Patient Information Leaflet: Read this leaflet carefully before taking the medicine, as it contains important information for you.

CitraFleet, (0.01 g + 3.50 g + 10.97 g)/bottle, oral solution
sodium picosulfate + light magnesium oxide + citric acid
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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

What CitraFleet is and what it is used for
What you need to know before taking CitraFleet
How to take CitraFleet
Possible side effects
How to store CitraFleet
Contents of the pack and other information

1. What CitraFleet is and what it is used for

CitraFleet oral solution is taken to cleanse the intestines (small and large intestine) before medical procedures requiring a clean bowel, such as colonoscopy (a procedure involving the insertion of a long, flexible instrument through the patient's anus to examine the inside of the intestine) or radiological examination of the intestines. CitraFleet is an oral solution with the smell and taste of pomegranate fruit. The solution contains two bowel-cleansing agents mixed in each bottle; after ingestion, these agents cause flushing and cleansing of the intestines. It is important that the patient's intestines are empty and clean so that the doctor or surgeon can obtain a clear view during the examination.
CitraFleet oral solution is indicated for use in adults aged 18 years and older (including elderly individuals).

2. Important information before taking CitraFleet

When not to take CitraFleet:

if the patient is allergic to sodium picosulfate, magnesium oxide, citric acid, or any of the other ingredients of this medicine (listed in section 6);
if the patient has congestive heart failure (the heart is unable to pump blood adequately throughout the body);
if the patient has delayed gastric emptying (the stomach does not empty food properly);
if the patient has peptic ulcer (sometimes referred to as stomach or duodenal ulcers);
if the patient has intestinal obstruction or impaired bowel movements (sometimes referred to as intestinal obstruction);
if the patient has been informed by a doctor about intestinal wall damage (also known as toxic colitis);
if the patient has toxic megacolon (also known as toxic dilation of the colon);
if the patient has recently experienced vomiting or nausea;
if the patient feels intense thirst or suspects they may be severely dehydrated;
if the patient has been informed by a doctor about abdominal swelling due to fluid accumulation (ascites);
if the patient has recently undergone abdominal surgery, e.g. due to appendicitis;
if the patient may have experienced perforation and/or damage or blockage of the intestine (intestinal perforation or obstruction);
if the patient has been informed by a doctor about active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis);
if the patient has been informed by a doctor about muscle tissue damage leading to breakdown products entering the bloodstream (rhabdomyolysis);
if the patient has severe kidney disease or the doctor has diagnosed excessively high blood magnesium levels (hypermagnesemia).

Warnings and precautions
Before starting treatment with CitraFleet oral solution, speak with
a doctor if:

the patient has recently undergone intestinal surgery;
the patient has kidney or heart problems;
the patient has fluid and/or electrolyte imbalances (sodium or potassium), or the patient is taking medications that may affect fluid and/or electrolyte balance (sodium or potassium), such as diuretics, corticosteroids, or lithium;
the patient has epilepsy or has had seizures in the past;
the patient has low blood pressure (hypotension);
the patient feels thirsty or suspects they may be mildly or moderately dehydrated;
the patient is elderly or physically frail;
the patient has ever had low blood levels of sodium or potassium (also known as hyponatremia or hypokalemia);
the patient develops severe or persistent abdominal pain and/or rectal bleeding after taking CitraFleet, and should inform the doctor. This is because use of CitraFleet has rarely been associated with intestinal inflammation (colitis).

The patient must remember that after taking a dose of CitraFleet oral solution, frequent, watery bowel movements will occur. It is important to drink large amounts of clear fluids (see section 3) to replace lost fluids and salts. Otherwise, dehydration and low blood pressure may occur, which could lead to fainting.

CitraFleet and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Concurrent use of CitraFleet oral solution with other medicines may affect their effectiveness. Other medicines may also affect the action of CitraFleet. If the patient is taking medicines belonging to any of the groups listed below, the doctor may decide to prescribe an alternative medicine or adjust the dose. Therefore, if the patient has not yet discussed the following medicines with their doctor, they should return to the doctor and ask how to proceed:

Oral contraceptives, as their effectiveness may be reduced.
Medicines used in the treatment of diabetes or epilepsy (seizures), as their effectiveness may be reduced.
Antibiotics, as their effectiveness may be reduced.
Other laxatives, including bran.
Diuretics, such as furosemide, taken to control fluid retention in the body.
Corticosteroids, for example prednisone, used to treat inflammation in conditions such as arthritis, asthma, hay fever, skin inflammation, and intestinal inflammation.
Digoxin, used in the treatment of heart failure.
Non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid and ibuprofen, used to treat pain and inflammatory conditions.
Tricyclic antidepressants, such as imipramine and amitriptyline, and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, paroxetine, and citalopram, used to treat depression and anxiety.
Antipsychotics, such as haloperidol, clozapine, and risperidone, used to treat schizophrenia.
Lithium, used in the treatment of bipolar disorder (manic-depressive psychosis).
Carbamazepine, used in the treatment of epilepsy.
Penicillamine, used in the treatment of rheumatoid arthritis and other disorders.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
If after taking CitraFleet the patient experiences fatigue or dizziness, they should not drive or operate machinery.

