Dolmatil 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulpiride

Available from:

DE Pharmaceuticals

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
DOLMATIL® 200MG TABLETS
DOLMATIL® 400MG FILM-COATED
TABLETS
sulpiride
Is this leaflet hard to see or
read?
Phone [phone] for
help
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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist
IN THIS LEAFLET:
1. What Dolmatil Tablets are and what they are
used for
2. Before you take Dolmatil Tablets
3. How to take Dolmatil Tablets
4. Possible side effects
5. How to store Dolmatil Tablets
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 works by blocking the
effect of a chemical in the brain. Dolmatil
Tablets are used to treat Schizophrenia.
2. BEFORE YOU TAKE DOLMATIL TABLETS
DO NOT TAKE THIS MEDICINE AND TELL
YOUR DOCTOR IF:
X You are allergic (hypersensitive) to sulpiride or
any of the other ingredients of Dolmatil
Tablets (listed in Section 6 Further
Information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
X You have a tumour on the adrenal gland
called ‘phaeochromocytoma’
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
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 Dolmatil
Tablets.
Take special care with Dolmatil Tablets
Check with your doc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dolmatil 400mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg of the active substance sulpiride.
Also contains 133.75mg of lactose.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White film coated stick shaped tablet with break bar engraved SLP 400
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute and chronic schizophrenia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults _
A starting dose of 400mg to 800mg 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 400mg twice daily is recommended, increasing if necessary up
to a
suggested maximum of 1200mg 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 800mg
daily;
therefore, a starting dose of 400mg twice daily is recommended.
Reducing this
dose towards 200mg 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 400-600mg twice
daily.
_Children _
Clinical experience in children under 14 years of age is insufficient
to permit
specific recommendations.
_Elderly _
The same dose ranges are applicable in the elderly, but the dose
should be
reduced if there is evidence of renal impairment.
4.3
CONTRAINDICATIONS
Phaeochromocytoma and acute porphyria.
Hypersensitivity to sulpiride or to any of the excipients.
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)