Dolmatil 200mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sulpiride

Available from:

Neuraxpharm Ireland Limited

ATC code:

N05AL; N05AL01

INN (International Name):

Sulpiride

Pharmaceutical form:

Tablet

Therapeutic area:

Benzamides; sulpiride

Authorization status:

Marketed

Authorization date:

1987-04-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLMATIL® 200MG 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 ‘phaechromocytoma’
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 DOCTOR OR PHARMACIST BEFORE YOU TAKE TH

Summary of Product characteristics

Health Products Regulatory Authority
29 September 2023
CRN00D8TH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolmatil 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg sulpiride.
Excipient: Lactose monohydrate 23 mg/tablet.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White to ivory-white, round tablet scored on one side, engraved
‘D200’ on the other side. The score line 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 if there is evidence of renal impairment.
4.3 CONTRAINDICATIONS
Phaeochromocytoma and acute porphyria. Hypersensitivity to the active
substance or any of the excipients listed in section 6.1
Concomitant pr