Olopeg

Package Leaflet: Information for the Patient

Olopeg, 52.5 g/100 ml (13.125 g/25 ml), Concentrate for Solution
Macrogol

• Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Olopeg and what is it used for
• 2. Important information before using Olopeg
• 3. How to use Olopeg
• 4. Possible side effects
• 5. How to store Olopeg
• 6. Contents of the pack and other information

1. What is Olopeg and what is it used for

Olopeg is an osmotic laxative.
Indications

• Symptomatic treatment of constipation
• Bowel cleansing before diagnostic examination (e.g., colonoscopy) and before bowel surgery

Treatment of constipation with this medicine only supports a healthy lifestyle and diet of the patient (increased fluid and fiber intake, adequate physical activity, and restoration of the bowel movement reflex).

2. Important information before using Olopeg

When not to use Olopeg

• if the patient is allergic to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6),
• if the patient has abdominal pain of unknown cause,
• if the patient has intestinal obstruction or suspected intestinal obstruction,
• if the patient has narrowing, perforation, or risk of perforation in the gastrointestinal tract,
• in patients with a tendency to gastric emptying disorders,
• in patients with acute gastrointestinal ulcer disease,
• in patients with severe, inflammatory bowel disease (Crohn's disease, Ulcerative Colitis, toxic megacolon, toxic or rapidly progressive colitis),
• if the patient has heart and circulatory failure or kidney function disorders (kidney failure) or liver disease,
• in unconscious patients or patients with impaired consciousness,
• in patients with a tendency to choking or regurgitation of food and with swallowing and pharyngeal reflex disorders,
• in patients with severe dehydration.

Warnings and precautions

If during the use of Olopeg for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, they should contact a doctor or seek medical help immediately.
In patients with water and electrolyte balance disorders (with symptoms such as edema, dyspnea, increasing fatigue, dehydration, heart weakness), Olopeg should be discontinued, and electrolyte levels should be measured and appropriate measures taken if necessary.
The product contains potassium. Warning regarding dosing in patients with limited kidney function or those on a low-potassium diet: The medicine contains 1.26 mmol (or 49 mg) of potassium per dose (125 ml of ready-to-drink solution), which should be taken into account in patients with reduced kidney function and in patients controlling potassium intake in their diet.
The product contains sodium. Warning regarding dosing in patients on a low-sodium diet: The medicine contains 186 mg of sodium (the main component of table salt) in each dose unit (125 ml of ready-to-drink solution). This corresponds to 9.3% of the maximum recommended daily sodium intake in the diet for adults.
In diabetic patients, there is no need to count additional bread units.
In patients with a tendency to water and electrolyte balance disorders (e.g., elderly patients, patients with liver or kidney function disorders, patients taking diuretics), Olopeg can be used on the explicit recommendation of a doctor with special caution. In case of diarrhea in these patients, water and electrolyte balance control is recommended.
Elderly patients should use Olopeg with special caution, as they are usually more prone to adverse reactions to medicines.
This should be particularly remembered in case of diarrhea and water and electrolyte balance disorders.
In patients with reflux esophagitis or heart rhythm disorders (conduction disorders between the sinus node and the atrium, sick sinus syndrome), Olopeg can be used only under medical supervision.

Children

There have been no sufficient studies on the use of the medicine in children and adolescents, therefore, Olopeg should not be used in children and adolescents under 18 years of age.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
There have been no sufficient studies on the use of the medicine during pregnancy, therefore, Olopeg can be used in pregnant women only if necessary.
There have been no sufficient studies on the use of the medicine during breastfeeding, therefore, Olopeg can be used in breastfeeding women only if necessary.

Driving and using machines

The medicine has no influence or has a negligible influence on the ability to drive and use machines.
The solution does not containsodium sulfate or sugar.

Olopeg and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
During diagnostic tests performed using enzymatic methods (e.g., ELISA), there may be an interaction between polyethylene glycol and enzymes.
Interactions between Olopeg and other medicines used during the treatment of constipation
There are no clinical reports of interactions with other medicines. However, macrogol increases the solubility of substances soluble in alcohol and relatively poorly soluble in water. Therefore, there is a theoretical possibility that the absorption of such medicines may be temporarily reduced. Therefore, it is recommended to maintain a break of at least two hours between taking Olopeg and other medicines.
Interactions between Olopeg and other medicines used during bowel cleansing
If the patient has taken other medicines a few hours before or during the use of Olopeg, there may be a flushing of these medicines from the stomach and intestines or a reduction in their absorption or complete blockade of absorption. This applies especially to medicines with delayed release of active substances. If it is necessary to administer another medicine with a life-saving indication shortly before or during the use of Olopeg, it may be necessary to abandon oral administration of this medicine and use an intravenous or intramuscular form.

