DOLMATIL 400 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SULPIRIDE

Available from:

LTT Pharma Limited

INN (International Name):

SULPIRIDE

Dosage:

400 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

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 400mg Film-Coated 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 200mg 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 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 n

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolmatil 400 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg sulpiride.
Also contains lactose.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK._
White film coated stick shaped tablets with SLP 400 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
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