ИЦИНОВА 176 ML Oral solution

Содержание инструкции

1. Izinova concentrate for oral solution
   1. What is Izinova and what is it used for
   2. What you need to know before you take Izinova
   3. How to take Izinova
   4. Possible side effects
   5. How to store Izinova
   6. Package Contents and Other Information

Izinova concentrate for oral solution

Anhydrous sodium sulfate, magnesium sulfate heptahydrate and potassium sulfate

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 their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Izinova is and what it is used for
• 2. What you need to know before you take Izinova
• 3. How to take Izinova
• 4. Possible side effects
• 5. How to store Izinova
• 6. Contents of the pack and other information

1. What is Izinova and what is it used for

Izinova contains three different active ingredients: sodium sulfate, magnesium sulfate and potassium sulfate.
Izinova is used in adults to clean the bowel before a medical procedure or intestinal surgery.
Izinova is not a treatment for constipation.
Izinova must be diluted before use with the amount of water specified in the method of administration
(see section 3).

2. What you need to know before you take 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:
• A known or suspected bowel obstruction
• A bowel perforation
• Problems with gastric emptying (such as gastroparesis)
• Paralytic ileus
• Toxic colitis or toxic megacolon
• Profuse 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 insufficiency)
• If you suffer from active inflammatory bowel diseases (Crohn's disease or ulcerative colitis)

If you are not sure, talk to 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,
feeling dizzy, reduced urination compared to normal, extreme fatigue, 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 salt levels. Your
doctor may need to monitor you during treatment.
If you have kidney problems.
If you have liver problems.
If you have a problem with “uric acid” (gout or other).
If you have difficulty swallowing.
If you have a problem with “reflux” whereby acid from the stomach passes into the digestive tract.
If you are physically weak or frail.
If you have reduced mobility in part or all of the intestine (intestinal hypomotility).
If you have a history of gastrointestinal surgery or surgery that predisposes to disorders of hypomotility.
If you are frail or elderly (65 years or older), if you have a serious kidney, liver or heart problem or if you are at
risk of changes in salt levels in the body (electrolyte imbalances) your doctor may decide to
carry out monitoring before and after the procedure. You should also pay particular attention to
“How to take Izinova”.
If you suffer from significant vomiting or if you feel symptoms of dehydration (e.g. dry mouth, feeling
thirsty) after taking this medicine, contact your doctor who may define rehydration measures.
If any of the above cases apply to you (or you are not sure) consult your doctor before taking
Izinova.
After taking this medicine you will have frequent bowel movements. This is normal and shows that the
medicine is working. Make sure you are close to a toilet until the effect of the medicine has worn off.
You must follow the instructions for use of Izinova exactly and drink as much water or clear fluids as possible to avoid
dehydration.

Children and adolescents
Izinova is not indicated in patients under 18 years of age. Its safety and efficacy have not yet been
established in this population.

Other medicines and Izinova
Tell your doctor or pharmacist if you are taking, have recently taken, or may take
any other medicines, including over-the-counter medicines and herbal products.
If you are taking other medicines, take them one to three hours before taking Izinova or at least one hour after
the end of the cleansing procedure. This is because the diarrhea caused by Izinova can remove medicines
from the body preventing them from having the expected effect.
Particular care must be taken with:

• Medicines that can alter fluid or salt levels in the blood (such as diuretics, calcium channel blockers or lithium treatment) or medicines that can alter heart rhythm.
• Medicines taken regularly by mouth: for example oral contraceptives, antiepileptics, antidiabetics or antibiotics, levothyroxine (a hormone used to treat reduced thyroid 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, or suspect you are pregnant or planning to become pregnant, ask
your doctor or pharmacist for advice before taking the medicine.
If you are breastfeeding, you should not breastfeed your baby for 48 hours after taking the second dose
of Izinova.

Driving and operating machinery
Izinova does not impair the ability to drive or operate machinery.

Izinova contains sodium and potassium
If you are following a controlled salt diet (sodium or potassium), be aware that each bottle of Izinova contains
5,684 g (247,1 mmol) of sodium and 1,405g (35,9 mmol) of potassium.

3. How to take Izinova

as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

Taking the medicine
Take this medicine by mouth.
The day before the procedure you can have a light breakfast. After breakfast, drink only clear liquids
for lunch, dinner and on any other occasion until the procedure is performed. Do not drink
red or purple liquids, milk or alcoholic beverages.
Izinova is supplied as 2 bottles sealed in a box with a measuring cup for dilution and for
taking the medicine. You need all of this for your treatment.

