Sulpiride 400mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Sulpiride

Dostupné z:

Arrow Generics Ltd

ATC kód:

N05AL01

INN (Medzinárodný Name):

Sulpiride

Dávkovanie:

400mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04020100

Príbalový leták

pg 1/2
pg 2/2
TEVA UK Ref:
231-30-57004-V LEA SULPIRIDE 200MG/400MG TAB TUK (WOC)

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Súhrn charakteristických

1. NAME OF THE MEDICINAL PRODUCT
Sulpiride 400mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg of the active substance sulpiride.
Also contains 256mg of Lactose Monohydrate
For
the full list of
excipients, see
section
6.1.
3. PHARMACEUTICAL FORM
Film coated Tablet.
White, oval, film coated tablets marked S400 and break line 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 PRECAUTION