Klean-prep

Leaflet attached to the packaging: patient information

Klean-Prep, powder for oral solution in a sachet

Macrogol 3350 + Anhydrous sodium sulfate + Sodium hydrogen carbonate + Sodium chloride + Potassium chloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 Klean-Prep and what is it used for
• 2. Important information before using Klean-Prep
• 3. How to use Klean-Prep
• 4. Possible side effects
• 5. How to store Klean-Prep
• 6. Contents of the packaging and other information

1. What is Klean-Prep and what is it used for

Klean-Prep contains macrogol 3350 and a mixture of salts. It comes in the form of a powder, which is used to prepare an oral solution.
The medicine is used orally:

• to cleanse the lower part of the digestive tract as preparation for a diagnostic examination or surgical operation, especially of the colon.
• for constipation, as a short-acting laxative.

2. Important information before using Klean-Prep

When not to use Klean-Prep

• in patients with congestive heart failure,

If the patient has any of the above-mentioned diseases or symptoms, they should not use Klean-Prep. In case of doubts, they should consult a doctor or pharmacist before using Klean-Prep.

Klean-Prep should not be used in children and adolescents.

Warnings and precautions

Before taking or administering Klean-Prep, oral solution powder, the patient should consult a doctor or pharmacist if:

• the patient has had a recent heart attack, unstable angina,
• the patient is elderly,
• the patient has swallowing problems,
• the patient suffers from gastroesophageal reflux,
• the patient has an impaired gag reflex,
• the patient has esophagitis,
• the patient has enteritis,
• the patient has electrolyte imbalance disorders occurring in renal failure, heart damage, and during treatment with diuretics,
• the patient suffers from phenylketonuria, a rare inherited disease, as Klean-Prep contains aspartame.

If the patient experiences sudden abdominal pain or bleeding from the anus while taking Klean-Prep for bowel cleansing, they should contact a doctor or seek medical help immediately.
If the patient has any of the above-mentioned diseases or suspects they may have one, they should consult a doctor or pharmacist.

Children and adolescents

Klean-Prep should not be used in children and adolescents.

Klean-Prep and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. This also applies to herbal medicines.
Klean-Prep may reduce the absorption of other medicines. The patient should avoid taking other laxatives or bowel cleansing medicines at the same time.
If the patient needs to thicken fluids to swallow them safely, Klean-Prep may counteract the effect of the thickener.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines

The effect of the medicine on the ability to drive and use machines has not been described.

Klean-Prep contains aspartame

The medicine contains aspartame, which is a source of phenylalanine. It may be harmful to patients with phenylketonuria. If the patient has phenylketonuria, they should consult a doctor before taking the medicine.

3. How to use Klean-Prep

This medicine should always be used as directed by a doctor. If the patient has any doubts, they should consult a doctor or pharmacist.
Adults:

Using the medicine for bowel cleansing and preparation for diagnostic examination or surgical operation:

The patient should remain fasting for at least 2 hours before taking Klean-Prep and not eat until the surgical operation and/or diagnostic examination is completed.
To reconstitute, the patient should dissolve the entire contents of a Klean-Prep sachet in 1000 ml (1 liter) of water, stirring to facilitate dissolution of the powder. The prepared solution is colorless and has a characteristic vanilla odor. The usual dose of Klean-Prep is 4 liters of solution (4 sachets), taken in 200-250 ml doses every 10-15 minutes until the entire prepared solution (4 liters) is consumed or until the fluid coming out of the anus becomes clear.
The required amount of solution can be taken in its entirety over 4-6 hours in the evening before a morning examination or divided as follows: 2 liters in the evening before the planned examination and up to 2 liters in the morning on the day of the examination. To ensure complete bowel cleansing, the patient should drink the last glass of prepared solution at least 1 hour before the examination.
Approximately 1 hour after taking the medicine, diarrhea should occur. This is a normal symptom indicating that the medicine has started to work.
The prepared solution tastes better when chilled.
When administered through a nasogastric tube, the infusion rate should be 20-30 ml/minute.

Note:

If the patient feels bloated or starts to experience discomfort in the abdominal cavity, they should slow down the drinking pace or walk until they feel relief. The patient should contact the person performing the examination or surgical procedure if they are concerned that they will not be able to drink the entire amount of solution before the examination.

For use as a short-acting laxative in constipation:

As with all laxatives, long-term use is not recommended.
The period of use of Klean-Prep for constipation should not be longer than 2 weeks, although if necessary, treatment can be repeated after this time and the product can be used for another 2 weeks. The patient should mix the contents of one sachet with 1000 ml of water and then drink the prepared solution over 4-6 hours.

Use in children and adolescents

Klean-Prep should not be used in children and adolescents under the age of 18.

4. Possible side effects

Like all medicines, Klean-Prep can cause side effects, although not everybody gets them.
The patient should stop taking Klean-Prep and contact a doctor immediately if they experience any of the following serious side effects, which may require immediate medical attention:

• swelling of the lips, face, tongue, or throat, difficulty breathing or fainting, itching, and hives. These symptoms may be a sign of an allergic reaction. Allergic reactions to Klean-Prep are rare (may affect 1 in 1000 patients) but can be serious.

Other side effects

Common (may affect up to 1 in 10 people):
Nausea, bloating, abdominal distension, abdominal discomfort
Uncommon (may affect up to 1 in 100 people):
Abdominal pain and epigastric pain, vomiting, anal irritation, seizures associated with low sodium levels in the blood
Rare (may affect up to 1 in 1000 people):
Headache, electrolyte imbalance disorders such as low sodium and potassium levels in the blood, shortness of breath, edema, chills
Very rare (two documented cases in the literature): vomiting induced by the intake of a laxative solution containing macrogol caused a tear in the esophageal mucosa (Mallory-Weiss syndrome) and consequent bleeding from the upper gastrointestinal tract.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Klean-Prep

Store in a place out of sight and reach of children.
Do not use Klean-Prep after the expiry date stated on the sachet and carton or after the expiry date on the container. The expiry date refers to the last day of the month.
Store below 25°C. The solution should be stored for 48 hours in the refrigerator (2-8°C) or 2 hours at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Klean-Prep contains

• The active substances of the medicine are: macrogol 3350, anhydrous sodium sulfate, sodium hydrogen carbonate, sodium chloride, and potassium chloride. Each sachet contains: 59 g of macrogol, 5.685 g of anhydrous sodium sulfate, 1.685 g of sodium hydrogen carbonate, 1.465 g of sodium chloride, and 0.7425 g of potassium chloride
• Other ingredients are: aspartame (E 951), vanilla flavor (Vanilla flavor 17410067).

After dissolving the contents of one sachet in 1 liter of water, the resulting solution contains:
Sodium
125 mmol/l
Potassium
10 mmol/l
Sulfates
40 mmol/l
Chlorides
35 mmol/l
Bicarbonates
20 mmol/l

What Klean-Prep looks like and what the pack contains

• The medicine is a white or cream-colored powder for dissolution in water. After dissolution, it forms a clear, colorless solution with a vanilla odor.

Packaging types:
The medicine is packaged in sachets placed in a carton or in sachets placed in a container with a screw cap.
Pack sizes:
2 or 4 sachets in a carton.
4 sachets in a container with a screw cap.
Not all pack sizes may be marketed.

Marketing authorization holder

Perffarma Sp. z o.o.
ul. Królowej Marysieńki 13/11
02-954 Warsaw

Manufacturer

Helsinn Birex Pharmaceuticals Ltd.
Damastown, Mulhuddart, Dublin 15
Ireland

Date of last revision of the leaflet: