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Wockhardt UK Ltd

Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

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Summary of Product Characteristics last updated on the eMC: 29/07/2010
SPC Sulpiride Tablets 200mg, 400mg


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1. Name of the medicinal product

Sulpiride 200mgTablets

Sulpiride 400mg Film-Coated Tablets


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2. Qualitative and quantitative composition

Sulpiride 200mg.

Sulpiride 400mg.

For excipients, see 6.1.


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3. Pharmaceutical form

Tablets.

Sulpiride 200mg Tablets are white circular tablets marked S200 and breakline on one face and CP on the reverse.

Sulpiride 400mg Tablets are white, oval, film coated tablets marked S400 and breakline on one face and CP on the reverse.


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4. Clinical particulars

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4.1 Therapeutic indications

The treatment of acute and chronic schizophrenia.


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4.2 Posology and method of administration

Adults:

The initial dose depends on the nature of the symptoms.

In patients with predominantly negative symptoms the usual starting dose is 400mg twice daily. This can be reduced to 200mg twice daily as a response occurs, increasing the alerting effect of sulpiride that occurs at lower doses.

In patients with predominantly positive symptoms the usual starting dose is 400mg twice daily increasing if necessary to a suggested maximum of 1200 mg twice daily.

In patients with positive and negative symptoms, with neither predominating, a dose of 400mg-600mg twice daily is recommended.

Elderly:

Initially one quarter to one half of the adult dose.

Children:

Not recommended for children under 14 years of age.

Renal impairment:

The dosage should be reduced or the dosage interval increased.


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4.3 Contraindications

• Sensitivity to sulpiride or any of the ingredients of sulpiride tablets

• Phaeochromocytoma

• Acute porphyria

• Comatose state or CNS depression

• Bone-marrow suppression

• Prolactin-dependant tumours


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4.4 Special warnings and precautions for use

Increased motor agitation has been reported at high dosage in a small number of patients given sulpiride. Sulpiride may aggravate symptoms in aggressive, agitated or excited phases of the disease process. Care should be exercised where mania or hypomania is present.

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 should be given with caution to patients suffering from extrapyramidal disturbances as these may be aggravated by sulpiride. Patients on concomitant dopaminergics should be monitored for deterioration in parkinsonism and mental state (see 4.5 Interactions with other medicaments and other forms of interaction).

Avoid concomitant neuroleptics. As with all neuroleptic drugs, the presence of unexplained hyperthermia could indicate the development of neuroleptic malignant syndrome (NMS) (see section 4.8). In this event treatment with sulpiride and any associated neuroleptic should be discontinued until the origin of the fever has been determined.

Sulpiride should be given with caution to elderly patients as they are more prone to falls, possibly as a consequence of postural hypotension or sedation ( refer to 4.8, Undesirable Effects) and the dosage should be reduced (see 4.2 Posology and method of administration). Elderly patients are more susceptible to extrapyramidal and anticholinergic effects.

Sulpiride should be given with caution to patients with renal disease and the dosage or frequency of administration should be reduced (see 4.2 Posology and method of administration).

Sulpiride should be used with caution in patients with a history of jaundice or with hepatic impairment, as it may precipitate coma.

Sulpiride should be used with caution in patients with hypertension, cardiovascular disease, family history of QT prolongation, severe respiratory disease, myasthenia gravis and prostatic hypertrophy.

Caution is advised when prescribing sulpiride for patients with epilepsy as the condition may be aggravated.

Sulpiride should be used with caution in patients with a personal or family history of angle-closure glaucoma.

As photosensitisation may occur with higher doses, avoidance of undue exposure to direct sunlight is recommended.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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.

Sulpride is not licensed for the treatment of dementia-related behavioural disturbances.


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4.5 Interaction with other medicinal products and other forms of interaction

Alcohol: increased effect

Anaesthetics: The hypotensive effect of anaesthetics may be enhanced by concomitant use.

