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

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 × 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 × 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). 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

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. To avoid dehydration, it is important to follow the liquid intake recommendation as advocated together with the PICOLAX dosing whilst the effects of PICOLAX persist (see section 4.2, 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.

Directions for reconstitution in adults (including elderly)

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 with a faint odour of orange. Drink the solution. If it becomes warm, wait until it cools sufficiently to drink.

Directions for reconstitution in children

Reconstitute the required amount of powder in a cup containing approximately 50 ml water per spoonful. Stir for 2-3 minutes, the solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes warm, wait until it cools sufficiently to drink.

Discard the remaining contents of the sachet.

For directions on reconstitution of the full sachet for children of 4-9 years, refer to the instructions given for adults.

Overdose would lead to profuse diarrhoea. Treatment is by general supportive measures and correction of fluid and electrolyte balance.

3 years.

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

Store in the original package in order to protect from moisture.

Sachet: 4 layers: paper-low density polyethylene-aluminium-thermofusible resin

Pairs of sachets can be separated by tearing apart the perforated strip.

Weight of sachet contents: 16.1g

A measuring spoon for paediatric dosing is included in the pack.

PICOLAX is supplied in packages of 2 sachets, 100 sachets (50 packs of 2 sachets), or 300 sachets (150 packs of 2 sachets).

Not all pack sizes may be marketed.

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