Amisulpride 400mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Amisulpride

זמין מ:

DE Pharmaceuticals

קוד ATC:

N05AL05

INN (שם בינלאומי):

Amisulpride

כמות:

400mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04020100

עלון מידע

PACKAGE LEAFLET:
INFORMATION FOR THE USER
AMISULPRIDE
50MG, 100MG, 200MG &
400MG TABLETS
(Amisulpride)
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 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 or nurse. This includes
any possible side effects not listed in this leaflet.
see section 4.
WHAT IS IN THIS LEAFLET
1.
What Amisulpride Tablets are and what they are
used for
2.
What you need to know before you take
Amisulpride Tablets
3.
How to take Amisulpride Tablets
4.
Possible side effects
5.
How to store Amisulpride Tablets
6.
Contents of the pack and other information
Amisulpride belongs to a group of medicines called
antipsychotics.
The tablets are used to treat an illness called
schizophrenia. Schizophrenia can make you feel, see
or hear things which do not exist, have strange and
frightening thoughts, change how you act, and make
you feel alone. Sometimes people with these
symptoms may also feel tense, anxious or depressed.
Amisulpride tablets work by improving disturbed
thoughts, feelings and behaviour. It is used to treat
schizophrenia when it starts and also over the long
term.
DO NOT TAKE AMISULPRIDE TABLETS:
•
If you are allergic to amisulpride or any of the
other ingredients of this medicine (listed in section
6). Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue.
•
If you are pregnant, might become pregnant or
are breast-feeding (see Pregnancy and
breastfeeding section)
•
If you have a prolactin dependent tumour or
breast cancer
•
If you have phaeochromocytoma (a tumour on
the adrenal gland)
•
If you are under 18 years of age.
•
If you are taking antiarrhythmic drugs for
controlling the heart rhyt

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 400 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of active substance Amisulpride.
Also contains 200 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
Tablets description:
White, biconvex, capsule shaped tablets, scored on both sides, with
dimensions 19 x
10 mm.
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/d and 800 mg/d
are
recommended. In individual cases, the daily dose may be increased up
to 1200 mg/d.
Doses above 1200 mg/d 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 characterized by predominant negative symptoms, oral
doses between 50
mg/d and 300 mg/d 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. Reduction in dosage may also be r