Plenvu Dose 1 oral powder 115.96g sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium; Potassium; Chloride; Macrogol '3350'

Available from:

Forum Health Products Ltd

ATC code:

A06AD65

INN (International Name):

Sodium; Potassium; Chloride; Macrogol '3350'

Dosage:

321.8mmol/1litre ; 26.6mmol/1litre ; 95.2mmol/1litre ; 100gram

Pharmaceutical form:

Powder for oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PLENVU POWDER FOR ORAL SOLUTION
Macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic
acid, sodium
chloride and potassium chloride.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor,
pharmacist or nurse have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Plenvu is and what it is used for
2.
What you need to know before you take Plenvu
3.
How to take Plenvu
4.
Possible side effects
5.
How to store Plenvu
6.
Contents of the pack and other information
1. WHAT PLENVU IS AND WHAT IT IS USED FOR
Plenvu contains the combination of active substances macrogol 3350,
sodium ascorbate,
sodium sulfate anhydrous, ascorbic acid, sodium chloride and potassium
chloride.
Plenvu is a laxative.
Plenvu is intended for adults 18 years of age and older prior to any
clinical procedure
requiring a clean bowel.
Plenvu cleans your bowel by causing you to have diarrhoea.
2
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PLENVU
DO NOT TAKE PLENVU:

if you are allergic (hypersensitive) to the active substances or any
of the other
ingredients of Plenvu (listed in section 6)

if you have a blockage in your bowel (bowel obstruction)

if you have an opening in the wall of your stomach or bowel (bowel
perforation)

if you have paralysis of the gut (ileus)

if you experience problems with food and fluid emptying from your
stomach
(e.g. gastric paresis, gastric retention)

if you suffer from phenylketonuria. This is a hereditary inability of
the body to
use a particular amino acid. Pl

Summary of Product characteristics

OBJECT 1
PLENVU POWDER FOR ORAL SOLUTION
Summary of Product Characteristics Updated 27-Oct-2017 | Norgine
Limited
1. Name of the medicinal product
Plenvu powder for oral solution
2. Qualitative and quantitative composition
The ingredients of Plenvu are contained in three separate sachets. The
first dose is supplied in one sachet
and the second dose is supplied in two sachets, A and B.
DOSE 1 SACHET contains the following active substances:
Macrogol 3350
100 g
Sodium sulfate anhydrous
9 g
Sodium chloride
2 g
Potassium chloride
1 g
The concentration of electrolyte ions when the first dose is made up
to 500 ml of solution is as follows:
Sodium
160.9 mmol/500 ml
Sulfate
Chloride
Potassium
63.4 mmol/500 ml
47.6 mmol/500 ml
13.3 mmol/500 ml
Dose 1 also contains 0.79 g of sucralose (E955).
DOSE 2 (SACHETS A AND B) contains the following active substances:
SACHET A:
Macrogol 3350
40 g
Sodium chloride
3.2 g
Potassium chloride
1.2 g
SACHET B:
Sodium ascorbate
48.11 g
Ascorbic acid
7.54 g
The concentration of electrolyte ions when the second dose (Sachets A
and B) is made up to 500 ml of
solution is as follows:
Sodium
297.6 mmol/500 ml
Ascorbate
Chloride
285.7 mmol/500 ml
70.9 mmol/500 ml
Potassium
16.1 mmol/500 ml
Excipients with known effect
Dose 2 (Sachet A) also contains 0.88 g of aspartame (E951).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral solution.
White to yellow powders.
4. Clinical particulars
4.1 Therapeutic indications
Plenvu is indicated in adults for bowel cleansing prior to any
procedure requiring a clean bowel.
4.2 Posology and method of administration
Posology
_ADULTS AND ELDERLY_
A course of treatment consists of two separate non-identical 500 ml
doses of Plenvu. At least 500 ml of
additional clear fluid, which may include water, clear soup, fruit
juice without pulp, soft drinks, tea and/or
coffee without milk must be taken with each dose.
This course of treatment can be taken according to a two-day or
one-day dosing schedules as specified
below:
Two-day dosing