Klean-prep

Patient Information Leaflet

Klean-Prep, powder for oral solution in sachet
Macrogol 3350 + Sodium sulfate anhydrous + Sodium hydrogen carbonate + Sodium chloride + Potassium chloride
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Klean-Prep is and what it is used for
2. Important information before taking Klean-Prep
3. How to take Klean-Prep
4. Possible side effects
5. How to store Klean-Prep
6. Contents of the pack and other information

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

Klean-Prep contains macrogol 3350 and a mixture of salts. It is available as a powder used to prepare an oral solution.
The medicine is taken by mouth:

• to cleanse the lower gastrointestinal tract in preparation for diagnostic procedures or surgical interventions, particularly of the large intestine.
• for constipation, as a short-acting laxative.

2. Important information before using Klean-Prep

When not to use Klean-Prep

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• in patients with congestive heart failure,
• in patients with severe kidney damage,
• in patients with peptic ulcer disease of the stomach or intestines,
• in cases of acute toxic colitis,
• in cases of severe abdominal distension (colonic dilation),
• if the patient has or is suspected of having intestinal obstruction or perforation,
• if the patient has intestinal obstruction (passage of food content from the stomach to the intestine is blocked or slowed),
• if the patient has gastric retention,
• if the patient is unconscious or not fully conscious,
• if the patient has a tendency towards aspiration or regurgitation of food,
• if the patient is debilitated,
• if the patient has impaired sphincter muscle function.

If any of the above conditions or symptoms are present in the patient, Klean-Prep must not be used.
In case of doubt, consult a doctor or pharmacist before using Klean-Prep.
Klean-Prep must not be used in children and adolescents.
Warnings and precautions

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

• the patient has acute myocardial infarction, unstable angina pectoris,
• the patient is elderly,
• the patient has difficulty swallowing,
• the patient suffers from gastroesophageal reflux,
• the patient has impaired vomiting reflex,
• the patient has esophagitis,
• the patient has enteritis,
• the patient has electrolyte imbalance due to kidney failure, heart damage, or during treatment with diuretics,
• the patient has phenylketonuria, a rare inherited disorder, because Klean-Prep contains aspartame.

If during administration of Klean-Prep for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, contact a doctor or seek immediate medical attention.
If any of the above conditions are present or suspected in the patient, consult a doctor or pharmacist.
Children and adolescents

Klean-Prep must not be used in children and adolescents.
Klean-Prep and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. This also includes herbal medicines.
Klean-Prep may reduce the absorption of other medicines. Concomitant use of other laxatives or bowel cleansing agents should be avoided.
If thickening of fluids is required to facilitate safe swallowing, Klean-Prep may interfere with the action of thickeners.
Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery

The effect of Klean-Prep on the ability to drive and operate machinery has not been reported.
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, he or she should contact a doctor before taking this medicine.

3. How to use Klean-Prep

This medicine should always be used as directed by a physician. If in doubt, consult your doctor or pharmacist.

Adults:

Use of the medicine for bowel cleansing prior to diagnostic examination or surgical procedure:

It is recommended that the patient remain fasting for at least 2 hours before administration of Klean-Prep and refrain from eating until after completion of the scheduled diagnostic tests and/or surgical procedure.

To reconstitute, dissolve the entire contents of one Klean-Prep sachet in 1000 ml (1 litre) of water, stirring to aid dissolution of the powder. The resulting solution is colourless and has a characteristic vanilla odour. The usual dose of Klean-Prep is 4 litres of solution (4 sachets), taken as 200–250 ml every 10–15 minutes until the entire 4-litre volume is consumed or until rectal effluent becomes clear.

The required volume may be taken entirely over 4–6 hours the evening before a morning procedure, or divided as follows: 2 litres in the evening before the scheduled examination and the remaining 2 litres in the morning on the day of the examination. To ensure complete bowel cleansing, it is recommended to drink the last glass of solution at least one hour before the procedure.

Approximately one hour after taking the medicine, diarrhoea should develop. This is a normal effect indicating that the medicine has started to work.

The prepared solution tastes better if chilled.

When administered via a nasogastric tube, the infusion rate should be 20–30 ml/minute.

Note:

If the patient experiences bloating or abdominal discomfort, the rate of ingestion should be slowed or the patient should walk around until relief is obtained. Contact the healthcare provider who will perform the examination or surgical procedure if there is concern about not being able to drink the entire volume of solution before the procedure.

Use as a short-acting laxative in constipation:

As with all laxative products, prolonged use is not recommended. The duration of treatment with Klean-Prep in constipation should usually not exceed 2 weeks. However, if necessary, treatment may be repeated after this period and the product may be used for an additional 2 weeks. Mix the contents of one sachet in 1000 ml of water and drink the prepared solution within 4–6 hours.

Use in children and adolescents:

Klean-Prep must not be used in children and adolescents under 18 years of age.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should stop taking Klean-Prep and contact your doctor immediately if any of the following serious adverse reactions occur, which may require urgent medical attention:

• swelling of the lips, face, tongue or throat, difficulty breathing or fainting, itching and raised rash
  These symptoms may be signs of an allergic reaction. Allergic reactions during treatment with Klean-Prep are rare (may affect 1 in 1,000 treated patients) but can be serious.

Other adverse reactions
Common (may occur in 1 out of 10 patients):
Nausea, flatulence, abdominal distension, abdominal discomfort

Uncommon (may occur in 1 out of 100 patients):
Abdominal and epigastric pain, vomiting, irritation of the anal area, cramps associated with low blood sodium levels

Rare (may occur in 1 out of 1,000 patients):
Headache, disturbances in electrolyte balance such as low levels of sodium and potassium in the blood, shortness of breath, oedema, chills

In very rare cases (two documented cases in the literature), vomiting induced by ingestion of a bowel cleansing solution containing macrogol has led to oesophageal mucosal tear (Mallory-Weiss syndrome) and subsequent upper gastrointestinal bleeding.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Klean-Prep

Keep out of the sight and reach of children.
Do not use Klean-Prep after the expiry date stated on the sachet, cardboard box, or container. The expiry date refers to the last day of the stated month.
Store below 25°C. After preparation, the solution may be stored: for 48 hours in the refrigerator (2–8°C) or for 2 hours at room temperature below 25°C.
Medicines must 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 Klean-Prep contains

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

After dissolving the contents of one sachet in one litre of water, the resulting solution contains:
Sodium 125 mmol/l
Potassium 10 mmol/l
Sulfate 40 mmol/l
Chloride 35 mmol/l
Bicarbonate 20 mmol/l

What Klean-Prep looks like and contents of the pack

• The medicine is a white or cream-coloured powder for dissolution in water. After dissolution, a clear, colourless solution with a vanilla odour is obtained.

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

Marketing Authorisation Holder
Perffarma Sp. z o.o.
ul. Królowej Marysieńki 13/11
02-954 Warszawa
Poland

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