Citrafleet

Package Leaflet: Information for the User

CitraFleet, (0.01 g + 3.50 g + 10.97 g)/sachet, powder for oral solution
sodium picosulfate + magnesium oxide + citric acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package contents and other information

1. What is CitraFleet and what is it used for

CitraFleet is used to cleanse the intestines and colon before examinations that require clean intestines, such as colonoscopy (a procedure that uses a long, flexible instrument that the doctor inserts through the patient's anus) or radiological imaging. CitraFleet is a powder with a citrus flavor and smell. The powder contains two laxative substances mixed in each sachet. After dissolving in water and drinking, these substances will cleanse the intestines. It is essential that the patient's intestines are empty and clean so that the doctor has a clear image during the examination. CitraFleet 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, 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 whole body);
• if the patient has gastric retention(the stomach does not empty properly);
• if the patient has gastric or duodenal ulcers;
• if the patient has intestinal obstruction or bowel disorders;
• if the patient has been informed by the doctor of bowel wall damage(also known as toxic megacolon);
• if the patient has colonic dilatation(also known as paralytic ileus);
• if the patient has recently experienced nausea or vomiting;
• if the patient feels severe thirstor may be severely dehydrated;
• if the patient has been informed by the doctor of fluid accumulation in the abdominal cavity(known as ascites);
• if the patient has recently undergone abdominal surgery, e.g., due to appendicitis;
• if the patient may have bowel perforation/damage or obstruction;
• if the patient has been informed by the doctor of active inflammatory bowel disease(such as Crohn's disease or ulcerative colitis);
• if the patient has been informed by the doctor of muscle tissue damage, where breakdown products enter the blood (rhabdomyolysis);
• if the patient has severe kidney diseaseor the doctor has found high levels of magnesium in the blood (hypermagnesemia).

Warnings and precautions

Before starting CitraFleet, talk to your doctor if:

• the patient has recently undergone intestinal surgery;
• the patient has kidney or heart disease;
• the patient has electrolyte imbalance(sodium or potassium) or is taking medicines that may affect electrolyte balance(sodium or potassium), such as diuretics, corticosteroids, or lithium;
• the patient has a history of epilepsyor seizures;
• the patient has low blood pressure(hypotension);
• the patient feels thirsty or suspects they may be moderately dehydrated;
• the patient is elderlyor physically weak;
• the patient has ever had low sodium or potassium levels in the blood(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 CitraFleet has been rarely associated with colitis (inflammation of the colon).

The patient should be prepared for frequent, loose stools after taking the dose of CitraFleet. They should drink plenty of clear fluids (see section 3) to replace lost fluids and electrolytes. Otherwise, dehydration and low blood pressure may occur, which can cause the patient to faint.

CitraFleet and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Taking CitraFleet with other medicines can affect their action. Other medicines can also affect the action of CitraFleet. If you are taking medicines belonging to any of the following groups, your doctor may decide to prescribe a different medicine or adjust the dose of CitraFleet. If you have not yet talked to your doctor about the following medicines, you should go back to your doctor and ask how to proceed:

• oral contraceptives, as their effect may be reduced;
• medicines used in diabetesor to treat epilepsy(seizures), as their effect may be reduced;
• antibiotics, as their effect may be reduced;
• other laxatives, including bran;
• diuretics, such as furosemide (diuretics);
• corticosteroidssuch as prednisone used in diseases 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 antidepressantssuch as imipramine and amitriptyline and selective serotonin reuptake inhibitors (SSRIs)such as fluoxetine, paroxetine, and citalopram used to treat depression and anxiety;
• antipsychotic drugssuch 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 diseases.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If, after taking CitraFleet, you feel drowsy or dizzy, do 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 taken into account in patients with reduced kidney function and in patients controlling their potassium intake. This medicine contains less than 1 mmol of sodium (23 mg) per sachet, which means that the medicine is considered "sodium-free".

3. How to take CitraFleet

This medicine should always be taken exactly as your doctor has told you. If your intestines are not completely cleansed, it may be necessary to repeat the examination. If you are unsure, ask your doctor or pharmacist.

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

This is normal and indicates that the medicine is working. The patient should ensure they have access to a toilet until bowel movements have stopped. It is essential to follow a special diet (low-residue) the day before the examination. From the start of taking the medicine until the examination, no solid foods should be taken. Always follow the doctor's advice on diet. If you have any questions, contact your doctor or pharmacist. Unless otherwise advised by your doctor, you should not take more than the recommended dose in 24 hours.

Treatment plan

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

• One sachet in the evening before the examination/procedure, the second sachet in the morning of the examination/procedure, or
• One sachet in the afternoon, the second sachet in the evening before the examination/procedure. This scheme is recommended when the examination/procedure is scheduled early in the morning, or
• Both sachets in the morning of the examination/procedure. This scheme is suitable only if the examination/procedure is scheduled for the afternoon or evening.

In all of the above schemes, maintain at least a 5-hour interval between the administration of the first and second sachets. The contents of the sachet should be dissolved in a glass of water. Do not drink fluids immediately after taking the medicine to avoid further dilution of the product. After taking each sachet, wait about 10 minutes, 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 second sachet of CitraFleet and drinking about 1.5-2 liters of fluids, do not eat or drink for at least 2 hours before the examination or follow the doctor's advice.

RECOMMENDATIONS FOR USE:

Adults (including the elderly) aged 18 and over.

• Step 1- Pour the contents of 1 sachet into a glass of cold water (about 150 ml).
• Step 2- Mix for 2-3 minutes. If the contents warm up during mixing, wait until it cools before drinking the entire solution. The suspension should be drunk immediately after preparation. The suspension will be cloudy.

Taking more than the recommended dose of CitraFleet

If you take more than the recommended dose of CitraFleet, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, CitraFleet can cause side effects, although not everybody gets them. Known side effects resulting from taking CitraFleet are described below 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, discomfort in the anal region, and pain in the anal region, fatigue (feeling tired), sleep disturbances, headache, dry mouth, nausea (vomiting).

Uncommon (may affect up to 1 in 100 people):

Dizziness, vomiting, inability to control bowel movements (fecal incontinence).

Other side effects, frequency not known (cannot be estimated from the available data):

Anaphylactic reaction or hypersensitivity, which are severe symptoms of an allergic reaction. If you experience breathing difficulties, redness, or any symptoms indicating a severe allergic reaction, go to the hospital immediately. Hyponatremia (low sodium levels in the blood), hypokalemia (low potassium levels in the blood), epilepsy, seizures, orthostatic hypotension (low blood pressure when standing, which can lead to dizziness or instability), confusion, rash including hives, itching (pruritus), and purpura (bleeding under the skin). Bloating (gas) and pain. The medicine is intended to cause regular, loose stools, similar to diarrhea. However, if after taking this medicine, bowel movements become troublesome or worrying, contact your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CitraFleet

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the sachet after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CitraFleet contains

• The active substances are: sodium picosulfate 0.01 g, magnesium oxide 3.50 g, citric acid 10.97 g.
• The other ingredients are: potassium bicarbonate, sodium saccharin, lemon flavor (lemon flavor, maltodextrin, tocopherol E307). 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, 50 (25x2), 100, 100 (50x2), 200, 200 (100x2), 500, 500 (250x2), or 1000 sachets. Each sachet contains a single dose for an adult of 15.08 g. 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 on CitraFleet, contact:

info@casenrecordati.com 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: 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).

Date of last revision of the package leaflet: