Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
CitraFleet, (0.01 g + 3.50 g + 10.97 g)/sachet, powder for oral solution
(sodium picosulfate + magnesium oxide + citric acid)
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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 of the leaflet

What CitraFleet is and what it is used for
Information you must read 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 is taken to cleanse the intestines and colon before examinations requiring clean bowels, such as colonoscopy (a procedure to visualize the intestine using a long, flexible instrument inserted by the doctor through the patient's anus) or radiological imaging. CitraFleet comes as a lemon-flavoured and lemon-scented powder. Each sachet contains two laxative substances. When dissolved in water and ingested, these agents will cleanse the intestines. It is important that the patient's intestines are empty and clean so that the doctor has a clear view during the examination.
CitraFleet is indicated for use in adults aged 18 years and above (including elderly patients).

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 properly);
if the patient has gastric or duodenal ulcers;
if the patient has intestinal obstruction or bowel movement disorders;
if the patient has been informed by a doctor about intestinal wall damage (also known as toxic colitis);
if the patient has colonic dilation (also known as paralytic ileus);
if the patient has recently experienced nausea or vomiting;
if the patient feels intense thirst or may be severely dehydrated;
if the patient has been informed by a doctor about abdominal swelling due to fluid accumulation in the abdominal cavity ( known as ascites );
if the patient recently underwent abdominal surgery, e.g. due to appendicitis;
if the patient may have experienced perforation/injury or intestinal 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 magnesium levels in the blood ( hyper-magnesemia ).

Warnings and precautions
Before starting to take CitraFleet, talk to a doctor if:

the patient recently underwent intestinal surgery;
the patient has kidney or heart disease;
the patient has fluid and electrolyte imbalance (sodium or potassium), or the patient is taking medicines that may affect fluid and electrolyte balance (sodium or potassium), such as diuretics, corticosteroids, or lithium;
the patient has been diagnosed with epilepsy or has a history of seizures;
the patient has low blood pressure (hypotension);
the patient feels thirsty or suspects they may be moderately dehydrated;
the patient is elderly or physically frail;
the patient has ever had low blood levels of sodium or potassium (hyponatremia or hypokalemia);
the patient experiences severe or persistent abdominal pain and/or rectal bleeding after taking CitraFleet, they should inform the doctor. This is because CitraFleet has rarely been associated with intestinal inflammation (inflammation of the large intestine). The patient should expect frequent loose stools after taking a dose of CitraFleet. Large amounts of clear fluids should be consumed (see section 3) to replace lost fluids and salts. Otherwise, dehydration and low blood pressure may occur, potentially leading to fainting.

CitraFleet and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Taking CitraFleet together 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 medicines listed below with their doctor, they should return to the doctor and ask how to proceed:

oral contraceptives, because their effectiveness may be reduced;
medicines used for diabetes or treating epilepsy (seizures), because their effectiveness may be reduced;
antibiotics, because their effectiveness may be reduced;
other laxatives, including bran;
diuretics, such as furosemide (water tablets);
corticosteroids such as prednisone, used in conditions such as arthritis, asthma, hay fever, skin inflammation, and inflammatory bowel disease;
digoxin, used in treating 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;
antipsychotic medicines such as haloperidol, clozapine, and risperidone, used to treat schizophrenia;
lithium, used in treating manic-depressive psychosis (bipolar disorder);
carbamazepine, used in treating epilepsy;
penicillamine, used in treating rheumatoid arthritis and other conditions.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
If the patient feels tired or dizzy after taking CitraFleet, they should not drive or operate machinery.
CitraFleet contains potassium and sodium
CitraFleet contains 5 mmol (or 195 mg) of potassium per sachet, which should be considered in patients with impaired kidney function and in patients monitoring potassium intake in their diet.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, meaning the medicine is considered "sodium-free".

3. How to take CitraFleet

This medicine should always be taken according to the doctor's instructions, because if the intestines are not completely cleansed, the examination may need to be repeated. If in doubt, consult your doctor 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 moment treatment is started until the examination is performed, no solid foods should be consumed. Always follow your doctor's dietary instructions. If you have any questions, contact your doctor or pharmacist.