Analgesics: enhanced sedative and hypotensive effect with opioid
analgesics.

Antacids: Administration of sucralfate or antacids containing aluminium and magnesium hydroxides may reduce the bioavailability of sulpiride, which should be administered at least 2 hours before and not with or after sucralfate or these antacids.

Anti-arrhythmics: increased risk of ventricular arrhythmias with drugs that prolong the QT interval.

Antibacterials: increased risk of arrhythmias with quinupristin and dalfopristin.

Antidepressants: possibility of extrapyramidal symptoms, including parkinson-like symptoms or dystonia, in patients taking sulpiride and fluoxetine concurrently. Possibly increased risk of ventricular arrhythmias with tricyclic antidepressants.

Antiepileptics: The convulsive threshold may be lowered by sulpiride.

Antihistamines: increased risk of ventricular arrhythmias with terfenadine and misolastine.

Antihypertensives: As with other psychotropic compounds, sulpiride may enhance the hypotensive effect of antihypertensives.

Antimalarials: increased risk of ventricular arrhythmias with mefloquine and quinine.

Other antipsychotics: There is an increased risk of arrhythmias when antipsychotics are given with other antipsychotic drugs (including depot presentations).

Anxiolytics: increased effect of CNS depressants including hypnotics and anxiolytics.

Diuretics and other drugs which cause electrolyte disturbances such as stimulant laxatives, amphotericin and glucocorticoids: increased risk of ventricular arrhythmias.

Dopaminergics: Antagonism of the effects of dopaminergic agents such as amantadine, bromocriptine, cabergoline, levodopa and lisuride. Pramipexole and ropinirole should be avoided. Concomitant use of dopaminergic agents may also lead to exacerbation of psychotic symptoms. The patient should be monitored for deterioration in parkinsonism and mental state (refer to 4.4, Special Warnings and Precautions for Use).

Lithium: increased risk of extrapyramidal effects.

Sympathomimetics: The pressor effects of sympathomimetics may be antagonised when taken concomitantly with sulpiride, resulting in severe hypotension.


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4.6 Pregnancy and lactation

Despite the negative results of teratogenicity studies in animals and lack of teratogenic effects observed clinically after long term use in other countries, sulpiride should be avoided during pregnancy particularly during the first trimester, with potential benefits being weighed against possible hazards.

The use of sulpiride in the third trimester of pregnancy may result in extrapyramidal effects, lethargy and hypotonia in the neonate.

Sulpiride is excreted into breast milk and its use should be avoided in mothers wishing to breast-feed.


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4.7 Effects on ability to drive and use machines

Sulpiride is less prone to produce drowsiness than other conventional neuroleptics. Patients receiving high doses of sulpiride should be warned of the hazards of driving or operating machinery until the drug has been shown not to interfere with their physical or mental ability.


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4.8 Undesirable effects

Sulpiride is very well tolerated and usually only minor side-effects occur, if at all, at the recommended doses.

Hypersensitivity reactions: contact sensitivity, exfoliative dermatitis and urticaria.

Haematological: agranulocytosis, haemolytic anaemia, thrombocytopenic purpura and leucopenia.

Antimuscarinic: dry mouth, blurred vision, difficulties with micturition and constipation.

Metabolic: hyperglycaemia, hypothermia, hyperthermia, weight gain.

Male sexual dysfunction: ejaculatory dysfunction, impotence, increased and decreased libido have been reported.

Cardiovascular: hypotension (in high doses), hypertension, electrocardiographic (ECG) changes, QT prolongation, ventricular fibrillation and tachycardia (rare), cardiac arrest, Torsades de pointes and sudden unexplained death.

Hepatic: Jaundice and elevated hepatic enzymes.

Neurological/psychiatric: delirium/confusion, catatonia, depression, somnolence, lassitude and insomnia. Sleep disturbances, overstimulation and agitation may occur. Extrapyramidal effects, including akathisia, acute dystonia and parkinsonism have been observed in a small number of patients but tardive dyskinesia is rare. Convulsions have been reported in patients with no previous history.

