PEGLAX Powder for oral solution Ref.[7756] Active ingredients: Macrogol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Casen Recordati, S.L., Autovía de Logroño, Km 13,300, 50180 UTEBO, Zaragoza (Spain)

Product name and form

PEGLAX 10 g powder for oral solution in sachet.

Pharmaceutical Form

Powder for oral solution in sachet.

Almost white powder.

Qualitative and quantitative composition

Each sachet contains 10 g of macrogol 4000.

Excipient(s) with known effect: 0.0000018 mg of sulphur dioxide (E-220) per sachet and less than 1 mmol of sodium per sachet.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Macrogol

High molecular weight (4000) macrogols are long linear polymers which retain water molecules by means of hydrogen bonds. When administered by the oral route, they lead to an increase in volume of intestinal fluids.

List of Excipients

Saccharin sodium (E954), apple flavour*

* Composition of the apple flavour: Natural flavour, maltodextrine, gum arabic E414, sulphur dioxide E220, alpha tocopherol E307

Pack sizes and marketing

Sachet made of heat-sealable polyethylene, aluminium and polyester film (polyester/aluminium/polyethylene complex).

Single dose sachets presented in pack sizes of 10, 20, 30, 50, 60 and 100 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Casen Recordati, S.L., Autovía de Logroño, Km 13,300, 50180 UTEBO, Zaragoza (Spain)

Marketing authorization dates and numbers

PL 43885/0006

17/01/2016

Drugs

Drug Countries
PEGLAX Ireland, United Kingdom

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