Unless otherwise directed by a doctor, the patient should not take a dose higher than recommended within 24 hours.

Treatment schedule
The patient should receive two CitraFleet sachets. Each sachet contains a single dose intended for an adult.
Treatment should be carried out using one of the following regimens:

One sachet in the evening the day before the examination/procedure, and the second sachet in the morning on the day of the examination/procedure, or
One sachet in the afternoon, and the second sachet in the evening the day before the examination/procedure. This regimen is recommended when the examination/procedure is scheduled early in the morning, or
Both sachets in the morning on the day of the examination/procedure. This regimen is appropriate only if the examination/procedure is scheduled for the afternoon or evening.

For any of the above regimens, at least a 5-hour interval must be maintained between the first and second sachet.

The contents of each sachet should be dissolved in a cup of water. Immediately after taking the medicine, fluids should not be consumed to avoid further dilution of the product.

Approximately 10 minutes after taking each sachet, drink about 1.5–2 liters of clear fluids, consuming approximately 250 ml (a glass) to 400 ml each hour. To prevent dehydration, consumption of clear soups and/or balanced electrolyte drinks is recommended. Drinking plain water is not recommended.

After taking the second sachet 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 your doctor's instructions.

DOSING INSTRUCTIONS:
Adults (including elderly patients) aged 18 years and older.

Step 1 – Pour the contents of 1 sachet into a cup of cold water (approximately 150 ml).
Step 2 – Mix for 2–3 minutes. If the mixture warms during mixing, wait until it cools before drinking the entire solution. The suspension should be taken immediately after preparation. The suspension will be cloudy.

Taking more CitraFleet than recommended
If more CitraFleet than recommended has been taken, contact your doctor or pharmacist immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The known adverse effects associated with taking CitraFleet are described below, listed 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 of thirst, sensation of discomfort around the anus, pain around the anus, fatigue (feeling tired), sleep disturbances, headache, dry mouth, nausea (feeling sick).
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 not known (cannot be estimated from available data):
Anaphylactic reaction or hypersensitivity, which are severe allergic reaction symptoms. If breathing difficulties, redness, or any other symptoms indicating a severe allergic reaction occur, seek immediate hospital care.
Hyponatremia (low sodium levels in blood), hypokalemia (low potassium levels in blood), epilepsy, seizures, orthostatic hypotension (low blood pressure upon standing, which may lead to dizziness or instability), confusion, rash including urticaria, itching, and purpura (subcutaneous bleeding).
Flatulence (gas) and pain.
The medicine is intended to produce regular, loose stools similar to those occurring during 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, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects helps to provide more information on the safety of the medicine.

5. How to store CitraFleet

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What CitraFleet contains

The active substances are: sodium picosulfate 0.01 g (10.0 mg), light magnesium oxide 3.50 g, citric acid 10.97 g.
The other ingredients are: potassium hydrogen carbonate, sodium saccharin, lemon flavour (lemon flavour, maltodextrin, α-tocopherol (E 307)). See section 2.

What CitraFleet looks like and contents of the pack
CitraFleet is a white, crystalline powder for oral solution, available in packs containing 2, 50 or 100 sachets. Each sachet contains a single adult dose of 15.08 g.
For more detailed information, please contact the responsible entity or parallel importer.
Responsible entity in the Czech Republic, country of export:
Casen Recordati, S.L., Autovía de Logroño, km 13,300, 50180 Utebo - Saragossa, Spain
Manufacturer:
Casen Recordati, S.L., Autovía de Logroño, km 13,300, 50180 Utebo – Saragossa, Spain
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
Authorisation number in the Czech Republic, country of export: 61/403/13-C
Parallel import authorisation number: 150/25
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Citrafleet: Croatia, Czech Republic, Denmark, Norway, Slovenia
CitraFleet: Austria, Belgium, Bulgaria, Cyprus, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland)