Coloprep 1500 mg Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Sodium phosphate monobasic; Sodium phosphate dibasic, anhydrous

Tillgänglig från:

Laboratoires Mayoly Spindler

ATC-kod:

A06AD; A06AD17

INN (International namn):

Sodium phosphate monobasic; Sodium phosphate dibasic, anhydrous

Dos:

1500 milligram(s)

Läkemedelsform:

Tablet

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Osmotically acting laxatives; sodium phosphate

Bemyndigande status:

Not marketed

Tillstånd datum:

2017-09-01

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLOPREP 1500 MG TABLETS
Sodium dihydrogen phosphate monohydrate
Disodium phosphate anhydrous
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
⁻
Keep this leaflet. You may need to read it again.
⁻
If you have any further questions, ask your doctor or pharmacist.
⁻
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
⁻
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 Coloprep is and what it is used for
2.
What you need to know before you take Coloprep
3.
How to take Coloprep
4.
Possible side effects
5.
How to store Coloprep
6.
Contents of the pack and other information
1.
WHAT COLOPREP IS AND WHAT IT IS USED FOR
Coloprep contains the active substances sodium dihydrogen phosphate
monohydrate and disodium
phosphate anhydrous which belong to a group of medicines that are
described as purgatives (very
strong laxatives). They are used to clean the bowel by causing large
amounts of water to be drawn into
the bowel resulting in diarrhoea.
Coloprep is used for cleansing the bowel before certain diagnostic
procedures such as colonoscopy.
Coloprep is indicated in adults over the age of 18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLOPREP
DO NOT TAKE COLOPREP IF YOU HAVE:

an allergy (hypersensitivity) to sodium phosphate salts or to any of
the other ingredients of this
medicine (listed in section 6).

been told that you have kidney failure or that your kidneys have been
damaged by the
formation of phosphate crystals (phosphate nephropathy).

a problem with your parathyroid gland known as primary
hyperparathyroidism.

problems with your heart, heart failure or severe chest pains.

an accumulation of fluid in your abdomen (ascites).

bowel problems such

Produktens egenskaper

Health Products Regulatory Authority
01 November 2021
CRN009XWF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coloprep 1500 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1102 mg of sodium dihydrogen phosphate
monohydrate and 398 mg of disodium phosphate anhydrous
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white oval compressed 18.7 mm x 10 mm tablets. The upper
half bisected with a monogram “SLX” on the left and
“102” on the right, and the lower half plain. The score line is
only to facilitate breaking for ease of swallowing and not to divide
into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated for cleansing of the bowel when required as
a preparation for certain diagnostic procedures such as
colonoscopy.
Coloprep is indicated in adults over 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS (OVER 18 YEARS OF AGE):
The usual adult dosage of this medicine is 32 tablets. The total dose
of phosphate is 32.79 g.
The intake of this medicine should begin the day before the
colonoscopy. The day before the colonoscopy, patients may have
a light, low-fibre breakfast (coffee or tea with or without sugar,
toast, butter or equivalent, fruit jelly or honey). After noon,
taking only “clear liquids” is permitted. “Clear liquid” may
be water, light soup, diluted fruit juice without pulp, weak tea or
black coffee, light soda with or without bicarbonate.
Recommended administration regimen:
The evening before the colonoscopy procedure:
· Take 4 tablets with 250 ml of water (or another clear liquid)
· Then repeat 4 times in the same conditions, every 15 minutes, for a
total of 20 tablets to swallow.
The day of the colonoscopy procedure, (starting 3-5 hours before the
procedure):
· Take 4 tablets with 250 ml of water (or another clear liquid)
· Then repeat 2 times in the same conditions, every 15 minutes for a
total of 12 tablets to swallow.
Health