PACKAGE LEAFLET: INFORMATION FOR THE USER
Olopeg 52.5 g/100 ml (13.125 g/25 ml)
Concentrate for oral solution
Macrogol
{For member states were the medicinal product is subject to medical prescription:}
Read all of this leaflet carefully before you start taking 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.
{For member states were the medicinal product is not subject to medical prescription:}
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.
- You must talk to a doctor if you do not feel better or if you feel worse after 2 days.
What is in this leaflet
1. What Olopeg is and what it is used for
2. What you need to know before you take Olopeg
3. How to Olopeg
4. Possible side effects
5. How to store Olopeg
6. Contents of the pack and other information
1. What Olopeg is and what it is used for
Olopeg is an osmotic laxative.
Olopeg is used for
- short term relief of constipation
- bowel cleansing before diagnostic examination of the intestines (e.g. colonoscopy) and prior to
surgery on the bowels.
2. What you need to know before you take Olopeg
Do not take Olopeg in case of
- known allergy to macrogol (polyethylene glycol) or any of the other ingredients of this
medicine (listed in section 6)
- abdominal pain of uncertain cause
- obstruction of the intestines or obstruction is suspected (ileus)
- abnormal narrowing (stenosis), perforation or risk of perforation in the stomach or intestines
- disturbance in stomach emptying
- acute gastrointestinal ulcer
- severe inflammatory bowel diseases (Crohn's disease, ulcerative colitis, toxic megacolon,
toxic or rapidly progressive colitis)
- unconsciousness
Warnings and precautions
If you are in poor health or have a serious medical condition, you should be particularly aware of
the possible side effects listed in section 4. Contact your doctor or pharmacist if you are
concerned.
Talk to your doctor before taking Olopeg if you have any of the following:
- heart failure, circulatory failure or functional disturbances of the kidney (renal insufficiency)
and liver diseases
- disturbance of consciousness
- tendency for breathing in fluid material into the lungs or vomiting as well as disturbed
swallowing reflex and gag reflex
- severe dehydration.
If you have symptoms like e.g. oedema, breathlessness, increasing tiredness, dehydration or
cardiac failure indicating an imbalance between water and electrolytes in the body, the intake of
Olopeg must be immediately stopped, electrolytes should be measured and appropriate measures
should be taken if necessary.
If you are diabetic, carbohydrate exchange units must not be taken into account when using this
medicine.
If you have predisposition to water and electrolyte imbalance (e.g. patients taking diuretics) you
should use Olopeg only after explicit advice of their physician and with increased caution. In case
of diarrhoea, a monitoring of your water and electrolyte balance is indicated.
Elderly should use Olopeg with greater caution as elderly patients are more sensitive to potential
adverse effects caused by medicinal products. This has to be considered especially in case of
diarrhoea and the possible disturbance in the water and the electrolyte balance.
If you suffer gastric reflux disease or heart rhythm disturbance you should use Olopeg only under
the supervision of a physician.
You should contact your doctor even if above-mentioned remarks concern past situations.
Children
For constipation, the available data does not support the use of Olopeg in children < 2 years.
For bowel cleansing prior to diagnostic investigation there is no sufficient experience in the
application to children below 18 years. Therefore, for bowel cleansing Olopeg should not be used
in children and adolescents younger than 18 years.
Other medicines and Olopeg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
When diagnostic tests are performed on the liquid flushed out of the bowels, enzymes that may be
used in these tests (e.g. ELISA) can be affected by the polyethylene glycol contained in Olopeg.
Interactions between Olopeg and other medicines during treatment of constipation:
There are no clinical reports on interactions between Olopeg and other medicines. However, the
effect of some medicines may be weakened while using Olopeg because their absorption by the
body could be temporarily decreased. Therefore, it is recommended to take other medicines at
least two hours after or before the intake of Olopeg.
