Prospect: information for the patient

CitraFleetPowder for oral solution in sachet

Picosulfate sodium / light magnesium oxide / citric acid

Read this prospect carefully before starting to take this medicine, 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 medicine has been prescribed only to you, and you must 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 and for what it is used

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

3.How to take CitraFleet

4.Possible adverse effects

5Storage of CitraFleet

6. Contents of the package and additional information

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 see inside your intestine using a flexible and long instrument that is inserted through your anus) or a radiological examination.CitraFleet is a lemon-scented and tasting powder.It contains two types of laxatives mixed in each packet 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 foradults aged 18 years and older (including elderly individuals).

Do not take CitraFleet 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 throughout 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).

-haveexcessive thirst or think you may be severely dehydrated.

-have been informed by your doctor that you have your abdomen distended 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 havemuscle damage with 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 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).

-havethirst or think you may be slightly to moderately dehydrated.

-areelderlyor are physically weak.

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

-haveintense or persistent abdominal pain and/or bleeding 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, you will have liquid stools. You should drink enough clear liquids (see section 3) to replace fluid and electrolyte loss. If not, you may become dehydrated and experience low blood pressure, which can cause dizziness.

Taking CitraFleet with other medications

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

CitraFleet 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 these, go back and consult with them to know what to do regarding:

-Oral contraceptives,as their effects may be reduced.

-Medicationsfor diabetesor medications used to treatepilepsy(seizures), 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 conditions 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 antidepressantssuch as imipramine, and amitriptylineand selective serotonin reuptake inhibitors (SSRIs)such as fluoxetine, paroxetine, and citalopram used to treat depression and anxiety.

-Antipsychoticssuch 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.

CitraFleet contains potassium and sodium

This medication contains 5mmol (or 195mg) of potassium per tablet, which should be taken into account in patients with kidney problems or patients on low-potassium diets.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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 and frequent bowel movements at any time after taking a dose of CitraFleet.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) the day before your procedure is scheduled. When you start taking the sachets of this medication, you should not eat any solid food until you have completed your procedure.You must always follow your doctor's dietary instructions.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 sachets of CitraFleet.Each sachet contains an adult dose

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

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

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

You should dissolve each sachet in a glass of water. Do not dilute the product by drinking water immediately after taking each sachet.

Wait around 10 minutes after taking each sachet 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 prevent 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 according to your doctor's recommendations.

MODE OF USE:

Adults over 18 years old (including elderly people):

• Step 1– Mix the contents of 1 sachet in a glass of cold running water (approximately 150ml).
• Step 2– Shake for 2-3 minutes.If it warms up while shaking, wait until it has cooled down 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.The following describes the known side effects of CitraFleet and are listed in order of how often they occur:

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), drowsiness, anal discomfort and proctalgia (anal pain), fatigue (tiredness), sleep disturbances, headache, dry mouth, nausea (urge to vomit).

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 to the hospital immediately if you have any breathing difficulties, start to notice that your skin is red, or have any other symptoms that you think could be a manifestation of a severe allergic reaction.

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

Flatulence (gas) and pain.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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 side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store above 25°C.

Do not use this medication after the expiration date that appears on the package 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 you no longer need at the SIGRE collection pointof the pharmacy. Please ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of CitraFleet

• The active principles are sodium picosulfate 10.0 mg, magnesium oxide 3.5 g, and citric acid 10.97 g per dose.
• The other components are: potassium hydrogen carbonate, sodium saccharin, lemon aroma (lemon aroma, maltodextrin, tocopherol E307). See section 2.

Appearance of the product and contents of the packaging

CitraFleet is an oral solution powder 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 an adult dose. Only some pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

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 authorization holder via the following email address: [email protected]

This medicinal product 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 about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/