NIFLEC
COMPOSITION
One sachet (137.155 g) contains :
Macrogol 4000 118.000 g
Sodium sulfate 11.37 g
Sodium hydrogen carbonate 3.37 g
Sodium chloride 2.930 g
Potassium chloride 1.485 g
ACTIONS
When sufficient volume of PEG is taken, it leads to an increase in volume in the colon. This
distends the colon and there by stretch the receptors resulting in increased peristaltic
movements. This products voluminous liquid stool.
The Sodium Chloride, Sodium Sulphate, Potassium Chloride and Sodium Bicarbonate salts
prevents both loss and net absorption of ions from the body.
INDICATION
Clean the remains in the intestinal tracts, as initial action prior to large intestine endoscopy and
surgery.
METHOD OF USAGE AND DOSAGE
Dilute one sachet of drug into 2 liters water to make solution.
Normally for one time usage, an adult takes the solution of 4 liters with drinking rate of about 1
liter each hour. However, stop taking the drug if the excretion fluid is already clear. The dosage
must not exceed 4 liters.
As initial Action Prior to Large Intestine Endoscopy
Administered on the same day of examination : do not take breakfast on the same day
(1) (only drinking is allowed in order to add body fluid), administration commences 4 hours
prior to the scheduled examination.
Administered one day prior to the day examination : fasting after dinner at the previous
night (only drinking is allowed in order to add body fluid), administration commences 1
(2)
hour after dinner. However, food with little waste must be taken for breakfast and lunch,
and liquid food instead of solid food for dinner.
As Initial Action Prior to Large Intestine Surgery
Fasting should commence after lunch on the day of surgery (only drinking is allowed in order to
add body fluid), then administration of this drug commences after more than about 3 hours after
lunch.
PRECAUTION
1. This drug should be administered with caution to the following patients :
a. Patients suffering from angina pectoris, myocardial infarction (with the administration of this
drug, the body temperature may decline, that sometimes resulted in chest pain).
b. Patients with renal function disorder (sometimes it may induce nausea).
2. Basic important things to note
a. Sometimes it may result in Mallory Weis syndrome, tiny holes in the intestinal tract,
followed by bleeding large intestine inflammation, therefore, in administering this drug, the
following must be taken into notice :
Mallory Weis syndrome will appear due to the increasing pressure in the stomach or
nausea, therefore avoid administering this drug within a short period of time
(administer this drug about 1 liter per hour).
The contraction in the intestinal tract or the detention of this drug and the contents of
intestines may cause nausea, that will result in such syndromes.
Tiny holes at the intestinal tract and bleeding large intestine inflammation are caused
by the increasing pressure in the intestinal tract, thus at the time of contraction in the
intestinal tract or the detention of remaining food in the intestinal tract, this drug
should be administered with caution.
Drug is administered after bowel movement on the previous day prior to the
administration of drug or prior to the administration of drug on the same day.
Avoid administering this drug within a short period of time (administer this drug about
1 liter per hour).
If one liter has been administered, but there is no bowel movement, first ensure that
there is no nausea or abdominal pain before administration of this drug is continued,
while keep monitoring bowel movements.
Caution should be taken in administering this drug for patients wit cavity in the
intestinal tract, because development of tiny holes in the intestinal tract has been
reported due to the increased pressure in the intestinal tract.
b. If other ingredients or aromatic materials are added into the solution of this drug, this will
change the osmosis pressure and electrolyte density, and it will probably result in
inflammable gas produced by bacteria in the intestine, thus such materials are prohibited.
c. If the patient applies this drug at home, the following should be taken into notice.
In case of side effect, it will be difficult to handle, thus it is warned not to use the drug
while alone.
Drink should be done slowly and it is warned to take notice of the initial syndromes of
anaphylaxis.
Give detail of the side effects of using this drug, such as syndromes of the digestive
tract (nausea, abdominal pain, and others), shock anaphylaxis, and it should be
warned that in case of any of the syndromes, stop using this drug and seek medical
assistance.
d. Administration of drug to patient who is using insulin or other diabetes drugs :
For patients who is controlling blood sugar by insulin or other diabetes drug, avoid
administering this drug prior to the day of examination.
The drug should be given on the day of examination under strict supervision.
Insulin or other diabetes drugs should be administered after meal on the day of
examination (because during the period of food control, it is worried that low blood
sugar condition may arise).
e. Effect on absorption of other drugs :
Administration of this drug may probably cause the impediment in absorbing other
drugs.
This drug may also cause problems for patient who is taking clinical test, this drugs
must be administered in hospital under strict supervision.
