Citrafleet

Leaflet accompanying the packaging: information for the user

CitraFleet, (0.01 g + 3.50 g + 10.97 g)/bottle, oral solution
sodium picosulfate + light magnesium oxide + citric acid

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is CitraFleet and what is it 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 packaging and other information

1. What is CitraFleet and what is it used for

CitraFleet oral solution is taken to cleanse the intestines (small and large intestine) before examinations that require the intestines to be clean, such as colonoscopy (a procedure involving the insertion of a long, flexible apparatus into the intestine, which the doctor inserts through the patient's anus to examine the inside of the intestine) or radiological examination of the intestines. CitraFleet has the form of an oral solution with the smell and taste of pomegranate. The solution contains two laxative substances mixed in each bottle, which, after drinking, cause the intestines to be flushed and cleaned. It is essential that the patient's intestines are empty and clean so that the doctor or surgeon can see a clear image during the examination.
CitraFleet oral solution is indicated for use in adults aged 18 and over (including the elderly).

2. Important information before taking CitraFleet

When not to take CitraFleet:

• if the patient is allergicto 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 not able to pump blood to the entire body);
• if the patient has delayed gastric emptying(the stomach does not empty properly from food);
• if the patient has gastric ulcer(also known as stomach or duodenal ulcers);
• if the patient has intestinal obstruction or evacuation disorders(also known as intestinal obstruction);
• if the patient has been informed by the doctor about intestinal wall damage(also known as toxic colitis);
• if the patient has colonic dilatation(also known as toxic colonic dilatation);
• if the patient has recently experienced vomiting or nausea;
• if the patient feels strong thirst or suspects that they may be severely dehydrated;
• if the patient has been informed by the doctor about the occurrence of swelling in the abdominal cavity due to fluid accumulation (ascites);
• if the patient has recently undergone abdominal surgery, e.g., due to appendicitis;
• if the patient may have perforation and/or damage or obstruction of the intestine(perforation or intestinal obstruction);
• if the patient has been informed by the doctor about active, inflammatory bowel disease(such as Crohn's disease or ulcerative colitis);
• if the patient has been informed by the doctor about muscle tissue damage, in which breakdown products enter the blood (rhabdomyolysis);
• if the patient has severe kidney diseaseor the doctor has found too high a level of magnesium in the blood (hypermagnesemia).

Warnings and precautions

Before starting to take CitraFleet oral solution, you should talk to your doctor if:

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

The patient must remember that after taking a dose of CitraFleet oral solution, they will experience frequent, liquid stools. They should drink large amounts of clear fluids (see section 3) to replenish lost fluids and salts. Otherwise, dehydration and low blood pressure may occur, which can cause the patient to faint.

CitraFleet and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking CitraFleet oral solution with other medicines may affect their action. Other medicines may also affect the action of CitraFleet. If the patient is taking medicines from any of the following groups, the doctor may decide to prescribe a different medicine or adjust the dose of the medicine. In this case, if the patient has not yet spoken to their doctor about the following medicines, they should go back to their doctor and ask how to proceed:

• Oral contraceptives, as their action may be reduced.
• Medicines used in diabetesor in the treatment of epilepsy(seizures), as their action may be reduced.
• Antibiotics, as their action may be reduced.
• Other laxatives, including bran.
• Diuretics, such as furosemide taken to control fluid retention in the body.
• Corticosteroids, such as prednisone, used to treat inflammation in conditions such as arthritis, asthma, hay fever, skin inflammation, and colitis.
• 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 drugs, such as haloperidol, clozapine, and risperidone, used to treat schizophrenia.
• Lithiumused to treat manic-depressive psychosis (bipolar disorder).
• Carbamazepineused to treat epilepsy.
• Penicillamineused to treat rheumatoid arthritis and other conditions.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

If, after taking CitraFleet, the patient starts to feel tired or dizzy, they should not drive vehicles or operate machines.

CitraFleet oral solution contains sodium, sodium metabisulfite (E 223), sodium methyl parahydroxybenzoate (E 219), ethanol, and sodium propyl parahydroxybenzoate

This medicine contains sodium metabisulfite (E 223). The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains sodium methyl parahydroxybenzoate (E 219) and sodium propyl parahydroxybenzoate. The medicine may cause allergic reactions (possible late reactions).
This medicine contains 66 mg of alcohol (ethanol) in each 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 have noticeable effects.
This medicine contains 3.4 g of sodium in each bottle, which is approximately 173.6% of the WHO-recommended maximum daily intake of sodium for adults.

