CITRAFLEET ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

CitraFleetoral solution

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, 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 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 pack

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

5 Conservation of CitraFleet oral solution

1. Contents of the pack and further information

1. What CitraFleet oral solution is and what it is used for

You are taking CitraFleet oral solution to cleanse 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, long instrument inserted through your anus) or a radiological examination. CitraFleet is a solution with a grape flavor and aroma. It contains two types of laxatives mixed in each bottle that, when ingested, empty and cleanse the intestines. It is essential to have an empty and clean intestine so that your doctor or surgeon can see it clearly.

CitraFleet oral solution is indicated in adults over 18 years of age (including elderly people).

2. What you need to know before you take CitraFleet oral solution

Do not take CitraFleet oral solution if you:

• are allergic to sodium picosulfate, 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 walls (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 oral solution 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).

Keep in mind that after taking CitraFleet oral solution, you will have liquid or soft stools and frequent bowel movements at any time. This is normal and shows that the medicine is working. It would be practical to ensure you have access to a bathroom until the effects have passed.

Taking CitraFleet oral solution with other medicines

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

CitraFleet oral solution 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 already 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 antiepileptic medications, 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 for the treatment of 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 for the treatment of 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, use tools, or operate machinery if you start to feel tired or dizzy after taking CitraFleet oral solution.

CitraFleet oral solution contains sodium, sodium metabisulfite (E 223), methylparaben sodium (E 219), ethanol, and propylparaben sodium (E 217)

This medicine contains sodium metabisulfite (E 223). It can rarely cause severe hypersensitivity reactions and bronchospasm.

This medicine contains methylparaben sodium (E 219) and propylparaben sodium (E 217). They can cause allergic reactions (possibly delayed).

This medicine contains 66 mg of alcohol (ethanol) in each bottle. The amount 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 does not produce any noticeable effect.

This medicine contains 3.4 g of sodium (main component of table/cooking salt) in each bottle. This is equivalent to 173.6% of the maximum recommended daily intake of sodium for an adult.

3. How to take CitraFleet oral solution

Follow the administration instructions of this medicine indicated by your doctor or pharmacist exactly, 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 stools and frequent bowel movements at any time after taking a dose of CitraFleet oral solution. This is normal and shows that the medicine is working. It would be practical to ensure you have access to a bathroom until the effects have passed.

It is essential to follow a special diet (low in solids and without residue) the day before your procedure is scheduled. When you start taking the bottles of this medicine, do 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, do not take more than the recommended dose in any 24-hour period.

Treatment plan

You should have been given two bottles of CitraFleet oral solution. Each bottle contains a single adult dose.

CitraFleet oral solution is ready to be taken directly from the bottle. No dilution or mixing is needed.

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

• The first bottle in the evening of the day before the procedure and the second bottle in the morning of the day of the procedure.
• The first bottle 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 bottles 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 bottles should be at least 5 hours.

Do not dilute the product by drinking water immediately after taking each bottle.

Wait about 10 minutes after taking each bottle, then drink, slowly, approximately 1.5 to 2 liters of clear liquids, at a rate of about 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 bottle, 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.

If you take more CitraFleet oral solution 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 oral solution 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 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 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 up, which can make you feel dizzy or unsteady), confusion, skin rashes including urticaria, pruritus (itching), and purpura (bleeding under the skin).

Flatulence (gas) and pain.

This medicine is intended to allow you to have very regular, liquid or soft stools, similar to diarrhea. However, if after taking this medicine your stools become difficult or a cause for 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of CitraFleet oral solution

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the label of the bottle after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of CitraFleet oral solution

• The active ingredients are sodium picosulfate 10.0 mg, light magnesium oxide 3.5 g, citric acid 10.97 g per bottle (160 ml).
• The other ingredients are: malic acid, sodium metabisulfite (E 223), methylparaben sodium (E 219), propylparaben sodium (E 217), sucralose, flavor masking agent (sweet modulator), grape flavor (contains ethanol and propylene glycol (E 1520)), sodium hydroxide (for pH adjustment), and purified water. See section 2.

Appearance of the product and contents of the pack

CitraFleet is a clear, colorless or slightly yellowish oral solution with a grape flavor, supplied in:

• packs containing 2, 20, 40, or 80 bottles, or
• multiple packs containing 20 (10x2), 40 (20x2), or 80 (40x2) bottles.

The bottles contain a single dose of 160 ml. Each bottle contains a single 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:[email protected]

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

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

Date of the last revision of this leaflet:November 2024

Other sources of information

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