Acute and chronic schizophrenia.

Adults
A starting dose of 400mg to 800mg daily, given as one or two tablets twice daily (morning and early evening) is recommended.
Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200mg twice daily. Increasing the dose beyond this level has not been shown to produce further improvement.
Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy, as well as depression) respond to doses below 800mg daily; therefore, a starting dose of 400mg twice daily is recommended. Reducing this dose towards 200mg twice daily will normally increase the alerting effect of Genprid.
Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of400-600mg twice daily.
Children
Clinical experience in children under 14 years of age is insufficient to permit specific recommendations.
Elderly
The same dose ranges are applicable in the elderly, but the dose should be reduced if there is evidence of renal impairment.

Phaeochromocytoma and acute porphyria. Hypersensitivity to sulpiride or to any of the excipients. 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).

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 Genprid may aggravate symptoms. Care should be exercised where hypomania is present.
Extrapyramidal reactions, principally akathisia have been reported in a small number of cases. If warranted, reduction in dosage or antiparkinsonian 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 Genprid, 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.
Increased Mortality in Elderly people with dementia:
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.
Genprid is not licenced for the treatment of dementia-related behavioural disturbances.
Venous thromboembolism:
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 Genprid 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.
Precautions:
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 Genprid who are receiving anticonvulsant therapy, the dose of the anticonvulsant should not be changed.
Cases of convulsions, sometimes in patients with no previous history, have been reported.
Genprid 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. 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.
Prolongation of the QT interval:
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:
Bradycardia less than 55 bpm
Electrolyte imbalance in particular hypokalaemia
Congenital prolongation of the QT interval
Ongoing treatment with a medication likely to produce pronounced bradycardia (< 55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QTc interval (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.
Avoid concomitant treatment with other neuroleptics (see section 4.5).
Stroke:
In randomised clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3fold 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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucosegalactose malabsorption should not take this medicine.
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Genprid.
Unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8) and requires immediate haematological investigation.
Genprid 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.

Associations contraindicated
Levodopa, antiparkinsonian drugs (including ropinirole): reciprocal antagonism of effects between levopoda or antiparkinsonian drugs (including ropinirole) and neuroleptics.
Associations not recommended.
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):
- Bradycardia-inducing medications such as betablockers, Bradycardia-inducing calcium channel blockers such as diltiazem and verapamil, clonidine; digitalis.
- Medications which induce electrolyte imbalance, in particular those causing hypokalaemia:
hypokalaemic diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, tetracosactides.
Electrolyte imbalance should be corrected
- Class Ia antiarrhythmic agents such as quinidine, disopyramide.
- Class III antiarrhythmic agents such as amiodarone, sotalol.
- Other medications such as pimozide, haloperidol; methadone, imipramine antidepressants; lithium,
cisapride, thioridazine, IV erythromycin, halofantrine, pentamidine.
Associations to be taken into account.
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 coadministration.
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.

Pregnancy:
A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed in treated animals. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development and/or postnatal development. In humans, very limited clinical data on exposed pregnancies are available. In almost all cases of foetal or neonatal disorders reported in the context of sulpiride use during pregnancy, alternative explanations can be suggested and seem more likely.
Therefore the use of sulpiride is not recommended during pregnancy because of the limited experience.
Neonates exposed to antipsychotics (including Genprid) 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.
Lactation:
Sulpiride has been found in the breast milk of treated women. Therefore breastfeeding is not recommended during treatment.

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).
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 in overdosage is limited.
The range of single toxic doses is 1 to 16g but no death has occurred even at the 16g dose.
Fatal outcomes have been reported mainly in combination with other psychotropic agents.
The clinical manifestations of poisoning vary depending upon the size of the dose taken. After single doses of 1 to 3g restlessness and clouding of consciousness have been reported and (rarely) extrapyramidal symptoms. Doses of 3 to 7g may produce a degree of agitation, confusion and extrapyramidal symptoms (see section 4.8 Undesirable Effects); more than 7g can cause, in addition, coma and low blood pressure.
The duration of intoxication is generally short, the symptoms disappearing within a few hours. Comas which have occurred after large doses have lasted up to four days.
No haematological or hepatic toxicity has been reported.
Sulpiride is partly removed by haemodialysis.
There is no specific antidote to sulpiride. Treatment is only symptomatic. Appropriate supportive measures should therefore be instituted, close supervision of vital functions and cardiac monitoring (risk of QT interval prolongation and subsequent ventricular arrhythmias) is recommended until the patient recovers.
If severe extrapyramidal symptoms occur anticholinergics should be administrated.
Overdose may be treated with alkaline osmotic diuresis and, if necessary, antiparkinsonian drugs. Coma needs appropriate nursing, and cardiac monitoring is recommended until the patient recovers. Emetic drugs are unlikely to be effective in Genprid overdosage

Pharmacotherapeutic group: Psycholeptics; Benzamides,
ATC code: N05AL01
Genprid is a member of the group of substituted benzamides, which are structurally distinct from the phenothiazines, butyrophenones and thioxanthenes. Current evidence suggests that the actions of Genprid hint at an important distinction between different types of dopamine receptors or receptor mechanisms in the brain.
Behaviourally and biochemically, Genprid shares with these classical neuroleptics a number of properties indicative of cerebral dopamine receptor antagonism. Essential and intriguing differences include lack of catalepsy at doses active in other behavioural tests, lack of effect in the dopamine sensitive adenylate cyclase systems, lack of effect upon noradrenaline or 5HT turnover, negligible anticholinesterase activity, no effect on muscarinic or GABA receptor binding, and a radical difference in the binding of tritiated sulpiride to striatal preparations invitro, compared to 3Hspiperone or 3Hhaloperidol.
These findings indicate a major differentiation between Genprid and classical neuroleptics which lack such specificity.
One of the characteristics of Genprid is its bimodal activity, as it has both antidepressant and neuroleptic properties.
Schizophrenia characterised by a lack of social contact can benefit strikingly. Mood elevation is observed after a few days treatment, followed by disappearance of the florid schizophrenic symptoms. The sedation and lack of affect characteristically associated with classical neuroleptics of the phenothiazine or butyrophenone type are not features of Genprid therapy

Peak sulpiride serum levels are reached 3-6 hours after an oral dose. The plasma half-life in man is approximately 8 hours. Approximately 40% sulpiride is bound to plasma proteins. 95% of the compound is excreted in the urine and faeces as unchanged sulpiride.

In long-term animal studies with neuroleptic drugs, including sulpiride, an increased incidence of various endocrine tumours (some of which have occasionally been malignant) has been seen in some but not all strains of rats and mice studied. The significance of these findings to man is not known; there is no current evidence of an association between neuroleptic use and tumour risk in man.

Microcrystalline cellulose(PH101) , Hydroxypropyl cellulose LF, Maize starch , Micro crystalline cellulose(PH102) ,Colloidal anhydrous silica , Sodium starch glycollate , Magnesium stearate.

Not applicable

3 Years

Do not store above 30 °C
Store in the original pack to protect from light & moisture

Transparent PVC-PVDC film / Aluminium foil blister of 10 Tablets & the pack contains 2 blisters.

Not applicable.