Summary of Product Characteristics (SmPC) - Molaxole powder for oral solution
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:
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.
4.3 Contraindications
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.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
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.
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.
In case of diarrhoea, caution should be exercised, particularly in patients who are at higher risk for water-electrolyte balance disorders (e.g. the elderly, patients with impaired hepatic or renal function, or patients taking diuretics) and electrolyte control should be considered.
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).
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 4.5.
This medicinal product contains 187 mg sodium in each sachet, equivalent to 9.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Paediatric population
Not recommended for children below 12 years old.
4.5 Interaction with other medicinal products and other forms of interaction
There is a possibility that the intestinal absorption of other medicinal products could be transiently reduced during use with Molaxole (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti- epileptics. Other medicinal products should therefore not be taken orally one hour before, during or one hour after taking Molaxole.
Molaxole may result in a potential interactive effect if used with starch-based food thickeners. Macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited data on the use of macrogol 3350 in pregnant women. Studies in animals have shown indirect reproduction toxicity (see section 5.3). No effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. Molaxole can be used during pregnancy.
Breast feeding
No effects on a breast-feeding child are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible. Moxalole can be used when breast-feeding.
Fertility
There are no clinical data on the effect of Molaxole on fertility. A non-clinical study indicates that there is no effect of macrogol 3350 on the fertility of rats (see section 5.3).
4.7 Effects on ability to drive and use machines
Molaxole has no effect on the ability to drive and use machines.
4.8 Undesirable effects
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 |
| Immune system disorders | Common | Pruritus |
| Uncommon | Rash | |
| Very rare | Allergic reactions, including anaphylaxis, angioedema, dyspnoea, erythema, urticaria and | |
Metabolism and nutrition disorders | Very rare | Electrolyte disturbances, particularly |
| Not known | hyperkalaemia and Dehydration, electrolyte disturbances (hyponatraemia) | |
| Nervous system | Common | Headache |
| Gastrointestinal disorders | Very common | Stomach ache and cramp, diarrhoea, vomiting, |
| Uncommon | nausea, borborygmi, Dyspepsia, abdominal | |
| 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Severe pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for constipation, osmotically acting laxatives.
ATC-code: A06A D65
Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. Macrogol 3350 increases the stool volume which triggers colon motility via neuromuscular pathways. The physiological consequences are an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium or water.
For the indication of faecal impaction controlled comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, macrogol, sodium chloride, potassium chloride and sodium hydrogen carbonate cleared the faecal impaction in 12/27 (44%) after 1 days´ treatment; 23/27 (85%) after 2 days´ treatment and 24/27 (89%) at the end of 3 days.
Clinical studies in the use of macrogol, sodium chloride, potassium chloride and sodium hydrogen carbonate in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time. Many patients respond to between 1 and 2 sachets a day, but this dose should be adjusted depending on individual response.
5.2 Pharmacokinetic properties
Macrogol is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract and has no known pharmacological activity. Any macrogol 3350 that is absorbed is excreted via the urine.
5.3 Preclinical safety data
Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxic effect. This has been determined based on conventional studies of pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development (in rats).
No direct embryotoxic or teratogenic effects were seen in rats even at levels that were toxic to the mother, which were 66 times higher than the maximum human recommended dose for chronic constipation and 25 times higher than that for faecaloma. Indirect embryofoetal effects including reduction in foetal and placental weight, reduced foetal survival, increased hyperflexion in extremities and paws as well as miscarriage were observed in rabbits at doses toxic to the mother, equivalent to 3.3 times the maximum recommended human dose for the treatment of chronic constipation, and 1.3 times the maximum recommended dose for faecaloma. Rabbits are exceptionally sensitive to the effect of substances that act on the gastrointestinal tract, and the studies were performed under exaggerated conditions with the administration of high doses which are not clinically relevant. The findings may be a consequence of an indirect effect of macrogol 3350 combined with the mother being in poor general condition, caused by an exaggerated pharmacodynamic response in the rabbit. There were no signs of teratogenic effects.
Long-term studies on the toxicity and carcinogenicity of use of macrogol 3350 have been performed in animals. Results from these and other toxicity studies, in which high doses of orally-administered macrogols were used with high molecular weight, support the safety of the product at the recommended therapeutic doses.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Acesulfam potassium (E950), lemon flavour.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
Store the reconstituted solution in refrigerator (2ºC-8ºC) and discard any solution not used within 6 hours.
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. For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Sachets of Paper/LDPE/Aluminium/LDPE alternatively
Sachets of Paper/PE/Aluminium/ Ethylene Methacrylic Acid Copolymer e.g. Surlyn
Package of: 2, 6, 8, 10, 20, 30, 40, 50, 60 and 100 sachets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Cooper Consumer Health B.V.,
Verrijn Stuartweg 60, 1112 AX Diemen,
The Netherlands
8 MARKETING AUTHORISATION NUMBER(S)
PL 60682/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/07/2008
10 DATE OF REVISION OF THE TEXT
16/06/2025