Clensia

Package Leaflet: Information for the User

Clensia, Powder for Oral Solution

List of active substances, see section 6.

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Clensia and what is it used for
• 2. Important information 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 is Clensia and what is it used for

Clensia is a lemon-flavored, gut-acting medicine, available as an oral powder in 8 sachets.
The set contains 4 large sachets A and 4 small sachets B. Before use, their contents should be dissolved in water.
The medicine is taken to cleanse the intestines before a diagnostic examination.
Clensia works by emptying the intestines of their contents, so after taking it, you can expect watery stools.
This medicine is intended for adults only.

2. Important information before taking Clensia

When not to take Clensia

• if you are allergic to macrogol or any of the other ingredients of this medicine (listed in section 6).
• if you have a bowel obstruction
• if you have a perforation of the gastrointestinal tract
• if you have gastric emptying disorders
• if you have paralysis of the gastrointestinal tract (frequent after abdominal surgery)
• if you have toxic megacolon or toxic colitis (severe complication of acute colitis).

Clensia should not be given to unconscious patients.

Warnings and precautions

Before taking Clensia, discuss it with your doctor or pharmacist.
If your health is poor or you have a serious illness, you should be particularly aware of the possible side effects listed in section 4. In case of doubt, consult your doctor or pharmacist.
If you experience sudden abdominal pain or rectal bleeding while taking Clensia for bowel cleansing, contact your doctor or seek medical help immediately.
Before taking Clensia, tell your doctor if you:

• need to thicken fluids to swallow them safely
• have a tendency to regurgitate swallowed drinks, food, or acidic stomach contents
• have kidney disease
• have heart failure or heart disease, including hypertension or arrhythmias
• are dehydrated (have lost fluids from your body, which may result in weight loss, thirst, dizziness, dry mouth, headache, darkening and concentration of urine)
• have an acute flare-up of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Clensia should not be given to patients with impaired consciousness without medical supervision.

Children and adolescents

Clensia is not recommended for children under 18 years of age.

Clensia with other medicines

If you are taking other medicines, take them at least one hour before or at least one hour after taking Clensia, as they may be flushed out of the gastrointestinal tract and not work properly. In particular, a transient increase in blood pressure has been observed, related to insufficient absorption of antihypertensive drugs.
Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
If you are taking medicines that affect kidney function (e.g., diuretics, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers), after taking Clensia, there is a higher risk of water and electrolyte disorders. You will be monitored for proper hydration. Before and after treatment, your doctor will consider performing laboratory tests (electrolytes, creatinine, and urea in the blood).
If you need to thicken fluids to swallow them safely, Clensia may reverse the effect of the thickener used.

Clensia with food and drink

During treatment with this medicine until the diagnostic examination is completed, do not eat any solid foods.

Pregnancy and breastfeeding

Since the absorption of Clensia into the body is very low, this medicine can be used during pregnancy if necessary.
There is no documented experience with the use of this medicine during breastfeeding. Since the absorption of this medicine into the body of a breastfeeding woman is very low, this medicine can be used during breastfeeding if necessary.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Clensia does not affect the ability to drive and use machines.

Clensia contains sodium and potassium

This medicine contains 3877.8 mg of sodium (the main component of common salt) per liter. This corresponds to 194% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine contains 11.2 mmol of potassium per liter. This should be taken into account in patients with renal failure or patients on a potassium-restricted diet.

3. How to take Clensia

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is for oral use only.
The packaging contains 4 large sachets A and 4 small sachets B. During a single treatment cycle, dissolve 8 sachets in 2 liters of water.
Dissolve 2 sachets A and 2 sachets B in 1 liter of water.
Before taking Clensia, read the instructions below carefully. You should know:

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

When to take Clensia
Instructions on when to take this medicine will be provided by your doctor or nurse.
Treatment with this medicine should be completed before the clinical examination; the following instructions can be applied:
Full dose the day before the examination: Dissolve 4 sachets A and 4 sachets B in 2 liters of water and drink it in the evening the day before the examination.

• Divided dose:Dissolve 2 sachets A and 2 sachets B in 1 liter of water and drink it in the evening the day before the examination, and then dissolve the next 2 sachets A and 2 sachets B in 1 liter of water and drink it in the morning on the day of the examination.

Important: After taking Clensia and until the examination is completed, do not eat solid foods.

