having side effects, including extrapyramidal symptoms and / or withdrawal symptoms. These symptoms may vary in both duration and severity. Cases of agitation,
hypertonia, hypotonia, tremor, somnolence, respiratory distress, or eating disorders have been reported.
Therefore, newborns should be carefully monitored.
Breast feeding:
Sulpiride has been found in milk treated by women and breastfeeding is therefore not recommended.

Although sulpirid is used in accordance with the recommendations, it may cause drowsiness and reduce the ability to drive or operate machinery.

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).
Blood and lymphatic system disorders (see section 4.4)
Uncommon: leukopenia
Not known: neutropenia, agranulocytosis
Immune system disorders
Not known: anaphylactic reactions; urticaria, dyspnoea, hypotension and anaphylactic shock
Endocrine disorders
Common: hyperprolactinaemia
Psychiatric disorders
Common: insomnia
Not known: confusion
Nervous system disorders
Common: sedation or drowsiness, extrapyramidal disorder (these symptoms are generally reversible upon administration of antiparkinsonian medication), 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
Metabolism and nutrition disorders:
Not known: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Cardiac disorders
Rare: ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia
Not known: electrocardiogram QT prolonged, cardiac arrest, torsade de pointes, sudden death (see section 4.4).
Vascular disorders
Uncommon: orthostatic hypotension
Not known: venous embolism, pulmonary embolism, deep vein thrombosis (see section 4.4)
Respiratory, thoracic and mediastinal disorders:
Not known: pneumonia aspiration (mainly in association with other CNS depressants)
Gastrointestinal disorders
Common: constipation
Uncommon: salivary hypersecretion
Hepatobiliary disorders
Common: hepatic enzyme increased
Skin and subcutaneous tissue disorders
Common: maculo-papular rash
Musculoskeletal and connective tissue disorders
Not known: torticollis, trismus
Pregnancy, puerperium and perinatal conditions
Not known: extrapyramidal symptoms, drug withdrawal syndrome neonatal (see section 4.6)
Reproductive system and breast disorders
Common: breast pain, galactorrhoea
Uncommon: breast enlargement, amenorrhoea, orgasm abnormal, erectile dysfunction.
Not known: gynaecomastia
General disorders and administration site conditions
Common: weight gain
To report any side effects
      - National Pharmacovigilance and Drug Safety Center (NPC)
               o Fax: +966-11-205-7662
               o To call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353 – 2356 – 2317 – 2354 – 2334 – 2340
               o Toll-free: 8002490000
               o E-mail: npc.drug@sfda.gov.sa
               o Website: www.sfda.gov.sa/npc

Experience with sulpiride overdose is limited.
In case of overdose, dyskinetic manifestations may occur with spastic torticollis, tongue protrusion and trismus. In some patients, overdose can lead to life threatening signs of parkinsonism and coma.
Since sulpiride is poorly dialysable and hemodialysis is therefore only partially removed, dialysis should not be used to eliminate the drug.
There is no specific antidote. Treatment is symptomatic only. Appropriate support measures should therefore be implemented. Until the patient heals, careful monitoring of vital functions and cardiac monitoring (risk of prolongation of the QT interval and subsequent ventricular arrhythmia) is recommended.
If severe extrapyramidal symptoms arise, anticholinergics should be given.
Fatal cases were reported mainly in combination with other psychotropic agents.

Pharmacotherapeutic group: antipsychotic, neuroleptic, ATC code: N05AL01.

Sulpiride is a benzamide neuroleptic. Specifically antagonize D2 and D3 dopamine receptors primarily in the mesolimbic and tuberoinfundibular area and therefore has a weak extrapyramidal side effects than classical neuroleptics. In patients with psychosis with negative symptoms, sulpiride is effective at doses of 150 to 600 mg per day. In this dose range, sulpiride does not affect the positive symptoms. Dosing from 600 to 1600 mg daily improves the positive symptoms in patients with acute or chronic psychosis. Only very high doses of sulpiride produce sedative effects.

Absorption
After intramuscular injection of 100 mg sulpiride, peak plasma levels (2.2 mg / l) are reached after 30 minutes.
After oral administration, sulpiride is absorbed within 4.5 hours, the maximum plasma level is 0.25 mg / l per capsule with 50 mg of the active substance.
Distribution
The bioavailability of oral dosage forms ranges from 25 to 35% and has a large interindividual variability.
Plasma levels of sulpiride are proportional to the dose administered.
Sulpirid quickly transitions into the tissues, primarily into the liver and kidneys. The transfer to the brain is small.
Less than 40% of the drug is bound to proteins, erythrocytes distribution coefficient - 1. The amount of plasma is excreted in breast milk is about 1/1000 daily dose.
Sulpirid is not actively metabolised in humans, 92% of the intramuscular dose is excreted into the urine in unchanged form.
Elimination
The plasma elimination half-life is approximately 7 hours, the steady state volume of distribution is 0.94 l / kg. Total clearance is 126 ml / min. (7.56 l / h).
Sulpiride is primarily secreted by the kidneys by glomerular filtration. Renal clearance is usually the same as total clearance.

Studies have shown no mutagenic or carcinogenic effects.

Microcrystalline cellulose (PH101)
Hydroxypropyl cellulose LF
Maize starch
Sodium starch glycollate (Type A)
Magnesium stearate.
Capsule Shell (size 4) RP 8

Not applicable

Store below 30°C.
Store in the original pack to protect from light & moisture

Transparent PVC-PVDC film / Aluminium foil blister of 10 capsules & the pack contains 3 blisters

Not applicable.