CitraFleet powder for oral solution in sachets

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

CitraFleet Powder for oral solution in sachet

sodium picosulfate / light magnesium oxide / citric acid

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What CitraFleet is and what it is used for
2. What you need to know 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

You are taking CitraFleet to clean your intestines (including the colon) before undergoing any diagnostic procedure that requires a clean bowel, such as a colonoscopy (a procedure that allows the doctor to view inside your intestine using a long, flexible instrument inserted through your anus) or a radiological examination. CitraFleet is a lemon-flavored and lemon-scented powder. It contains two types of laxatives combined in each sachet, which, when dissolved in water and taken orally, empty and cleanse the intestines. It is important to have an empty and clean intestine so that your doctor or surgeon can clearly see inside.

CitraFleet is indicated for use in adults aged 18 years and older (including elderly individuals).

2. What you need to know before taking CitraFleet

Do not take CitraFleet if you:

• are allergic to sodium picosulfate, magnesium oxide, citric acid, or any of the other ingredients of this medicine (listed in section 6).
• have congestive heart failure (your heart cannot properly pump blood through your body).
• have a condition called gastric retention (your stomach does not empty properly).
• have a stomach ulcer (sometimes called gastric or duodenal ulcer).
• have intestinal blockage or inability to produce normal bowel movements (sometimes called ileus).
• have been told by your doctor that you have a damaged intestinal wall (also known as toxic colitis).
• have a swollen large intestine (also known as toxic megacolon).
• have recently been vomiting or feeling nauseous (nausea or vomiting).
• are very thirsty or think you may be severely dehydrated.
• have been told by your doctor that you have abdominal swelling due to fluid accumulation (called ascites).
• have recently had abdominal surgery, e.g., due to appendicitis.
• have or suspect you may have a perforated or blocked intestine (perforated or obstructed bowel).
• have been told by your doctor that you have active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• have been told by your doctor that you have damaged muscles with leakage of muscle contents into your blood (rhabdomyolysis).
• have severe kidney problems or your doctor has informed you that you have too much magnesium in your blood (hypermagnesemia).

Warnings and precautions

Talk to your doctor or pharmacist before taking CitraFleet if:

• you have recently had intestinal surgery.
• you have kidney or heart problems.
• you have fluid and/or electrolyte imbalance (sodium or potassium), or are taking medicines that could affect fluid and/or electrolyte (sodium or potassium) balance in the body, such as diuretics, corticosteroids, or lithium.
• you have epilepsy or a history of seizures.
• you have low blood pressure (hypotension).
• you are thirsty or think you may be mildly to moderately dehydrated.
• you are elderly or physically weak.
• you have ever had low sodium or potassium levels in your blood (also known as hyponatremia or hypokalemia).
• you experience severe or persistent abdominal pain and/or rectal bleeding after taking CitraFleet, consult your doctor. This is because CitraFleet has been rarely associated with intestinal inflammation (colitis).

Please note that after taking CitraFleet you will have liquid bowel movements. You must drink enough clear fluids (see section 3) to replace lost fluids and salts. If you do not, you may suffer dehydration and low blood pressure, which could cause you to faint.

Taking CitraFleet with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

CitraFleet may affect, or be affected by, other medicines if taken at the same time. If you are taking any of the following medicines, your doctor may decide to prescribe a different medicine or adjust your dose. Therefore, if you have not yet spoken to your doctor about these, please consult again to find out what to do regarding:

• Oral contraceptives, as their effects may be reduced.
• Antidiabetic medicines or medicines used to treat epilepsy (seizures), as their effects may be reduced.
• Antibiotics, as their effects may be reduced.
• Other laxatives, including bran.
• Diuretics, such as furosemide, used to control fluid retention in the body.
• Corticosteroids such as prednisone, used to treat inflammation in conditions such as arthritis, asthma, hay fever, dermatitis, 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.
• Antipsychotics such as haloperidol, clozapine, and risperidone, used to treat schizophrenia.
• Lithium, used to treat manic depression (bipolar disorder).
• Carbamazepine, used to treat epilepsy.
• Penicillamine, used to treat rheumatoid arthritis and other conditions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and use of machines

Do not drive or operate tools or machinery if you feel tired or dizzy after taking CitraFleet.

CitraFleet contains potassium, sodium, and sulfites including metabisulfites

This medicine contains 5 mmol (or 195 mg) of potassium per sachet, which should be taken into account in patients with renal impairment or those on potassium-restricted diets.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; i.e., it is essentially "sodium-free".