3. How to take CitraFleet

This medicine should always be taken according to the doctor's recommendations, as if the intestines are not completely cleaned, it may be necessary to repeat the examination. In case of doubts, the patient should consult their doctor or pharmacist.

The patient should prepare for the occurrence of frequent, loose stools at any time after taking the dose of CitraFleet

It is normal and indicates that the medicine is working. The patient should ensure that they have access to a toilet until the bowel movements subside.
It is essential to follow a special diet (low-residue) on the day before the examination. From the start of taking the medicine to the time of the examination, the patient should not take any solid foods. The patient should always follow the doctor's recommendations regarding diet. If they have any questions, they should contact their doctor or pharmacist.
If the doctor does not recommend otherwise, the patient should not take a dose larger than recommended within 24 hours.

Treatment plan

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 require mixing with another liquid or dilution.
Treatment can be administered using one of the following schedules:

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

The patient should maintain at least a 5-hour interval between taking the contents of the first and second bottles.
Immediately after drinking the medicine, the patient should not drink fluids to avoid further dilution of the product.
After taking the contents of each bottle, the patient should wait about 10 minutes and then drink about 1.5-2 liters of clear fluids in amounts of about 250 ml (a glass) to 400 ml every hour.
To prevent dehydration, it is recommended to consume clear soups and/or balanced electrolyte drinks. Drinking pure water is not recommended.
After taking the contents of the second bottle of CitraFleet and drinking about 1.5-2 liters of fluids, the patient should not eat or drink for at least 2 hours before the examination or procedure, or follow the doctor's recommendations.

Taking a higher dose of CitraFleet than recommended

In case of taking a higher dose of CitraFleet than recommended, the patient should immediately contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Known side effects resulting from taking CitraFleet have been described below in order of frequency:

Very common (may occur more frequently than 1 in 10 people):

Abdominal pain.

Common (may occur no more frequently than 1 in 10 people):

Abdominal bloating, feeling of thirst, feeling of discomfort in the anal area, and anal pain (pain in the anal area or in the lower abdomen), fatigue (feeling of fatigue), sleep disturbances, headache, dry mouth, nausea (nausea).

Uncommon (may occur no more frequently than 1 in 100 people):

Dizziness, vomiting, inability to control bowel movements (fecal incontinence).
Other side effects, for which the frequency is not known(cannot be determined from available data):
Anaphylactic reaction or hypersensitivity, which are severe allergic reactions. If the patient experiences difficulty breathing, redness, or any other symptoms indicating a severe allergic reaction, they should immediately go to the hospital.
Hypnatremia (low sodium levels in the blood), hypokalemia (low potassium levels in the blood), epilepsy, seizures (seizures), orthostatic hypotension (low blood pressure when standing, which can lead to dizziness or feeling unsteady), feeling of disorientation, rash including hives, itching (itching), and purpura (bleeding under the skin).
Bloating (gas) and pain.
The medicine is intended to cause regular, loose stools, similar to those experienced with diarrhea. However, if after taking this medicine, the bowel movements become troublesome or worrying, the patient should contact their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store CitraFleet

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the 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 given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What CitraFleet contains

• The active substances of the medicine 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 metabisulfite (E 223), sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), sucralose, flavoring agent (sweetness modifier), pomegranate flavor (contains ethanol and propylene glycol (E 1520)), sodium hydroxide (to adjust pH), purified water. See section 2.

What CitraFleet looks like and what the pack contains

CitraFleet is a clear, colorless or slightly yellowish oral solution with a pomegranate flavor and is packaged in cardboard boxes containing:

• 2, 20, 40, or 80 bottles, or
• bulk packs containing 20 (10 x 2), 40 (20 x 2), or 80 (40 x 2) bottles. The bottles contain a single dose, which is 160 ml. Each bottle contains one dose of the medicine intended for an adult.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

For more information about CitraFleet, please contact:

[email protected] or contact the representative of the marketing authorization holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel. 22 206 84 50

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

CitraFleet: France, Finland, Germany, Greece, Ireland, Italy, Norway, Poland, Portugal, Spain, Sweden.

Date of last revision of the leaflet: 10/2024