FORLAX POWDER

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

LITHA PHARMA (PTY) LTD

Dosage:

See ingredients

Pharmaceutical form:

POWDER

Composition:

EACH SACHET CONTAINS MACROGOL 4000 10,0 g

Authorization status:

Registered

Authorization date:

2016-11-03

Patient Information leaflet

APPLICANT: Acino Pharma (Pty) Ltd
PROPRIETARY NAME: Forlax Powder for Injection
1.5.5. Clean Amended Proposed Patient Information Leaflet
Page 1 of 9
APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S0
FORLAX 10 G POWDER FOR SOLUTION
MACROGOL 4 000
CONTAINS SORBITOL: 1,7 MG PER SACHET
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
FORLAX is available without a doctor's prescription, for you to treat
a mild
illness. Nevertheless, you still need to use FORLAX carefully to get
the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share FORLAX with any other person.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
3 days.
_ _
WHAT IS IN THIS LEAFLET
1. What FORLAX is and what it is used for
2. What you need to know before you take FORLAX
3. How to take FORLAX
4. Possible side effects
5. How to store FORLAX
6. Contents of the pack and other information
APPLICANT: Acino Pharma (Pty) Ltd
PROPRIETARY NAME: Forlax Powder for Injection
1.5.5. Clean Amended Proposed Patient Information Leaflet
Page 2 of 9
1.
WHAT FORLAX IS AND WHAT IT IS USED FOR
FORLAX contains the active substance macrogol 4 000 and belongs to a
group of medicines called osmotic laxatives. It works by adding water
to the
stools, which helps to overcome problems caused by very slow bowel
movements. FORLAX is not absorbed into the bloodstream or broken down
in the body.
FORLAX is used for the treatment of chronic functional constipation in
adults
and in children aged 8 years and above.
If symptoms persist despite associated dietary measures, you should
contact a doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FORLAX
DO NOT USE FORLAX:
•
If you are hypersensitive (allergic) to macrogol (polyethylene glycol)
or
any of the ingredients of FORLAX. (listed in section 6).
•
If you have an existing disease, such as, severe intestinal disease:
o
inflammatory bowel disease (such as ulcerative c

Summary of Product characteristics

APPLICANT: Acino Pharma (Pty) Ltd
PROPRIETARY NAME: Forlax Powder for Injection
1.5.5.1 Clean Amended Proposed Professional Information
Page 1 of 9
APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S0
1
NAME OF THE MEDICINE
FORLAX Powder for solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 10 g of macrogol 4 000.
Contains sugar: sorbitol 1,7 mg per sachet.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral solution in sachet.
A white or almost white powder having a reminiscent odour of orange
and
grapefruit.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of chronic functional constipation in adults and
children
aged 8 years and above.
An organic disorder should have been ruled out before initiation of
treatment.
FORLAX should remain a temporary adjuvant treatment to appropriate
lifestyle
and dietary management of constipation, with a maximum 3-month
treatment
course in children. If symptoms persist despite associated dietary
measures,
an underlying cause should be suspected and treated.
APPLICANT: Acino Pharma (Pty) Ltd
PROPRIETARY NAME: Forlax Powder for Injection
1.5.5.1 Clean Amended Proposed Professional Information
Page 2 of 9
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
1 to 2 sachets per day, preferably taken as a single dose in the
morning.
The effects of FORLAX becomes apparent within 24 to 48 hours after its
administration.
In children, treatment should not exceed 3 months due to the lack of
clinical
data
for
more
than
3
months.
Treatment-induced
restoration
of
bowel
movements will be maintained by lifestyle and dietary measures.
In adults the need for continuing treatment should be reassessed at 3
months.
The daily dose should be adapted according to the clinical effects and
may
range from one sachet every other day (especially in children) up to 2
sachets
a day.
METHOD OF ADMINISTRATION
Oral use.
The content of each sachet should be dissolved in a glass about 50 ml
of water
just before use. The resultant solutio