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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Product name and form

PICOLAX powder for oral solution.

Pharmaceutical Form

Powder for oral solution.

White crystalline powder.

Qualitative and quantitative composition

Each sachet contains the following active ingredients:

Sodium picosulfate: 10.0mg
Magnesium oxide, light: 3.5g
Citric acid, anhydrous: 12.0g

Each sachet also contains:

Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg) potassium]
Lactose (as a component of the flavour)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Citric acid

Potassium citrate is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, uric acid lithiasis with or without calcium stones. When potassium citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, potassium citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate.

Magnesium oxide

Magnesium oxide (MgO), or magnesia, is an empirical formula of MgO and consists of a lattice of Mg2+ ions and O2− ions held together by ionic bonding.

Sodium picosulfate

Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon, has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum.

List of Excipients

Potassium hydrogen carbonate
Sodium saccharin
Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic acid, butylated hydroxyanisole

Pack sizes and marketing

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.

Marketing authorization holder

Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Marketing authorization dates and numbers

PL 03194/0014

1st September 2013

Drugs

Drug Countries
PICOLAX Ireland, Malta, United Kingdom, South Africa

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