Sulpiride 200mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Sulpiride

Disponible depuis:

Kent Pharma (UK) Ltd

Code ATC:

N05AL01

DCI (Dénomination commune internationale):

Sulpiride

Dosage:

200mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04020100

Notice patient

390 mm
160 mm
TEVA UK Ref:
231-30-20126-F LEA SULPIRIDE 200MG TAB TUK

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Résumé des caractéristiques du produit

1. NAME OF THE MEDICINAL PRODUCT
Sulpiride 200mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of the active substance sulpiride.
Also contains 128mg of Lactose Monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White,
c
ircular tablet marked S200 on one face and plain on the reverse.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
This medicinal product is for
the
treatment of acute and chronic schizophrenia.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The initial dose depends on the nature of the symptoms.
In patients with predominantly negative symptoms (flattening of
affect, poverty of speech,
anergia, apathy, as well as depression) the usual starting dose is 400
mg 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 (formal thought
disorder, hallucinations,
delusions, incongruity of affect) the usual starting dose is 400mg
twice daily increasing if
necessary to a suggested maximum of 1200mg 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:
Clinical experience in children under 14 years of age is insufficient
to permit specific
recommendations.
Renal impairment:
The dosage should be reduced or the dosage interval increased.
4.3 CONTRAINDICATIONS
Phaeochromocytoma
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 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).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS:
Increased motor