Citrafleet

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the 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
Natrii picosulfas + Magnesii oxidum leve + Acidum citricum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What CitraFleet is and what it is used for
2. Important information before taking CitraFleet
3. How to take CitraFleet
4. Possible side effects
5. How to store CitraFleet
6. 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 prior to examinations requiring clean bowels, such as colonoscopy (an imaging procedure of 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 powder. Each sachet contains two cleansing substances. When dissolved in water and consumed, 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 individuals).

2. Important information before taking CitraFleet

When not to take CitraFleet:

• if the patient is allergic to sodium picosulfate, light 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 peptic ulcers (gastric or duodenal ulcers);
• if the patient has intestinal obstruction or defecation 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 colonic ileus or 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 (ascites);
• if the patient recently underwent abdominal surgery, e.g. due to appendicitis;
• if the patient may have experienced intestinal perforation, intestinal damage, 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 allowing breakdown products to enter the bloodstream (rhabdomyolysis);
• if the patient has severe kidney disease or the doctor has diagnosed excessively high magnesium levels in the blood (hypermagnesemia).

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

• the patient recently underwent intestinal surgery;
• the patient has kidney or heart disease;
• the patient has fluid and electrolyte imbalances (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 moderate dehydration;
• the patient is elderly or physically frail;
• the patient has ever experienced low blood sodium or potassium levels (hyponatremia or hypokalemia).

The patient should expect frequent, loose bowel movements after taking a dose of CitraFleet. It is important to drink large amounts of clear fluids (see section 3) to replace lost fluids and electrolytes. Otherwise, dehydration and low blood pressure may occur, which could lead 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 any of the medicines 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 consult the doctor again to determine the appropriate course of action:

• oral contraceptives, as their effectiveness may be reduced;
• medicines used for 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 (water pills);
• corticosteroids such as prednisone, used in conditions such as arthritis, asthma, hay fever, skin inflammation, and inflammatory bowel disease;
• 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 inflammation;
• 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 the treatment of manic-depressive psychosis (bipolar disorder);
• 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, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

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

CitraFleet contains potassium and sodium
This medicine contains 5 mmol (or 195 mg) of potassium per sachet, which should be considered in patients with impaired kidney function and in patients on a potassium-restricted 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 as directed by a physician, because if the intestines are not
completely cleansed, the examination may need to be repeated. In case of doubt, consult a 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 on the day before the procedure. From the moment
the medicine is started until the examination is performed, no solid food should be consumed. Always
follow the doctor’s dietary instructions. If in doubt, contact the doctor or pharmacist.
Unless otherwise directed by a physician, the patient should not take more than the recommended
dose within 24 hours.

Treatment schedule
The patient should receive two sachets of CitraFleet. 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 on 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 on the day before the examination/procedure. This regimen is recommended when the examination/procedure is scheduled for early 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.

In each of the above regimens, there must be at least a 5-hour interval between taking 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.
After taking each sachet, wait approximately 10 minutes, then drink about 1.5–2 liters of clear fluids,
consuming approximately 250 ml (one glass) to 400 ml each hour. To prevent dehydration, it is
recommended to drink clear soups and/or balanced electrolyte solutions. Drinking plain water is not
recommended.
After taking the second sachet and consuming about 1.5–2 liters of fluids, do not eat or drink anything
for at least 2 hours before the procedure, or follow the 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 up during mixing, wait until it cools before drinking the entire solution. The suspension should be consumed immediately after preparation. The suspension will be cloudy.

Taking more CitraFleet than recommended
If more CitraFleet has been taken than recommended, contact a 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.
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 reaction symptoms. If breathing difficulties, redness, or any symptoms indicating a severe allergic reaction occur, seek immediate hospital care.
Hyponatremia (low blood sodium levels), hypokalemia (low blood potassium levels), seizures, convulsions, 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 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
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store CitraFleet

Keep this medicine out of sight and reach of children.
Do not store above 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 properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What CitraFleet contains

• The active substances in this medicinal product are: sodium picosulfate 0.01 g (10.0 mg), light magnesium oxide 3.50 g, citric acid 10.97 g.
• The other components are: potassium hydrogen carbonate, sodium saccharin, lemon flavour (lemon flavour, maltodextrin, RRR-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 party or parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Casen Recordati, S.L.
Autovía de Logroño Km 13,300
50180 Utebo - Zaragoza
Spain

Manufacturer:
Casen Recordati, S.L.
Autovía de Logroño Km 13,300
50180 Utebo - Zaragoza
Spain

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland

SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Poland

CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Germany, the country of export: 68805.00.00
Parallel Import Licence Number: 82/23

This medicinal product is authorised for marketing in the European Economic Area member states 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).