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SULPIRIDE GRINDEKS is a brand name for Sulpiride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Acute and chronic schizophrenia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults A starting dose of 400 mg to 800 mg, given 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 400 mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200 mg 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 800 mg daily; therefore, a starting dose of 400 mg twice daily is recommended.
Reducing this dose towards 200 mg twice daily will normally increase the alerting effect of Sulpiride Grindeks. Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400-600 mg twice daily.
Paediatric population Clinical experience in children under 14 years of age is insufficient to permit specific recommendations. Elderly The same dose ranges may be required in the elderly, but should be reduced if there is evidence of renal impairment.
Method of administration For oral use. The tablet should be swallowed whole with a sufficient amount of water.
Adverse reactions are presented according to the MedDRA system organ classes and MedDRA frequency convention: 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).
4. 2 Characterized by rhythmic and involuntary movements mainly of the tongue and/or face, has 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.
4) is a life-threatening complication. 6. Reporting of suspected adverse reactions 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.
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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 Grindeks 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. Sulpiride Grindeks induces slight electroencephalogram (EEG) modifications.
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 Sulpiride Grindeks who are receiving anti-convulsant therapy, the dose of the anti-convulsant should not be changed.
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. 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.
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 Sulpiride Grindeks.
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.
1. 8). - Phaeochromocytoma. 5). - Acute porphyria. -
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 8). It is known that this effect may potentiate the risk of serious ventricular arrhythmias such as torsade de pointes. 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 randomized 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. , 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 Grindeks is not licensed for the treatment of dementia-related behaviour 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 Sulpiride Grindeks and preventative measures undertaken.
Breast cancer Sulpiride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family […]