Sulpiride 200mg/5ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulpiride

Available from:

Essential Pharma Ltd

ATC code:

N05AL01

INN (International Name):

Sulpiride

Dosage:

40mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5016119117893

Patient Information leaflet

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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
200mg/5ml
BLACK
KEYLINE
UKL412
395
300 x 210mm
N/A
150 x 30mm
1
8pt
N/A
150ml
150ml
N/A
G7BD1RBJ2
G7BD1RBJ1
N/A
1 of 2
Sulpiride Rosemont 200mg/5ml Oral Solution
12/04/18
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DH
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4
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TICK APPLICABLE BOX
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n
yellowing of your skin and whites of the eyes (jaundice), inflammation
of your liver (hepatitis)
n
skin reaction to sunlight
n
difficulty in passing water.
TALK TO YOUR DOCTOR OR PHARMACIST IF ANY OF THE FOLLOWING SIDE
EFFECTS GETS SERIOUS OR LASTS LONGER THAN A FEW DAYS:
COMMON (may affect up to 1 in 10 people)
n
abnormal production of breast milk in men and women
n
weight gain
n
painful breasts in men and women
n
feeling drowsy or sleepy
n
difficulty sleeping (insomnia)
n
skin rashes
n
constipation
UNCOMMON (may affect up to 1 in 100 people)
n
breast enlargement in women
n
loss of menstrual periods
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difficulty in getting or keeping an erection or in ejaculating
(impotence) or being unable to have an orgasm
n
producing more saliva than usual
n
you have movements that you cannot control, mainly of the
tongue, mouth, jaw, arms and legs (dystonia)
NOT KNOWN (frequency cannot be estimated from the available data)
n
breast enlargement in men
n
uncontrollable movements of the mouth, tongue and limbs (tardive
dyskinesia)
n
tired, weak, confused and have muscles that ache, are stiff or do not
work well. This may be due to low sodium
levels in your blood
n
feeling unwell, confused and/or weak, feeling sick (nausea

Summary of Product characteristics

OBJECT 1
SULPIRIDE ROSEMONT 200MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 23-Apr-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Sulpiride Rosemont 200mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml contains 200 milligrams Sulpiride
Excipient(s) with known effect:
Each 5ml of oral solution contains 3073.5 mg liquid maltitol.
Each 5ml of oral solution contains 6 mg methyl hydroxybenzoate
Each 5ml of oral solution contains 1.5 mg propyl hydroxybenzoate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
A colourless to slightly yellow oral solution
4. Clinical particulars
4.1 Therapeutic indications
Sulpiride is indicated in acute and chronic schizophrenia.
4.2 Posology and method of administration
Posology
_Adults _
A starting dose of 400mg to 800mg daily, given in two divided doses
(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 400mg
twice daily is recommended,
increasing if necessary up to a suggested maximum of 1200mg 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
800mg daily; therefore, a starting dose of 400mg twice daily is
recommended. Reducing this dose
towards 200mg twice daily will normally increase the alerting effect
of sulpiride.
Patients with mixed positive and negative symptoms, with neither
predominating, will normally respond
to dosage of 400-600mg twice daily.
_Paediatric population_
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.
Method of administration
For oral administrat