SULPIRIDE Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Sulpiride 200mg Tablets.
Qualitative and quantitative composition
Sulpiride 200mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets. Sulpiride 200mg Tablets are white circular tablets marked S200 on one face and CP on the reverse.
Therapeutic indications
The treatment of acute and chronic schizophrenia.
Posology and method of administration
Posology 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, ...
Contraindications
Phaeochromocytoma and acute porphyria. Hypersensitivity to sulpiride or to any of the excipients listed in section 6.1. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast ...
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 ...
Interaction with other medicinal products and other forms of interaction
Associations contra-indicated Levodopa, antiparkinsonian drugs (including ropinirole): reciprocal antagonism of effects between levodopa or antiparkinsonian drugs (including ropinirole) and neuroleptics. ...
Fertility, pregnancy and lactation
Pregnancy There are only very limited data available from the use of sulpiride in pregnant women. The safety of sulpiride during human pregnancy has not been established. Sulpiride crosses the placenta. ...
Effects on ability to drive and use machines
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).
Undesirable effects
The following 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 ...
Overdose
Experience with sulpiride in overdosage is limited. The range of single toxic doses is 1 to 16g but no deaths have occurred even at a dose of 16g. Fatal outcomes have been reported mainly in combination ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psycholeptics; Benzamides <b>ATC code:</b> N05AL01 Sulpiride is a member of the group of substituted benzamides, which are structurally distinct from the phenothiazines, ...
Pharmacokinetic properties
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 ...
Preclinical safety data
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 ...
List of excipients
Lactose Povidone K30 Microcrystalline cellulose Sodium starch glycollate Magnesium stearate
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
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.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0193
Date of first authorization / renewal of the authorization
03/03/08
Date of revision of the text
31/10/2019
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