Manxolax powder for oral solution – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Manxolax powder for oral solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains the following active ingredients:

Sodium picosulfate 10.0mg

Magnesium oxide, heavy 3.5g

Citric acid, anhydrous 12.0g

Each sachet also contains:

Potassium carbonate 0.5g [equivalent to 7.24 mmol (283 mg) potassium]

Excipient with known effect:

Each sachet contains 967.3 mg Lactose anhydrous

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for oral solution.

White powder.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Manxolax is indicated in adults, adolescents and children from the age of 9 years:

• To clean the bowel prior to X-ray examination or endoscopy.
• To clean the bowel prior to surgery when judged clinically necessary (see section 4.4 regarding open colorectal surgery).

4.2 Posology and method of administration

Posology

Adults (including the elderly):

The two Manxolax sachets are taken dependent on the planned time of the procedure:

• The first reconstituted sachet is taken 10 to 18 hours before the procedure, followed by at least five 250 ml drinks of clear liquids, spread over several hours
• The second reconstituted sachet is taken 4 to 6 hours before the procedure, followed by at least three 250 ml drinks of clear liquids, spread over several hours
• Clear liquids may be consumed until 2 hours before the time of the procedure

Special populations

Limited data is available for treatment of patients with low body weight (BMI less than 18). The rehydration regimen above has not been tested in such individuals and therefore monitoring of their hydration status is required and the regimen may need to be altered appropriately (see section 4.4).

Paediatric population:

9 years and above: adult dose

Maintaining hydration in children is very important. Guidelines for treating dehydration in children should be followed to ensure adequate hydration during treatment with Manxolax.

Method of administration

Route of administration: Oral

Directions for reconstitution (Adults and children 9 years and above):

Reconstitute the contents of one sachet in a cup of water (approximately 150 ml). Stir for 2-3 minutes, the solution should now become an off-white, cloudy liquid. Drink the solution. If it becomes hot, wait until it cools sufficiently to drink.

A low residue diet is recommended on the day prior to the procedure. A clear liquid diet is recommended on the day of the procedure. To avoid dehydration it is important to follow the liquid intake recommendation as advocated together Manxolax dosing whilst the effects of Manxolax persist (see section 4.2, Posology). Apart from the liquid intake together with the treatment regimen (Manxolax + additional liquids), a normal, thirst driven intake of clear liquids is recommended.

Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream) and water. Do not drink only water.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Congestive cardiac failure
• Gastric retention
• Gastro-intestinal ulceration
• Toxic colitis
• Toxic megacolon
• Ileus
• Nausea and vomiting
• Acute surgical abdominal conditions such as acute appendicitis
• Known or suspected gastro-intestinal obstruction or perforation.
• Severe dehydration
• Rhabdomyolysis
• Hypermagnesemia
• Active inflammatory bowel disease
• In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.

4.4 Special warnings and precautions for use

Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery if clearly needed. The risks of the treatment should be carefully weighed against possible benefits and needs depending on surgical procedures performed.

An insufficient or excessive oral intake of water and electrolytes could create clinically significant, deficiencies, particularly in less fit patients. In this regard patients with low body weight, children, the elderly, debilitated individuals and patients at risk of hypokalaemia or hyponatremia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hypokalaemia or hyponatremia.

Drinking only water to replace the fluid losses may lead to electrolyte imbalance, which may

in severe cases lead to complications such as seizures and coma. In rare cases, Manxolax can

cause severe or life-threatening electrolyte problems or impaired renal function in fragile or

debilitated patients.

Care should also be taken in patients with recent gastro-intestinal surgery, renal impairment, heart disease or inflammatory bowel disease.

Use with caution in patients on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium (see section 4.5).

Manxolax may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy (see sections 4.5 and 4.8).

The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.

For an early time of the day procedure it may be required to take the second dose during the night and possible sleep disturbance may occur.

This medicine contains 7.24 mmol (or 283 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.

Manxolax should not be used as a routine laxative.

4.5 Interaction with other medicinal products and other forms of interaction

As a purgative, Manxolax increases the gastrointestinal transit rate. The absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period (see section 4.4). Medicines with the

potential to chelate with magnesium, such as tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of Manxolax to avoid chelation with magnesium.

