Sulprix

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Amisulpride 50mg

Dostopno od:

Viatris Limited

INN (mednarodno ime):

Amisulpride 50 mg

Odmerek:

50 mg

Farmacevtska oblika:

Tablet

Sestava:

Active: Amisulpride 50mg Excipient: Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

Tip zastaranja:

Prescription

Izdeluje:

Laboratorios Espinos Y Bofill SA (LEBSA)

Terapevtske indikacije:

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.

Povzetek izdelek:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 50 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Datum dovoljenje:

2013-06-25

Navodilo za uporabo

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
SULPRIX
®
_AMISULPRIDE TABLETS 100 MG, 200 MG AND 400 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Sulprix.
This leaflet answers some common
questions about Sulprix.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SULPRIX
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT SULPRIX IS USED
FOR
Sulprix is used to treat symptoms of
schizophrenia, which is a condition
that affects the way you think, feel
and/or act. Schizophrenia may
cause symptoms such as
hallucinations, delusions, unusual
suspiciousness, emotional and
social withdrawal. People with
schizophrenia may also feel
depressed, anxious or tense.
Sulprix contains the active
ingredient amisulpride. It belongs to
a group of medicines called
antipsychotics.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
SULPRIX
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE SULPRIX IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
amisulpride
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT TAKE SULPRIX IF YOU ARE
TAKING THE FOLLOWING MEDICINES:
•
medicines used to treat irregular
heart rhythm or heart conditions
such as quinidine, disopyramide,
amiodarone, sotalol and bepridil
•
antibiotics such as erythromycin
and pentamidine, given as an
injection into th

Lastnosti izdelka

Page 1 of 15
NEW ZEALAND DATA SHEET
SULPRIX
®
1. PRODUCT NAME
SULPRIX, 50 mg, 100 mg & 200 mg, tablet.
SULPRIX, 400 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg, 100 mg, 200 mg or 400 mg of amisulpride.
Excipient with known effect: lactose monohydrate
Allergen declaration: sugars as lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
SULPRIX Tablets 50 mg: White round shaped tablets with 'AA 50' on one
side and 'G' on the reverse,
approximately 6 mm in diameter.
SULPRIX Tablets 100 mg: White round shaped tablets with 'AMI'
breakline '100' on one side and 'G'
on the reverse, approximately 7.5 mm in diameter.
SULPRIX Tablets 200 mg: White round shaped tablets with 'AMI'
breakline '200' on one side and 'G'
on the reverse, approximately 10 mm in diameter.
SULPRIX Film-coated Tablets 400 mg: White film-coated, 18.0 ± 0.5 mm
capsule shaped tablet,
embossed with "AS 400" on one side and a break-line on the reverse.
The 100 mg, 200 mg and 400 mg tablets can be divided into equal doses.
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_
_DOSE AND METHOD OF ADMINISTRATION_
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. Doses above
800 mg/day have not been shown to be superior to lower doses and may
increase the incidence of
Page 2 of 15
adverse events. No specific titration is required when initiating the
treatment with amisulpride. Doses
should be adjusted according to individual res