Sulpiride 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulpiride

Available from:

A A H Pharmaceuticals Ltd

ATC code:

N05AL01

INN (International Name):

Sulpiride

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5037563004133

Patient Information leaflet

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WHAT IS IN THIS LEAFLET:
1. What Sulpiride Tablets are and what they
are used for
2. What you need to know before you take
Sulpiride Tablets
3. How to take Sulpiride Tablets
4. Possible side effects
5. How to store Sulpiride Tablets
6. Contents of the pack and other information
1. WHAT SULPIRIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Sulpiride Tablets.
It contains sulpiride. This belongs to a group
of medicines called benzamides. It works by
blocking the effect of a chemical in the brain.
Sulpiride is used for treating acute and
chronic schizophrenia.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SULPIRIDE TABLETS
DO NOT TAKE SULPIRIDE TABLETS:
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ingredients of this medicine (listed in Section
6). The signs of an allergic reaction include a
rash, swallowing or breathing problems,
swelling of your lips, throat or tongue.
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called ‘phaeochromocytoma’
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which affects your metabolism
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pituitary gland
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for Parkinson's Disease
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apply to you. If you are not sure, talk to your
doctor or pharmacist before taking this medicine.
WARNINGS AND PRECAUTIONS
Talk your doctor or pharmacist before taking
Sulpiride Tablets:
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agitation
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of heart problems. Your doctor may test your
heart function before you take this medicine.
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history of blood clots, as medicines like
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of blood clots
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body (hypokalaemia)
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Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Sulpiride 200mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of the active substance sulpiride.
Also contains 128mg of Lactose Monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White,
c
ircular tablet marked S200 on one face and plain on the reverse.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
This medicinal product is for
the
treatment of acute and chronic schizophrenia.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The initial dose depends on the nature of the symptoms.
In patients with predominantly negative symptoms (flattening of
affect, poverty of speech,
anergia, apathy, as well as depression) the usual starting dose is 400
mg twice daily. This can
be reduced to 200mg twice daily as a response occurs, increasing the
alerting effect of
sulpiride that occurs at lower doses.
In patients with predominantly positive symptoms (formal thought
disorder, hallucinations,
delusions, incongruity of affect) the usual starting dose is 400mg
twice daily increasing if
necessary to a suggested maximum of 1200mg twice daily.
In patients with positive and negative symptoms, with neither
predominating, a dose of
400mg-600mg twice daily is recommended.
Elderly:
Initially one quarter to one half of the adult dose.
Children:
Clinical experience in children under 14 years of age is insufficient
to permit specific
recommendations.
Renal impairment:
The dosage should be reduced or the dosage interval increased.
4.3 CONTRAINDICATIONS
Phaeochromocytoma
Acute porphyria
Hypersensitivity to sulpiride or to any of the excipients listed in
section 6.1.
Concomitant prolactin-dependent tumours e.g. pituitary gland
prolactinomas and
breast cancer (See section 4.8 Undesirable effects).
Association with levodopa or antiparkinsonian drugs (including
ropinirole) (See
section 4.5 Interactions with other medicinal products and other forms
of interaction).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS:
Increased motor