Prospect: information for the patient

CitraFleet oral solution

Picosulfate sodium / light magnesium oxide / citric acid

Read this prospect carefully before starting to take this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take CitraFleet oral solution

4.Possible adverse effects

5Storage of CitraFleet oral solution

6.Contents of the package and additional information

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 your doctor to see inside your intestine using a flexible and long instrument that is inserted through your anus) or a radiological examination.CitraFleet is a solution with a lemon flavor.It contains two types of laxatives mixed in each bottle that, when 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 oral solution is indicated foradults aged 18 years and older (including elderly individuals).

Do not take CitraFleet oral solution if you:

-areallergicto picosulfate sodium, magnesium oxide, citric acid, or any of the other components of this medication (listed in section 6).

-havecongestive heart failure(your heart cannot pump blood effectively through your body).

-have a condition calledgastroparesis(your stomach does not empty properly).

-have astomach ulcer(also known as a gastric or duodenal ulcer).

-haveintestinal obstruction or inability to produce normal bowel movements(sometimes called ileus).

-have been informed by your doctor that you have adamaged intestinal lining(also known as toxic colitis).

-have yourlarge intestine distended(also known as toxic megacolon).

-recentlyhave beenvomiting or have a desire to vomit(nausea or vomiting).

-have excessive thirst or think you may beseverely dehydrated.

-have been informed by your doctor that you have your abdomen swollen due to fluid accumulation(ascites).

-haverecently undergone abdominal surgery, e.g., for appendicitis.

-have or suspect that you may have yourintestine perforated/damaged or blocked(intestine perforated or obstructed).

-have been informed by your doctor that you have anactive inflammatory bowel disease(such as Crohn's disease or ulcerative colitis).

-have been informed by your doctor that you have muscle damage with its contents leaking into your blood (rhabdomyolysis).

-havesevere kidney problemsor your doctor has informed you that you have too much magnesium in your blood(hypermagnesemia).

Warnings and precautions

Consult your doctor orpharmacist before starting to take CitraFleet oral solution if:

-you haverecently undergone intestinal surgery.

-havekidney or heart problems.

-havefluid 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.

-haveepilepsyor a history of seizures.

-havelow blood pressure(hypotension).

-have thirst or think you may bea little to moderately dehydrated.

-areelderlyor are physically weak.

-haveever had low sodium or potassium levels in the blood(also known as hyponatremia or hypokalemia).

-if you have intense or persistent abdominal pain and/or bleeding through the anus after taking CitraFleet, consult your doctor.This is because CitraFleet has been associated with rare cases of intestinal inflammation (colitis).

Be aware that after taking CitraFleet oral solution, you will have liquid stools. You should drink sufficient clear liquids (see section 3) to replace fluid and electrolyte loss. If not, you may suffer dehydration and low blood pressure, which can cause dizziness.

Taking CitraFleet oral solution with other medications

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

CitraFleet oral solution may affect or be affected by other medications if you take them at the same time.If you are taking any of the medications listed below, your doctor may decide to give you a different medication or adjust your dose.So, if you have not yet spoken with your doctor about thesereturn to consult with them to know what to do regarding:

-Oral contraceptives, as their effects may be reduced.

-Medicationsfor diabetesor medications used to treatseizures(attacks), as their effects may be reduced.

-Antibiotics, as their effects may be reduced.

-Otherlaxatives, including psyllium.

-Diuretics, such as furosemide used to control fluid retention in the body.

-Corticosteroidssuch 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.

-Nonsteroidal anti-inflammatory drugs (NSAIDs)such as aspirin 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.

-Lithiumused to treat manic depression (bipolar disorder).

-Carbamazepineused to treat epilepsy.

-Penicillamineused to treat rheumatoid arthritis and other conditions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machines

Do not drive, oroperate tools or machines, if you start to feel tired or dizzy after taking CitraFleet oral solution.

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

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

This medication contains methyl parahydroxybenzoate (E 219) and propyl parahydroxybenzoate (E 217). It may cause allergic reactions (possibly delayed).

This medication contains 66 mg of alcohol (ethanol) in each bottle. The amount in 160 ml of this medication is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medication has no perceptible effect.

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

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

Be prepared to wait for 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 medication is working.It would be practical to ensure that you have access to a bathroom until the effects have passed.

It is essential that you 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 medication, you should not eat any solid food until you have completed your procedure.Always follow the dietary instructions of your doctor.If you have any questions, contact your doctor or pharmacist.

Unless your doctor tells you otherwise, you should 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 an adult dose.

CitraFleet oral solution is ready to be taken directly from the bottle. It does not need to be diluted or mixed.

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

• The first bottle the evening before the procedure and the second bottle the morning of the procedure.
• The first bottle in the evening and the second at night, both the day before the procedure. This regimen is recommended for procedures performed in the early morning.
• The two bottles in the morning of the procedure. This regimen is only suitable for procedures performed in the afternoon.

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

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

Wait around 10 minutes after taking each bottle and 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. Clear 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 medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them. The following describes the known side effects of CitraFleet oral solution and are listed in order of frequency with which they occur:

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

Abdominal pain.

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

Abdominal distension (swollen abdomen), drowsiness, anal discomfort and proctalgia (anal pain), fatigue (tiredness), sleep disturbances, headache, dry mouth, nausea.

Infrequent (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 immediately go to the hospital if you experience any breathing difficulties, notice your skin becoming red, 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, seizures (convulsions), orthostatic hypotension (low blood pressure when standing that may cause dizziness or insecurity), confusion, skin eruptions including urticaria, pruritus (itching), and purpura (bleeding under the skin).

Flatulence (gas) and pain.

This medication is indicated to allow you to have very regular, liquid or soft bowel movements, similar to diarrhea. However, if after taking this medication your bowel movements become difficult or a cause for concern, you should speak with your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special conditions for preservation.

Do not use this medication after the expiration date that appears on the label of the bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit containers and medicines that you no longer need at the SIGRE collection pointof the pharmacy. Please ask your pharmacist how to dispose of containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of CitraFleet oral solution

• The active principles are sodium picosulfate 10.0 mg, magnesium oxide 3.5 g, and citric acid 10.97 g per bottle (160 ml).
• The other components are: malic acid, sodium metabisulphite (E 223), methyl parahydroxybenzoate (E 219), propyl parahydroxybenzoate (E 217), sucralose, sweetener masking agent (sweetness modulator), granadilla 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 container

CitraFleet is a transparent, colorless, or slightly yellowish oral solution with a granadilla flavor that is supplied in:

- containers containing 2, 20, 40, or 80 bottles, or

- multiple containers containing 20 (10x2), 40 (20x2), or 80 (40x2) bottles.

The bottles contain a single dose of 160 ml. Each bottle contains an adult dose. Only some container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo - Zaragoza

Spain

For further information about this medicine, please contact the marketing authorization holder at the following email address: [email protected]

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Last review date 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 Medical Devices (AEMPS) http://www.aemps.gob.es/