Izinova
Italy
Table of Contents
Package leaflet: Information for the user
Izinova oral solution concentrate
Anhydrous sodium sulfate, magnesium sulfate heptahydrate and potassium sulfate
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 others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist.
Contents of this leaflet:
- What Izinova is and what it is used for
- What you need to know before taking Izinova
- How to take Izinova
- Possible side effects
- How to store Izinova
- Contents of the pack and other information
1. What Izinova is and what it is used for
Izinova contains three different active substances: sodium sulfate, magnesium sulfate and potassium sulfate.
Izinova is used in adults to clean the bowel before a medical or intestinal surgical procedure.
Izinova is not a treatment for constipation.
Izinova must be diluted before use with the amount of water specified in the administration instructions (see section 3).
2. What you need to know before taking Izinova
Do not take Izinova:
- If you are allergic to sodium sulfate, magnesium sulfate, or potassium sulfate, or to any of the other ingredients of this medicine (listed in section 6).
- If you have any of the following intestinal or stomach problems:
- Known or suspected intestinal obstruction
- Intestinal perforation
- Problems with stomach emptying (such as gastroparesis)
- Intestinal paralysis
- Toxic colitis or toxic megacolon
- Severe vomiting
- If you are severely dehydrated
- If you have severe heart problems (congestive heart failure)
- If you have ascites
- If you have severe kidney problems (severe renal failure)
- If you suffer from active inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
If you are unsure, speak with your doctor before taking Izinova.
Warnings and precautions
Talk to your doctor before taking Izinova if:
You are dehydrated (signs may include dry mouth, feeling thirsty, headache, dizziness, reduced urination compared to normal, extreme tiredness, palpitations, and confusion).
You have had abnormal levels of sodium or potassium in your blood.
You have heart problems.
Izinova may affect your heart rhythm due to changes in blood electrolyte levels. Your doctor may need to monitor you during treatment.
If you have kidney problems.
If you have liver problems.
If you have a condition involving "uric acid" (gout or other).
If you have difficulty swallowing.
If you have "reflux" problems, where acid from the stomach passes into the digestive tract.
If you are physically weak or in poor general health.
If you have reduced motility in part or all of your intestine (intestinal hypomotility).
If you have a medical or surgical history affecting the gastrointestinal tract that predisposes you to hypomotility disorders.
If you are frail or elderly (65 years of age or older), have serious kidney, liver, or heart problems, or are at risk of electrolyte imbalances, your doctor may decide to monitor you before and after the procedure. You should also pay special attention to the recommendations provided in this section of the leaflet, as well as in the sections “Other medicines and Izinova” and “How to take Izinova”.
If you experience significant vomiting or symptoms of dehydration (e.g. dry mouth, feeling thirsty) after taking this medicine, contact your doctor, who may recommend rehydration measures.
If any of the above conditions apply to you (or if you are unsure), consult your doctor before taking Izinova.
After taking this medicine, you will experience frequent bowel movements. This is normal and shows that the medicine is working. Make sure you stay close to a toilet until the medicine’s effect has worn off.
You must strictly follow the instructions for use of Izinova and drink as much water or clear fluids as possible to avoid dehydration.
Children and adolescents
Izinova is not indicated for patients under 18 years of age. Its safety and efficacy have not yet been established in this population.
Other medicines and Izinova
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter drugs and herbal products.
If you are taking other medicines, take them one to three hours before taking Izinova or at least one hour after completion of the bowel cleansing procedure. This is because the diarrhea caused by Izinova may eliminate other medicines from your body before they can have their intended effect.
Particular caution is required with:
- Medicines that may alter fluid or electrolyte levels in the blood (such as diuretics, calcium channel blockers, or lithium treatment) or medicines that may affect heart rhythm.
- Medicines taken regularly by mouth: for example, oral contraceptives, antiepileptics, antidiabetics, or antibiotics, levothyroxine (a hormone used to treat reduced thyroid gland function), or digoxin (used for heart problems), as Izinova may delay or completely block the absorption of these oral medicines, making them less effective or ineffective.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
If you are breastfeeding, you must not breastfeed your baby for 48 hours after taking the second dose of Izinova.
Driving and using machines
Izinova does not affect your ability to drive or operate machinery.
Izinova contains sodium and potassium
If you are on a salt-restricted diet (sodium or potassium), note that each bottle of Izinova contains 5.684 g (247.1 mmol) of sodium and 1.405 g (35.9 mmol) of potassium.
3. How to take Izinova
Take this medicine exactly as described in this leaflet or as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Taking the medicine
Take this medicine by mouth.
On the day before the procedure, you may have a light breakfast. After breakfast, drink only clear liquids for lunch, dinner, and any other meals until the procedure. Do not drink red or purple liquids, milk, or alcoholic beverages.
Izinova is supplied as 2 bottles in a box, together with a dosing cup for dilution and administration of the medicine. You will need all of these for your treatment.
Do not drink the contents of both bottles at the same time.
Do not drink the contents of the bottles before diluting them.
Do not forget to drink the additional amount of water or allowed clear liquids.
Your doctor will provide you with a form to record when you started treatment and how much liquid you drank during bowel preparation. You must follow the instructions exactly and drink as much water or clear liquids as possible to avoid the risk of dehydration.