Interactions between Olopeg and other medicines taken during bowel cleansing:
Medicinal products can be washed out of the gastrointestinal tract or their absorption by the body
can be decreased or stopped if these products are taken several hours before the intake of Olopeg
or during the treatment with Olopeg. This concerns especially medicinal products with delayed
release. Often it is necessary to give another medicinal product due to vital indication shortly
before or during the intake of Olopeg. In these cases the oral form of the other medicinal product
should be replaced with intravenous or intramuscular form.
Olopeg with food and drink
Taking Olopeg for bowel cleansing before diagnostic examination or prior to surgery on the bowels,
you should stop eating solid food 2 to 3 hours prior to the first taking of Olopeg until the end of the
examination.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
The use of Olopeg during pregnancy and lactation has not been adequately studied. Therefore, the
medicinal product Olopeg should be administered to pregnant or breast-feeding women only when
absolutely necessary.
Driving and using machines
There is no evidence that Olopeg affects the ability to drive or use machines.
Olopeg contains potassium and sodium
Potassium diet or reduced kidney function:
If you suffer from reduced kidney function or you are on low potassium diet please pay attention on
the amount of 1.26 mmol (49 mg) of potassium contained in one dose (125 ml of ready-to-use
solution) of Olopeg.
Sodium diet:
If you are on low sodium diet please pay attention on the amount of 8.09 mmol (186 mg) of sodium
contained in one dose (125 ml of ready-to-use solution) of Olopeg.
3. How to take Olopeg
{For member states were the medicinal product is subject to medical prescription:}
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
{For member states were the medicinal product is not subject to medical prescription:}
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
As for all laxatives, the use of Olopeg is not recommended for longer periods. The period of
treatment with Olopeg should not exceed two weeks. If required, Olopeg can be used repeatedly.
Short term relief of constipation
For additional treatment with maintaining an appropriate lifestyle and an appropriate diet.
The daily dose should be adjusted according to the results obtained.
Before treatment begins, your physician has to exclude an organic disease.
Daily dosage:
Use in children and adolescents:
From 2 to 4 years: 7.5 ml to 15 ml of Olopeg concentrate*
From 4 to 8 years: 15 ml to 30 ml of Olopeg concentrate*
From 8 to 18 years: 20 ml to 35 ml of Olopeg concentrate*
* The necessary amount of Olopeg concentrate must be mixed with fourfold volume of water
before ingestion (e.g. 7.5 ml of Olopeg concentrate + 30 ml of water).
Adults:
2-3 times daily: Mix 25 ml of Olopeg concentrate with 100 ml of water (125 ml total) before taking.
Elderly:
Initially, once daily: Mix 25 ml of Olopeg concentrate with 100 ml of water (125 ml total) before
taking.
Bowel cleansing prior to diagnostic examination
The intake of the bowel cleansing solution should be started over a period of about 4 hours,
generally on the day of the examination. Alternatively, the total required amount can also be taken
in the evening prior to the investigation or, alternatively, a part can be taken in the evening before
the investigation and the remaining part in the morning of the investigation day.
2 to 3 hours prior to the first taking of Olopeg until the end of the examination, you should not eat
solid food.
To obtain 1 litre of the ready-to-use solution, mix 200 ml of Olopeg concentrate with 800 ml of
drinking water.
For complete bowel evacuation 3 to 4 litres of the ready-to-use solution should be taken.
You should take this ready-to-use solution in portions of 200-300 ml every 10 minutes, until the
rectal outflow is clear or until most 4 litres have been taken.
You will basically have diarrhoea as part of the bowel cleansing process. Therefore you should
have ready access to a toilet.
If you suffer of gastrointestinal problems, you should reduce the intake of Olopeg temporarily or
stop intake until the symptoms subside.
Use in children:
For bowel cleansing the use of Olopeg in children younger than 18 years has not been adequately
studied. Therefore, for bowel cleansing Olopeg should not be used in children and adolescents
younger than 18 years.
If you take more Olopeg than you should
If you take more Olopeg than you should, you may develop severe pain, flatulence or severe
diarrhoea. If you have any of these reactions please contact your doctor immediately!
