Clensia

Package leaflet: Information for the user

Clensia powder for oral solution

For the list of active substances, see section 6.
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 lime-flavoured bowel preparation available as an oral powder in
8 sachets.
The pack contains 4 sachets A (large) and 4 sachets B (small), to be reconstituted in water
before use.
You take this medicine to clean the bowel in preparation for an examination.
Clensia works by emptying the bowel contents, so you should expect to feel liquid moving
inside the abdomen.
This medicine is intended for use in adults only.

2. What you need to know before taking Clensia

Do not take Clensia

• if you are allergic to macrogol or to any of the other ingredients of this medicine (listed in section 6)
• if you have gastrointestinal obstruction
• if you have gastrointestinal perforation
• if you have disorders related to stomach emptying
• if you have intestinal paralysis (often occurring after abdominal surgery)
• if you suffer from toxic colitis or toxic megacolon (a serious complication of acute colitis).

Clensia must not be administered to unconscious patients.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clensia.
If you are in poor general health or have a serious medical condition, you should be
particularly aware of the possible side effects listed in section 4.
If in doubt, consult your doctor or pharmacist.
Talk to your doctor before taking Clensia if you are in any of the following situations:

• you need to thicken liquids in order to swallow them without difficulty
• you tend to regurgitate ingested drinks and food or gastric acids
• you suffer from kidney disease
• you have heart failure or heart conditions including arterial hypertension and irregular heartbeat
• you are dehydrated (loss of body fluids which may lead to reduced body weight, thirst, dizziness, dry mouth, headache, dark and concentrated urine)
• you have flare-ups of inflammatory bowel diseases (Crohn’s disease or ulcerative colitis)

Do not administer Clensia without medical supervision to patients with altered consciousness.
If you experience sudden abdominal pain or rectal bleeding while taking Clensia for bowel preparation, contact a doctor immediately.
Children and adolescents
Clensia must not be used in children under 18 years of age.
Other medicines and Clensia
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 through the intestine and may not work as intended. In particular, a transient increase in blood pressure has been observed due to inadequate absorption of antihypertensive drugs.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking medicines that affect kidney function (such as diuretics, non-steroidal anti-inflammatory drugs, ACE inhibitors, or Angiotensin Receptor Inhibitors), taking Clensia may increase your risk of developing fluid and electrolyte imbalances. You should be monitored to ensure adequate hydration, and laboratory tests (electrolytes, creatinine, and blood urea nitrogen) should be considered before and after treatment.
Clensia with food and drinks
Do not consume solid food from the time you start taking this medicine until after the procedure.
Pregnancy and breastfeeding
Since absorption of Clensia into the body is negligible, Clensia may be used during pregnancy, if necessary.
There are no data available regarding the use of this medicine during breastfeeding. Since absorption of this medicine into the body of a breastfeeding woman is negligible, it may be used during breastfeeding, if necessary.
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Clensia does not impair 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 liter. This corresponds to 194% of the maximum recommended daily dietary intake for an adult.
This medicine contains 11.2 mmol of potassium per liter. Patients with impaired kidney function or those on a potassium-controlled diet should take this into account.

3. How to take Clensia

Take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
This medicine is for oral use.
The package contains 4 sachets A (large) and 4 sachets B (small). For a single treatment course,
8 sachets must be dissolved in 2 litres of water.
Two sachets A and two sachets B must be dissolved in one litre of water.
Before taking Clensia, read the following instructions carefully. You need to know:

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

When to take Clensia
You should have received instructions from your doctor or nurse on when to take this medicine.
Treatment with this medicine must be completed before the clinical examination and can be taken as follows:

• Single dose the day before the examination: 4 sachets A and 4 sachets B dissolved in 2 litres of water, to be drunk the evening before the examination.
• Split dose regimen: 2 sachets A and 2 sachets B dissolved in 1 litre of water and drunk the evening before the examination, followed by 2 more sachets A and 2 more sachets B dissolved in 1 litre of water and drunk on the morning of the examination day.

Important: Do not eat solid foods from the time you start taking Clensia until after
the examination.
How to prepare Clensia

• Open 2 sachets A (large) and 2 sachets B (small).
• Pour 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 all the powder is dissolved.
• After reconstitution, the solution may be stored (covered) at a temperature below 25°C until bowel preparation begins. The solution may also be refrigerated.

