Citrafleet oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

CitraFleet oral solution

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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

5 Storage of CitraFleet oral solution

1. Contents of the pack and other information

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

You are taking CitraFleet oral solution 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 the doctor to view inside your intestine using a long, flexible instrument inserted through your anus) or a radiological examination. CitraFleet is a solution with a pomegranate flavour and aroma. It contains two types of laxatives mixed in each bottle, which, when ingested, empty and clean the intestines. It is important to have an empty and clean intestine so that your doctor or surgeon can clearly see inside.

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

2. What you need to know before taking 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 ingredients of this medicine (listed in section 6).
• have congestive heart failure (your heart cannot properly pump blood around 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 a swollen abdomen due to fluid accumulation (called ascites).
• have recently undergone abdominal surgery, e.g., due to appendicitis.
• have or suspect you may have a perforated/damaged 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 their contents 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

Talk to your doctor or pharmacist before taking CitraFleet oral solution if:

• you have recently undergone intestinal surgery.
• you have kidney or heart problems.
• you have fluid and/or electrolyte imbalance (sodium or potassium), or you are taking medicines that could 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 seizures.
• you have low blood pressure (hypotension).
• you are thirsty or think you may be mildly to moderately dehydrated.
• you are elderly or physically frail.
• you have ever had low sodium or potassium levels in your blood (also known as hyponatremia or hypokalemia).
• if 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 oral solution you will have liquid bowel movements. You must drink enough clear fluids (see section 3) to replace fluid and salt losses. If you do not, you may become dehydrated and develop low blood pressure, which could cause you to faint.

Taking CitraFleet oral solution with other medicines

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

CitraFleet oral solution 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 discussed this with your doctor, please consult them 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 using machines

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

CitraFleet oral solution contains sodium, sodium metabisulfite (E 223), sodium methyl parahydroxybenzoate (E 219), ethanol, and sodium propyl parahydroxybenzoate (E 217)

This medicine contains sodium metabisulfite (E 223). Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

This medicine contains sodium methyl parahydroxybenzoate (E 219) and sodium propyl parahydroxybenzoate (E 217). These may cause allergic reactions (possibly delayed).

This medicine contains 66 mg of alcohol (ethanol) per 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 contained in this medicine does not produce any noticeable effect.

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

3. How to take CitraFleet oral solution

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

Be prepared for liquid or soft, 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 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 solids and residue-free) on the day before your scheduled procedure. From the time you start taking 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 bottles of CitraFleet oral solution. Each bottle contains one adult dose.

CitraFleet oral solution is ready to use directly from the bottle. No dilution or mixing is required.

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

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

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

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

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

After taking the second bottle, continue drinking 1.5–2 liters of clear liquids. Do not eat or drink anything at least 2 hours before the procedure, or as otherwise directed by your doctor.

If you take more CitraFleet oral solution than you should, contact 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, stating the medicine and the amount ingested.

4. Possible adverse effects

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

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 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 available data):

Anaphylaxis or hypersensitivity, which are serious allergic reactions. You should go to the hospital immediately if you experience any breathing difficulties, notice redness of your skin, or have any other symptoms you think might indicate a serious 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 diarrhea. However, if after taking this medicine your bowel movements become difficult or cause concern, 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 Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CitraFleet oral solution

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information

Composition of CitraFleet oral solution

• The active substances are sodium picosulfate 10.0 mg, light magnesium oxide 3.5 g, citric acid 10.97 g per bottle (160 ml).
• The other components are: malic acid, sodium metabisulfite (E 223), sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), sucralose, flavour-masking agent (sweetness modulator), pomegranate flavour (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, colourless or slightly yellowish oral solution with pomegranate flavour 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 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

You can request further information about this medicine by contacting the Marketing Authorisation Holder via the following email address: [email protected]

This medicine is authorised 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 most recent review of this leaflet: November 2024

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/