Clensia

Package leaflet: Information for the user

Clensia, powder for oral solution
List of active substances, see section 6.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet contents

1. What Clensia is and what it is used for
2. What you need to know before taking Clensia
3. How to take Clensia
4. Possible side effects
5. How to store Clensia
6. Contents of the pack and other information

1. What Clensia is and what it is used for

Clensia is a lemon-flavoured intestinal-acting medicine, available as an oral powder in 8 sachets.
The pack contains 4 sachets A (large) and 4 sachets B (small). The contents must be dissolved in water before use.
Clensia is taken to cleanse the bowel prior to a diagnostic examination.
This medicine works by emptying the bowel contents, therefore watery stools may be expected after taking it.
This medicine is intended for adults only.

2. Important information before taking Clensia

When not to take Clensia

• if the patient is allergic to macrogol or any of the other ingredients of this medicine (listed in section 6).
• if the patient has gastrointestinal obstruction
• if the patient has gastrointestinal perforation
• if the patient has gastric emptying disorders
• if the patient has gastrointestinal paralysis (common after abdominal surgery)
• if the patient has toxic colitis or toxic megacolon (severe complications of acute colitis).

Clensia must not be given to unconscious patients.
Warnings and precautions
Before taking Clensia, discuss this with your doctor or pharmacist.
If the patient's general health condition is poor or the patient suffers from a serious illness, particular attention should be paid to the possible adverse reactions listed in section 4. In case of doubt, contact your doctor or pharmacist.
If, during administration of Clensia for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, contact a doctor or seek immediate medical assistance.
Before taking Clensia, inform the doctor if the patient:

• needs thickened fluids to swallow them safely
• has a tendency for regurgitation of swallowed drinks, food, or acidic stomach contents
• has kidney disease
• has heart failure or heart disease, including hypertension or arrhythmias
• is dehydrated (has lost body fluids, which may result in weight loss, thirst, dizziness, dry mouth, headache, dark and concentrated urine)
• has an acute flare-up of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Clensia must not be administered without medical supervision to patients with impaired consciousness.
Children and adolescents
Clensia is not recommended for use in children under 18 years of age.
Clensia and other medicines
If the patient is taking other medicines, they should be taken at least one hour before or at least one hour after taking Clensia, as they may be flushed out of the gastrointestinal tract and may not work properly. In particular, a transient increase in blood pressure has been observed due to inadequate absorption of antihypertensive drugs.
Tell your 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.
If the patient is taking medicines that affect kidney function (e.g. diuretics, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers), there is an increased risk of fluid and electrolyte disturbances after administration of Clensia. The patient will be monitored for adequate hydration. Before and after treatment, the doctor may consider performing laboratory tests (electrolytes, creatinine, and blood urea nitrogen).
If the patient requires thickened fluids to swallow safely, Clensia may counteract the effect of the thickening agent used.
Clensia with food and drink
During treatment with this medicine and until completion of the diagnostic procedure, no solid food should be consumed.
Pregnancy and breastfeeding
Since absorption of Clensia into the body is very low, this medicine may be used if necessary during pregnancy.
There is no documented experience regarding the use of this medicine during breastfeeding. Since absorption of this medicine into the body of a breastfeeding woman is very low, this medicine may be used if necessary during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Clensia has no influence on the ability to drive or operate machinery.
Clensia contains sodium and potassium
This medicine contains 3877.8 mg of sodium (the main component of table salt) per litre. This corresponds to 194% of the maximum recommended daily dietary sodium intake for adults.
This medicine contains 11.2 mmol of potassium per litre. This should be taken into account in patients with renal impairment or in patients on a potassium-restricted diet.

