Leaflet:information for the user

Clensia powder for oral solution

For a list of active ingredients, see section 6.

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Clensia and what it is used for

2. What you need to know before starting to take Clensia

3. How to take Clensia

4. Possible side effects

5. Storage of Clensia

6. Contents of the pack and additional information

Clensia is an intestinal preparation with a lime flavor available as an oral powder contained 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 is taking this medication to clean the intestine so that it is ready for examination.

Clensia acts by emptying the contents of the intestine, so that you or your child will feel bowel movements.

This medication is for use in adults, adolescents, and children aged 6 years and above.

Do not take Clensia:

-if you or your child is allergic to macrogol or any of the other components of this medication (listed in section 6)

-if you or your child has a blockage in your gastrointestinal tract

-if you or your child has a perforation in your gastrointestinal tract

-if you or your child has an alteration in gastric emptying

-if you or your child has intestinal paralysis (sometimes occurs after abdominal surgery)

-if you or your child has toxic colitis or toxic megacolon (a severe complication of acute colitis).

Clensia should not be administered to patients who are unconscious.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Clensia.

If you or your child has a serious medical condition or is frail, be aware of the possible adverse effects listed in section 4. If you are concerned, speak with your doctor or pharmacist.

You should consult your doctor before taking Clensia if you or your child presents any of the following situations:

-you or your child needs thickened liquids to safely swallow them

-tendency to regurgitate ingested drinks, food, or stomach acid

-kidney disease

-heart failure or heart disease, including high blood pressure and irregular heartbeats.

-dehydration (loss of body fluids that may lead to weight loss, thirst, dizziness, dry mouth, headache, dark and concentrated urine)

-acute outbreak of inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Clensia should not be administered to patients with altered consciousness without medical supervision.

If you or your child experiences sudden abdominal pain or rectal bleeding while taking Clensia for bowel preparation, contact your doctor or seek immediate medical attention.

Children

Do not administer this medication to children from birth to 2 years old because the safety and efficacy of Clensia have not been established in these children. No data are available.

Do not administer this medication to children between 2 and less than 6 years old because the efficacy of Clensia has not been established in these children. No recommendations can be made based on the available data.Administration of Clensia with other medications

If you or your child is taking other medications, take them at least one hour before taking Clensia or at least one hour after taking it, as they may be eliminated from the digestive tract and not act correctly. In particular, a transient increase in blood pressure has been observed related to the insufficient absorption of antihypertensive medications.

Inform your doctor or pharmacist if you or your child is taking, has taken recently, or may need to take any other medication.

If you or your child is taking medications that affect kidney function (e.g., diuretics, nonsteroidal anti-inflammatory drugs, ACE inhibitors, and angiotensin receptor blockers), you have a higher risk of experiencing electrolyte imbalances when using Clensia. You or your child should be monitored to maintain adequate hydration and should consider performing laboratory tests for baseline and post-treatment levels (electrolytes, creatinine, and blood urea nitrogen).

If you or your child needs to thicken liquids to safely swallow them, Clensia may neutralize the effect of the thickener.

Administration of Clensia with food and drinks

Do not eat any solid food from the time you or your child starts taking this medication until after the medical examination.

Pregnancy and lactation

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

No documented experience is available for the use of this medication during lactation. Since the absorption of this medication in the mother's body during lactation is insignificant, it can be used during lactation if necessary.

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Clensia does not affect the ability to drive or operate machinery.

Clensia contains sodium and potassium

This medication contains 3877.8 mg of sodium (main component of table salt/for cooking) per liter. This is equivalent to 194% of the recommended daily maximum sodium intake for an adult.

This medication contains 11.2 mmol of potassium per liter, which should be taken into account in the treatment of patients with renal insufficiency or those on low-potassium diets.

Use in adults

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is for oral use.

The package contains 4 large envelopes A (A) and 4 small envelopes B (B). To complete a full treatment cycle, it is necessary to dissolve 8 envelopes in 2 liters of water.

2 envelopes A and 2 envelopes B must be dissolved in 1 liter of water.

