Amisulpride 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amisulpride

Available from:

Rivopharm (UK) Ltd

ATC code:

N05AL05

INN (International Name):

Amisulpride

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: 5060388650025

Patient Information leaflet

Lineagrafica sa
6596 Gordola
Bozza no.: 4 / Recto
Data: 15.05.2018
Colore: Nero
Codice: Amisulpride Double-E Pharma UK
Formato: mm 130x 480
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
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 only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
You should specifically tell you doctor if you take:
Medicines used to control your heart beat such
as
quinidine,
disopyramide,
amiodarone
and
Other anti-psycothic medicines used for mental
Medicines for severe pain called opiates such as
Medicines for high blood pressure and heart
problems
such
as
diltiazem,
verapamil,
Clonidine used for migraines, flushing or high
Mefloquine used to treat malaria
Medicines
which
help
you
sleep
such
as
barbiturates and benzodiazepines
Pain-killers such as tramadol and indometacin
Antihistamines
such
as
promethazine
which
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
AMISULPRIDE TABLETS WITH FOOD, DRINK AND ALCOHOL
Swallow
Amisulpride
tablets
with
plenty
of
Do
not
drink
alcohol
while
you
are
taking
Amisulpride. This is because it can affect the
PREGNANCY AND BREAST-FEEDING AND FERTILITY
You
are
breast-feeding
or
planning
to
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
The following symptoms may occur in newborn
babies,
of
mothers
that
have
used
Amisulpride
tablets in the last trimester (last three months of
their pregnancy): shaking, muscle stiffness and/or
weakness,
sleepiness,
agitation,
breathing
problems, and difficulty in feeding.
If your baby dev

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 200 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
200 mg amisulpride
Excipient:
100 mg lactose monohydrate
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Amisulpride 200 mg tablets are white and round with break line on one
side and
embossed with A200 on the other side.
The tablets can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amisulpride is indicated for the treatment of acute and chronic
schizophrenic
disorders, in which positive symptoms (such as delusions,
hallucinations, thought
disorders) and/or negative symptoms (such as blunted affect, emotional
and social
withdrawal) are prominent, including patients characterised by
predominant negative
symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For
acute
psychotic
episodes,
oral
doses
between
400
mg/day
and
800
mg/day
are
recommended.
In individual cases, the daily dose may be increased up to 1200
mg/day. Doses above 1200
mg/day have not been extensively evaluated for safety and therefore
should not be used. No
specific titration is required when initiating the treatment with
Amisulpride. Doses should be
adjusted according to individual response.
For patients with mixed positive and negative symptoms, doses should
be adjusted to obtain
optimal control of positive symptoms.
Maintenance treatment should be established individually with the
minimally effective dose.
For patients characterised by predominant negative symptoms, oral
doses between 50 mg/day
and 300 mg/day are recommended. Doses should be adjusted individually.
Amisulpride can be administered once daily at oral doses up to 300 mg,
higher doses should
be administered bid.
The minimum effective dose should be used.
Elderly: The safety of amisulpride has been examined in a limited
number of elderly patients.
Amisulpride should be used with particular caution because of a
possible risk of hypotension
and sedation. Red