This medicine contains sulfites, including metabisulfites, derived from the maltodextrin present in the lemon flavoring. These may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take CitraFleet

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist, as the procedure may need to be repeated if you do not completely empty your bowels. If in doubt, consult your doctor or pharmacist again.

Be prepared for liquid or soft and frequent bowel movements at any time after taking a dose of CitraFleet. This is normal and shows that the medicine is working. It would be advisable to ensure you have access to a toilet until the effects have passed.

It is important that you follow a special diet (low in solid content) the day before your scheduled procedure. Once you start taking the packets of this medicine, you must not eat any solid food until after your procedure is completed. You must always follow your doctor’s dietary instructions. If you have any questions, contact your doctor or pharmacist.

Unless otherwise directed by your doctor, you should not take more than the recommended dose within any 24-hour period.

Treatment schedule

You should have been given two packets of CitraFleet. Each packet contains one adult dose.

The treatment can be administered in one of the following ways:

• The first packet in the evening of the day before the procedure and the second packet on the morning of the day of the procedure,
• The first packet in the afternoon and the second in the evening, both on the day before the procedure. This schedule is recommended for procedures performed early in the morning.
• Both packets on the morning of the day of the procedure. This schedule is only suitable for procedures performed in the afternoon.

The time interval between the two packets must be at least 5 hours.

Each packet must be dissolved in a glass of water. Do not dilute the product by drinking water immediately after taking each packet.

Wait approximately 10 minutes after taking each packet, then slowly drink approximately 1.5 to 2 liters of clear fluids, at a rate of about 250 ml (small glass) to 400 ml (large glass) per hour. Clear broths and isotonic solutions are recommended to prevent dehydration. It is advised not to drink water only.

After taking the second packet, continue drinking 1.5–2 liters of fluids. Do not eat or drink anything at least 2 hours before the procedure, or as recommended by your doctor.

DIRECTIONS FOR USE:

Adults over 18 years of age (including elderly people):

• Step 1 – Mix the contents of one packet into a glass of cold tap water (approximately 150 ml).
• Step 2 – Shake for 2–3 minutes. If the solution warms during shaking, wait until it has cooled before drinking the entire solution. Once the solution is ready, take it immediately. The solution will appear cloudy.

If you take more CitraFleet than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The known side effects of CitraFleet are described below and listed according to their frequency:

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

Abdominal pain.

Common (may affect up to 1 in 10 people):

Abdominal distension (bloating), thirst, anal discomfort and proctalgia (anal pain), fatigue (tiredness), sleep disturbances, headache, dry mouth, nausea (feeling sick).

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

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

Other side effects of unknown frequency (cannot be estimated from available data):

Anaphylaxis or hypersensitivity, which are severe allergic reactions. You should go immediately to hospital if you experience any breathing difficulties, notice redness of your skin, or have any other symptoms you think might indicate a severe allergic reaction.

Hyponatremia (low sodium levels in the blood), hypokalemia (low potassium levels in the blood), epilepsy, seizures (fits), orthostatic hypotension (low blood pressure upon standing, which may cause dizziness or unsteadiness), confusion, skin rashes including urticaria, pruritus (itching), and purpura (bleeding under the skin).

Flatulence (gas) and pain.

This medicine is intended to produce very regular liquid or soft bowel movements, similar to diarrhoea. However, if after taking this medicine your bowel movements become difficult or are otherwise concerning, you should speak with your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of 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 stated on the sachet after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of CitraFleet

• The active substances are sodium picosulfate 10.0 mg, light magnesium oxide 3.5 g, citric acid 10.97 g per sachet.
• The other components are: potassium hydrogen carbonate, sodium saccharin, lemon flavour (corn maltodextrin, natural flavouring substances, flavouring substances, flavouring preparations, sulphites, including metabisulphites). See section 2.

Nature of the product and contents of the pack

CitraFleet is a powder for oral solution in a sachet, supplied in packs of 2, 50, 50 (25x2), 100, 100 (50x2), 200, 200 (100x2), 500, 500 (250x2), or 1000 sachets containing a white crystalline powder. Each sachet contains one adult dose. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo - Zaragoza

Spain

For further information about this medicinal product, please contact the Marketing Authorisation Holder at the following email address: [email protected]

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Citrafleet: Croatia, Denmark, Slovenia, Norway, Czech Republic.

CitraFleet: Germany, Austria, Belgium, Bulgaria, Cyprus, Slovakia, Spain, Estonia, Finland, France, Greece, Netherlands, Hungary, Ireland, Iceland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Poland, Portugal, United Kingdom (Northern Ireland), Romania, Sweden.

Date of the most recent review of this leaflet: January 2026

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/