CITRAFLEET POWDER FOR ORAL SOLUTION IN SACHETS

Introduction

Package Leaflet: Information for the Patient

CitraFleetOral Powder for Solution in Sachet

sodium picosulfate / light magnesium oxide / citric acid

Read all of this 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is CitraFleet and what is it used for
2. What you need to know before you take CitraFleet
3. How to take CitraFleet
4. Possible side effects

5 Storage of CitraFleet

1. Contents of the pack and further information

1. What is CitraFleet and what is it used for

You are taking CitraFleet to clean your intestines (including the colon) before undergoing any diagnostic procedure that requires a clean intestine, for example a colonoscopy (a procedure that allows your doctor to look inside your intestine using a flexible and long instrument that your doctor inserts through your anus) or a radiological examination. CitraFleet is a powder that has a lemon flavor and aroma. It contains two types of laxatives mixed in each sachet that, when dissolved in water and ingested, empty and clean the intestines. It is essential to have an empty and clean intestine so that your doctor or surgeon can see it clearly.

CitraFleet is indicated in adults over 18 years old (including elderly people).

2. What you need to know before you take CitraFleet

Do not take CitraFleet if you:

• are allergic to sodium picosulfate, light magnesium oxide, citric acid, or any of the other components of this medicine (listed in section 6).
• have congestive heart failure (your heart cannot pump blood properly 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 informed by your doctor that you have damaged intestinal wall (also called toxic colitis).
• have a swollen large intestine (also known as toxic megacolon).
• have recently been vomiting or feeling like vomiting (nausea or vomiting).
• are very thirsty or think you may be severely dehydrated.
• have been informed by your doctor that you have a swollen abdomen due to fluid accumulation (called ascites).
• have recently had abdominal surgery, e.g., for appendicitis.
• have or suspect that you may have a perforated or damaged intestine or intestinal blockage.
• have been informed by your doctor that you have active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• have been informed by your doctor that you have damaged muscles whose contents are leaking 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

Consult your doctor or pharmacist before starting to take 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 medications that may affect fluid and/or electrolyte balance (sodium or potassium) in the body, such as diuretics, corticosteroids, or lithium.
• you have epilepsy or a history of epileptic 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 have severe and persistent abdominal pain and/or bleeding from the anus after taking CitraFleet, consult your doctor. This is because CitraFleet has been associated with intestinal inflammation (colitis) in rare cases.

Keep in mind that after taking CitraFleet, you will have liquid stools. You should drink enough clear liquids (see section 3) to replace lost fluids and salts. If not, you may suffer from dehydration and low blood pressure, which can cause you to faint.

Taking CitraFleet with other medicines

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

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

• Oral contraceptives, as their effects may be reduced.
• Antidiabetic or anti-epileptic medicines (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 diseases 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, 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 using machines

Do not drive, operate tools, or use machines if you start to feel tired or dizzy after taking CitraFleet.

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 kidney failure or in patients with low-potassium diets.

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

3. How to take CitraFleet

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist, as the hospital procedure may need to be repeated if you do not completely empty your intestines. In case of doubt, consult your doctor or pharmacist again.

Be prepared to expect liquid or soft and frequent stools at any time after taking a dose of CitraFleet.This is normal and shows that the medicine is working. It would be practical to make sure you have access to a bathroom until the effects have passed.

It is essential to follow a special diet (low in solids) the day before your procedure is scheduled. When you start taking the sachets of this medicine, you should not eat any solid food until you have finished your procedure. Always follow your doctor's dietary instructions.If you have any questions, contact your doctor or pharmacist.

Unless your doctor tells you to, you should not take more than the recommended dose in any 24-hour period.

Treatment plan

You should have been given two sachets of CitraFleet. Each sachet contains an adult dose.

Treatment can be administered in one of the following ways:

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

The time between the two sachets should be at least 5 hours.

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

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

After taking the second sachet, drink 1.5-2 liters of liquids. Do not eat or drink anything at least 2 hours before the procedure, or as recommended by your doctor.

METHOD OF ADMINISTRATION:

Adults over 18 years old (including elderly people):

• Step 1– Mix the contents of 1 sachet in a glass of cold tap water (approximately 150 ml).
• Step 2– Shake for 2-3 minutes. If it heats up when shaking, wait until it has cooled before taking 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following are known side effects of CitraFleet and are 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 (swollen abdomen), thirst, anal discomfort, and proctalgia (anal pain), fatigue (tiredness), sleep disorders, headache, dry mouth, nausea (feeling like vomiting).

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 the available data)

Anaphylaxis or hypersensitivity, which are severe allergic reactions. You should go to the hospital immediately if you have any difficulty breathing, start to notice that your skin is reddening, or have any other symptoms that you think may be a manifestation of a severe allergic reaction.

Hyponatremia (low sodium levels in the blood), hypokalemia (low potassium levels in the blood), epilepsy, convulsions (seizures), orthostatic hypotension (low blood pressure when standing, which can make you feel dizzy or unsteady), confusion, skin rash, including urticaria, pruritus (itching), and purpura (bleeding under the skin).

Flatulence (gas) and pain.

This medicine is intended to allow you to have liquid or soft stools very regularly, similar to diarrhea. However, if after taking this medicine your stools become difficult or cause concern, you should talk to your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal product in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of CitraFleet

• The active ingredients are sodium picosulfate 10.0 mg, light magnesium oxide 3.5 g, citric acid 10.97 g per sachet.
• The other ingredients are: potassium hydrogen carbonate, sodium saccharin, lemon flavor (lemon flavor, maltodextrin, tocopherol E307). See section 2.

Appearance and packaging of the product

CitraFleet is an oral powder for solution in sachet, which is 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 an adult dose. 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

You can request more information about this medicine by contacting the marketing authorization holder at the following email address:info@casenrecordati.com

This medicine is authorized in the Member States of the European Economic Area 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 last revision of this leaflet:June 2023

Other sources of information

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