Sulpiride 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulpiride

Available from:

Medreich Plc

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: 05060292740539

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT SULPIRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULPIRIDE TABLETS
3.
HOW TO TAKE SULPIRIDE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SULPIRIDE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SULPIRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Sulpiride belongs to a group of medicines called ‘benzamides’. It
works by
blocking the effect of a chemical in the brain. Sulpiride tablets are
used to
treat Schizophrenia.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULPIRIDE TABLETS
DO NOT TAKE SULPIRIDE TABLETS:
•
If you are allergic (hypersensitive) to sulpiride or any other
ingredients
in this product (_see Section 6 and end of Section_ 2). Signs of an
allergic
reaction include: a rash, swallowing or breathing problems, swelling
of
your lips, face, throat or tongue.
•
If
you
have
a
rare
illness
called
‘porphyria’
which
affects
your
metabolism.
•
If you have tumour on the adrenal gland called ‘phaeochromocytoma’
•
If you have breast cancer or cancer in the pituitary gland.
•
You are taking levodopa or ropinirole used for Parkinson’s disease
(see
‘Taking other medicines’ below)
Do not take this medicine if any of the above apply to you. If you are
not
sure, talk to your doctor or pharmacist before taking Sulpiride
Tablets.
TAKE SPECIAL CARE AND TELL TO YOUR DOCTOR OR PHARMACIST IF YOU:
•
have kidney problems
•
have high blood pressure
•
have epilepsy or have

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