MEROKEN

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

MACROGOLS; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Tillgänglig från:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC-kod:

A06AD10

Läkemedelsform:

POWDER FOR SOLUTION

Sammansättning:

MACROGOLS 315.0 G; POTASSIUM CHLORIDE 1.1175 G; SODIUM BICARBONATE 4.2840 G; SODIUM CHLORIDE 8.4240 G

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

TARO PHARMACEUTICAL INDUSTRIES LTD

Terapeutisk grupp:

MINERAL SALTS IN COMBINATION

Terapiområde:

MINERAL SALTS IN COMBINATION

Terapeutiska indikationer:

Bowel cleansing prior to colonoscopy and barium enema x-ray examinations.

Tillstånd datum:

2013-12-31

Bipacksedel

1
_Meroken PIL-Notification-08.2021 _
_-_
_ _
_ENG _
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
MEROKEN
®
POWDER FOR PREPARATION OF A LEMON-FLAVORED SOLUTION
_ _
ACTIVE INGREDIENTS
Each bottle contains
polyethylene glycol 3350
315.0 g
sodium chloride
8.424 g
sodium bicarbonate
4.284 g
potassium chloride
1.118 g
Inactive ingredients and allergens: see section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about the medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed for you; do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
This medicine is usually not intended for children and/or infants.
What is the most important information I should know about MEROKEN?
MEROKEN may cause severe side effects such as:
Severe loss of fluids (dehydration) and changes in salt (electrolyte)
balance in the blood.
These changes may cause:_ _
o
abnormal heart rate which may result in death_ _
o
convulsions, even if you have never had them before_ _
o
kidney problems_ _
The chance of losing fluids and of change in electrolyte balance in
the body when using
MEROKEN increases if you have:
o
heart conditions_ _
o
kidney diseases_ _
o
if you are taking diuretics or nonsteroidal anti-inflammatory drugs
(NSAIDs)
Consult a doctor immediately if you experience any of the following
effects:
o
vomiting_ _
o
dizziness_ _
o
decreased frequency of urination_ _
o
headache_ _
_ _
For further information about the side effects, see the section
4 ‘Side effects’.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
MEROKEN is a preparation intended for cleansing the bowels so that
they are ready for
examinations such as: colonoscopy, barium enema, etc.
THERAPEUTIC GROUP: osmotic laxative.
2
_Meroken PIL-Notification-08.2021 _
_-_
_

Produktens egenskaper

1
_Meroken SPC - Clean – 08.2021 _
MEROKEN
POWDER FOR PREPARATION OF A LEMON-FLAVORED SOLUTION
PER OS
ACTIVE INGREDIENTS:
POLYETHYLENE GLYCOL 3350, 315.0 G
SODIUM CHLORIDE, 8.424 G
SODIUM BICARBONATE, 4.284 G
POTASSIUM CHLORIDE, 1.118 G
PRESCRIBING INFORMATION
1. INDICATIONS AND USAGE
Meroken is indicated for bowel cleansing prior to colonoscopy and
barium enema x-ray
examinations.
2. DOSAGE AND ADMINISTRATION
2.1 DOSAGE OVERVIEW
Meroken, supplied as a powder, must be reconstituted with water before
its use; it is not for
direct ingestion
_[see Dosage and Administration (2.2), Warnings and Precautions
(5.8)]._
Do not reconstitute with other liquids and/or add starch-based
thickeners to the mixing
container
_[see Warnings and Precautions (5.7)]_
.
2.2 ADMINISTRATION INSTRUCTIONS PRIOR TO DOSAGE
It is preferable not to eat solid food the day before the examination
and
4
-
3
hours before
drinking the solution.
It is essential not to eat two hours before drinking the solution and
until the examination is
completed.
Only drink clear fluids:
•
On the day before the examination
•
When drinking the solution
•
After finishing drinking the solution until 2 hours before the
colonoscopy
The pharmacist should open the bottle, add 2.7 liters of tap water or
up to the line marked 3
liters at the top of the bottle, close the bottle and shake well until
completely dissolved.
2
_Meroken SPC - Clean – 08.2021 _
2.3 DOSAGE
The following is the recommended dose of reconstituted Meroken
solution for adults.
Instruct patients they may consume water or clear liquids during the
bowel preparation and
after completion of the bowel preparation up until 2 hours before the
time of the colonoscopy.
The solution is more palatable if chilled prior to administration.
Instruct patients to drink the 3 liters of solution at a rate of one
glass (240 ml) every 10
minutes until the solution is consumed. It is recommended to drink
each glass all at once.
The solution is lemon-flavored. Do not add any flavorings or any other
supplements to the