Sulpiride 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulpiride

Available from:

A A H Pharmaceuticals Ltd

ATC code:

N05AL01

INN (International Name):

Sulpiride

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5037563004140

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SULPIRIDE TABLETS 200 MG & 400 MG
(sulpiride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Sulpiride is and what it is used for
2.
Before you take Sulpiride
3.
How to take Sulpiride
4.
Possible side effects
5.
How to store Sulpiride
6.
Further information
1.
WHAT SULPIRIDE IS AND WHAT IT IS USED FOR
Sulpiride belongs to a group of medicines called benzamides. These act
on the brain
to reduce abnormal behaviour.
Sulpiride is used for treating schizophrenia. Symptoms can include
sensing, seeing or
hearing things that do not exist, becoming withdrawn and having
mistaken beliefs or
suspicions.
2.
BEFORE YOU TAKE SULPIRIDE
DO NOT TAKE SULPIRIDE AND TELL YOUR DOCTOR IF YOU
•
are allergic (hypersensitive) to sulpiride or any of the other
ingredients in these
tablets. The signs of an allergic reaction include a rash, itching or
shortness of
breath
•
have
high
blood
pressure
due
to
a
growth
on
your
adrenal
glands
(phaeochromocytoma)
•
have porphyria, which is a problem with your metabolism which can
cause skin
blisters, pain in and around your stomach (abdomen) and brain or
nervous
system problems
•
have
ever
had
breast
cancer
or
a
type
of
brain
tumour
called
‘pituitary
prolactinoma’
•
are taking a medicine called Levodopa (see “Taking other
medicines”)
•
suffer from CNS depression – a condition where the activity of your
central
nervous system is reduced. Symptoms include feeling sleepy and
uncoordinated,
staggering,
blurred
vision,
slurred
speech,
slowed
reflexes
and
breathing,
unconsciousness and coma.

Summary of Product characteristics

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