Dolmatil 200 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sulpiride

Available from:

Imbat Limited

ATC code:

N05AL; N05AL01

INN (International Name):

Sulpiride

Dosage:

200 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Benzamides; sulpiride

Authorization status:

Authorised

Authorization date:

2014-07-18

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLMATIL
® 200MG TABLETS
(sulpiride)
Your medicine is available using the name Dolmatil 200mg
Tablets but will be referred to as Dolmatil Tablets throughout
this leaflet.
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.
What you need to know before you take Dolmatil Tablets
3.
How to take Dolmatil Tablets
4.
Possible side effects
5.
How to store Dolmatil Tablets
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DOLMATIL TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to sulpiride or any of
the other ingredients of Dolmatil Tablets (listed in
Section 6 Contents of the pack and other information).
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue

You have a tumour on the adrenal gland called
‘phaeochromocytoma’

You have a rare illness called ‘porphyria’ which affects
your metabolism

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’)
Do not take this medicine if any of the above apply to you.
If y

Summary of Product characteristics

Health Products Regulatory Authority
13 November 2019
CRN0095YM
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolmatil 200 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg sulpiride.
Excipient with known effect: Lactose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from the UK:_
Plain, white, round tablet with a transverse breaking line on one side
and the mark ‘D200’ on the other. The score line is only to
facilitate breaking for ease of swallowing and not to divide into
equal doses.
4 CLINICAL PARTICULARS
As per PA0540/147/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/147/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Starch
Lactose
Methylcellulose
Magnesium stearate
Talc
Silica
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing aluminium blister strips.
Health Products Regulatory Authority
13 November 2019
CRN0095YM
Page 2 of 2
Pack size: 100 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/183/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 18
th
July 2014
10 DATE OF REVISION OF THE TEXT
November 2019