How to prepare Clensia

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

How to take Clensia

• Full dose In the evening before the procedure, dissolve 2 sachets A and 2 sachets B in 1 liter of water and drink the Clensia solution within 1 to 1.5 hours. Try to drink 250 ml of the medicine every 15-20 minutes. After a 1-2 hour rest, dissolve 2 sachets A and 2 sachets B in 1 liter of water again and drink the prepared solution. During the entire treatment course, it is recommended to drink an additional liter of clear fluid to prevent potential fluid loss due to diarrhea and maintain proper hydration. Suitable fluids are water, clear soup, fruit juice (without pulp), soft drinks, tea, or coffee (without milk). These drinks can be consumed at any time.
• Divided dose

In the evening before the procedure, dissolve 2 sachets A and 2 sachets B in 1 liter of water and drink the solution within 1 to 1.5 hours.
In addition, during the evening, drink at least 500 ml of 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 (2 sachets A and 2 sachets B dissolved in 1 liter of water) and drink it, then drink an additional 500 ml of clear fluid (water, fruit juice, soft drink, tea/coffee without milk).
Maintain at least a 2-hour interval between drinking fluids and the start of the colonoscopy.
What to expect
When you start drinking the Clensia solution, it is essential to have access to a toilet.
At some point, you will experience watery stools. This is completely normal and indicates that the solution is working.
Bowel movements will stop soon after you finish drinking the solution.
If you follow the instructions, your intestines will be cleansed, which will help perform an effective examination.

Use in children and adolescents

This medicine should not be used in children under 18 years of age.

Overdose of Clensia

If you take more Clensia than recommended, you may experience intense diarrhea, which can lead to dehydration. Drink plenty of fluids, especially fruit juices. In case of doubt, consult your doctor or pharmacist.

Missed dose of Clensia

If you forget to take Clensia, take the missed dose as soon as you remember.
If it has been several hours since the planned time of taking the medicine, consult your doctor or pharmacist. It is essential to complete the preparation at least two hours before the diagnostic examination.

Stopping Clensia

In case of further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clensia can cause side effects, although not everybody gets them.
It is normal for Clensia to cause diarrhea after taking it.
If you experience any of the following side effects, stop taking Clensia and consult your doctor as soon as possible. Do not take Clensia again until your doctor advises you to do so.

• rash or itching
• swelling of the face, ankles, or other parts of the body
• irregular heartbeat
• extreme fatigue
• shortness of breath

Very common side effects (may affect more than 1 in 10 people):

Nausea, abdominal pain, bloating.

Common side effects (may affect more than 1 in 100 people):

Headache, vomiting, anal inflammation.

Uncommon side effects (may affect more than 1 in 1,000 people):

Transient increase in blood pressure, abdominal pain, taste disorders, dry mouth, chills, decrease in potassium levels in the blood.
The following side effects have been reported with the use of other medicines containing polyethylene glycol, but it is not known how often they occur, as their frequency cannot be estimated from the available data:
allergic reactions (sometimes severe, up to anaphylactic shock), dehydration, dizziness, irregular heartbeat, malaise, hypoxia, dizziness, redness, urticaria, changes in electrolyte levels, e.g., decrease or increase in sodium, calcium, and chloride levels, as well as a decrease in bicarbonate levels.
The sodium level in the blood may also decrease, especially in patients taking medicines that affect the kidneys, such as angiotensin-converting enzyme inhibitors and diuretics used to treat heart disease (see also "Clensia with other medicines").
These reactions usually occur on the day of the examination. If they do not resolve, consult your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Clensia

Keep this medicine out of the 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 month.
Clensia sachets should be stored at a temperature below 30°C.
After dissolving the contents of the sachets in water, the solution can be stored (covered) at a temperature below 25°C or can be stored in the refrigerator (2°C-8°C).
Do not store the solution for more than 24 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Clensia contains

The active substances of Clensia are:

Sachet A

Macrogol 4000
52,500 g
Anhydrous sodium sulfate
3,750 g
Simethicone
0,080 g

Sachet B

Sodium citrate
1,863 g
Anhydrous citric acid
0,813 g
Sodium chloride
0,730 g
Potassium chloride
0,370 g
The concentration of electrolyte ions after dissolving the contents of two sachets A and two sachets B in one liter 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 flavor (composition: lemon oil, citric acid, citral, powdered sugar with cornstarch, arabic gum, maltodextrin).

What Clensia looks like and contents of the pack

Clensia is available in a single pack sufficient for one treatment cycle, which contains 4 large sachets A and 4 small sachets B, and in multipacks containing 24, 48, 96, 192 packs sufficient for a single treatment cycle.
Not all pack sizes may be marketed.

Marketing authorization holder:

Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96,
00-807 Warsaw

Manufacturer:

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

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 22.09.2023

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• - Information intended for healthcare professionals only:

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

• swallowing disorders with a tendency to aspiration or regurgitation of food
• impaired consciousness
• severe renal impairment (creatinine clearance <30 ml min)< li>
• heart failure (NYHA class III or IV)
• dehydration
• severe inflammatory bowel disease. Before administering Clensia to dehydrated patients, they should be rehydrated. During administration, especially through a nasogastric tube, patients with impaired consciousness and patients prone to aspiration or regurgitation of food should be carefully monitored. Clensia should not be given to unconscious patients.