Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Light magnesium oxide, Sodium picosulfate, Citric acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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You are taking CitraFleet to clean your bowels (also known as intestines and colon) before having any diagnostic procedure that requires a clean bowel, for example a colonoscopy (procedure that looks inside your bowel using a long, flexible instrument that the doctor inserts through your anus) or x-ray examination. CitraFleet is a powder that smells and tastes of lemons. It contains two types of laxatives mixed in each sachet which, when dissolved in water and drunk, wash-out and clean the bowels. It is important to have an empty, clean bowel so that your doctor or surgeon can see it clearly. CitraFleet is indicated in adults (including the elderly) aged 18 years and over. 2.
e CitraFleet
Do not take CitraFleet 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 is unable to properly pump blood round the body). have a condition called gastric retention (your stomach does not empty properly). have a stomach ulcer (sometimes called gastric or duodenal ulcers). have blockage of the gut or failure of normal bowel movements (sometimes called ileus). have been told by a doctor that you have a damaged gut wall (also called toxic colitis). have a swollen large bowel (also known as toxic megacolon). have recently been sick or feel sick (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 the collection of fluid (called ascites). have recently had surgery on your abdomen e.g. for appendicitis. may have a pierced/damaged or blocked gut (perforated or obstructed bowel). have been told by your doctor that you suffer from active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). have been told by your doctor that you have damaged muscles that are leaking their contents into your blood (rhabdomyolysis). have severe kidney problems or have been told by your doctor that you have too much magnesium in your blood (hypermagnesaemia). 1
Warnings and precautions Talk to your doctor or pharmacist before taking CitraFleet if you: –
have had recent surgery on your gut. have kidney or heart trouble. have water and/or electrolyte (sodium or potassium) imbalance or are taking medicines that might affect water and/or electrolyte (sodium or potassium) balance in the body, such as diuretics, corticosteroids or lithium. have epilepsy or a history of fits. have low blood pressure (hypotension). are thirsty or think you may be mildly to moderately dehydrated. are elderly or physically weak. have ever suffered from low sodium or potassium in the blood (also known as hyponatraemia or hypokalaemia). If severe or persistent abdominal pain and/or bleeding from the anus occurs after treatment with CitraFleet, notify your doctor. This is because CitraFleet has been associated in rare cases with intestinal inflammation (colitis).
You should keep in mind that after taking CitraFleet you will have frequent fluid stools. You should drink plenty of clear liquids (see Section 3) to replenish the loss of fluids and salts. Otherwise, you may suffer from dehydration and low blood pressure, which might cause you to faint. Other medicines and CitraFleet 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 concomitantly. If you are taking any of the types of medicines listed below, your doctor might decide that you should be given a different medicine or that the dose should be adjusted. So, if you have not already spoken with your doctor about these go back to your doctor and ask what to do: –
Oral contraceptives, as their effects may be reduced. Diabetic medicines or medicines used to treat epilepsy (fits), as their effects may be reduced. Antibiotic medicines, 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, and amtryptiline and selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, paroxetine and citalopram used to treat depression and anxiety. Antipsychotic drugs 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, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Do not drive, or use tools or machines, if you start to feel tired or dizzy after taking CitraFleet. 2
CitraFleet contains potassium and sodium This medicine contains 5 mmol (or 195 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 'sodiumfree'. 3.
CitraFleet
Always take this medicine exactly as your doctor or pharmacist has told you, as the hospital procedure may have to be repeated if you do not wash-out your bowels completely. Check with your doctor or pharmacist if you are not sure. Be prepared to expect frequent, loose bowel movements at any time after taking a dose of CitraFleet. This is normal and shows that the medicine is working. It would be sensible to make sure that you have access to a toilet until the effects have worn off. It is important you follow a special (low solids) diet on the day before your procedure is planned. When you start taking the sachets of this medicine, you should not have any solid food until after your procedure is finished. You should always follow the dietary instructions given by your doctor. If you have any questions contact your doctor or pharmacist. Unless directed by your doctor, 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 one adult dose. The treatment can be administered in one of the following ways: • • •
One sachet on the evening prior to the procedure and the second sachet in the morning of the day of the procedure, One sachet in the afternoon and the second sachet in the evening prior to the procedure. This schedule is recommended when the procedure is planned for early in the morning, or Both sachets in the morning of the day of the procedure. This regimen is only suitable when the procedure is planned in the afternoon/evening.
