Eziclen

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Eziclen (Izinova), (17.510 g + 3.276 g + 3.130 g)/bottle, concentrate for oral solution
Sodium sulfate anhydrous + Magnesium sulfate heptahydrate + Potassium sulfate
Eziclen and Izinova are different trade names of the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Eziclen is and what it is used for
2. Important information before taking Eziclen
3. How to take Eziclen
4. Possible side effects
5. How to store Eziclen
6. Contents of the pack and other information

1. What Eziclen is and what it is used for

Eziclen contains three different active substances: sodium sulfate anhydrous, magnesium sulfate heptahydrate, and potassium sulfate.
Eziclen is used in adults to cleanse the bowel before a medical examination or intestinal surgical procedure.
Eziclen is not a laxative for constipation.
Eziclen must be diluted with water before use, in the amount specified under Dosage instructions (see section 3).

2. Important information before using Eziclen

When not to use Eziclen:

• If the patient is allergic to sodium sulfate, magnesium sulfate, or potassium sulfate, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe heart disorders (congestive heart failure).
• If the patient has experienced a serious deterioration in general health such as severe dehydration.
• If the patient has acute phases of active intestinal inflammation (including Crohn’s disease and ulcerative colitis).
• If the patient has any of the following stomach or intestinal disorders:
  • known or suspected intestinal obstruction or narrowing
  • toxic colitis or toxic megacolon
  • diagnosed or suspected perforation of the intestinal wall
  • intestinal paralysis
  • problems with stomach emptying (e.g. gastric paresis, gastric stasis)
  • acute abdominal conditions requiring surgery, such as acute appendicitis
  • nausea and vomiting.
• If the patient has ascites.
• If the patient has severe kidney function disorders (severe renal failure).

If in doubt, consult the treating physician before using Eziclen.

Warnings and precautions

Before starting treatment with Eziclen, consult a doctor if:

• The patient is dehydrated (symptoms may include dry mouth, feeling thirsty, headache, dizziness, urinating less than usual, extreme tiredness, palpitations, or confusion).
• There have ever been abnormal blood levels of sodium or potassium.
• The patient has a heart condition. Eziclen may affect heart rhythm due to changes in blood salt concentrations. Monitoring during treatment may be necessary.
• The patient has kidney disease (renal failure).
  • Dehydration may lead to kidney function disorders (renal failure), which are reversible with appropriate treatment.
• The patient has liver disease.
• The patient has disorders related to "uric acid" (gout or other conditions).
• The patient has swallowing difficulties.
• The patient has "reflux", when stomach acid flows back into the oesophagus.
• The patient is physically weakened or frail.
• The patient has reduced motility of part or all of the intestine (impaired peristalsis).
• The patient has a history of gastrointestinal conditions or surgical procedures predisposing to impaired gastrointestinal motility.

If the patient is frail or elderly (aged 65 years or over), has severe kidney, liver, or heart disease, or is at risk of electrolyte imbalances (changes in salt levels in the body), the doctor may recommend special monitoring before and after the procedure. The patient should pay particular attention to the recommendations listed in this section, as well as in the sections “Other medicines and Eziclen” and “How to use Eziclen”.

If the patient experiences severe vomiting or symptoms of dehydration (e.g. dry mouth, feeling thirsty) after taking this medicine, inform the doctor, who will recommend rehydration measures.

If severe or persistent abdominal pain and/or rectal bleeding occur after taking Eziclen, consult a doctor. Rare cases of intestinal inflammation (colitis) have been reported during treatment with Eziclen.

If any of the above points apply to the patient (or if in doubt), consult the treating physician before using Eziclen.

After taking Eziclen, frequent passage of loose stools will occur. This is normal and indicates the medicine is working effectively. The patient should remain close to a toilet until the effect of the medicine subsides. Follow instructions carefully and drink as much water or clear fluids as needed to avoid dehydration.

Children and adolescents

Eziclen is not intended for use in patients under 18 years of age. The safety and efficacy of this medicine have not been established in this patient group.