3. How to take Clensia

This medicine should always be taken as directed by the physician. In case of doubt, consult your doctor or pharmacist.
This medicine is intended for oral use.
The package contains 4 sachets A (large) and 4 sachets B (small). During a single treatment cycle, 8 sachets should be dissolved in 2 litres of water.
2 sachets A and 2 sachets B should be dissolved in 1 litre of water.
Before taking Clensia, carefully read the instructions below. The patient should know:

• When to take Clensia
• How to prepare the Clensia solution
• How to drink Clensia
• What to expect

When to take Clensia
Instructions on when to take this medicine will be provided by the doctor or nurse.
Treatment with this medicine should be completed before the clinical examination; the following regimens may be used:
Full dose the day before the procedure: Dissolve 4 sachets A and 4 sachets B in 2 litres of water and drink in the evening the day before the examination.

• Split dose: Dissolve 2 sachets A and 2 sachets B in 1 litre of water and drink in the evening the day before the examination, then dissolve another 2 sachets A and 2 sachets B in 1 litre of water and drink in the morning on the day of the examination.

Important: After taking Clensia, solid foods must not be consumed until the examination is completed.
How to prepare Clensia

• Open 2 sachets A (large) and 2 sachets B (small).
• Empty the contents of 2 sachets A and 2 sachets B into a suitable container.
• Add 1 litre of water to the container and stir until the powder is completely dissolved.
• After preparation, the solution may be stored (covered) at a temperature below 25°C until the start of the bowel cleansing procedure. The solution may also be stored in a refrigerator.

How to take Clensia

• Full dose: In the evening before the procedure, dissolve 2 sachets A and 2 sachets B in 1 litre of water and drink the Clensia solution within 1 to 1.5 hours. Try to drink 250 ml of the solution every 15–20 minutes. After resting for 1–2 hours, dissolve another 2 sachets A and 2 sachets B in 1 litre of water and drink the prepared solution. Throughout the entire treatment course, it is recommended to drink an additional litre of clear fluid to help prevent potential fluid loss due to diarrhoea and maintain adequate hydration. Suitable fluids include water, clear soup, fruit juice (without pulp), non-carbonated or carbonated soft drinks, tea or coffee (without milk). These fluids may be consumed at any time.
• Split dose

In the evening before the procedure, dissolve 2 sachets A and 2 sachets B in 1 litre of water and drink the solution within 1 to 1.5 hours.
Additionally, during the evening, drink at least 500 ml of additional clear fluids (water, fruit juice, soft drinks, tea/coffee without milk).
On the day of the diagnostic examination, prepare the solution according to the same instructions (dissolve 2 sachets A and 2 sachets B in 1 litre of water), drink it, and then drink an additional 500 ml of clear fluid (water, fruit juice, soft drink, tea/coffee without milk).
Maintain at least a two-hour interval between drinking fluids and the start of colonoscopy.
What the patient should expect
When the patient starts drinking the Clensia solution, it is important to have access to a toilet.
At some point, the patient will experience watery bowel movements. This is completely normal and indicates that the solution is working.
Bowel movements will stop shortly after the patient finishes drinking the solution.
If the patient follows the instructions provided, the bowel will be adequately cleansed, which will help ensure an effective examination.
Use in children and adolescents
This medicine must not be used in children under 18 years of age.
Taking more Clensia than recommended
If a patient takes more Clensia than recommended, intense diarrhoea may occur, which could lead to dehydration. The patient should drink large amounts of fluids, especially fruit juices. In case of doubt, contact a doctor or pharmacist.
Missing a dose of Clensia
If the patient forgets to take Clensia, they should take the missed dose as soon as they remember.
If several hours have passed since the scheduled dose, consult a doctor or pharmacist. It is important to complete the preparation at least two hours before the diagnostic examination.
Stopping treatment with Clensia
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
It is normal to experience diarrhoea after taking Clensia.
If any of the adverse reactions listed below occur, you should stop taking the medicine and contact your doctor as soon as possible. Do not take Clensia again until you have received medical advice.

