Clensia powder for oral solution – patient leaflet, side effects, dosage

1. What Clensia is and what it is used for

Clensia is a lime flavoured bowel preparation available as oral powder in 8 sachets. There are 4 sachets A (large) and 4 sachets B (small) to be reconstituted with water before use.

You or your child are taking this medicine to make bowels clean so that they are ready for examination.

Clensia works by empting the contents of bowels, so you or your child should expect to have watery bowel movements.

This medicine is for use in adults, adolescents and children aged 6 years and older.

2. What you need to know before you take Clensia

Do not take Clensia

• if you or your child are allergic to macrogol or any of the other ingredients of this medicine (listed in section 6).
• if you or your child have a gastrointestinal obstruction
• if you or your child have a gastrointestinal perforation
• if you or your child have a disorder of stomach emptying
• if you or your child have paralysis of the gut (often occurs after an operation to the abdomen)
• if you or your child have toxic colitis or toxic megacolon (a severe compli-cation of acute colitis).

Clensia should not be given in unconscious patients.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clensia.

If you or your child are in poor health or have a serious medical condition, you should be particularly aware of the possible side effects listed in section

1. 4. Contact your doctor or pharmacist if you are concerned.

You should tell your doctor before taking Clensia if you or your child have any of the following:

• you or your child need to thicken fluids in order to swallow them safely
• a tendency to regurgitate swallowed drink, food or acid from the stomach
• kidney disease
• heart failure or heart disease, including high blood pressure and irregular heartbeats
• dehydration (loss of body fluids which may result in reduction in body weight, thirst, dizziness, dry mouth, headache, dark and concentrated urines) - acute flare of inflammatory bowel disease (Crohn’s disease or ulcerative colitis)

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

If you or your child experience sudden abdominal pain or rectal bleeding when taking Clensia for bowel preparation, contact your doctor or seek medical advice immediately.

Children

Do not give this medicine to children from birth to less than 2 years because the safety and efficacy of Clensia in these children have not been established. No data are available.

Do not give this medicine to children aged 2 to less than 6 years because the efficacy of Clensia in these children has not been established. No recommen-dation on a posology can be made from the available data.

Other medicines and Clensia

If you or your child are taking other medicines take them at least one hour before taking Clensia or at least one hour afterwards because they may be flushed through your digestive system and not work so well. In particular a transient increase of blood pressure related to insufficient absorption of anti-hypertensive drugs has been observed.

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.

If you or your child are taking medicines that affect renal function (such as di-uretics, nonsteroidal anti-inflammatory drugs, ACE-inhibitors, and Angiotensin Receptor Blockers), you have a higher risk of fluid and electrolyte abnormalities using Clensia. You or your child should be monitored for adequate hydration and baseline and post-treatment laboratory tests (electrolytes, creatinine, and blood urea nitrogen) should be considered.

If you or your child need to thicken fluids in order to swallow them safely, Clensia may counteract the effect of the thickener.

Clensia with food and drink

Do not take any solid food from when you or your child start taking this med-icine until after the examination.

Pregnancy and breast-feeding

Since the absorption of Clensia into the body is negligible, Clensia can be used during pregnancy, if necessary.

There is no documented experience with the use of this medicine during lacta-tion. Since the absorption of this medicine into the body of the breast-feeding woman is negligible, it can be used during breast-feeding, if necessary.

If you are pregnant or breast-feeding, think you may be pregnant or are plan-ning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Clensia does not affect your ability to drive or use machines.

Clensia contains sodium and potassium

This medicinal product contains 3877.8 mg sodium (main component of cook-ing/table salt) in each litre. This is equivalent to 194% of the recommended maximum daily dietary intake of sodium for an adult.

This medicinal product contains 11.2 mmol of potassium per litre. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

3. How to take Clensia

Use in adults

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is for oral use.

The pack contains 4 sachets A (large) and 4 sachets B (small). For a single course of treatment it is necessary to dissolve 8 sachets in 2 litres of water. 2 sachets A and 2 sachets B are to be dissolved in 1 litre of water. Before you take Clensia, please read carefully the following instructions. You need to know:

• When to take Clensia
• How to prepare Clensia solution
• How to drink Clensia
• What you should expect to happen

When to take Clensia

You should have been given instructions about when to take this medicine by your doctor or nurse. Your treatment with this medicine must be completed before your clinical examination and can be taken following these instructions:

• Full dose the day before examination:

  4 sachets A and 4 sachet B dissolved in 2 litres of water and drunk in the evening before the examination.