Other medicines and Eziclen

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use. This includes medicines available without a prescription and herbal products.

If the patient is taking any other medicines, they should be taken one to three hours before taking Eziclen, or at least one hour after completion of the bowel cleansing process.

This is because the diarrhoea caused by Eziclen may flush other medicines out of the body, causing them not to work as expected.

Special caution is required with:

• Medicines that may affect fluid balance or blood salt concentrations (such as diuretics, calcium channel blockers, or lithium salts), or medicines affecting heart rhythm.
• Regularly taken oral medicines, such as oral contraceptives, antiepileptics, antidiabetics, antibiotics, levothyroxine (a hormone used in hypothyroidism treatment), or digoxin (used in heart conditions), as Eziclen may delay or completely inhibit the absorption of these medicines, leading to reduced or absent efficacy.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Breastfeeding should be interrupted for 48 hours after administration of the second dose of Eziclen.

Driving and operating machinery

Eziclen is unlikely to affect the ability to drive or operate tools or machinery.

Eziclen contains sodium and potassium

If on a salt-controlled diet (sodium or potassium), note that each bottle of Eziclen contains 5.684 g (247.1 mmol) of sodium and 1.405 g (35.9 mmol) of potassium.

3. How to use Eziclen

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor. If in doubt, consult your doctor or pharmacist.
How to take the medicine

• This medicine is for oral use.
• On the day before the examination or procedure, a light breakfast may be consumed. After breakfast, only clear fluids should be taken for lunch, dinner, and any other meals, until the time of the examination or procedure. Do not consume beverages with red or purple coloring, milk, or alcoholic drinks.
• Eziclen is supplied in 2 bottles packed in a box with a dilution and dosing cup. All these components are required for administering the medicine.
• Do not consume the contents of both bottles at the same time.
• Do not consume the contents of the bottles before dilution.
• Do not forget to drink additional amounts of water or permitted clear fluids.
• Your doctor will provide you with a form to record the time treatment was started and the amount of fluids consumed during the bowel preparation. Follow the instructions carefully and drink as much water or clear fluids as needed to prevent dehydration.
• “Clear fluids” include water, tea or coffee (without milk or non-dairy creamer), carbonated or non-carbonated drinks, strained fruit juices without pulp (other than red or purple), clear broth or strained soup to remove all solid particles. Alcoholic beverages should not be consumed.

How and when to take this medicine
Eziclen may be administered according to a “Two-day” or “One-day” regimen. Your doctor will decide
which regimen and at what time the medicine should be taken.

• For examinations or procedures without general anesthesia, stop drinking fluids at least one hour before the examination or procedure.

• For examinations or procedures under general anesthesia, stop drinking fluids usually at least two hours before the examination or procedure; follow the anesthesiologist’s instructions.

• Two-day regimen Dosing is divided between the evening before the examination or procedure and the morning of the examination or procedure.
  On the day before the examination or procedure:

• administer the first part of the regimen (first bottle) in the early evening (i.e., no later than 6:00 PM).
  On the day of the examination or procedure:

• administer the second part of the regimen (second bottle) in the early morning, 10 to 12 hours after starting the first part of the regimen (first bottle).

• One-day regimen Dosing starts and ends in the evening on the day before the examination or procedure.
  On the day before the examination or procedure:

• administer the first part of the regimen (first bottle) in the early evening (i.e., no later than 6:00 PM)

• administer the second part of the regimen (second bottle) approximately 2 hours after starting the first part of the regimen (first bottle).

Regardless of the regimen chosen by the doctor, the following steps should be carried out for
both the first and second parts of the regimen:

1. Open the child-resistant bottle by pressing down on the cap and turning it counterclockwise.

2. Pour the contents of one Eziclen bottle into the cup.

3. Add water to the medicine up to the line marked on the cup.

4. Drink the entire contents of the cup slowly (within 30 minutes to one hour).

5. IMPORTANT INFORMATION: Drink two (2) additional full cups of water or clear fluid. Each time,
   fill the cup with water or clear fluid up to the marked line.

