Molaxole powder for oral solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Sodium chloride; Sodium hydrogen carbonate; Macrogol 3350; Potassium chloride

Saatavilla:

Primecrown 2010 Limited

ATC-koodi:

A06AD; A06AD65

INN (Kansainvälinen yleisnimi):

Sodium chloride; Sodium hydrogen carbonate; Macrogol 3350; Potassium chloride

Lääkemuoto:

Powder for oral solution

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Osmotically acting laxatives; macrogol, combinations

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-11-08

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
MOLAXOLE
® POWDER FOR ORAL SOLUTION
macrogol 3350/sodium chloride/sodium hydrogen carbonate/potassium
chloride
WHAT IS IN THIS LEAFLET:
1. What Molaxole is and what it is used for
2. What you need to know before you take Molaxole
3. How to use Molaxole
4. Possible side effects
5. How to store Molaxole
6. Contents of the pack and other information
1. WHAT MOLAXOLE IS AND WHAT IT IS USED FOR
Molaxole helps you to have a comfortable bowel movement even if you
have been constipated for a long time. Molaxole can also be used for
treatment of very bad constipation (called faecal impaction).
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
defecation. The salts in the formulation help maintain the body´s
normal
salt and water balance.
You must talk to a doctor if you do not feel better or if you feel
worse after
2 weeks of constipation. If you are treated for very bad constipation
(called
faecal impaction) you should follow your doctors instruction.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLAXOLE
DO NOT TAKE MOLAXOLE
•
if you are allergic (hypersensitive) to any of the active substances
macrogol,
sodium
chloride,
potassium
chloride
or
sodium
hydrogen
carbonate or any of the other ingredients of this medicines (listed in
section 6)
•
if you have an obstruction in the intestine (gut), a perforated gut
wall or
severe
inflammatory
bowel
disease
like
ulcerative
colitis,
Crohn´s
disease, toxic megacolon or ileus.
WARNINGS AND PRECAUTIONS
•
if you feel weak, breathless, very thirsty with a headache, have
cardiac
failure or get puffy ankles stop taking Molaxole and tell your doctor
immediately.
Do not take Molaxole for longer periods of time unless you have been
instructed to do so by your doctor for example if you take drugs that
can
cause constipation or if you have a disease which cause constipation
for
example Park

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Molaxole powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Powder for oral solution
_Product imported from the UK_
A white crystalline powder.
4 CLINICAL PARTICULARS
As per PA1332/038/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1332/038/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Acesulfam potassium (E950)
Lemon flavour
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf –life expiry date of this product shall be the date shown
on the container and outer package of the product on
the market in the country of origin.
Store the reconstituted solution in refrigerator (2°C-8°C) and
discard any solution not used within 6 hours.
Each sachet contains following active substances
Macrogol 3350
13.125 g
Sodium chloride
350.7 mg
Potassium chloride
46.6 mg
Sodium hydrogen carbonate
178.5 mg
The content of electrolyte ions per sachet when made up to 125 ml of
solution
Sodium
65 mmol/l
Potassium
5.4 mmol/l
Chloride
53 mmol/l
Hydrogen carbonate
17 mmol/l
For the full list of excipients, see section 6.1
H
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T
S
R
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G
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A
T
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R
Y
A
U
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H
O
R
I
T
Y
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special temperature
storage conditions.
Store in the original package in order to protect from moisture