Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Cleen Ready-to-Use Enema
⚠ This medicine appears to have been discontinued
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 Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Cleen Ready-to-Use Enema is a bowel cleanser, which you administer yourself. It acts by increasing the water content of your stools and in this way helps to relieve constipation and clear the bowel. It can be used in the relief of occasional constipation and where bowel cleansing is required, such as prior to your endoscopy, bowel surgery or X-ray examination. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. 2.
What you need to know before you take it
e Cleen Ready-to-Use Enema
Do not use Cleen Ready-to-Use Enema and tell your doctor if you: Are allergic (hypersensitive) to sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate or any of the other ingredients of this medicine (listed in section 6). Have a swollen large bowel (also known as megacolon). Have a narrowing or incomplete opening of the anus or rectum. Have a blockage of the lower colon (Hirschsprung's disease). Have a suspected blockage of the gut. Have blockage of the gut or failure of normal bowel movements (sometimes called paralytic ileus). Have been told by your doctor that you may have:
- appendicitis
- a pierced/damaged or blocked gut
- an active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). Have undiagnosed bleeding of the back passage. Have kidney problems. Have congestive heart failure (your heart is unable to properly pump blood around the body). Have recently been sick or feel sick or thirsty. Have a pain in your stomach (abdominal pain). The patient is under 3 years of age. 1
Warnings and precautions Talk to your doctor or pharmacist before using Cleen Ready-to-Use Enema if: You are frail or elderly. You may need assistance from a carer or healthcare professional to use Cleen Ready-to-Use Enema. You have uncontrolled blood pressure. You have a heart or kidney condition. You suffer from ascites (excess fluid in the peritoneal cavity). You suffer from rectal ulceration (ulceration of the back passage) or fissures (tears in the skin of the back passage). You have had a colostomy. You suffer from electrolyte disturbances (changes in the salt levels in the body such as low calcium, low potassium, high phosphate or high sodium levels). Please consult your doctor, even if these statements were applicable to you at any time in the past. You may need to be more closely supervised during treatment. Other medicines and Cleen Ready-to-Use Enema Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially: –
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medicines for the treatment of high blood pressure (hypertension) such as ACE-inhibitors (e.g. enalapril, ramipril, lisinopril) and angiotensin receptor blockers (e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan) or angina (calcium channel blockers). medicines to empty the bladder (diuretics). certain medicines for mental disorders (lithium). any other medicines that could make you dehydrated or alter the salt levels (potassium, sodium, phosphate or water) in your body, known as your electrolyte balance. certain medicines for cleaning the bowel (sodium phosphates). medicines that alter the rhythm of your heart (prolong the QT interval); such as amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide. non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or ibuprofen.
Pregnancy and breast-feeding 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. As the main ingredients contained in Cleen Ready-to-Use Enema may pass into breast milk, it is advised that breast milk is expressed and discarded for at least 24 hours after receiving the Cleen Ready-to-Use Enema. Driving and using machines Whilst there are no direct effects of Cleen Ready-to-Use Enema on your ability to drive or use machinery, you should remain near toilet facilities after using this medicine. Cleen Ready-to-Use Enema contains benzalkonium chloride which is an irritant and may cause skin reactions. 3.
How to take it
Cleen Ready-to-Use Enema
2
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This product is for self-use. If you are elderly or unable to use Cleen Ready-to-Use Enema by yourself, you may need the help of a carer or healthcare professional to follow these instructions. Adults and children 12 years old and over: The recommended dose is one bottle (118ml delivered dose) no more than once daily or as directed by your doctor. Children over 3 years to under 12 years old: as directed by your doctor. Do not administer to children under 3 years of age. For rectal use only. Unless directed by your doctor, Cleen Ready-to-Use Enema should not be used for more than one week. Administration of more than one enema in a 24 hour period can be harmful. Administration: 1. Wash your hands before handling this product and if possible use disposable gloves. 2. Lie on your left side with both knees bent and your arms at rest in front of you (Fig. 1, below).
3. Remove the orange protective shield. Pull the shield gently while holding the bottle upright and grasping the grooved bottle cap with your fingers (Fig. 2, below).
4. With a steady pressure, gently insert the enema Comfortip into the rectum with the tip pointing towards your navel. 5. Squeeze the bottle until nearly all the liquid has been emptied. Discontinue use if any resistance is encountered. Forcing an enema can result in injury. NOTE: It is not necessary to empty the unit completely. The bottle contains more than the amount of liquid needed for effective use, so a small residue will remain. 6. Gently remove the nozzle from your rectum. It is normal to experience some leakage of the enema liquid. 7. Remain in the same position (Fig. 1, above) until the urge to evacuate your bowels is strong usually within 2 to 5 minutes. 8. Return the used enema to the carton for disposal and wash your hands. 3
If rectal bleeding is noticed, administration must be discontinued immediately and you must contact a doctor immediately. Be prepared to expect frequent loose bowel movements within 5 minutes of taking a dose of Cleen Ready-to-Use Enema. This is normal and shows that the medicine is working. If you have not had a bowel movement within this time, consult your doctor. Do not use any more Cleen Readyto-Use Enema unless instructed to do so by your doctor. Remain near a toilet until the effects have worn off. Drink plenty of clear fluids e.g. water, clear soups, herbal tea, black tea or black coffee or diluted cordials/fruit juice without pulp (but not red or purple coloured juices) to avoid dehydration. In general you should drink 250ml (a small tumbler-sized glass) every hour until the effect of the Cleen Ready-to-Use Enema has worn off. After this, drink clear fluids, preferably water, to satisfy your thirst until after your hospital procedure, or as directed by your doctor. If you use more Cleen Ready-to-Use Enema than you should, or if you accidentally ingest (drink) the medicine, talk to a doctor or pharmacist immediately. If you use more Cleen Ready-toUse Enema than you should, you may feel dehydrated, be thirsty or have muscular rigidity. If possible take your bottle or the carton with you to show the doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Cleen Ready-to-Use Enema may very rarely (one out of 10,000 people) cause:
- Hypersensitivity: allergic reactions (with or without rash).
