Dolmatil 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulpiride

Available from:

Sanofi

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; GTIN: 5026474000167

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?
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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

OBJECT 1
DOLMATIL 400MG TABLETS
Summary of Product Characteristics Updated 15-Jul-2019 | SANOFI
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Dolmatil 400 mg Film-Coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 400 mg of the active substance sulpiride.
Also contains 133.75 mg 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 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 maximu