The time elapsed between the two sachets should be at least 5 hours. Each sachet should be reconstituted in a cup of water. Do not further dilute the product by drinking liquid immediately after the intake of each sachet. Wait about ten minutes after taking each sachet, and then drink approximately 1.5-2 litres of a variety of clear fluids, at a rate of approximately 250 ml (a small tumbler sized glass) to 400 ml (a large tumbler sized glass) every hour. Clear soups and/or balanced electrolyte solutions are recommended to avoid dehydration. It is advisable not to drink water alone. After you have taken the second sachet and drunk the 1.5-2 litres of fluid, do not eat or drink anything for at least 2 hours prior to the procedure, or as instructed by your doctor. DIRECTIONS FOR USE: Adults (including the elderly) aged 18 years and over. Step 1 – Mix the contents of 1 sachet in a cup of cold tap water (approximately 150 ml).
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Step 2 – Stir for 2 – 3 minutes. If it becomes hot when you stir it, wait until it has cooled down before drinking the whole solution. Once the solution is ready, drink it immediately. The solution will appear cloudy.
If you take more CitraFleet than you should, talk to your doctor or pharmacist immediately. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The known
of CitraFleet are described below and are listed according to the frequency with which 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), feeling thirsty, anal discomfort and proctalgia (anal or bottom pain), fatigue (tiredness), sleep disorders, headache, dry mouth, nausea (feeling sick). Uncommon (may affect up to 1 in 100 people): Dizziness, vomiting (being sick), inability to control your bowel movements (faecal incontinence). Other side effects for which the frequency of occurrence is not known (cannot be estimated from the available data): Anaphylaxis or hypersensitivity which are serious allergic reactions. You should go straight to hospital if you have difficulty in breathing, start to look flushed, or have any other symptom that you think might mean you are having a serious allergic reaction. Hyponatraemia (low levels of sodium in the blood), hypokalaemia (low levels of potassium in the blood), epilepsy, convulsions (fits), orthostatic hypotension (low blood pressure upon standing up which may make you feel dizzy or unsteady), feeling of confusion, rashes including urticaria (hives), pruritis (itching) and purpura (bleeding under the skin). Flatulence (wind) and pain. This medicine is intended to give you very regular, loose bowel movements, similar to diarrhoea. However, if after taking this medicine your bowel movements become troublesome or give you concern, you should talk to your doctor. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
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 which is stated on the sachet after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6.
What CitraFleet contains –
The active substances 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, saccharin sodium, lemon flavour (lemon flavour, maltodextrin, tocopherol E307). See section 2.
What CitraFleet looks like and contents of the pack CitraFleet is a powder for oral solution in sachet supplied in packs of 2, 50, 50 (25×2), 100, 100 (50×2), 200, 200 (100×2), 500, 500 (250×2), 1000 sachets or 50 and 50 (25×2) sachets (hospital pack). The sachets contain white powder crystals with single dose of 15.08g. Each sachet contains one adult dose. Not all 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 get more information on CitraFleet by contacting the following e-mail address: [email protected] This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Citrafleet: Croatia, Czech Republic, Denmark, Norway, Slovenia. CitraFleet: Austria, Belgium, Bulgaria, Cyprus, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, UK (NI). This leaflet was last revised in 01/2024
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CitraFleet, Powder for oral solution in sachet comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in CitraFleet, Powder for oral solution in sachet is light magnesium oxide, sodium picosulfate, citric acid.
This leaflet reproduces the patient information leaflet approved for CitraFleet, Powder for oral solution in sachet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination.
CitraFleet is indicated in adults (including the elderly) aged 18 years and over.
Posology
Adults (including the elderly) aged 18 years and over.
The treatment can be administered in one of the following ways:
• Usually, one sachet on the evening prior to the procedure and the second sachet in the morning of the day of the procedure.
• Both sachets on the afternoon and evening prior to the procedure. This schedule is more suitable when the procedure is early in the morning.
• Both sachets in the morning of the day of the procedure. This regimen is only suitable when the procedure is planned in the afternoon/evening.
The time elapsed between the two sachets should be at least 5 hours.
Method of administration
Route of administration: Oral use.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
A low residue diet or only clear liquids on the day before the procedure is recommended. No solid food should be taken from the start of the course of treatment until after the procedure.
Because the osmolarity of the product needs to be maintained in order to obtain the desired effect, each sachet should be reconstituted in a cup of water. Do not further dilute the product by drinking liquid immediately after the intake of each sachet.
After a period of ten minutes following the administration of each reconstituted sachet, it is recommended to drink approximately 1.5-2 litres of a variety of clear fluids at a rate of approximately 250-400 ml/h. Clear soups and/or balanced electrolyte solutions would be recommended. It is advisable not to drink clear or demineralised water alone.
The patient should be nil-by-mouth prior to the procedure (usually for at least 2 hours) in accordance with anaesthesia requirements.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, congestive cardiac failure, severe dehydration, hypermagnesaemia, gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro-intestinal obstruction or perforation.
