Citrafleet

LEAFLET INCLUDED IN THE PACKAGE: 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
Sodium picosulfate + Light magnesium oxide + Citric acid

You should carefully read the contents of the leaflet before using 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.
• In case of 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 package 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 (an imaging procedure of the intestine using 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 agents 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, 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);
• if the patient has gastric or duodenal ulcers;
• if the patient has intestinal obstruction or evacuation disorders;
• if the patient has been informed by their doctor about intestinal wall damage(also known as toxic megacolon);
• if the patient has colonic dilatation(also known as colonic paralysis);
• if the patient has recently experienced nausea or vomiting;
• if the patient feels strong thirst or may be severely dehydrated;
• if the patient has been informed by their doctor about abdominal swelling due to fluid accumulation(known as ascites);
• if the patient has recently undergone abdominal surgery, e.g., due to appendicitis;
• if the patient may have perforation/damage or intestinal obstruction;
• if the patient has been informed by their doctor about active inflammatory bowel disease(such as Crohn's disease or ulcerative colitis);
• if the patient has been informed by their doctor about muscle tissue damage, where 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, the patient should talk to their doctor if:

• the patient has recently undergone intestinal surgery;
• the patient has kidney or heart disease;
• the patient has water and electrolyte balance disorders(sodium or potassium) or is taking medicines that may affect water and electrolyte balance(sodium or potassium), such as diuretics, corticosteroids, or lithium;
• the patient has a history of epilepsy or 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).

The patient should prepare for the occurrence of frequent, loose stools at any time after taking a dose of CitraFleet. It is essential to 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 taking, have recently taken, or plan to take. Taking CitraFleet 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 CitraFleet. 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 effect may be reduced;
• medicines used in diabetes or epilepsy treatment(seizures), as their effect may be reduced;
• antibiotics, as their effect may be reduced;
• other laxative agents, including bran;
• diuretics, such as furosemide (diuretics);
• corticosteroids, such as prednisone, used in diseases 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 in the treatment of pain and inflammation;
• tricyclic antidepressants, such as imipramine and amitriptyline, and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, paroxetine, and citalopram, used in the treatment of depression and anxiety;
• antipsychotic drugs, such as haloperidol, clozapine, and risperidone, used in the treatment of 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 diseases.

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 using this medicine.

Driving and using machines

If, after taking CitraFleet, the patient starts to feel tired or dizzy, 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 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 the medicine is considered "sodium-free".

3. How to take CitraFleet

This medicine should always be taken according to the doctor's instructions, as if the intestines are not completely cleansed, 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 a dose of CitraFleet.

After taking a dose of CitraFleet, it is normal and proves that the medicine is working. The patient should ensure they have access to a toilet until the bowel movements stop. It is essential to drink large amounts of clear fluids (see section 3) to replenish lost fluids and salts. 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 fluid, the patient should not eat or drink for at least 2 hours before the examination or follow the doctor's instructions.

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 heat up during mixing, wait until it cools down before drinking the entire solution. The suspension should be drunk immediately after preparation. The suspension will be cloudy.

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, 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, feeling of discomfort in the anal area, and pain in the anal area, fatigue (feeling of fatigue), sleep disturbances, headache, dry mouth, nausea.

Uncommon (may affect up to 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 estimated from the available data):

Anaphylactic reaction or hypersensitivity, which are severe symptoms of an allergic reaction. If there are problems with breathing, redness, or any symptoms indicating a severe allergic reaction, the patient should immediately go to the hospital. 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, and purpura (subcutaneous bleeding). Bloating (gas) and pain. The medicine is intended to cause regular, loose stools, similar to those experienced during 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 the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store CitraFleet

The medicine should be stored 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 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 package and other information

What CitraFleet contains

• The active substances of CitraFleet are: sodium picosulfate 0.01 g (10.0 mg), light magnesium oxide 3.50 g, citric acid 10.97 g.
• Other ingredients are: potassium hydrogen carbonate, sodium saccharin, lemon flavor (lemon flavor, maltodextrin, RRR-α-Tocopherol (E 307)). See section 2.

What CitraFleet looks like and what the package contains

CitraFleet is a white, crystalline powder for oral solution, available in packages containing 2, 50, or 100 sachets. Each sachet contains a single dose for an adult in the amount of 15.08 g. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Germany, the country of export: 68805.00.00
Parallel import authorization number: 82/23

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 leaflet approval: 12.05.2023
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