VistaPrep oral powder 110g sachets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Sodium; Chloride; Potassium; Bicarbonate; Macrogol '3350'

Disponibbli minn:

Tillotts Pharma UK Ltd

Kodiċi ATC:

A06AD65

INN (Isem Internazzjonali):

Sodium; Chloride; Potassium; Bicarbonate; Macrogol '3350'

Dożaġġ:

65mmol/1litre ; 53mmol/1litre ; 5.4mmol/1litre ; 17mmol/1litre ; 105gram/1litre

Għamla farmaċewtika:

Powder for oral solution

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 01060400; GTIN: 7640129620968

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
VISTAPREP 110g Powder for oral solution.
Macrogol 3350, sodium chloride, sodium bicarbonate 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 or pharmacist has
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What VistaPrep is and what it is used for
2.
What you need to know before you take VistaPrep
3.
How to take VistaPrep
4.
Possible side effects
5.
How to store VistaPrep
6.
Contents of the pack and other information
1.
WHAT VISTAPREP IS AND WHAT IT IS USED FOR
VistaPrep is a white powder for oral solution with a laxative effect.
VistaPrep is used for bowel cleansing in preparation for the
examination of the colon (colonosco-
py) in adults over 18 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VISTAPREP
DO NOT TAKE VISTAPREP

if you are allergic to macrogol 3350, sodium chloride, sodium
bicarbonate, potassium
chloride saccharin sodium, orange flavour, lemon-lime flavour,
colloidal anhydrous silica
or any of the ingredients of this medicine (listed in section 6);

if you have a bowel obstruction or suspected bowel obstruction,
strictures or perforations
in the gastrointestinal area, or if you are at risk of perforations in
the gastrointestinal area;

if you suffer from problems emptying your stomach or have a severe,
highly inflammato-
ry form of colitis (colon inflammation) and a severe, abnormally
enlarged colon due to
this colitis (toxic megacolon);

if you have an impaired swallowing and gag reflex, or suffer from
general weakness.
VistaPrep should not be administered to patients with impaired
consciousness and patients pron

Karatteristiċi tal-prodott

OBJECT 1
VISTAPREP 110G POWDER FOR ORAL SOLUTION
Summary of Product Characteristics Updated 23-Apr-2018 | Tillotts
Pharma UK Limited
1. Name of the medicinal product
VistaPrep 110g Powder for oral solution.
2. Qualitative and quantitative composition
Each sachet contains the following active substances:
Macrogol 3350
105.000 g
Sodium chloride
2.800 g
Sodium bicarbonate
1.430 g
Potassium chloride
0.370 g
The electrolyte ion content of one sachet after preparation of 1,000
mL solution is equivalent to:
Sodium
65 mmol/L
Chloride
53 mmol/L
Bicarbonate
17 mmol/L
Potassium
5 mmol/L
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral solution.
Appearance: white powder.
4. Clinical particulars
4.1 Therapeutic indications
VistaPrep is used for bowel cleansing in preparation for colonoscopy.
VistaPrep is indicated in adults over 18 years of age.
4.2 Posology and method of administration
Posology
For complete bowel cleansing, 3 up to a maximum of 4 litres of
VistaPrep solution must be taken. 1
sachet corresponds to 1 L solution.
_Paediatric population_
VistaPrep should not be used in children because the safety has not
been established in this patient group.
Method of administration
The route of administration is for oral use.
The solution is drunk in portions of 200 - 300 mL every 10 minutes
until the rectal effluent is clear or 4
litres maximum have been drunk.
Administration takes place over a period of about 4 hours, generally
on the examination day. The total
amount required can also be taken on the evening before, or a part
taken on the evening before and the
remaining amount on the morning of the examination day.
Patients should consume no solid food for 2 to 3 hours prior to
administration of VistaPrep until after the
examination.
Precautions to be taken before handling or administering the medicinal
product
For instructions on reconstitution of the medicinal product before
administration, see section 6.6. For
further directions for use see section 6.2 Incompatibilities.
4.3 Cont