DOLMATIL 200 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SULPIRIDE

Available from:

LTT Pharma Limited

ATC code:

N05AL01

INN (International Name):

SULPIRIDE

Dosage:

200 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antipsychotics

Authorization status:

Authorised

Authorization date:

2014-07-11

Patient Information 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
Your medicine is called Dolmatil 200mg Tablets but will be referred
to as
Dolmatil Tablets throughout this leaflet.
Please note that the leaflet also contains information about other
strengths
of the medicine, Dolmatil 400mg Film-Coated Tablets. 
IN THIS LEAFLET:
What Dolmatil Tablets are and what they are used for   
Before you take Dolmatil Tablets 
How to take Dolmatil Tablets
Possible side effects 
How to store Dolmatil Tablets 
Further information
WHAT DOLMATIL TABLETS ARE AND WHAT THEY ARE USED   
FOR
Dolmatil Tablets contain 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.
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 Further 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 ‘phaechromocytoma’
*
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’ below)
Do not take this medicine if any of the above
apply to yo

Summary of Product characteristics

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: contains lactose.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from the UK._
Plain, white, round tables with D200 on one side and a break line on the other. The scoreline 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
Colloidal hydrated 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 and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
°
C.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 09/02/2015_
_CRN 2154553_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Supplied in blister packs of 100 (10X10) 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
LTT Pharma Limited
Unit 18, Oxleasow Road,
East Moons Moat, Redditch,
Worcestershire B98 0RE,
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/122/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 11
th
July 2014
10 DATE OF REVISION OF THE TEXT
February 2015
HEALTH PRODUCTS REG