Molaxole powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Mylan IRE Healthcare Limited

ATC code:

A06AD; A06AD65

INN (International Name):

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

Dosage:

13.125/350 milligram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Marketed

Authorization date:

2009-12-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MOLAXOLE® POWDER FOR ORAL SOLUTION,
Macrogol 3350
Sodium chloride
Sodium hydrogen carbonate
Potassium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor or pharmacist.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet.
–
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 doctor’s
instruction.
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 take 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. After consulting a doctor, 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 doctor’s instruction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLAXOLE
Do not take Molaxole
–
if you ar

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2020
CRN00C1SK
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Molaxole powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
3 PHARMACEUTICAL FORM
Powder for oral solution
A white crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of chronic constipation. 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
_ _
_Chronic constipation:_
Adults: 1-3 sachets daily in divided doses. Normal dose for most
patients is 1-2 sachets per day. Depending on the individual
response 3 sachets per day might be needed.
A course of treatment for constipation does not normally exceed two
weeks, although this can be repeated if required.
For extended use, the lowest effective dose should be used.
_Faecal impaction:_
Adults: 8 sachets daily, all of which should be consumed within a 6
hour period.
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:_
Health Products Regulatory Authority
24 November 2020
CRN00C1SK
Page 2 of 5
No dosage change is necessary for treatment of either constipation or
faecal impaction.
Paediatric population:
Not recommended for children below 12 years old.
METHOD OF ADMINISTRATION
Administration:
Each sachet should b