PURGOLENE POWDER

Land: Sydafrika

Språk: engelska

Källa: South African Health Products Regulatory Authority (SAHPRA)

Tillgänglig från:

Cipla Medpro (Pty) Ltd

Dos:

See ingredients

Läkemedelsform:

POWDER

Sammansättning:

EACH SACHET CONTAINS POLY ETHYLENE GLYCOL 3,350 13,125 g POTASSIUM CHLORIDE E 46,6 mg SODIUM BICARBONATE E 178,5 mg SODIUM CHLORIDE E 350,7 mg

Bemyndigande status:

Registered

Tillstånd datum:

2016-09-06

Bipacksedel

PATIENT INFORMATION LEAFLET FOR
PURGOLENE
SCHEDULING STATUS
PURGOLENE (13,8 G POWDER FOR ORAL SOLUTION)
MACROGOL 3350
SODIUM BICARBONATE
SODIUM CHLORIDE
POTASSIUM CHLORIDE
SUGAR FREE
CONTAINS SWEETENER (ACESULFAME POTASSIUM): 75 MG PER SACHET
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
PURGOLENE is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use PURGOLENE carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share PURGOLENE with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
7 days.
WHAT IS IN THIS LEAFLET
1.
What PURGOLENE is and what it is used for
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2.
What you need to know before you take PURGOLENE
3.
How to take PURGOLENE
4.
Possible side effects
5.
How to store PURGOLENE
6.
Contents of the pack and other information.
1.
WHAT PURGOLENE IS AND WHAT IT IS USED FOR
PURGOLENE is a laxative for the treatment of constipation in adults,
adolescents and
elderly. It is not recommended for children below 12 years of age.
PURGOLENE helps you to have a bowel movement even if you have been
constipated for a
long time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PURGOLENE
Do not take PURGOLENE:
•
If you are hypersensitive (allergic) to macrogol, sodium, chloride,
sodium bicarbonate,
potassium chloride or any of the other ingredients of PURGOLENE
(listed in SECTION 6).
•
a blockage in your gut (symptoms may include sever stomach pain,
nausea, vomiting
and an inability to pass wind or stools)
•
a perforated (ruptured)
)
gut wall (with symptoms such as severe stomach pain and
tenderness)
•
if you have severe inflammatory bowel disease like ulcerative colitis
(chronic disease
affecting the large bowel), Crohn’s disease (inflammation of last
part of small bowel) or
toxic megacolon (potentially lethal complication of inflammatory

Produktens egenskaper

PROFESSIONAL INFORMATION FOR
PURGOLENE (POWDER FOR ORAL SOLUTION)
SCHEDULING STATUS
_ _
1.
NAME OF THE MEDICINE
PURGOLENE (13,8 g sachet – Powder for oral solution)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 13,8 g sachet of PURGOLENE powder contains:
Macrogol (PEG) 3350
13,125 g
Sodium bicarbonate
178,5 mg
Sodium chloride
350,7 mg
Potassium chloride
46,6 mg
The content of electrolyte ions per sachet when made up to 125 ml of
solution is as follows:
Sodium
65 mmol/l
Chloride
53 mmol/l
Potassium
5,4 mmol/l
Bicarbonate
17 mmol/l
Sugar free.
Contains sweetener (acesulfame potassium): 75 mg
per sachet.
For the full list of excipients, see SECTION 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
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White, free flowing flaky powder with a lemon flavour and odour and a
sweet taste. When
the powder is dissolved the resultant solution is clear and colourless
or slightly hazy when
compared with an equal volume of water.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PURGOLENE is indicated for the treatment of chronic constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS:
1 to 3 sachets daily in divided doses, according to individual
response. The powder in each
sachet should be dissolved in 125 ml water and taken orally.
CHILDREN (BELOW 12 YEARS OLD): not recommended.
ELDERLY: Initially one sachet per day is recommended.
No dosage change is needed to be made for patients with renal
insufficiency.
A course of treatment with PURGOLENE should normally not exceed 2
weeks, although
this can be repeated if required.
Extended use may be necessary in the care of patients with severe
chronic or resistant
constipation, secondary to multiple sclerosis or Parkinson’s
Disease, or induced by regular
constipating medication, in particular opioids and antimuscarinics.
For extended use, the dose can be adjusted down to 1 or 2 sachets
daily, in divided doses,
each dissolved in 125 ml water and taken orally.
METHOD OF ADMINISTRATION
For oral administration.
4.3
CONTRAINDICATIONS
PURGOLENE is contraindica