"Clear liquids" include water, tea or coffee (without milk or cream), non-alcoholic carbonated or still beverages, fruit juices without pulp (not red or purple), clear soups or broths from which all solid particles have been removed.
Do not drink any alcoholic beverages.
How and when to take this medicine
Izinova can be taken according to either a "two-day" or a "one-day" dosing schedule. Your doctor will decide which schedule you should follow and the timing.
- Without anesthesia, you must stop drinking any liquids at least one hour before the start of the procedure.
- With anesthesia, you must generally stop drinking any liquids at least two hours before the start of the procedure, following the anesthesiologist's instructions.
"Two-day" schedule
Dosing is divided between the evening before the procedure and the morning of the procedure day.
The day before the procedure:
- Start the first part of the schedule (first bottle) in the early evening (i.e., no later than 6:00 p.m.).
The day of the procedure:
- Start the second part of the schedule (second bottle) in the early morning, 10 to 12 hours after starting the first part (first bottle).
"One-day" schedule
Dosing is started and completed on the evening before the procedure.
The day before the procedure:
- Start the first part of the schedule (first bottle) in the early evening (i.e., no later than 6:00 p.m.).
- Start the second part of the schedule (second bottle) approximately two hours after starting the first part (first bottle).
Regardless of which dosing schedule your doctor has chosen, follow the instructions below for both the first and second parts of the schedule:
- Open the child-resistant cap of the bottle by pressing down on the cap and turning it counterclockwise.
- Pour the contents of the Izinova bottle into the dosing cup.
- Add water to the medicine up to the line marked on the dosing cup.
- Take your time (more than 30 minutes and up to one hour) to drink all the liquid in the dosing cup.
- IMPORTANT: Drink two (2) additional dosing cups of water or clear liquids.
Each time, fill the dosing cup with water or clear liquids up to the marked line. - Take your time (more than 30 minutes) to drink all the liquid from each dosing cup.
Steps 1 to 6 should take about two hours and must be repeated for the second part of the schedule.
Regardless of the schedule followed, you must stop drinking any liquids:
- At least one hour before the start of the procedure if no anesthesia is used;
- Generally at least two hours before the start of the procedure if anesthesia is used, following the anesthesiologist's instructions.
If you take more Izinova than you should
If you think you have taken too much Izinova, or did not dilute it as instructed, or did not drink enough additional water, inform your doctor and drink sufficient water or clear liquids to avoid dehydration.
If you forget to take Izinova
If you forget to take a dose, contact your doctor as soon as possible, as this may mean the medicine will not work as intended.
If you have any further questions 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 everybody gets them. The following side effects may occur with this medicine.
Stop taking Izinova and contact a doctor immediately if you notice:
An allergic reaction – signs may include skin rash or redness, itching, difficulty breathing, or swelling of the throat.
Other side effects include:
Very common (may affect more than 1 in 10 people)
General malaise
Feeling unwell (nausea) or being unwell (vomiting)
Stomach swelling or pain
Uncommon (may affect up to 1 in 100 people)
Chills
Dry mouth
Headache
Dizziness
Pain during urination
Discomfort in the anal or rectal area
Changes in certain blood test values. Examples include: increased levels of "aspartate aminotransferase", "creatine phosphokinase", "lactate dehydrogenase", "phosphorus", "bilirubin", or "uric acid", and decreased levels of "sodium", "potassium", or "calcium".
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Izinova
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature conditions for storage.
Store in the original packaging to protect it from light.
After the first opening of the vial and/or dilution with water, the solution must be used
immediately.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Izinova contains
The active substances are: anhydrous sodium sulfate, magnesium sulfate heptahydrate and potassium sulfate. Each bottle of
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 content of electrolyte ions is as follows:
Content in g Content in mmol
1 bottle 2 bottles 1 bottle 2 bottles
Sodium* 5,684 11,367 247,1 494,2
Potassium 1,405 2,81 35,9 71,8
Magnesium 0,323 0,646 13,3 26,6
Sulfate 14,845 29,69 154,5 309,0
* derived from sodium sulfate (active substance) and sodium benzoate (excipient).
The other ingredients are sodium benzoate (E211), anhydrous citric acid, malic acid, sucralose, purified water and fruit flavour (containing natural and synthetic flavouring substances, propylene glycol E1520, ethanol, acetic acid E260 and benzoic acid E210).
Description of the appearance of Izinova and package contents
This medicine is a concentrate for oral solution; the concentrate is clear or slightly opalescent.
It is supplied as 2 bottles of approximately 176 ml each, packaged in a box with a dosing cup,
providing a total volume of about half a litre for dilution and administration of the medicine.
Pack sizes containing two bottles and one dosing cup are available as:
- Single pack of two 176 ml PE bottles and one dosing cup
- Pack containing 24 single packs of two 176 ml PE bottles and one dosing cup
- Pack containing 6 boxes of 24 single packs of two 176 ml PE bottles and one dosing cup (6x24=144 single packs)
- Pack containing 14 boxes of 24 single packs of two 176 ml PE bottles and one dosing cup (14x24=336 single packs)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
IPSEN CONSUMER HEALTHCARE S.R.L.
Via Giorgio Stephenson, 43/A
20157 Milano
Manufacturer
Beaufour Ipsen Industrie
Rue d’Ethé Virton
28100 Dreux
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