PICOLAX

Posology Adults (including elderly):

The two PICOLAX sachets (see Method of Administration section below for reconstitution guidance) 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 5 x 250 ml drinks of clear liquids (not only water), spread over several hours • The second reconstituted sachet is taken 4 to 6 hours before the procedure, followed by at least 3 x 250 ml drinks of clear liquids (not only water), spread over several hours • Clear liquids (not only water) 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:

A measuring spoon is provided with the product. It is recommended that a narrow flat edge, for example the back of a knife blade, is drawn across the top of a heaped measuring spoon to obtain a flat surface of the measure. This will give ¼ of a sachet (4 g powder) per spoonful.

For the timing of dosing in children, refer to the instructions given for adults from 1 up to 2 years: first dose is 1 spoonful, second dose is 1 spoonful from 2 up to 4 years: first dose is 2 spoonfuls, second dose is 2 spoonfuls from 4 up to 9 years: first dose is 1 sachet, second dose is 2 spoonfuls 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 PICOLAX.

Method of administration Route of administration:

Oral 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 (PICOLAX + 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. Liquid intake should not be restricted to only drinking water.

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. MedDRA Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Immune system disorder Anaphylactic reaction, hypersensitivity Metabolism and nutrition disorders Hypermagn esaemia Hypokalaemia Hyponatraemia 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 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, PICOLAX can cause severe or life-threatening electrolyte problems or impaired renal function in fragile or debilitated patients. Few episodes of severe hypermagnesaemia have been reported following the use of PICOLAX.

g. renal impairment or concomitant medication). 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. 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.

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 - Hypermagnesaemia - 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