Amisulpride 400mg 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:

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: 5060388650032

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
IF YOU FORGET TO TAKE AMISULPRIDE TABLETS
If
you
forget
a
dose,
take
it
as
soon
as
you
remember it. However, if it is nearly time for the
next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten
dose.
IF YOU STOP TAKING AMISULPRIDE TABLETS
Keep taking Amisulpride until your doctor tells you
to stop. Do not stop taking Amisulpride just because
you feel better. If you stop, your illness may get
worse or come back. Unless your doctor tells you
otherwise,
Amisulpride
should
not
be
stopped
suddenly. Stopping treatment suddenly may cause
withdrawal effects such as:
%
Feeling or being sick
%
Sweating
%
Difficulty sleeping or feeling very restless
%
Muscle stiffness or unusual body movements
%
Your original condition may come back
BLOOD TESTS
Taking Amisulpride may affect the results of some
blood tests. These include tests to measure the
hormone called ‘prolactin’ and liver tests. If you are
going to have a blood test, it is important to tell your
doctor you are taking Amisulpride.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
STOP TAKING AMISULPRIDE TABLETS AND SEE A DOCTOR
OR GO TO A HOSPITAL STRAIGHT AWAY IF:
%
You have a high temperature, sweating, stiff
muscles, fast heartbeat, fast breathing and feel
confused, drowsy or agitated. These could be the
symptoms of a serious but rare side effect called
‘neuroleptic malignant syndrome’
%
You have an unusual heart rate, very fast heart
rate or chest pain which could result in a heart
attack or life-threatening heart disorder
%
You have blood clots in the veins especially in
the legs (symptoms include swelling, pain and
redness in the leg), which may travel through
blood vessels to the lungs causing chest pain
anddifficulty in br

Summary of Product characteristics

OBJECT 1
Amisulpride 400mg Tablets
Summary of Product Characteristics Updated 13-Sep-2021 | Rivopharm UK
Ltd
•
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
Amisulpride 400 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains:
400 mg amisulpride
Excipient:
200 mg lactose monohydrate
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Film-coated tablets
Amisulpride 400 mg film-coated tablets are white to off white, and
capsule shaped tablets with break line on
one side.
The tablets can be divide 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 Posol