PICOLAX Powder for oral solution Ref.[50470] Active ingredients: Citric acid Magnesium oxide Sodium picosulfate

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 abnormalities, 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, PICOPREP 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 4.5).

PICOLAX 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 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 5 mmol (or 195 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 as a component of the flavour. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.

PICOLAX should not be used as a routine laxative.

As a purgative, PICOLAX increases the gastrointestinal transit rate. The absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may be decreased during the treatment period (see 4.4). Medicines with the potential to chelate with magnesium (e.g. tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine) should be taken not later than 2 hours before and not earlier than 6 hours after administration of PICOLAX.

The efficacy of PICOLAX 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 PICOLAX 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.

Pregnancy

For PICOLAX 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 PICOLAX during pregnancy.

Breastfeeding

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

Fertility

There are no data on the effect of PICOLAX 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).

Not relevant.

The most common adverse reactions are vomiting, nausea, abdominal pain and headache. Hyponatraemia is rare but is the most commonly reported serious adverse reaction.

Adverse reactions from spontaneous reports are presented by frequency category based on incidence in clinical trials when known. Frequency from spontaneous reports for adverse reactions never observed in clinical trials is based on an algorithm as recommended in the European Commission SmPC guideline, 2009, rev 2.

^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.

Not applicable.