Skin: pigmentation of the skin, photosensitivity and skin rashes.

Special senses: corneal and lens opacities, deposition of pigment in the eyes.

Respiratory: Nasal congestion.

As with other neuroleptics, rare cases of neuroleptic malignant syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK levels, have been reported. In such an event, all antipsychotic drugs, including sulpiride, should be discontinued.

Therapeutic doses of antipsychotics raise serum prolactin levels. Long term use may be associated with galactorrhoea and amenorrhoea, and less frequently with gynaecomastia. 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 strains of rats and mice studied. The significance of these to man is not known; there is no current evidence of any association between neuroleptic use and tumour risk in man. However, when prescribing neuroleptics to patients with existing mammary neoplasia or a history of this disease, possible risks should be weighed against benefits of therapy.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs - Frequency unknown.


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4.9 Overdose

The range of single toxic doses is 1 to 16g but no deaths have occurred even at a dose of 20g.

Symptoms

The clinical manifestations of poisoning vary depending upon the size of the dose taken. After single doses of 1g to 3g restlessness and clouding of consciousness have been reported and (rarely) extrapyramidal symptoms. Doses of 3g to 7g may produce a degree of agitation, confusion and extrapyramidal symptoms; 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.

There are no specific complications from overdose. In particular no haematological or hepatic toxicity has been reported.

Treatment

Overdose may be treated with alkaline osmotic diuresis and, if necessary, anti-parkinsonian drugs. Emetic drugs are unlikely to be effective. Coma needs appropriate nursing.


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5. Pharmacological properties

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5.1 Pharmacodynamic properties

Sulpiride is a member of the group of substituted benzamides, which are structurally distinct from the phenothiazines, butyrophenones and thioxanthenes.

Behaviourally and biochemically sulpiride shares with classical neuroleptics a number of properties indicative of cerebral dopamine receptor antagonism. Differences include lack of effect upon noradrenaline or 5HT turnover, negligible anticholinesterase activity, no effect on muscarinic or GABA receptor binding. These findings indicate a major differentiation between sulpiride and classical neuroleptics, which lack such specificity.

One of the characteristics of sulpiride is its bimodal activity, as it has both antidepressant and antipsychotic 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 sedative, anti-muscarinic, alpha-blocking and extrapyramidal effects of sulpiride are less pronounced than those characteristically associated with classical neuroleptics of the phenothiazine type.


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5.2 Pharmacokinetic properties

The bioavailability of the oral form ranges from 25-40%. Peak sulpiride serum levels are reached 2-6 hours after an oral dose. The plasma half-life in man is 6-8 hours.

Sulpiride is less than 40% bound to plasma proteins. Sulpiride crosses the blood-brain barrier. Ninety five percent of the compound is excreted in the urine and faeces as unchanged sulpiride.


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5.3 Preclinical safety data

There are no pre-clinical data of any relevance to the prescriber that are additional to those already included in other sections.


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6. Pharmaceutical particulars

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6.1 List of excipients

Lactose

Povidone K30

Microcrystalline cellulose

Sodium starch glycollate

Magnesium stearate


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6.2 Incompatibilities

None known


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6.3 Shelf life

3 years


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6.4 Special precautions for storage

Do not store above 25oC


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6.5 Nature and contents of container

Multiples of 10 or 14 tablets in strips of PVC/Aluminium foil.

Multiples of 10 or 14 tablets in polypropylene/polyethylene containers with tamper evident closures.


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6.6 Special precautions for disposal and other handling

None


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7. Marketing authorisation holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK


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8. Marketing authorisation number(s)

Sulpiride 200mgTablets - PL 29831/0193

Sulpiride 400mg Film-Coated Tablets - PL 29831/0192


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9. Date of first authorisation/renewal of the authorisation

03/03/08


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10. Date of revision of the text

21 /01/2010.



More information about this product

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