MANXOLAX

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).

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. 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.

The most frequent adverse reactions seen in clinical trials are nausea, headache and vomiting. 000) Immune system disorder Anaphylactic reaction, hypersensitivity Metabolism and Hypokalaemia Hyponatraemia nutrition disorders Nervous system disorders Headache Epilepsy, generalised tonic- clonic seizurea , seizure, Loss of or depressed level of consciousness, syncope, dizziness, Confusional state including disorientation Presyncope Gastrointestinal disorders Vomiting, nausea, abdominal pain Diarrhoeab Ileal ulcerc, anal incontinence, proctalgia Skin and subcutaneous tissue disorders Rash (including erythematous rash and maculo-papular rash, urticaria, purpura) 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

g. 5). g. 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.

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.

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.