CLENSIA Oral solution powder

Зміст інструкції

1. Clensia powder for oral solution
   1. What is Clensia and what is it 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

Clensia powder for oral solution

For the list of active ingredients see paragraph 6.

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 lime-flavored intestinal preparation available as an oral powder in
8 sachets.
The package contains 4 large sachets A and 4 small sachets B to be reconstituted with water
before use.
You take this medicine to clean the intestine in preparation for an examination.
Clensia works by emptying the contents of the intestine, so you must wait to feel
liquid movements inside the abdomen.
This medicine must be used exclusively in adults.

2. What you need to know before taking Clensia

Do not 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 gastrointestinal obstruction
• if you have a gastrointestinal perforation
• if you have disorders related to stomach emptying
• if you have intestinal paralysis (often occurs after abdominal surgery)
• if you suffer from toxic colitis or toxic megacolon (a serious complication of acute colitis).

Clensiashould not be administered to patients who are not conscious.

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 undesirable effects listed in section 4.
If you have any doubts, talk to your doctor or pharmacist.
Talk to your doctor before taking Clensia if you fall into any of the following situations:

• you need to thicken liquids to be able to swallow them without difficulty
• you tend to regurgitate drinks and food you have ingested or gastric acids
• you suffer from kidney disease
• you have heart failure or heart conditions including high blood pressure and irregular heartbeat
• you have dehydration (loss of body fluids which can lead to weight loss, 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 state of
consciousness.
If you experience sudden abdominal pain or rectal bleeding during
taking Clensia for bowel preparation, seek immediate medical attention.

Children and adolescents
Clensia should 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 taking Clensia or
at least one hour after, as they may be eliminated through the intestine and not act
as they should. In particular, a transient increase in blood pressure has been observed due to insufficient absorption of antihypertensive drugs.
Tell 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 Blockers),
taking Clensia you have a higher risk of developing fluid and
electrolyte imbalances. You will need to be monitored to ensure you are adequately hydrated and
laboratory tests (electrolytes, creatinine and
azotemia) may need to be considered before and after treatment.

Clensia with food and drink
Do not eat solid food from the time you start taking this medicine until after the examination.

Pregnancy and breastfeeding
Since the absorption of Clensia into the body is negligible, Clensia can be used
during pregnancy, if necessary.
No data are available regarding the use of this medicine during breastfeeding. Since
the absorption of this medicine into the body of the breastfeeding woman is
negligible, it can be used during breastfeeding, if necessary.
If you are pregnant or breastfeeding, if you suspect you are pregnant or are
planning a pregnancy, ask your doctor or pharmacist for advice before taking
this medicine.

Driving and operating machinery
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 litre. This is equivalent to 194% of the maximum recommended daily intake with the
diet of an adult.
This medicine contains 11.2 mmol of potassium per litre. Patients with reduced
kidney function or patients following a potassium-controlled diet
should be aware of this.

3. How to take Clensia

Take this medicine following the instructions of your doctor exactly. 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 cycle of
treatment, it is necessary to dissolve 8 sachets in 2 liters of water.
Two sachets A and two sachets B must be dissolved in one liter of water.
Before taking Clensia, read the following instructions carefully. You should know:

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

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

• Taking the complete dose the day before the examination: 4 sachets A and 4 sachets B dissolved in 2 liters of water and drunk the evening before the examination.
• Fractionated dose intake: 2 sachets A and 2 sachets B dissolved in 1 liter of water and drunk the evening before the examination, and 2 sachets A and 2 sachets B dissolved in 1 liter of water and drunk in the morning of the day of the examination.

Important: do not take solid foods from when 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 liter of water to the container and mix until all the powder is dissolved.
• After reconstitution, the solution can be stored (keeping it covered) at a temperature below 25ºC until you begin the intestinal preparation. The solution can also be refrigerated.

How to take Clensia

• Single intake The evening before the day of the examination, dissolve 2 sachets A and 2 sachets B in 1 liter of water and drink the Clensia solution over 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 liter of water and drink the solution. During treatment, we recommend that you drink 1 additional liter (eight glasses) of clear liquid to prevent possible fluid loss due to diarrhea and maintain adequate hydration. Water, clear broth, fruit juice (without pulp), soft drinks, tea or coffee (without milk) are all suitable beverages. These drinks can be taken at any time you wish.
• Fractionated dose intake The evening before the diagnostic examination day, dissolve 2 sachets A and 2 sachets B in 1 liter of water and drink the Clensia solution over 1-1.5 hours. In addition, drink at least 500 ml (four glasses) of another clear liquid (water, fruit juice, soft drinks, tea/coffee without milk) during the evening. In the morning of the diagnostic examination, the solution must be prepared following the same procedure (2 sachets A and 2 sachets B dissolved in 1 liter of water), followed by 500 ml (four glasses) of another clear liquid (water, fruit juice, soft drinks, tea/coffee without milk).

Allow 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 important to be near a bathroom. At
some point, you will begin to feel liquid movements in your intestines. This is perfectly
normal and indicates that the solution is working. Bowel movements will stop once
you have finished drinking.
If you follow these instructions, the intestine will be clean and this will promote the performance and success
of the examination.

Use in children and adolescents
This medicine should 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 diarrhea which may cause
dehydration. Take plenty of fluids, especially fruit juices. If
you are worried, contact your doctor or pharmacist.

If you forget to take Clensia
If you forget to take Clensia, take the dose as soon as you remember you haven't taken it.
If many hours have passed since you should have taken it, ask your
doctor or pharmacist for advice. It is important that you complete the preparation at least two hours
before the examination.

If you stop the treatment with Clensia
If you have any doubts about the use of 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 diarrhea 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 fatigue
• 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, altered taste, dry mouth, chills, decreased potassium levels in the blood.
The following side effects have been reported in connection with the use of other formulations containing polyethylene glycol, but the frequency with which they occur is not known because it cannot be defined based on available data: allergic reactions (sometimes severe up to shock), dehydration, dizziness, irregular heartbeat, feeling unwell, feeling of fainting, feeling that the room is spinning (vertigo), flushing, hives, changes in blood salt 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 for the treatment of 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after
“expiry”.
The expiry date refers to the last day of the month.
Store the sachets of Clensia at a temperature below 30°C.
Once you have dissolved the contents of the sachets in water, the solution can be
stored (keeping it covered) at a temperature below 25°C. It can also be stored
in a refrigerator (2°C - 8°C).
Do not store it for more than 24 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clensia contains
The active ingredients are:

Sachet A
Macrogol (also known as polyethylene glycol) 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
When the components of 2 sachets A and 2 sachets B are mixed in 1 liter of water, the
electrolyte 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 acesulfame potassium (E950), lime flavour (containing flavouring
preparations, natural flavouring substance, icing sugar with the addition of corn
starch, gum arabic (E414), maltodextrin).

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the
following denomination:
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
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The following information is intended exclusively for doctors or healthcare professionals:

Note for medical personnel:
Clensia should be administered with caution to debilitated patients in poor general health
or to patients with severe clinical alterations such as:

• impaired swallowing reflex, or with a tendency to aspiration or regurgitation
• altered state of consciousness
• severe renal failure (clearanceof creatinine < 30 ml/min)
• heart failure (NYHA class III or IV)
• dehydration
• severe acute inflammatory disease. The presence of dehydration must be corrected before using Clensia. Patients in a semi-conscious state or with a tendency to aspiration or regurgitation must be closely monitored during administration, particularly if it occurs via nasogastric tube. Clensia should not be administered to unconscious patients.