Before taking Clensia, please read the following instructions carefully. You need to know:

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

When to take Clensia

Your doctor or nurse should have informed you when to take this medication. Your treatment with this medication should be completed before the clinical examination takes place and you can take it following these instructions:

• Full dose the day before the examination:

Dissolve 4 envelopes A and 4 envelopes B in 2 liters of water and drink them in the evening before the examination.

• Fractured dose:

Dissolve 2 envelopes A and 2 envelopes B in 1 liter of water, drink it in the evening before the examination and dissolve 2 envelopes A and 2 envelopes B in 1 liter of water and drink it in the morning of the examination day.

Important: Do not eat any solid food from the start of Clensia intake until after the examination.

How to prepare Clensia

• Open 2 envelopes A (large) and 2 envelopes B (small).
• Add the contents of 2 envelopes A and 2 envelopes B to a suitable container.
• Add 1 liter of water to the container and stir until all the powder has dissolved.
• After preparing the solution, it can be stored (covered) below 25 °C until the preparation of the intestine is initiated. The solution can also be stored in the refrigerator.

How to take Clensia

• Full dose

In the evening before the procedure day, dissolve 2 envelopes A and 2 envelopes B in 1 liter 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 break of 1-2 hours, dissolve again 2 envelopes A and 2 envelopes B in 1 liter of water and drink the solution.

During this treatment, it is recommended to drink an additional 1 liter of clear liquid (eight glasses) to prevent potential fluid loss due to diarrhea and maintain adequate hydration. Water, broth, fruit juices (without pulp), soft drinks, tea or coffee (without milk) are suitable. These drinks can be taken at any time you want.

• Fractured dose

In the evening before the procedure, dissolve 2 envelopes A and 2 envelopes B in 1 liter of water and drink the solution over 1 to 1.5 hours. Additionally, drink at least 500 ml (four glasses) of clear liquid (water, fruit juices, soft drinks, tea/coffee without milk) over the evening.

On the morning of the procedure day, you must prepare the solution following the same process (2 envelopes A and 2 envelopes B dissolved in 1 liter of water), followed by 500 ml (four glasses) of clear liquid (water, fruit juices, soft drinks, tea/coffee without milk).

Leave a space of at least two hours without drinking before starting the colonoscopy.

What you should expect to happen

When you start drinking the Clensia solution, it is essential that you are near a toilet.

At some point, you will start to feel intestinal movements. This is very normal and indicates that the solution is working.

The intestinal movements will cease immediately after you have finished drinking it.

By following these instructions, your intestine will be clean, and this will help you have a correct examination.

Use in children and adolescents

Adolescents and children from 6 years old

Administer this medication to your child exactly as your doctor has indicated. Consult your doctor if you are unsure.

This medication is for oral use.

Clensia must be administered as a full dose regimen the day before the diagnostic procedure starting in the late afternoon (4-6 pm).

Dissolve 2 envelopes A and 2 envelopes B in 1 liter of water to obtain the first liter of Clensia solution.

Dissolve 2 envelopes A and 2 envelopes B in another liter of water to prepare the second liter of Clensia solution if necessary.

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

Children between 6 and less than 12 years old

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 (without milk) for rehydration.

Weight between25-35 Kg:give 1000 ml of Clensia in 1-2 hours. In addition, give 500 ml of clear liquid (water, fruit juice, soft drinks, tea (without milk) for rehydration.

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 (without milk) for rehydration.

If your child has not had clear and watery stools 3 hours after completing the intestinal solution, give them up to 500 ml of additional Clensia.

Adolescents over 12 years old

Weight ≤ 45 Kg:give 1500 ml in 2-3 hours. In addition, give 750 ml of clear liquid (water, fruit juice, soft drinks, tea (without milk) for rehydration.

Weight > 45 Kg:give 1750 ml in 2-3 hours. In addition, give 875 ml of clear liquid (water, fruit juice, soft drinks, tea (without milk) for rehydration.

If the adolescent does not present clear and watery stools 3 hours after completing the intestinal solution, administer Clensia up to a maximum accumulated dose of 2000 ml.