3. How to use Olopeg

This medicine should always be used as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Before drinking, Olopeg should be diluted in water according to the following scheme.
Symptomatic treatment of constipation
The medicine is used as an aid, with a healthy lifestyle and diet maintained.
Adults
2-3 times a day, 25 ml of Olopeg should be diluted in 100 ml of water (a total of 125 ml of solution per dose), and then drunk.
Elderly patients
Initially, once a day, 25 ml of Olopeg should be diluted in 100 ml of water (resulting in 125 ml of solution), and then drunk.
As with all laxatives, long-term use of Olopeg is not recommended. Olopeg should not be used for more than 2 weeks. If necessary, it can be used again.
Bowel cleansing before diagnostic examination
To prepare one liter of solution, 200 ml of Olopeg should be added to 800 ml of water.
To completely cleanse the bowel, 3-4 liters of solution should be drunk.
The solution should be drunk in portions of 200-300 ml every 10 minutes until the stool is clear or the patient has taken 3 liters (or a maximum of 4 liters) of the solution.
The bowel cleansing solution is usually taken about 4 hours before the start of the examination.
The patient may also need to drink the required amount of solution the previous evening or part of the solution the previous evening and the rest in the morning on the day of the examination.
For 2-3 hours before the administration of Olopeg and until the examination is performed, no solid food should be taken.
If gastrointestinal symptoms occur, the solution prepared with Olopeg should be drunk more slowly or its administration should be stopped until these symptoms disappear.

Using a higher dose of Olopeg than recommended

In case of symptoms indicating an overdose, such as severe pain, bloating, or severe diarrhea, consult a doctor.

Missing a dose of Olopeg

If the amount of solution drunk is significantly less than the recommended dose, bowel cleansing may be insufficient, which may make it impossible to perform the planned examination. The recommended dosage by the doctor or the instructions in the patient leaflet should be strictly followed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of severe side effects, including allergic reactions to the medicine (see below), the medicine should be discontinued, and a doctor or the Emergency Department of the nearest hospital should be contacted immediately.
Side effects related to the treatment with macrogol 3350 and macrogol 4000.
Side effects in the treatment of chronic constipation
Common: diarrhea
Uncommon: abdominal pain, bloating, bowel sounds, nausea, sudden need to defecate, fecal incontinence.
Very rare: allergic reactions, hypersensitivity reactions (itching, rash, facial swelling, Quincke's edema, anaphylactic shock (a severe, potentially life-threatening, generalized allergic reaction)).
Side effects in bowel cleansing
Common: nausea, feeling of fullness, bloating.
Uncommon: sudden need to defecate, fecal incontinence.
Rare: vomiting, stomach cramps, anal irritation. The cause of these side effects is the consumption of a relatively large amount of fluid in a short time.
Very rare: heart rhythm disorders, tachycardia, pulmonary edema. In patients at high risk, water and electrolyte balance should be closely monitored.
Frequency not known: decreased calcium ion levels in serum, electrolyte disorders (too low levels of calcium or potassium in the blood), rash, urticaria, edema, rhinorrhea, skin inflammation probably of allergic origin, malaise, insomnia.
There have been documented cases of Mallory-Weiss syndrome (longitudinal tears of the gastric mucosa in the region of the cardia) due to vomiting after the administration of a bowel lavage solution containing polyethylene glycol.
If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Olopeg

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister pack and carton.
Expiry date. The expiry date refers to the last day of the month stated.
Shelf life: 3 years
After first opening the bottle: 3 weeks
Prepared solution: 48 hours
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olopeg contains

• The active substance of the medicine is macrogol 4000,
• The other ingredients are: sodium citrate dihydrate, anhydrous citric acid, sodium chloride, potassium chloride, raspberry flavor (H + R No. 203580), acesulfame potassium, purified water.

What Olopeg looks like and contents of the pack

The medicine is a concentrate for solution preparation.
It is packed in plastic bottles in a cardboard box.
The pack contains 100 ml, 200 ml, 500 ml, or 1000 ml of syrup. A measuring cup is attached to the pack.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
Tel.: 58 303 93 62
Fax: 58 322 16 13
e-mail: [email protected]

Manufacturer

Chephasaar, Chemisch-pharmazeutische Fabrik GmbH
Mühlstrasse 50
D-66386 St. Ingbert
Germany

Date of last revision of the leaflet: