Sulpiride 200mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Sulpiride

可用日期:

Alliance Healthcare (Distribution) Ltd

ATC代码:

N05AL01

INN（国际名称）:

Sulpiride

剂量:

200mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04020100

资料单张

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

阅读完整的文件

产品特点

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