BIO-SULPIRIDE 200 TABLET

Држава: Јужноафричка Република

Језик: Енглески

Извор: South African Health Products Regulatory Authority (SAHPRA)

Доступно од:

Biotech Laboratories (Pty) Ltd

Дозирање:

See ingredients

Фармацеутски облик:

TABLET

Састав:

EACH TABLET CONTAINS SULPIRIDE 200,0 mg

Статус ауторизације:

Registered

Датум одобрења:

1997-09-06

Информативни летак

Biotech Laboratories (Pty) Ltd.
1.3.2 Approved Patient Information Leaflet
BIO-SULPIRIDE 200 Tablets (Each tablet contains
200 mg sulpiride -30/2.6.5/0511– registered)
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S5
BIO-SULPIRIDE 200, TABLETS
SULPIRIDE
CONTAINS SUGAR (LACTOSE MONOHYDRATE 67,0 MG PER TABLET)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
BIO-SULPIRIDE 200.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
BIO-SULPIRIDE 200 has been prescribed for you personally and you
should not share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What BIO-SULPIRIDE 200 is and what it is used for
2. What you need to know before you take BIO-SULPIRIDE 200
3. How to take BIO-SULPIRIDE 200
4. Possible side effects
5. How to store BIO-SULPIRIDE 200
6. Contents of the pack and other information
1. WHAT BIO-SULPIRIDE 200 IS AND WHAT IT IS USED FOR
BIO-SULPIRIDE 200 belongs to a group of medicines called benzamides.
It works by blocking the effect of a
chemical in the brain.
BIO-SULPIRIDE 200 is used to treat acute episodes of schizophrenia (a
mental illness with behaviour problems),
and the prevention of future episodes.
Biotech Laboratories (Pty) Ltd.
1.3.2 Approved Patient Information Leaflet
BIO-SULPIRIDE 200 Tablets (Each tablet contains
200 mg sulpiride -30/2.6.5/0511– registered)
Page 2 of 11
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIO-SULPIRIDE 200
DO NOT TAKE BIO-SULPIRIDE 200:
•
If you are hypersensitive (allergic) to sulpiride or any of the other
ingredients of BIO-SULPIRIDE 200
(listed in section 6).
•
If you have a tumour on the adrenal gland called phaeochromocytoma.
•
If you are pregnant or breastfeeding your baby.
•
If you have bone marrow depression.
•
With any other medication that may decrease your white blood cell
count or affect the cellular elements of
the blood. I

Карактеристике производа

Biotech Laboratories (Pty) Ltd.
1.3.1.1 Approved Professional Information
BIO-SULPIRIDE 200 Tablets (Each tablet contains 200
mg sulpiride -30/2.6.5/0511– registered)
Page
1
of
16
SCHEDULING STATUS
S5
1. NAME OF THE MEDICINE
BIO-SULPIRIDE 200 Tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg sulpiride.
Contains sugar (lactose monohydrate 67,0 mg per tablet).
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets
White circular flat bevelled edged tablet with a breakline on one side
and plain on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Schizophrenia.
The management of acute episodes and the prevention of acute relapses
in chronic cases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
INITIAL TREATMENT
200 to 800 mg orally in divided doses 8 or 12 hourly over 24 hours.
Duration one to six weeks.
Biotech Laboratories (Pty) Ltd.
1.3.1.1 Approved Professional Information
BIO-SULPIRIDE 200 Tablets (Each tablet contains 200
mg sulpiride -30/2.6.5/0511– registered)
Page
2
of
16
MAINTENANCE TREATMENT
600 to 800 mg per day (three to four BIO-SULPIRIDE 200 tablets) in
divided doses.
Duration as long as necessary.
Plasma concentrations may be increased in elderly patients due to
renal insufficiency (see section 4.4) for dosage
adaption).
There is a progressive reduction
in the rate of elimination and an increase in half-life with
decreasing renal function
(see section 4.4).
Patients with renal impairment or the elderly, with creatinine
clearance of 30 to 60 ml/minute require a reduction
of 70 % of normal dose, 10 to 30 ml/minute require a reduction of 50 %
of normal dose and creatinine clearance
of less than 10 ml/minute require a reduction of 35 % of normal dose.
Alternatively, increase the dosage interval
between doses by a factor of 1,5; 2 and 3, respectively.
METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to sulpiride or to any of the excipients of
BIO-SULPIRIDE 200, listed in section 6.1.
•
BIO-SUL