Sulpiride 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulpiride

Available from:

Viatris UK Healthcare 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

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hearing things that do not exist, becoming withdrawn and having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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sulpiride Tablets 400 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of sulpiride.
Sulpiride is a benzamide derivative
For full list of excipients, see section 6.1. List of Excipients.
3
PHARMACEUTICAL FORM
Tablet
White, oblong tablet debossed “SD/400” on one side and “G” on
the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute and chronic schizophrenia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sulpiride has bimodal dose-dependent therapeutic activity; its actions
at low dose
levels are therefore qualitatively different to those at high dose
levels.
Adults
A starting dose of 400 mg to 800 mg per day, given as two divided
doses (morning
and early evening), is recommended.
Where positive symptoms predominate (hallucinations, delusions, formal
thought
disorder, incongruity of affect) these symptoms respond to higher
doses and a starting
dose of at least 400 mg twice daily is recommended. This can then be
increased if
necessary up to a maximum daily dose of 2400 mg, taken as two divided
doses.
Increasing the dose beyond 1200mg twice daily has not shown to produce
further
improvement.
Where negative symptoms predominate, (anergia, apathy, flattening of
affect, poverty
of speech) and for depression, doses below 800mg are most effective. A
starting dose
of 400 mg twice daily is therefore recommended. Reducing this dose
towards 200
mg twice daily will normally increase the alerting effect of
sulpiride.
Where neither negative or positive symptoms predominate a response is
usually seen
to a dose of 400 mg to 600 mg twice daily.
Elderly and patients with renal impairment
The same maintenance dose ranges may be required in the elderly but
should be
reduced in cases of renal impairment according to the following
guidelines:
Creatinine clearance 30-60ml/min: 2/3 of normal dose
Creatinine clearance 10-30ml/min: 1/2 of normal dose
Creatinine clearance <10ml/min: 1/3 of normal dose
Alternatively the dosage interval