• Split-dose:

  2 sachets A and 2 sachets B dissolved in 1 litre of water and drunk in the evening before the examination and 2 sachets A and 2 sachets B dissolved in 1 litre of water and drunk in the morning of the day of the examination.

Important: Do not take any solid food from when you start taking Clensia until after the examination.

How to prepare Clensia

• Open 2 sachets A (large) and 2 sachets B (small).
• Add the contents of 2 sachets A and 2 sachets B into an appropriate container. • Add 1 litre of water into the container and stir until all the powder has dis-solved.
• After reconstitution the solution may be stored (keeping covered) below 25ºC until the time of starting bowel preparation. The solution may also be refrigerated.

How to take Clensia

• Full dose

On the evening before the day of the procedure, dissolve 2 sachets A and 2 sachets B in 1 litre of water and drink the Clensia solution over 1 to 1.5 hours. Try to drink 250 ml (two glasses) every 15-20 minutes.

After a rest of about 1-2 hours, dissolve again 2 sachets A and 2 sachets B in 1 litre of water and drink the solution.

During the course of this treatment, you are recommended to drink a further 1 litre (eight glasses) of clear liquid to prevent potential loss of fluids due to diarrhoea and maintain adequate hydration. Water, clear soup, fruit juice (without pulp), soft drinks, tea or coffee (without milk) are all suitable. These drinks can be taken at any time you choose.

• Split-dose

The evening before the diagnostic procedure dissolve 2 sachets A and 2 sachets B in 1 litre of water and drink the solution over 1 to 1.5 hours. In addition drink at least 500 ml (four glasses) of additional clear liquid (water, fruit juice, soft drink, tea/coffee without milk) during the evening.

On the morning of the day of the diagnostic procedure, the solution should be prepared following the same process (2 sachets A and 2 sachets B dissolved in 1 litre of water), followed by 500 ml (four glasses) of additional clear liquid (water, fruit juice, soft drink, tea/coffee without milk).

Leave a gap of at least two hours without drinking prior to start colonoscopy.

What you should expect to happen

When you start drinking Clensia solution, it is important that you stay close to a toilet.

At some point, you will start to experience watery bowel movements. This is quite normal and indicates that the solution is working.

The bowel movements will stop soon after you have finished drinking. If you follow these instructions, your bowel will be clear, and this will help you to have a successful examination.

Powder for oral solution

Clensia

1 litre

B

A

Use in children and adolescents

Adolescents and children from 6 years and older

Give this medicine to your child exactly as your doctor has told you. Check with your doctor if you are not sure.

This medicine is for oral use.

Clensia should be administered as full dose regimen the day before the diag-nostic procedure starting in the mid-late afternoon (4-6 p.m). Dissolve 2 sachets A and 2 sachets B in 1 litre of water to obtain the first liter of Clensia solution.

Dissolve 2 sachets A and 2 sachets B in a further 1 litre of water to prepare the second liter of Clensia solution if needed.

The dose depends on the child age and body weight in kilograms.

Children aged 6 to less than 12 years:

Weight ≤ 25 Kg: give 750 ml of Clensia in 1-2 hours. In addition, give 375 ml of clear liquid (water, fruit juice, soft drinks, tea (no milk) for re-hydration purposes.

Weight within 25-35 Kg: give 1000 ml of Clensia in 1-2 hours. In addition, give 500 ml of clear liquid (water, fruit juice, soft drinks, tea (no milk) for re-hydra-tion purposes.

Weight > 35 Kg: give 1250 ml of Clensia in 1-2 hours. In addition, give 625 ml of clear liquid (water, fruit juice, soft drinks, tea (no milk) for re-hydration purposes.

If your child does not have watery clear stools by 3 hours after completing the bowel solution, give up to 500 ml of additional Clensia.

Adolescents older than 12 years:

Weight ≤ 45 Kg: give 1500 ml in 2-3 hours. In addition, give 750 ml of clear liquid (water, fruit juice, soft drinks, tea (no milk) for re-hydration purposes.