If you forgot to take Olopeg
If you have taken significantly less than the recommended dose of Olopeg, bowel cleansing may be
insufficient and the planned investigation cannot be performed. Follow your doctor’s instructions or
the instructions in this leaflet closely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with macrogol 3350 and 4000.
Possible side effects during treatment of constipation
Common side effects, occurring in 1 to 10 out of 100 treated patients:
abdominal pain, abdominal bloating, stomach growling and nausea as a result of increased volume
of intestinal contents.
Very rare side effects, occurring in less than 1 out of 10,000 treated patients:
allergic reactions like skin reaction, snuffles (rhinitis), swelling of the dermis (Quinckes oedema)
and anaphylactic shock.
Possible side effects during bowel cleansing
Common side effects, occurring in 1 to 10 out of 100 treated patients:
Nausea, abdominal bloating, abdominal cramps and flatulence. These reactions are caused by
taking relatively huge amounts of liquid within a short time. Also feeling ill and difficulty sleeping
were reported.
Uncommon side effects, occurring in 1 to 10 out of 1,000 treated patients:
Vomiting and anal irritation.
Very rare side effects, occurring in less than 1 out of 10,000 treated patients:
After the intake of polyethylene glycol solutions arrhythmia, tachycardia and accumulation of fluid
in body tissues (oedema) were observed. Therefore, in case of high-risk patients a close
monitoring of the water and the electrolyte balance is necessary. In individual cases the calcium
level in serum decreased.
Skin rash (urticaria), runny nose (rhinorrhoea) or eczema (dermatitis) and anaphylactic shock were
observed. These symptoms are presumed to be symptoms of allergy. Stop taking Olopeg and
contact your doctor immediately.
Side effects, occurring with not known frequency (cannot be estimated from the available data):
Some cases of Mallory-Weiss syndrome (tears in the stomach lining close to where the stomach
joins the oesophagus) caused by vomiting after taking polyethylene glycol-containing solution for
bowel preparation have been observed.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.
5. How to store Olopeg
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Shelf-life: 3 years.
Shelf-life after the first opening: 3 weeks.
Shelf-life of ready-to-use solution: 48 hours.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the
carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Olopeg contains
The active substances are macrogol 4000, sodium citrate, citric acid, anhydrous, sodium
chloride and potassium chloride.
1 ml of the concentrate (5 ml of the ready-to-use solution) contains
macrogol 4000
525.0 mg
sodium citrate
19.5 mg
citric acid, anhydrous
sodium chloride
potassium chloride
-
16.5 mg
7.3 mg
1.9 mg
The other ingredients are raspberry flavour, acesulfame potassium and purified water.
The concentration of electrolyte ions when diluted to one litre of ready-to-use solution is as follows:
Sodium
64.8 mmol/l
Potassium 10.1 mmol/l
Chloride 30.1 mmol/l
Citrate
30.5 mmol/l
What Olopeg looks like and contents of the pack
Olopeg is a clear and colourless liquid.
The ready-to-use solution is a clear and colourless liquid with odour and taste of raspberry.
Available packaging: Transparent PET-bottles of amber colour containing 100 ml, 200 ml, 500 ml
and 1000 ml respectively, closed with a PP/PE screw cap. A measuring cup made of polyethylene
is placed into a cardboard box.
The included measuring cup has the following graduation: 2 ml, 2.5 ml, 4 ml, 5 ml, 6 ml, 7.5 ml, 8
ml, 10 ml, 12.5 ml, 15 ml, 17.5 ml, 20 ml, 22.5 ml, 25 ml, 27.5 ml, 30 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MIP Pharma GmbH
Kirkeler Straße 41
D-66440 Blieskastel
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
< {Name of the Member State} >
< {Name of the medicinal product} >
< {Name of the Member State} >
< {Name of the medicinal product} >
This leaflet was last approved in 2013-06-26