Dolmatil 400mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sulpiride

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N05AL; N05AL01

INN (International Name):

Sulpiride

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Benzamides; sulpiride

Authorization status:

Marketed

Authorization date:

1990-03-23

Patient Information leaflet

*704064*
PACKAGE LEAFLET
:
INFORMATION FOR
THE USER
DOLMATIL®
200MG
T
A
BLETS
DOLMATIL® 400MG
FILM-COATED
T
A
BLETS
sulpiride
Is
this
leaf
let
hard
to
see
or
r
ead?
Phone [phone]
for help
READ
ALL OF
THIS LEAFLET CAREFULLY
BEFOR
E
YOU START TAKING THIS
MEDICINE
•
Keep
this
leaflet. You may need
to read
it
ag
ain
•
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
y
our
s
•
If
any of the side effects gets serious, or
if
you notice any side effects not listed
in this
leaflet, please tell your doctor or
pharmacist
IN
THIS
LEAFLET:
1.
Wha
t
Dolmatil
Tablets are and
what
they are used
for
2.
Before you take Dolmatil
T
a
blets
3.
How
to
take Dolmatil
T
a
blets
4.
Possible side
effects
5.
How
to
store Dolmatil
T
a
blets
6.
Further
Information
1.
WHAT DOLMATIL TABLETS ARE
AND
WHAT THEY ARE USED
FOR
Dolmatil
Tablets contains a medicine
called
sulpiride. This belongs to a group
of
medicines
called ‘benzamides’.
It
wor
k
s
by
blocking the
effect of a chemical
in
the
brain.
Dolmatil
Tablets are used
to treat
Schizophrenia.
2.
BEFORE YOU TAKE DOLMATIL
T
A
BLETS
DO NOT TAKE THIS MEDICINE AND
TELL
YOUR DOCTOR
IF:
X
You are allergic (hypersensitive)
to sulpi-
ride or
any
of the
other ingredients
of
Dolmatil
Tablets (listed
in
Section
6
Further Informa
tion)
Signs
of
an allergic reaction include: a
rash,
s
w
allowing
or
breathing problems,
s
w
elling
of
your lips, face,
throat
or tongue
X
You have
a tumour on the
adrenal
gland
called
‘phaechromocytoma’
X
You have
a
rare illness called
‘porphyria’
which affects your
metabolism
X
You have breast cancer
or
cancer
in the
pituitary gland
X
You are taking levodopa
or ropinirole
used
for
Par
k
inson’
s
disease (see
‘T
ak
ing
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 Dolmatil
T
a
blets.
TAKE SPECIAL CARE WITH
DOLMA
TIL
T
A
BLETS

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2020
CRN0093GJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolmatil 400mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg sulpiride.
Also contains 133.75mg lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
A white, stick shaped film-coated tablet with break-bar and engraved
'SLP 400' on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute and chronic schizophrenia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
A starting dose of 400 mg to 800 mg daily, given as one or two tablets
daily(morning and early evening) is recommended.
Predominantly positive symptoms (formal thought disorder,
hallucinations, delusions, incongruity of affect) respond to higher
doses, and a starting dose of at least 400 mg twice daily is
recommended, increasing if necessary up to a suggested maximum
of 1200 mg twice daily. Increasing the dose beyond this level has not
been shown to produce further improvement.
Predominantly negative symptoms (flattening of affect, poverty of
speech, anergia, apathy), as well as depression, respond to
doses below 800 mg daily; therefore, a starting dose of 400 mg twice
daily is recommended. Reducing this dose towards 200
mg twice daily will normally increase the alerting effect of Dolmatil.
Patients with mixed positive and negative symptoms, with neither
predominating, will normally respond to dosage of 400-600
mg twice daily.
CHILDREN
Clinical experience in children under 14 years of age is insufficient
to permit specific recommendations.
ELDERLY
The same dose ranges may be required in the elderly, but should be
reduced if there is evidence of renal impairment.
4.3 CONTRAINDICATIONS
Phaeochromocytoma and acute porphyria.
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1