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 + magnesium oxide light + citric acid
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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 before medical procedures requiring clean bowels, such as colonoscopy (a procedure to visualize the intestine using a long, flexible instrument inserted through the patient's anus) or radiological imaging. CitraFleet comes as a lemon-scented and flavored powder. Each sachet contains two laxative substances. When dissolved in water and taken orally, these agents will cleanse the intestines. It is important that the patient's intestines are empty and clean so that the doctor can obtain 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 adequately throughout the body);

• if the patient has delayed gastric emptying (the stomach does not empty properly);

• if the patient has stomach or duodenal ulcers;

• if the patient has intestinal obstruction or bowel movement disorders;

• if the patient has been informed by a doctor about damage to the intestinal wall (also known as toxic colitis);

• if the patient has colonic distension (also known as paralytic ileus);

• if the patient has recently experienced nausea or vomiting;

• if the patient feels excessive thirst or may be severely dehydrated;

• if the patient has been informed by a doctor about the presence of 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 perforation/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 leading to breakdown products entering the bloodstream (rhabdomyolysis);

• if the patient has severe kidney disease or the doctor has diagnosed abnormally 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 takes 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 weak;
• the patient has ever had low levels of sodium or potassium in the blood (hyponatremia or hypokalemia);
• the patient experiences severe or persistent abdominal pain and/or rectal bleeding after taking CitraFleet, and 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 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
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient 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 dose. Therefore, if the patient has not yet discussed the following medicines with the doctor, the patient should return to the doctor and ask for advice on how to proceed:

• oral contraceptives, because their effectiveness may be reduced;
• medicines used for diabetes or epilepsy (seizures), because their effectiveness may be reduced;
• antibiotics, because 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;
• antipsychotics 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 to treat 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, 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 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 exactly as directed by the doctor, because if the intestines are not completely cleared, the examination may need to be repeated. In case of 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 on the day before the examination. From the time the medicine is started until the examination is performed, no solid food should be consumed. Always follow your doctor's dietary instructions. If you have any questions, contact your doctor or pharmacist.
Unless otherwise instructed by the doctor, the patient should not take a dose higher than recommended 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 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.

In each 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 consuming each sachet, the patient should 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 consuming about 1.5–2 liters of fluids, the patient should not eat or drink anything for at least 2 hours before the procedure, or should 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 – Stir for 2–3 minutes. If the mixture warms during stirring, 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 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, 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 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 other symptoms indicating a severe allergic reaction occur, seek immediate hospital care.
Hyponatremia (low sodium blood levels), hypokalemia (low potassium blood levels), 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 bothersome 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 of the 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 effects helps to gather further information on the safety of the medicine.

5. How to store CitraFleet

Keep the 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 the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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 marketing authorisation holder or the parallel importer.
Marketing authorisation holder 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:
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 the Czech Republic, country of export: 61/403/13-C
Parallel import authorisation number: 18/25
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).