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.
Each sachet contains following active substances
Sodium hydrogen carbonate
The content of electrolyte ions per sachet when made up to 125 ml of solution.
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.
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:
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
Each sachet should be dissolved in 125 ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.
Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.
The cause of constipation should be investigated if daily use of laxatives is necessary.
Patients using this preparation should seek medical advice if there is no improvement after two weeks.
Long term use can be necessary in serious chronical or refractory constipation due to i.e multiple sclerosis (MS) or Parkinsons disease, or constipation induced by drugs, especially opioides or antimuscarine products.
If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Molaxole should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.
There is no clinical data on the use of Molaxole in children, therefore it is not recommended.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by Molaxole (see section 4.5).
Not recommended for children below 12 years old.