MOLAXOLE powder for oral solution sachet

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

sodium bicarbonate, Quantity: 178.5 mg; potassium chloride, Quantity: 46.6 mg; sodium chloride, Quantity: 350.7 mg; macrogol 3350, Quantity: 13.125 g

Dostupné s:

Viatris Pty Ltd

INN (Mezinárodní Name):

macrogol 3350,potassium chloride,sodium bicarbonate,sodium chloride

Léková forma:

Solution, powder for

Složení:

Excipient Ingredients: acesulfame potassium; Flavour

Podání:

Oral

Jednotky v balení:

10, 20, 8, 6, 2, 30

Druh předpisu:

Not scheduled. Not considered by committee

Terapeutické indikace:

For effective relief from constipation, treatment of chronic constipation. Molaxole is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of the abdomen and rectum.

Přehled produktů:

Visual Identification: White crystalline powder; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Licence status A

Datum autorizace:

2013-08-08

Informace pro uživatele

MOLAXOLE
® POWDER
FOR ORAL SOLUTION
_macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MOLAXOLE. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine.
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 MOLAXOLE IS
USED FOR
MOLAXOLE helps you to have a
comfortable bowel movement even if
you have been constipated for a long
time.
MOLAXOLE also works in very bad
constipation (called faecal
impaction), as determined by your
doctor.
Macrogol 3350 increases the volume
of faeces by binding water leading to
a normalisation of motility in the
colon. The physiological
consequences are an increased
movement of the softened stools and
easing of defaecation. The salts in the
formulation help maintain the body's
normal salt and water balance.
This medicine is available without a
doctor’s prescription. However, you
still need to take MOLAXOLE
carefully to get the best results from
it.
BEFORE YOU TAKE
MOLAXOLE
_WHEN YOU MUST NOT TAKE IT_
Do not take MOLAXOLE if you
have an allergy to any of the
ingredients listed at the end of this
leaflet.
Do not give this medicine to a child
under the age of 12 years.
Do not take MOLAXOLE if your
doctor has told you that you have:
•
An obstruction in your intestine
(gut)
•
A perforated gut wall
•
Severe inflammatory bowel
disease like ulcerative colitis,
Crohn's disease or toxic
megacolon
•
Paralysis of the bowel
Do not take MOLAXOLE after the
expiry date printed on the pack. If
you use this medicine after the expiry
date has passed,

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
MOLAXOLE
®
_macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride _
_powder for oral solution _
1
NAME OF THE MEDICINE
macrogol 3350, sodium chloride, sodium bicarbonate and potassium
chloride
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 13.8 g sachet of MOLAXOLE contains:
Macrogol 3350 13.125 g
Sodium chloride 350.7 mg
Sodium bicarbonate 178.5 mg
Potassium chloride 46.6 mg
When it is made into a drink with 125 mL water, each sachet provides:
Sodium 65 mmol/L
Chloride 53 mmol/L
Bicarbonate 17 mmol/L
Potassium 5.4 mmol/L
Excipients with known effect: Each sachet contains 26 mg of potassium
and 187 mg of sodium.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White crystalline powder for oral solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For effective relief from constipation, treatment of chronic
constipation and treatment of faecal impaction
defined as refractory constipation with faecal loading of the rectum
and/or colon confirmed by physical
examination of abdomen and rectum.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage in adults and children over 12 years:
CONSTIPATION:
The dose is 1 sachet daily. This may be increased up to 3 sachets
daily, if required.
FAECAL IMPACTION AS DIAGNOSED BY A DOCTOR:
8 sachets daily, consumed within 6 hours. A course of treatment
for faecal impaction does not normally exceed 3 days.
PATIENTS WITH IMPAIRED CARDIOVASCULAR FUNCTION:
For the treatment of faecal impaction the dose should be
divided so that no more than two sachets are taken in any one hour.
PATIENTS WITH RENAL INSUFFICIENCY:
No dosage change is necessary for treatment of either constipation or
faecal impaction.
Administration:
MOLAXOLE
®
– PRODUCT INFORMATION
2
For oral administration. Each sachet should be dissolved in 125 mL
water. For faecal impaction, 8 sachets
may be dissolved in 1 litre of water and stored well covered in the
fridge for up to 6 hours (see Section 6.4
SPECIAL PRECAUTIONS FOR STORAGE).