How to take Clensia

• Single dose regimen On the evening before the examination day, dissolve 2 sachets A and 2 sachets B in 1 litre of water and drink the Clensia solution within 1–1.5 hours. Try to drink 250 ml (two glasses) every 15–20 minutes. After an interval of approximately 1–2 hours, dissolve another 2 sachets A and 2 sachets B in 1 litre of water and drink this solution. During treatment, you are advised to drink an additional 1 litre (eight glasses) of clear fluid to prevent potential fluid loss due to diarrhoea and to maintain adequate hydration. Water, clear broth, fruit juice (without pulp), non-carbonated drinks, tea or coffee (without milk) are all suitable beverages. These drinks may be taken at any time you wish.
• Split dose regimen On the evening before the diagnostic examination, dissolve 2 sachets A and 2 sachets B in 1 litre of water and drink the Clensia solution within 1–1.5 hours. In addition, drink at least 500 ml (four glasses) of another clear fluid (water, fruit juice, non-carbonated drinks, tea/coffee without milk) during the evening. On the morning of the diagnostic examination, prepare the solution following the same procedure (2 sachets A and 2 sachets B dissolved in 1 litre of water), followed by 500 ml (four glasses) of another clear fluid (water, fruit juice, non-carbonated drinks, tea/coffee without milk).

Wait at least two hours without drinking anything before starting the colonoscopy.
What to expect
When you start drinking the Clensia solution, it is important to stay close to a toilet. At some point, you will begin to feel liquid moving through your intestines. This is completely normal and indicates that the solution is working. Bowel movements will stop once you have finished drinking the solution.
If you follow these instructions, your bowel will be clean, which will help ensure the examination is properly performed and successful.
Use in children and adolescents
This medicine must not be taken by children under 18 years of age.
If you take more Clensia than you should
If you take more Clensia than you should, you may experience excessive diarrhoea, which could lead to dehydration. Drink plenty of fluids, especially fruit juices. If you are concerned, contact your doctor or pharmacist.
If you forget to take Clensia
If you forget to take Clensia, take the missed dose as soon as you remember. If several hours have passed since the time you were supposed to take it, consult your doctor or pharmacist. It is important that you complete the bowel preparation at least two hours before the examination.
If you stop taking Clensia
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is normal to have diarrhoea when taking Clensia.
If any of the following occur, stop taking the medicine and contact your doctor immediately. Do not take any further Clensia until you have informed your doctor:

• skin rash or itching
• swelling of the face, ankles or other parts of the body
• irregular heartbeat
• excessive tiredness
• difficulty breathing

Very common side effects (may affect more than 1 in 10 people):
Nausea, abdominal pain, abdominal distension.

Common side effects (may affect more than 1 in 100 people):
Headache, vomiting, anal pain.

Uncommon side effects (may affect more than 1 in 1,000 people):
Temporary increase in blood pressure, stomach pain, taste disturbances, dry mouth, chills, decreased potassium levels in the blood.

The following side effects have been reported with other formulations containing polyethylene glycol, but their frequency is unknown because it cannot be estimated from the available data: allergic reactions (sometimes severe, up to shock), dehydration, dizziness, irregular heartbeat, feeling unwell, feeling faint, sensation that the room is spinning (vertigo), flushing, urticaria, changes in blood electrolyte levels such as decreased or increased sodium, calcium and chloride, and decreased bicarbonate.

Blood sodium levels may also decrease, particularly in patients taking medicines that affect the kidneys, such as ACE inhibitors and diuretics used to treat heart conditions (see also “Other medicines and Clensia”).

These reactions usually occur on the day of the examination. If they persist, consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 packaging after "expiry".
The expiry date refers to the last day of the month.
Store Clensia sachets at a temperature below 30°C.
Once the contents of the sachets have been dissolved in water, the solution may be stored (kept covered) at a temperature below 25°C. It may also be stored in the refrigerator (2°C - 8°C).
Do not store it for more than 24 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Clensia contains
The active substances are:
Pouch A
Macrogol (also known as polyethylene glycol) 4000 52.500 g
Anhydrous sodium sulfate 3.750 g
Simethicone 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

When the contents of 2 pouches A and 2 pouches B are mixed in 1 liter of water, the electrolyte ion concentration is as follows:
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

The other excipients are potassium acesulfame (E950), lime flavour (containing flavouring preparations, natural flavouring substance, powdered sugar with added maize starch, gum arabic (E414), maltodextrin).

Description of the appearance of Clensia and contents of the pack
This pack contains 4 large pouches A and 4 small pouches B.

Marketing Authorization Holder:
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)

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
Netherlands: Clensia Poeder voor drank
Poland: Clensia Proszek do sporządzania 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

The following information is intended exclusively for physicians or healthcare professionals:
Note for medical personnel:
Clensia must be administered with caution in frail patients with poor general health or in patients with severe clinical conditions such as:

• impaired swallowing reflex, or tendency to aspiration or regurgitation
• altered state of consciousness
• severe renal impairment (creatinine clearance < 30 ml/min)
• cardiac failure (NYHA class III or IV)
• dehydration
• severe acute inflammatory disease

Dehydration, if present, must be corrected before using Clensia. Patients who are semi-conscious or have a tendency to aspiration or regurgitation must be closely monitored during administration, especially if administered via nasogastric tube. Clensia must not be administered to unconscious patients.