DOGMATIL 200MG TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SULPIRIDE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SULPIRIDE

Unit dalam pakej:

12Tablet Tablets

Dikeluarkan oleh:

SANOFI WINTHROP INDUSTRIE

Risalah maklumat

_ _
1
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DOGMATIL
® TABLET
_ _
Sulpiride
(200 mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Dogmatil is used for
2. How Dogmatil works
3. Before you use Dogmatil
4. How to use Dogmatil
5. While you are using it
6. Side effects
7. Storage and Disposal of Dogmatil
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT DOGMATIL IS USED FOR
•
Acute
and
chronic
psychotic
disorders, such as
- schizophrenia
- chronic non-schizophrenia delusions
(a belief that is not true)
- paranoid delusions
-
chronic
hallucinatory
psychosis
(hearing voices or seeing things which
are not there)
HOW DOGMATIL WORKS
Dogmatil tablets belongs to a group of
medicines
known
as
neuroleptic
antipsychotics. It is a type of medicine
known as a benzamide.
BEFORE YOU USE DOGMATIL
If you have been told by your doctor
that you have an intolerance to certain
sugars,
contact
your
doctor
before
taking this medicine.
-
_ When you must not use it _
Do not take Dogmatil if:
•
You are allergic to sulpiride or any
of
the
other
ingredients
of
this
medicine (listed at the end of this
leaflet).
•
You
have
pheochromocytoma
(excessive
growth
of
the
adrenal
glands around the kidneys, releasing
substances
that
cause
high
blood
pressure).
•
You
have
a
prolactin-dependent
tumour (prolactin is a hormone that
stimulates
milk
production),
e.g.
breast cancer or pituitary disorders.
•
You
are
taking
another
medicine,
check
that
combined
use
with
Dogmatil
tablet
is
not
contraindicated
(see
information
under
the
heading
“
_Taking _
_other _
_medicines_
”).
•
You
have
a
blood
disease
characterised
by
accumulation
of
pigments
in
the
body
(acute
porphyria).
If you are unsure of anything, do not
hesitate
to
ask
your
doctor
or
pharmacist for advice.
_- Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before taking Dogmatil tablet.
• Your doctor may ask you to have an
electrocardiogram
(ECG)
before
starting treatment. This is because this
medicine can cause hear

Ciri produk

MY/DOG200/0421/CCDSv14 15 16
DRAFT PACKAGE INSERT
NAME OF THE MEDICINAL PRODUCT
DOGMATIL
® 200 MG, SCORED TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulpiride base
..................................................................................................................
200.00 mg
For one scored tablet.
PHARMACEUTICAL FORM
Scored tablets.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
•
Acute psychotic disorders.
•
Chronic psychotic disorders (schizophrenia, chronic non-schizophrenic
delusions: paranoid
delusions, chronic hallucinatory psychosis).
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
FOR USE IN ADULTS ONLY.
The minimum effective dose should always be used. If the patient’s
clinical condition allows, treatment
should be initiated at a low dose, then gradual dosage titration may
be used.
The daily dose is 200 to 1000mg.
CONTRAINDICATIONS
This medicinal product must never be used in the following situations:
•
hypersensitivity to the active substance or to any of the excipients,
•
prolactin-dependent tumours e.g. pituitary gland prolactinomas and
breast cancer,
•
known or suspected pheochromocytoma,
•
in combination with:
•
non-antiparkinsonian dopamine agonists (cabergoline, quinagolide),
•
citalopram, escitalopram, hydroxyzine, domperidone and piperaquine,
•
acute porphyria.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SPECIAL WARNINGS
•
A neuroleptic malignant syndrome, a potentially fatal complication
reported with antipsychotics, is
characterized by hyperthermia, pallor, autonomic dysfunction, altered
consciousness, muscle
rigidity, rhabdomyolysis, elevated serum creatine phosphokinase levels
and dysautonomia. Cases
with atypical features, such as hyperthermia without muscle rigidity
or hypertonia, have been
observed. In case of hyperthermia of undiagnosed origin, which may be
considered either as an
early sign/symptom of neuroleptic
malignant syndrome or
an
atypical
neuroleptic
malignant
syndrome, sulpiride and all other antipsychotics should be
discontinued promptly, u