Citrafleet

Package leaflet: Information for the user

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

• Keep this leaflet to be able to 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 pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 before examinations requiring clean bowels, such as colonoscopy (a procedure imaging 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 consumed, these agents will cleanse the intestines. It is important that the patient's bowels 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, 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 effectively 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 called toxic colitis);
• if the patient has colonic dilation (also known as colonic paralysis);
• if the patient has recently experienced nausea or vomiting;
• if the patient feels intense thirst or may be seriously dehydrated;
• if the patient has been informed by a doctor about fluid accumulation in the abdominal cavity causing swelling (ascites);
• if the patient has recently undergone abdominal surgery, for example due to appendicitis;
• if the patient may have intestinal perforation, damage, 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 magnesium levels in the blood (hypermagnesemia).

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

• the patient has recently undergone intestinal surgery;
• the patient has kidney or heart disease;
• the patient has fluid and electrolyte imbalances (sodium or potassium), or the patient is taking medications 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 levels of sodium or potassium in the blood (hyponatremia or hypokalemia);
• after taking CitraFleet, the patient experiences severe or persistent abdominal pain and/or rectal bleeding, the doctor should be informed immediately. This is because CitraFleet has rarely been associated with intestinal inflammation (colitis).

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 salts. 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 the patient is currently taking, has recently taken, or plans 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 dosage. 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 tablets);
• corticosteroids, such as prednisone, used for conditions such as arthritis, asthma, hay fever, skin inflammation, and inflammatory bowel disease;
• digoxin, used to treat 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 to treat manic-depressive psychosis (bipolar disorder);
• carbamazepine, used to treat epilepsy;
• penicillamine, used to treat rheumatoid arthritis and other conditions.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she might 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, he or she 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 potassium-restricted diets.
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 the physician, because if the intestines are not completely cleared, it may be necessary to repeat the examination. 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 on the day before the procedure. From the time the medication is started until the examination is performed, no solid foods should be consumed. Always follow the physician's dietary instructions. If you have any questions, contact your physician or pharmacist.

Unless otherwise directed by the physician, the patient should not take a higher dose 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 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 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 in order 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, it is recommended to consume clear soups and/or balanced electrolyte drinks. 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 physician's instructions.

INSTRUCTIONS FOR USE:
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 consumed immediately after preparation. The suspension will be cloudy.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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, thirst, sensation of discomfort around the anus, anal pain, 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 reactions for which frequency is unknown (cannot be estimated from available data):
Anaphylactic reaction or hypersensitivity, which are severe allergic reactions. If breathing difficulties, redness, 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, 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 your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safe use 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 dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack 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 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 marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Germany, the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Germany, the country of export: 68805.00.00
Parallel import authorisation number: 425/19
This medicinal product is authorised for marketing in the European Economic Area member states under the following trade 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).