Weight > 45 Kg: give 1750 ml in 2-3 hours. In addition, give 875 ml of clear liquid (water, fruit juice, soft drinks, tea (no milk) for re-hydration purposes.

If the adolescent does not have watery clear stools by 3 hours after complet-ing the bowel solution, give additional Clensia up to a cumulative maximum dose of 2000 ml.

If you take more Clensia than you should

If you or your child take more Clensia than you should you or your child may develop excessive diarrhoea, which can lead to dehydration. Take generous amounts of fluid, especially fruit juices. If you are worried contact your doctor or pharmacist.

If you forget to take Clensia

If you or your child forget to take Clensia take the dose as soon as you realise you or your child have not taken it.

If this is several hours after the time when you or your child should have taken it, contact your doctor or pharmacist for advice. It is important that you or your child complete your preparation at least two hours before your examination.

If you stop taking Clensia

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not every-body gets them.

It is normal to get diarrhoea when you take Clensia.

If you experience any of the following, stop taking this medicine and contact your doctor immediately. You should not take any more Clensia until you have checked with your doctor:

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

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, soreness of the anus.

Uncommon side effects (may affect more than 1 in 1000 people):

Temporary increase in blood pressure, stomach ache, taste disturbances, dry mouth, chills, blood potassium levels decreased.

The following side effects have been reported with the use of other polyeth-ylene glycol formulations, but it is not known how often they occur because the frequency cannot be estimated from the available data: allergic reactions (sometime severe until shock), dehydration, dizziness, irregular heartbeat, feeling unwell, near fainting, sensation of the room going round (vertigo), redness, hives, changes in the levels of salts in the blood such as decrease or increase of sodium, calcium and chloride and decrease of bicarbonate. Blood sodium levels could also decrease particularly in patients taking med-icines that affect the kidney such as ACE inhibitors and diuretics used for the treatment of heart disease (see also “Other medicines and Clensia”).

These reactions usually appear on the day of examination. Should they persist, consult your doctor.

Additional side effects in children and adolescents

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

Nausea, abdominal pain, abdominal distension, vomiting, fatigue Common side effects (may affect more than 1 in 100 people):

Anal irritation, asthenia

Uncommon side effects (may affect more than 1 in 1000 people):

Headache, chills, diarrhoea, abnormal faeces, eructation

Reporting of side effects

If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store Clensia sachets below 30ºC.

After you have dissolved the content of the sachets in the water, the solution may be stored (keeping covered) below 25ºC. The solution may be refrigerated (2°C-8°C).

Do not keep it for more than 24 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Clensia contains

The active substances are:

Sachet A

Macrogol (also known as polyethylene glycol) 4000 52.500 g Sodium sulphate anhydrous 3.750 g Simeticone 0.080 g

Sachet B

Sodium citrate 1.863 g Citric acid anhydrous 0.813 g Sodium chloride 0.730 g Potassium chloride 0.370 g

The concentration of electrolyte ions when 2 sachets A and 2 sachets B are dissolved in 1 litre of water is as follows:

Sodium 168.6 mmol/l Sulphate 52.8 mmol/l Chloride 34.9 mmol/l Potassium 11.2 mmol/l Citrate 21.1 mmol/l

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

What Clensia looks like and contents of the pack

Clensia is available in one pack containing a single treatment of 8 sachets [4 sachets A (large) and 4 sachets B (small)] and in multipacks containing 24, 48, 96, 192 packs of a single treatment.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Alfasigma S.p.A.,

Via Ragazzi del ‘99 5,

Bologna, 40133,

ITALY

Manufacturer:

Sigmar Italia S.p.A.

Via Sombreno, 11

24011 Almé (BG)

Italy

This leaflet was last revised in 07/2025

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The following information is intended for healthcare professionals only:

Note for medical staff:

Clensia should be administered with caution to fragile patients in poor health or patients with serious clinical impairment such as:

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

The presence of dehydration should be corrected before the use of Clensia. Semi-conscious patients or patients prone to aspiration or regurgitation should be closely observed during administration especially if this is via a nasogastric route.

Clensia should not be given to unconscious patients.

In children unable to drink the required amount of solution a nasogastric tube may be used, with an administration rate of 20 - 30 ml/minute.

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