MOLAXOLE

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:

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 be dissolved in 125 ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.

The most common undesirable effects are gastrointestinal effects. These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of Molaxole.

Mild diarrhoea usually responds to dose reduction. Adverse events are listed below by system organ class and frequency.

Frequencies are defined as:

Very common ( ≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), not known (cannot be estimated from the available data). System Organ Class Frequency Adverse Event Common Pruritus Uncommon Rash Immune system disorders Very rare Allergic reactions, including anaphylaxis, angioedema, dyspnoea, erythema, urticaria and rhinitis Metabolism and nutrition disorders Very rare Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.

Not known Dehydration, electrolyte disturbances (hyponatraemia) Nervous system disorders Common Headache Very common Stomach ache and cramp, diarrhoea, vomiting, nausea, borborygmi, flatulence Uncommon Dyspepsia, abdominal distension Gastrointestinal disorders Very rare Anal discomfort General disorders and administration site conditions Common Peripheral oedema Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The fluid content of Moxalole, when reconstituted with water, cannot substitute normal fluid intake, and a suitable level of fluid intake should therefore be maintained. 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. e multiple sclerosis (MS) or Parkinsons disease, or constipation induced by drugs, especially opioides or antimuscarine products.

g. the elderly, patients with impaired hepatic or renal function, or patients taking diuretics) and electrolyte control should be considered. 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. 5). In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tracts, such as Crohn´s disease and ulcerative colitis and toxic megacolon. 1.