3. Administration of drug to elderly. In general, the biological function of the elderly has dropped,
thus the administration of drug must be slowed down. Drug must be given under strict
supervision.
4. Administration of drug to pregnant women, delivering mothers, nursing mothers and others.
a. This drug is only administered to pregnant women or those with pregnancy probability,
when it is determined that the advantages in treatment exceed the potential risk.
b. Safety in the administration of this drug to pregnant women is still uncertain.
5. Administration of drug to children
Safety in the administration of this drug is still uncertain.
SIDE EFFECT
1. Shock, anaphylaxis
a. This drug must be under strict supervision due to the probability of shock and anaphylaxis.
b. The drug must be stopped and appropriate action should be taken in case of symptoms
such as paleness, declining blood pressure, vomiting, continued nausea, anxiety,
dizziness, feeling cold, rash, respiratory problems, swelling on the face, etc.
2. Tiny holes in the intestinal tract
a. This drug must be administered under strict supervision because tiny holes may develop in
the intestinal tract.
b. Drug must be stopped and appropriate actions must be taken when abnormal symptom is
detected.
3. Heavy vomiting which results in low sodium vomiting syndrome may cause consciousness
problem, and others.
In case of such syndrome, appropriate actions must be given, such as compensation of
electrolyte fluid and others.
4. Other side effects :
Above 5% or unclear
0.1% - below 5% Below 0.1%
percentage
Oversensitive Measles, rash
Central and
Unsteadiness,
peripheral nerve
feeling cold
system
Psychotropic nerve
Insomnia
system
Abdominal swelling,
Noise in the
Digestive system nausea, abdominal Anus pain
stomach
pain, vomiting
Respiratory system Chest pain
Syndromes of
low blood
sugar, high
Internal secretion Positive ketone
blood
system body
pressure,
increase of
uric acid
Increase of GOT,
Increase of GPT,
Increase of LDH,
Increase of
Bilirubin,
Liver
Increase of protein,
Decrease of
Protein, Increase of
alkali postage
Protein in urine
Kidney
being positive
Sharp
increase of
leukocytes;
increase of
Blood Leukopenia sodium in
blood serum,
decline of
sodium in
blood serum
Headache, dry Fever,
mouth, frequent shivering,
Others Fatigue
bowel movements, feeling of
heat in chest heavy head
WARNING IN USAGE
1. Method of preparation
Dissolved one sachet of this drug in water about 2 liters, then given to the patient orally.
2. During preparation
The solution of this drug must not be added with other composition or aromatic substances.
3. During storage
After being dissolved, it is better to use it directly, otherwise, keep it in the refrigerator and it
must be used within 48 hours.
4. Length of time in administering drug
Move the solution (about 180 ml) into the glass. Within one hour drink about 6 glasses (about
one liter).
5. During administration of drug
In many cases, bowel movement usually commences after administration of about one liter
solution.
Administration of this drug is continued until the excretion fluid becomes clear.
Maximum dosage is 4 liters.
After the administration of drug is completed, the patient will still have a few bowel
movements.
If there is still no bowel movement after administration of 2 liters solution, the drug must be
stopped and may only be re-administered after there is no nausea, vomiting, abdominal
pain and after bowel movement.
6. Purpose of usage
Please note that this drug is not suitable for initial actions prior to intestine X-ray inspection
with Barium injection.
CONTRAINDICATIONS
Do not administered to the following patients :
1. Symptoms of digestive tract blockage (risk of tiny holes in the stomach and intestines).
2. Tiny holes in the intestinal tract (risk of complications, such as peritonitis, etc.).
3. Symptoms of toxic colitis (appearance of tiny holes that causes peritonitis and intestinal tract
bleeding).
DRUG INTERACTIONS
1. Administration of drug to patient who is using insulin or other diabetes drugs :
a. Avoid administering this drug prior to the day of examination.
b. The drug should be given on the day of examination under strict supervision.
c. Insulin or other diabetes drugs should be administered after meal on the day of examination.
2. Administration of this drug may probably cause the impediment in absorbing other drugs.
STORAGE
Stored at room temperature (15ºC - 30ºC).
PACKAGING
Box, one sachet @ 137.155 g
Reg. no.
Imported by :
PT MEIJI INDONESIAN
PHARMACEUTICAL INDUSTRIES
BANGIL-PASURUAN, JAWA TIMUR-INDONESIA
Manufactured by :
AJINOMOTO PHARMA CO., LTD
7 – 2, YAESU – CHOME, CHUO – KU
TOKYO 104 – 0028, JAPAN