If you take more Clensia than you shouldtake more Clensia than you should

If you or your child take more Clensia than you should, you or your child may experience excessive diarrhea that may lead to dehydration. Drink generous amounts of liquids, especially fruit juices. If you are concerned, contact your doctor or pharmacist.

If you forgot to take Clensia

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

If several hours have passed since you or your child should have taken it, ask your doctor or pharmacist for advice. It is essential that you or your child complete the administration at least two hours before the examination.

If you interrupt the treatment with Clensia

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is normal to have diarrhea when you take Clensia.

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

• hives or itching
• swelling of the face, ankles, or any other part 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, abdominal distension.

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

Headache, vomiting, anal irritation.

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

Temporary increase in blood pressure, stomach pain, alterations in taste, dry mouth, chills, decrease in potassium levels in the blood.

The following side effects have been reported with the use of other formulations with polyethylene glycol, but it is not known how often they occur because this cannot be estimated from the available data: allergic reactions (sometimes severe to shock), dehydration, dizziness, irregular heartbeat, feeling unwell, feeling dizzy, feeling like the room is spinning (vertigo), redness, rashes, changes in electrolyte levels in the blood such as decreased or increased sodium, calcium, and chloride, and decreased bicarbonate.

The levels of sodium in the blood may also decrease particularly in patients taking medications that affect the kidneys such as ACE inhibitors and diuretics used to treat heart disease (see also “Taking Clensia with other medicines”).

These reactions usually appear on the day of the examination. If 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.

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

Headache, chills, diarrhea, abnormal stools, belching.

Reporting side effects

If you or your child experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store Clensia packets below 30°C.

After dissolving the contents of the packets in water, the solution can be stored (keeping it covered) below 25°C. The solution can be refrigerated in a refrigerator (2°C-8°C).

Do not store it for more than 24 hours.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE Point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need.This way, you will help protect the environment.

Composition of Clensia

The active principles are:

On A

Macrogol (also known as polyethylene glycol) 400052,500 g

Anhydrous sodium sulfate3,750 g

Simeticone0,080 g

On B

Sodium citrate1,863 g

Anhydrous citric acid0,813 g

Sodium chloride0,730g

Potassium chloride0,370 g

The concentration of electrolytes when 2 packets A and 2 packets B are dissolved in 1 liter of water is as follows:

Sodium168.6 mmol/l

Sulfate52.8 mmol/l

Chloride34.9 mmol/l

Potassium11.2 mmol/l

Citrate21.1 mmol/l

The other excipients are potassium acesulfame (E950), lime aroma (containing flavor preparations, natural flavorings, glucose syrup with cornstarch, gum arabic (E414), maltodextrin).

Appearance of the product and contents of the packaging

Clensia is available in a package containing a single treatment of 8 packets [4 large packets A and 4 small packets B] and in multiple packages containing 24, 48, 96, 192

packages with single treatments.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona

Spain

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 with the following names:

Germany:Clensia Powder for the preparation of a solution for oral administration

Czech Republic:Clensia Powder for oral solution

Slovakia:Clensia Powder for oral solution

Spain:Clensia Powder for oral solution

France:Ximepeg Powder for oral solution

Italy:Clensia Powder for oral solution

Netherlands:Clensia Powder for drink

Poland:Clensia Powder for oral solution

Portugal:Clensia Powder for oral solution

Romania:Clensia Powder for oral solution

Last review date of this leaflet:April 2024

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Nota para el personal médico:

Clensia should be administered with caution in patients who are fragile or have poor health or in patients with severe clinical alterations such as:

• swallowing disorders or tendency to aspiration or regurgitation
• altered consciousness
• severe renal insufficiency (creatinine clearance <30)
• severe heart failure (NYHA III or IV)
• deshidratación
• acute inflammatory disease.

Presence of dehydration should be corrected before using Clensia.

Patients who are semi-conscious or prone to aspiration or regurgitation should be carefully observed during administration, especially if it takes place through a nasogastric tube.

Clensia should not be administered to unconscious patients.

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