Do notdrink the contents of both bottles at the same time.

Do notdrink the contents of the bottles before diluting them.

Do notforget to drink the additional amount of water or clear liquids allowed.
Your doctor will give you a form to record the time you started treatment and the amount of
liquids you consumed during the preparation for the bowel cleansing. You must follow the instructions exactly and
drink as much water or clear liquids as possible to avoid the risk of dehydration.
"Clear liquids" are water, tea or coffee (without milk or cream), carbonated
(fizzy) or non-carbonated drinks, 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 either according to a “two-day” or “one-day” schedule. Your doctor will decide
which schedule you must follow and the timings.

• If you are not undergoing anesthesia, you must stop drinking any liquids at least one hour before the start of the procedure.
• If you are undergoing anesthesia, you generally must stop drinking any liquids at least 2 hours before the start of the procedure, taking into account the anesthesiologist's instructions.

“Two-day” schedule
The administration is divided between the evening before the procedure and the morning of the day of 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 PM). On 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 of the schedule (first bottle).

“One-day” schedule
The administration is started and completed 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 PM).
• start the second part of the schedule (second bottle) about two hours after starting the first part of the schedule (first bottle).

Whatever schedule your doctor has chosen, the instructions below must be followed for the first and second part of the schedule:

• 1) Open the child-proof cap of the bottle by pushing down on the lid and turning it counterclockwise.
• 2) Pour the contents of the Izinova bottle into the measuring cup.
• 3) Add water to the medicine until you reach the line on the measuring cup.

• 4) Take your time (more than half an hour and up to an hour) to drink all the liquid in the measuring cup.

• 5) IMPORTANT: Drink another two (2) measuring cups of water or clear liquids. Each time, fill the measuring cup with water or clear liquids up to the line.
• 6) Take your time (more than half an hour) to drink all the liquid in each measuring cup.

Steps 1 to 6 should take about 2 hours and must be repeated for the second part of the schedule.
Whatever schedule you follow, you must stop drinking any liquids:

• At least one hour before the start of the procedure if you are not undergoing anesthesia;
• Generally at least 2 hours before the start of the procedure if you are undergoing anesthesia, taking into account the anesthesiologist's instructions.

If you take more Izinova than you should
If you believe you have taken too much Izinova or have not diluted it as indicated, or have not drunk enough additional water,
inform your doctor and drink enough 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 that the medicine will not work as expected.
If you have any further questions about 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 everybody gets them.
The following side effects may occur with this medicine.

Stop taking Izinova and consult your 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 feeling of being unwell
Feeling sick (nausea) or being sick (vomiting)
Swelling or pain in the stomach.

Uncommon (may affect up to 1 in 100 people)
Chills
Dry mouth
Headache
Dizziness
Pain when urinating
Discomfort at the anal or rectal level
Changes in certain blood 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 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 reported at the address 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 which is stated on the pack and the vial after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular temperature conditions for storage.
Store in the original package in order 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 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. Package Contents and Other Information

What Izinova contains
The active ingredients are: anhydrous sodium sulfate, magnesium sulfate heptahydrate and potassium sulfate. Each bottle of
approximately 176 ml 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 electrolytes 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 ingredient) 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, ethyl alcohol, acetic acid E260 and benzoic acid E210).

Description of the appearance of Izinova and contents of the pack
This medicine is a concentrate for oral solution, the concentrate is clear or slightly cloudy.
It is presented as 2 bottles of approximately 176 ml each, packaged in a carton with a measuring cup,
with a volume of approximately half a litre for diluting and administering the medicine.
Packs of two bottles and a measuring cup are available as:

• Single pack of two 176 ml PE bottles and a measuring cup
• Pack containing 24 single packs of two 176 ml PE bottles and a measuring cup
• Pack containing 6 cartons of 24 single packs of two 176 ml PE bottles and a measuring cup (6x24=144 single packs)
• Pack containing 14 cartons of 24 single packs of two 176 ml PE bottles and a measuring cup (14x24=336 single packs)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MAH
IPSEN CONSUMER HEALTHCARE S.R.L.
Via Giorgio Stephenson, 43/A
20157 Milan

Manufacturer
Beaufour Ipsen Industrie
Rue d’Ethé Virton
28100 Dreux