Izinova concentrate for oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium sulfate; Magnesium sulfate heptahydrate; Sodium sulfate anhydrous

Available from:

Allergan Ltd

INN (International Name):

Potassium sulfate; Magnesium sulfate heptahydrate; Sodium sulfate anhydrous

Dosage:

17.784mg/1ml ; 18.614mg/1ml ; 99.489mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01060500

Patient Information leaflet

_________________________________________________________________________________________________________
Document name: 23_IZI_UK
Reason for change: FR/H/511/01/ IAIN/020 Update to section 4.3 of SmPC
and PIl to include safety information for colic
formulations
Document replaced: 17_IZI_UK
Preparation date: 181204
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
IZINOVA CONCENTRATE FOR ORAL SOLUTION
Sodium sulphate anhydrous, magnesium sulphate heptahydrate and
potassium sulphate
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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 Izinova
is and what it is used for
2.
What you need to know before you take Izinova
3.
How to take Izinova
4.
Possible side effects
5.
How to store Izinova
6.
Contents of the pack and other information
1.
WHAT IZINOVA IS AND WHAT IT IS USED FOR
Izinova contains three different active substances called: sodium
sulphate, magnesium sulphate and
potassium sulphate.
Izinova is used in adults to cleanse your bowel before a medical
procedure or bowel surgery.
Izinova is not a treatment for constipation.
Izinova must be diluted before use with the amount of water stated in
the method of administration (see
section 3).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IZINOVA
DO NOT TAKE IZINOVA IF:

You are

Summary of Product characteristics

OBJECT 1
IZINOVA CONCENTRATE FOR ORAL SOLUTION (IPSEN
LIMITED)
Summary of Product Characteristics Updated 23-Dec-2015 | Allergan Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Izinova concentrate for oral solution.
2. Qualitative and quantitative composition
This medicinal product is a concentrated sulphate-based saline
solution to be further diluted in water
before administration [see section 4.2]. One treatment comprises the
intake of two bottles. The content of
each of the two bottles is identical. Quantities of active ingredients
in one and two bottles are presented
below:
1 bottle containing about 176 ml
concentrate (195.375 g)
2 bottles corresponding to 2 x about
176 ml concentrate (390.750 g)
Sodium sulphate anhydrous
17.510 g
35.020 g
Magnesium sulphate
heptahydrate
3.276 g
6.552 g
Potassium sulphate
3.130 g
6.260 g
The total content of electrolyte ions is as follows:
Content in g
Content in mmol
1 bottle
2 bottles
1 bottle
2 bottles
Sodium*
5.683
11.366
247.2
494.4
Potassium
1.405
2.81
35.9
71.8
Magnesium
0.323
0.646
13.3
26.6
Sulphate
14.844
29.688
154.5
309.0
* derived from sodium sulphate (active ingredient) and sodium benzoate
(excipient).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for oral solution.
Clear to slightly hazy solution.
4. Clinical particulars
4.1 Therapeutic indications
Izinova is indicated in adults for bowel cleansing prior to any
procedure requiring a clean bowel (e.g.
bowel visualisation including endoscopy and radiology or surgical
procedure).
Izinova is not a treatment for constipation.
4.2 Posology and method of administration
POSOLOGY
Adults
Two bottles of Izinova are needed for appropriate cleansing of the
bowel. Prior to administration, the
content of each bottle must be diluted in water, using