CitraFleet oral solution contains sodium, sodium metabisulfite (E 223), methylparaben sodium (E 219), ethanol, and sodium propylparaben
This medicine contains sodium metabisulfite (E 223). The medicine may rarely cause severe allergic reactions and bronchospasm.
This medicine contains methylparaben sodium (E 219) and sodium propylparaben. The medicine may cause allergic reactions (including delayed-type reactions).
This medicine contains 66 mg of alcohol (ethanol) per bottle. The amount of alcohol in 160 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains 3.4 g of sodium per bottle, which is approximately 173.6% of the WHO recommended maximum daily sodium intake for adults.

3. How to take CitraFleet

This medicine should always be taken as directed by the physician, because if the intestines are not
completely cleared, the procedure may need to be repeated. In case of doubt, consult a physician or
pharmacist.
The patient should be prepared for frequent, loose bowel movements at any time after taking a dose of
CitraFleet. This is normal and indicates that the medicine is working. The patient should ensure
access to a toilet until bowel movements cease.
It is important to follow a special low-residue diet the day before the procedure. From the time the
medication is started until the procedure is performed, no solid foods should be consumed. Always
follow the physician's dietary instructions. If in doubt, contact the physician or pharmacist.
Unless otherwise directed by the physician, the patient should not take more than the recommended
dose within 24 hours.

Dosing schedule
The patient should receive two bottles of CitraFleet oral solution. Each bottle contains a single dose
intended for an adult.
The CitraFleet solution is ready to drink directly from the bottle. The solution does not need to be
mixed with another liquid or diluted.
Treatment may be administered according to one of the following regimens:

The contents of one bottle in the evening the day before the procedure, and the contents of the second bottle in the morning on the day of the procedure, or
The contents of one bottle in the afternoon, and the contents of the second bottle in the evening of the day before the procedure. This regimen is recommended when the procedure is scheduled early in the morning, or
The contents of both bottles in the morning on the day of the procedure. This regimen is appropriate only if the procedure is scheduled for the afternoon or evening.

There should be at least a 5-hour interval between taking the contents of the first and second
bottles.
Immediately after taking the medicine, fluids should not be consumed to avoid further dilution of the
product.
Approximately 10 minutes after taking the contents of each bottle, drink about 1.5–2 liters of clear
fluids, consuming approximately 250 ml (a glass) to 400 ml each hour.
To prevent dehydration, it is recommended to consume clear soups and/or balanced electrolyte
drinks. Drinking plain water is not recommended.
After taking the contents of the second bottle and drinking about 1.5–2 liters of fluids, do not eat or
drink anything for at least 2 hours before the procedure, or follow the physician's instructions.

Taking more than the recommended dose of CitraFleet
If more than the recommended dose of CitraFleet has been taken, contact a physician or
pharmacist immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The known adverse effects associated with taking CitraFleet are listed below,
in order of frequency:
Very common (may affect more than 1 in 10 people):
Abdominal pain.
Common (may affect up to 1 in 10 people):
Abdominal bloating, feeling thirsty, sensation of discomfort around the anus, anal pain (pain in the
anal area or lower abdomen), fatigue (feeling tired), sleep disturbances, headache, dry mouth, nausea.
Uncommon (may affect up to 1 in 100 people):
Dizziness, vomiting, inability to control bowel movements (faecal incontinence).
Other adverse effects for which frequency is unknown (cannot be estimated from available data):
Anaphylactic reaction or hypersensitivity, which are severe allergic reactions. If breathing difficulties,
flushing, or any other symptoms indicating a severe allergic reaction occur, seek immediate medical attention at a hospital.
Hyponatremia (low sodium levels in blood), hypokalemia (low potassium levels in blood), epilepsy,
seizures (seizure attacks), orthostatic hypotension (low blood pressure upon standing, which may
lead to dizziness or feeling unsteady), disorientation, skin rash including urticaria, pruritus (itching), and purpura (subcutaneous bleeding).
Flatulence (gas) and pain.
The medicine is intended to produce regular, loose stools similar to diarrhoea. However, if bowel movements become troublesome or concerning after taking this medicine, consult a doctor.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can 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 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store CitraFleet

Keep this medicine out of the sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the bottle label after EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via 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 CitraFleet contains

The active substances are: sodium picosulfate 0.01 g, light magnesium oxide 3.50 g, citric acid 10.97 g per bottle (160 ml).
Other ingredients are: malic acid, sodium pyrosulfite (E 223), sodium methylparahydroxybenzoate (E 219), sodium propylparahydroxybenzoate (E 217), sucralose, flavour-masking agent (sweetness modulator), pomegranate flavour (containing ethanol and propylene glycol (E 1520)), sodium hydroxide (for pH adjustment), purified water. See
point 2.
What CitraFleet looks like and contents of the pack
CitraFleet is a clear, colourless or slightly yellowish oral solution with a pomegranate flavour, supplied in cardboard packs containing:
2, 20, 40 or 80 bottles, or
multipacks containing 20 (10 x 2), 40 (20 x 2) or 80 (40 x 2) bottles. The bottles contain a single dose of 160 ml. Each bottle contains one dose of the medicinal product intended for an adult.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño, Km 13,300
50180 Utebo - Zaragoza
Spain
For further information about CitraFleet, please contact:
[email protected] or contact the representative of the Marketing Authorisation Holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel. 22 206 84 50
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
CitraFleet: France, Finland, Germany, Greece, Ireland, Italy, Norway, Poland, Portugal,
Spain, Sweden.