Do not use in patients with rhabdomyolysis as laxatives may induce rhabdomyolysis and may therefore exacerbate the condition.
Do not use in patients with active inflammatory bowel disease e.g. Crohn's disease, ulcerative colitis.
In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.
CitraFleet should not be used as a routine laxative.
CitraFleet could rarely lead to severe and potentially fatal cases of electrolyte disorders or impaired renal function in frail or debilitated patients. Therefore, the benefit/risk ratio of CitraFleet needs to be carefully considered before initiating treatment in this at-risk population.
Special attention should be taken when prescribing CitraFleet to any patient with regard to known contra-indications and special attention made to the importance of adequate hydration and, in at-risk populations (as defined below), to the importance of also obtaining baseline and post-treatment electrolyte levels.
Elderly and debilitated patients, and patients at risk of hypokalaemia or hyponatraemia, may need particular attention.
CitraFleet should be used with caution in patients with known disorders of water and/or electrolyte balance or on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium (see 4.5).
Care should also be taken in patients who have recently undergone gastrointestinal surgery or who have renal impairment, mild to moderate dehydration, hypotension or heart disease.
The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.
Diarrhoea due to the evacuating effect of CitraFleet may result in fluid and electrolyte losses, hypovolemia and hypotension. Additionally, vasovagal reflex may be triggered by abdominal stimuli, e.g. pain, which may lead to low blood pressure and loss of consciousness. Adequate intake of clear liquids is required, see section 4.2.
CitraFleet may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy (see 4.5 and 4.8).
This medicine contains 5mmol (or 195 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 'sodium-free'.
As a purgative, CitraFleet increases the gastrointestinal transit rate. Absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period (see 4.4). Tetracycline and fluoroquinolone antibiotics, and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of CitraFleet to avoid chelation with magnesium.
The efficacy of CitraFleet is lowered by bulk-forming laxatives.
Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk i.e. cardiac glycosides). Caution is also advised when CitraFleet is used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.
Pregnancy
For CitraFleet neither clinical data on exposed pregnancy nor reproductive toxicity are available. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of CitraFleet during pregnancy.
Breast-feeding
There is no experience with the use of CitraFleet in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with CitraFleet may be considered for females who are breastfeeding.
CitraFleet may cause fatigue or dizziness, probably as a result of dehydration, and this may have a mild to moderate effect on the ability to drive or use machinery.
The most common adverse events reported in clinical trials using the combination of sodium picosulfate and magnesium citrate were related to direct effects on the bowel (abdominal pain and nausea) and the consequences of diarrhoea and dehydration (sleep disturbance, dry mouth, thirst, headache and fatigue).
Undesirable effects are presented below by MedDRA System Organ Class and Preferred Term, using the following frequency convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100). The frequency calculations are based on data derived from an analysis of clinical studies. Undesirable effects that were not reported in these clinical trials are described as 'Frequency not known (cannot be estimated from the available data)'.
Immune system disorders
Frequency not known: Anaphylactoid reaction, hypersensitivity.
Metabolism and nutrition disorders
Frequency not known: Hyponatraemia.
Frequency not known: Hypokalaemia.
Psychiatric disorders
Common: Sleep disorder.
Nervous system disorders
Common: Headache.
Uncommon: Dizziness.
Frequency not known: Epilepsy, grand mal convulsion, convulsion, confusional state.
Vascular disorders
Uncommon: Orthostatic hypotension.
Gastrointestinal disorders
Very common: Abdominal pain.
Common: Dry mouth, nausea, abdominal distension, anal discomfort, proctalgia.
Uncommon: Vomiting, faecal incontinence.
Frequency not known: Diarrhoea*, flatulence.
* Diarrhoea is the primary clinical effect of CitraFleet
Skin and subcutaneous tissue disorders
Frequency not known: Rash (including erythematous and maculo-papular rash), urticaria, pruritus, purpura.
General disorders and administrative site conditions
Common: Thirst, fatigue.
Frequency not known: Pain.
Hyponatraemia has been reported with or without associated convulsions (see 4.4). In epileptic patients, there have been reports of seizure/grand mal convulsion without associated hyponatraemia (see 4.4 and 4.5).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
No cases of overdose with CitraFleet, or similar combinations of sodium picosulfate and magnesium citrate, have been reported. However, because of its modes of action, an overdose of CitraFleet would be expected to cause profuse diarrhoea with dehydration and electrolyte loss. Dehydration could also lead to orthostatic hypotension and dizziness. Dehydration and electrolyte imbalances should be corrected with fluid and electrolytes as necessary.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Light magnesium oxide, Sodium picosulfate, Citric acid. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Light magnesium oxide, Sodium picosulfate, Citric acid. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about CitraFleet, Powder for oral solution in sachet. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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