• Rash or itching
• Swelling of the face, ankles or other body parts
• Irregular heartbeat
• Severe fatigue
• Shortness of breath

Very common adverse reactions (may affect more than 1 in 10 people):
Nausea, abdominal pain, bloating.
Common adverse reactions (may affect more than 1 in 100 people):
Headache, vomiting, inflammation of the anus.
Uncommon adverse reactions (may affect more than 1 in 1,000 people):
Transient increase in blood pressure, abdominal pain, taste disturbances, dry mouth, chills, decreased potassium levels in blood.

The following adverse reactions have been reported with the use of other medicines containing polyethylene glycol, but their frequency is unknown because it cannot be estimated based on available data:
allergic reactions (sometimes severe, up to shock), dehydration, dizziness, irregular heartbeat, malaise, pre-syncope, sensation of spinning surroundings, redness, urticaria, changes in blood electrolyte levels, e.g. decreased or increased levels of sodium, calcium and chloride, and decreased bicarbonate levels.
Blood sodium levels may also decrease, particularly in patients taking medicines affecting the kidneys, such as angiotensin-converting enzyme inhibitors and diuretics used in the treatment of heart diseases (see also "Clensia and other medicines").
These reactions occur mainly on the day of the procedure. If they do not resolve, medical advice should be sought.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, PL - 02 222 Warsaw,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Clensia

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the specified month.
Clensia sachets should be stored at a temperature below 30°C.
After dissolving the contents of the sachets in water, the solution may be stored (covered) at a temperature below 25°C or it may also be stored in a refrigerator (2°C–8°C).
The solution should not be stored for longer than 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Clensia contains
The active substances in the medicine are:
Pouch A
Macrogol 4000 52.500 g
Anhydrous sodium sulfate 3.750 g
Simeticone 0.080 g
Pouch B
Sodium citrate 1.863 g
Anhydrous citric acid 0.813 g
Sodium chloride 0.730 g
Potassium chloride 0.370 g

Electrolyte ion concentration after dissolving the contents of two pouches A and two pouches B in one litre of water is:
Sodium 168.6 mmol/l
Sulfate 52.8 mmol/l
Chloride 34.9 mmol/l
Potassium 11.2 mmol/l
Citrate 21.1 mmol/l

Other excipients are potassium acesulfame (E950), lemon flavour (composition: lemon oil, lemon essential oil, citral, powdered sugar with corn starch, gum arabic, maltodextrin).

What Clensia looks like and contents of the pack
Clensia is available in single packs sufficient for one treatment cycle, containing 4 pouches A (large) and 4 pouches B (small), as well as in multi-packs containing 24, 48, 96, or 192 single-cycle packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96,
00-807 Warsaw, Poland

Manufacturer:
Sigmar Italia S.p.A.
Via Sombreno, 11
24011 Almé (BG)
Italy

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
France: Ximepeg Poudre pour solution buvable
Germany: Clensia Pulver zur Herstellung einer Lösung zum Einnehmen
Italy: Clensia Polvere per soluzione orale
Netherlands: Clensia Poeder voor drank
Poland: Clensia Proszek do sporzadzania roztworu doustnego
Portugal: Clensia Pó para solução oral
Czech Republic: Clensia Prášek pro perorální roztok
Romania: Clensia Pulbere pentru soluţie orală
Slovakia: Clensia Prášok na perorálny roztok
Spain: Clensia Polvo para solución oral

• • Information intended exclusively for healthcare professionals:

Warning for healthcare professionals:
Clensia should be used with caution in sensitive patients with poor general health and in patients with serious clinical conditions, such as:

• swallowing disorders with a tendency to aspiration or regurgitation
• impaired consciousness
• severe renal impairment (creatinine clearance <30 ml/min)
• cardiac insufficiency (NYHA class III or IV)
• dehydration
• severe inflammatory disease

Dehydrated patients should be rehydrated before administration of Clensia. Patients with impaired consciousness, as well as patients prone to aspiration or regurgitation, should be carefully monitored during administration of Clensia, especially when administered via nasogastric tube. Clensia must not be administered to unconscious patients.