PICOLAX POWDER

País: África do Sul

Língua: inglês

Origem: South African Health Products Regulatory Authority (SAHPRA)

Disponível em:

Ferring (Pty) Ltd

Dosagem:

See ingredients

Forma farmacêutica:

POWDER

Composição:

EACH SACHET CONTAINS CITRIC ACID 12,0 g MAGNESIUM OXIDE 3,5 g SODIUM PICOSULPHATE 10,0 mg

Status de autorização:

Registered

Data de autorização:

2012-02-03

Folheto informativo - Bula

Ferring (Pty) Ltd.
1.5.5.4 Clean Patient Information Leaflet
Picolax (Powder for oral solution) – A39/11.5/0058
Each sachet contains: Sodium picosulphate 10,0
mg, Magnesium oxide 3,5 g, Citric acid 12,0 g
Sequence 0006
Response to CCR dated 02/03/2022
Submitted: 17 March 2022
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
PICOLAX
® POWDER FOR ORAL SOLUTION
SODIUM PICOSULPHATE, MAGNESIUM OXIDE, LIGHT, CITRIC ACID, ANHYDROUS
CONTAINS SWEETENER (SODIUM SACCHARIN 60 MG PER SACHET)
CONTAINS SUGAR (LACTOSE COMPONENT OF THE FLAVOURING)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PICOLAX®
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
PICOLAX
®
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 PICOLAX
®
is and what it is used for
2. What you need to know before you take PICOLAX
®
3. How to take PICOLAX
®
4. Possible side effects
5. How to store PICOLAX
®
6. Contents of the pack and other information
1. WHAT PICOLAX® IS AND WHAT IT IS USED FOR
PICOLAX
®
is a powder that contains sodium picosulfate, a laxative that works by
increasing the activity
S3
Ferring (Pty) Ltd.
1.5.5.4 Clean Patient Information Leaflet
Picolax (Powder for oral solution) – A39/11.5/0058
Each sachet contains: Sodium picosulphate 10,0
mg, Magnesium oxide 3,5 g, Citric acid 12,0 g
Sequence 0006
Response to CCR dated 02/03/2022
Submitted: 17 March 2022
Page 2 of 11
of the intestine. PICOLAX
®
also contains magnesium citrate, another type of laxative that works
by
holding back fluid in the bowel to provide a wash-out effect.
PICOLAX
®
is used to remove the bowel contents and cleanse it prior to
examination by radiography (X-
ray examination), endoscopy or surgery when judged clinically
necessary.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PICOLAX®
DO NOT TA

Características técnicas

Ferring (Pty) Ltd.
1.5.5.2 Proposed Clean PI
Picolax (Powder for oral solution) – A39/11.5/0058
Each sachet contains: Sodium picosulphate 10,0 mg,
Magnesium oxide 3,5 g, Citric acid 12,0 g
Sequence 0006: Response to CCR dated
02/03/2022
Submitted: 17 March 2022
Page
1
of
14
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
PICOLAX
®
, Powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following active ingredients:
Sodium picosulphate
10,0 mg
Magnesium oxide, light
3,5 g
Citric acid, anhydrous
12,0 g
Each sachet also contains:
Sweetener: Sodium saccharin 60 mg per sachet.
Lactose (as a component of the flavour)
For the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
White crystalline powder with a faint odour of orange.
Reconstituted solution is off
-white, cloudy liquid with a faint odour of orange.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PICOLAX
®
is indicated for bowel emptying and cleansing by means of total
gastrointestinal tract
perfusion in preparation for gastrointestinal examination (such as
colonoscopy, barium enema x-ray
Ferring (Pty) Ltd.
1.5.5.2 Proposed Clean PI
Picolax (Powder for oral solution) – A39/11.5/0058
Each sachet contains: Sodium picosulphate 10,0 mg,
Magnesium oxide 3,5 g, Citric acid 12,0 g
Sequence 0006: Response to CCR dated
02/03/2022
Submitted: 17 March 2022
Page
2
of
14
examination), prior to intravenous pyelograms (IVP), surgery or in
severe constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults (including elderly):
The first PICOLAX
®
sachet (see method of Administration section below for reconstitution
guidance) is
taken the night before the procedure, and the second is taken the next
day, in the morning prior to the
procedure.
On the day before the procedure – 1 sachet:
•
The first reconstituted sachet is taken in the late afternoon /
evening (e.g., 5:00 to 9:00 PM),
followed by at least 5 x 250 ml drinks of clear liquids (not only
water), spread over several hours