6. Drink the entire contents of each cup slowly (within 30 minutes).

Completing steps 1 to 6 takes approximately 2 hours and should be repeated for the second part of the regimen.
Regardless of the regimen used, stop drinking fluids:

• at least one hour before the examination or procedure, in case of an examination or procedure without general anesthesia,
• usually at least two hours before the examination or procedure, in case of an examination or procedure under general anesthesia; follow the anesthesiologist’s instructions.

Taking more than the recommended dose of Eziclen

• If the patient believes they have taken more than the recommended dose of Eziclen, did not dilute the medicine as instructed, or did not drink enough additional water, they should inform their
  doctor and drink sufficient amounts of water or clear fluids to prevent dehydration.

Missing a dose of Eziclen

• If a dose is missed, contact your doctor as soon as possible, as this may mean the medicine will not work as expected.

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

4. Possible adverse reactions

If rectal bleeding occurs during bowel preparation or after colonoscopy, you should contact your doctor.
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during use of this medicine:
If any of the symptoms listed below occur, discontinue use of Eziclen and immediately consult a doctor:

• Allergic reaction – symptoms may include skin rash or redness, itching, difficulty breathing, or swelling of the throat.

Other adverse reactions include:
Very common (may affect more than 1 in 10 people)

• General discomfort
• Nausea or vomiting
• Abdominal bloating or stomach pain

Uncommon (may affect up to 1 in 100 people)

• Chills
• Dry mouth
• Headache
• Dizziness
• Pain during urination
• Discomfort around the anus or rectum
• Changes in blood levels of certain components. Examples include increased activity of aspartate aminotransferase, creatine kinase, lactate dehydrogenase, increased levels of phosphates, bilirubin, or uric acid, and decreased levels of sodium, potassium, or calcium.

Frequency not known (frequency cannot be estimated from available data):

• Intestinal ulcers or intestinal disorders (ischemic colitis). Immediately inform your doctor if you experience severe abdominal pain or rectal bleeding.
• Dehydration, changes in serum electrolyte levels, fatigue, tremor, sweating, palpitations, loss of consciousness (seizures), disorientation, muscle cramps.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Eziclen

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• There are no special storage temperature requirements.
• Store in the original packaging to protect from light.
• After first opening the bottle and/or diluting the contents with water, the solution should be used immediately.
• Medicines should not be disposed of 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 package and other information

What Eziclen contains

• The active substances are: anhydrous sodium sulfate, magnesium sulfate heptahydrate and potassium sulfate. Each bottle containing approximately 176 ml of concentrate contains 17,510 g of anhydrous sodium sulfate, 3,276 g of magnesium sulfate heptahydrate and 3,130 g of potassium sulfate.

The total electrolyte content is as follows:
Content in g Content in mmol
1 bottle 2 bottles 1 bottle 2 bottles
Sodium* 5,684 11,367 247,1 494,42
Potassium 1,405 2,81 35,9 71,8
Magnesium 0,323 0,646 13,3 26,6
Sulfates 14,845 29,690 154,5 309,0
* derived from sodium sulfate (active substance) and sodium benzoate (excipient).
Other ingredients are sodium benzoate (E 211), citric acid, sucralose, malic acid, purified water and fruit cocktail flavour [a mixture of natural and synthetic flavours, propylene glycol (E 1520), ethyl alcohol, acetic acid and benzoic acid (E 210)].

What Eziclen looks like and contents of the pack

• This medicinal product is a concentrate for oral solution; the concentrate is clear or slightly cloudy.
• It is supplied in 2 bottles with a capacity of approximately 176 ml each, packed in a carton with a 500 ml measuring cup for dilution and administration of the medicinal product.
• Pack sizes available:
• 1 pack containing two bottles and one cup

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, country of export:
IPSEN CONSUMER HEALTHCARE, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
Manufacturer: Beaufour Ipsen Industrie, 20 rue Ethe Virton, 28100 Dreux, France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in France, country of export: 269 952-4
34009 269 952 49
Parallel import authorisation number: 6/19