MOLAXOLE 13.125/350 Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Available from:

Meda Health Sales Ireland Limited

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Dosage:

13.125/350

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives

Authorization status:

Transfer Pending

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 doctors 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  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 waterbalance. 

You must talk to a doctor if you do not feel
better or if you feel worse a

Summary of Product characteristics

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
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:_
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
HEALTH PRODUCTS REGULATORY AUTHORITY
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