The efficacy of Manxolax is lowered by bulk-forming laxatives.

Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk i.e. cardiac glycosides). Caution is also advised when Manxolax is used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.

4.6 Fertility, pregnancy and lactation

Pregnancy

For Manxolax no clinical data on exposed pregnancy are available.

Studies in animals have shown reproductive toxicity (see section 5.3). As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of Manxolax during pregnancy.

Breastfeeding

There is no experience with the use of Manxolax in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with Manxolax may be considered for females who are breastfeeding.

Fertility

There are no data on the effect of Manxolax on fertility in humans.

Male and female rat fertility was not affected by oral doses of sodium picosulfate up to 100 mg/kg (see section 5.3)

4.7 Effects on ability to drive and use machines

Not Relevant

4.8 Undesirable effects

The most frequent adverse reactions seen in clinical trials are nausea, headache and vomiting.

^a In epileptic patients, there have been isolated reports of seizure/generalised tonic-clonic seizure without associated hyponatraemia.

^b Isolated cases of severe diarrhoea have been reported post-marketing.

^c Isolated cases of mild reversible aphthoid ileal ulcers have been reported.

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, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Contact Laxatives

ATC code: A06A B58

The active components of Manxolax are sodium picosulfate and magnesium citrate. Sodium picosulfate is a locally acting stimulant cathartic, which after bacterial cleavage in the colon forms the active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), which has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum. Magnesium citrate acts as an osmotic laxative by retaining moisture in the colon. The combined action of the two substances is of a 'washing out' effect combined with peristaltic stimulation to clear the bowel.

The product is not intended for use as a routine laxative.

Clinical efficacy and safety

The dosing regimen as described in section 4.2 Posology, and herein further referred to as the tailored dosing regimen, was investigated and evaluated in trial 000121 (OPTIMA) that compared the efficacy, safety and tolerability of Manxolax administered according to the tailored dosing regimen versus the fixed schedule of dosing (i.e. first dose is taken before 8am and second dose is taken 6-8 hours later on the day before procedure), called day before dosing regimen (204 patients were randomized, 131 received tailored dosing, 73 received day before dosing).

Superiority of the tailored dosing regimen was demonstrated compared to the day before dosing regimen in overall colon cleansing and responder status for ascending colon cleansing. For overall colon cleansing, the tailored dosing regimen was compared to the day before dosing regimen, based on the treatment difference in mean total Ottawa Scale score (4.26 versus 8.19 in mean total Ottawa scale score for tailored dosing regimen and day before dosing regimen respectively, with a corresponding p-value <0.0001, for the Intend to Treat (ITT) analysis set). For the responder status of the ascending colon, the proportion of patients with an Ottawa Scale score of either 0 (excellent) or 1 (good), was compared between the tailored dosing regimen and the day before dosing regimen. Patients randomized to the tailored dosing regimen were observed to have a 4.05 greater chance of being a responder with respect to ascending colon cleansing compared to patients randomized to the day before dosing regimen.

5.2 Pharmacokinetic properties

Both active components are locally active in the colon, and neither are absorbed in any detectable amounts.

5.3 Preclinical safety data

Prenatal developmental studies in rats and rabbits did not reveal any teratogenic potential after oral dosing of sodium picosulfate, but embryotoxicity has been observed in rats at 1000 and 10000 mg/kg/day and in rabbits at 1000mg/kg/day. The corresponding safety margins were 3000 to 30000 times the anticipated human dose. In rats, daily doses of 10 mg/kg during late gestation (fetal development) and lactation reduced body weights and survival of the offspring. Male and female rat fertility was not affected by oral doses of sodium picosulfate up to 100 mg/kg.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose anhydrous

Polyvinyl pyrollidone (E1201)

Potassium carbonate (E501)

Sucralose (E955)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

4 years

Once the sachet has been opened, use immediately and discard any unused powder or solution.

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Sachet:

printed four layer laminated paper foil

Weight of sachet contents: 17.15 g

Manxolax is supplied in packages of 2 sachets.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL,

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 11311/0810

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

17/05/2022

10 DATE OF REVISION OF THE TEXT

16/10/2025