- Dehydration.
- Muscle twitches and spasms due to changes in the amounts of salts (electrolytes) in the blood.
- Abdominal pain or bloating (distension).
- Gastrointestinal pain.
- Nausea or vomiting.
- Anal itching, stinging, pain or discomfort.
- Blisters.
- Diarrhoea.
- Chills. 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.
How to store it
Cleen Ready-to-Use Enema
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the packaging. The expiry date refers to the last day of that month. Do not store above 25oC. Do not refrigerate.
4
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. 6.
Contents of the pack and other information
What Cleen Ready-to-Use Enema contains Active substances: Each 118ml dose delivers the equivalent of 21.4g (18.1% w/v) Sodium Dihydrogen Phosphate Dihydrate and 9.4g (8.0% w/v) Disodium phosphate Dodecahydrate. Contains 4.4g sodium per delivered dose. The other ingredients (excipients) are Benzalkonium Chloride, Disodium Edetate, Purified Water. The nozzle lubricant is white soft paraffin. Contains 80mg benzalkonium chloride per delivered dose. What Cleen Ready-to-Use Enema looks like and the contents of the pack Cleen Ready-to-Use Enema is a clear, colourless, odourless solution contained in a white plastic bottle with a white cap and orange protective shield. The bottle contains 133ml of Cleen Ready-toUse Enema, of which 118ml is the delivered dose. Marketing Authorisation Holder and Manufacturer Casen Recordati, S.L. Autovía de Logroño, km. 13,300 50180 Utebo, Zaragoza, Spain. Marketing Authorisation Number: PL 43885/0003 If you have any questions or comments about this product, please contact us on: [email protected] This leaflet was last revised in February 2022.
5
Frequently asked questions about Cleen Ready-to-Use Enema
What is the active substance in Cleen Ready-to-Use Enema?
The active substance in Cleen Ready-to-Use Enema is sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate.
Are there equivalent medicines to Cleen Ready-to-Use Enema?
Medicines with the same active substance, strength and form include: Fletcher’s Phosphate Enema (Long Tube), Fletcher’s Phosphate Enema (Short Tube), Phosphates Enema BP Formula B (Long Tube). In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Cleen Ready-to-Use Enema, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Cleen Ready-to-Use Enema without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
• For use in the relief of occasional constipation.
• For use where bowel cleansing is required, such as before and after lower bowel surgery, delivery and post partum, before proctoscopy, sigmoidoscopy or colonoscopy and before radiological examinations of the lower bowel.
4.2. Posology and method of administration
Posology
Adults, Elderly and Children over 12 years old: 1 bottle (118ml delivered dose) no more than once daily or as directed by a physician (see section 4.4).
Children aged 3 years to less than 12 years: As directed by a physician (see section 4.4 and 4.9).
Cleen Ready-to-Use Enema is contraindicated in children under 3 years of age (see section 4.3).
Renal impairment
Do not administer to patients with clinically significant impairment of renal function (see section 4.3).
The product should be used with caution in patients with impaired renal function, when the clinical benefit is expected to outweigh the risk of hyperphosphataemia (see section 4.4).
Hepatic impairment:
No dose adjustment is required in patients with hepatic impairment.
Method of administration
For rectal use only:
Lie on left side with both knees bent, arms at rest.
Remove orange protective shield.
With steady pressure, gently insert enema Comfortip into anus with nozzle pointing towards navel.
Squeeze bottle until nearly all liquid is expelled.
Discontinue use if resistance is encountered. Forcing the enema can result in injury.
Return enema to carton for disposal.
Generally, 2 to 5 minutes are sufficient to obtain the desired effect. If delayed discontinue further use and consult a physician
For occasional constipation rectal enemas are to be used to provide short-term relief only.
4.3. Contraindications
Cleen Ready-to-Use Enema is contraindicated in patients with:
• Hypersensitivity to active ingredients or to any of the excipients listed in section 6.1 .
.
• Conditions causing increased absorption capacity or decreased elimination capacity, such as when bowel obstruction or decreased bowel motility is present; e.g.,
o suspected intestinal obstruction
o paralytic ileus
o anorectal stenosis
o imperforate anus
o congenital or acquired megacolon
o Hirschsprung's disease
• Undiagnosed gastrointestinal pathology, e.g.,
o symptoms suggestive of appendicitis, intestinal perforation or active inflammatory bowel disease
o Undiagnosed rectal bleeding
• Congestive heart failure.
• Dehydration
• Children under 3 years of age.
• Clinically significant impairment of renal function.
No other sodium phosphates preparations including sodium phosphates oral solution or tablets should be given concomitantly (see section 4.5).
4.4. Special warnings and precautions for use
Do not use Cleen Ready-to-Use Enema when nausea, vomiting or abdominal pain is present unless directed by a physician.
Patients should be advised to expect liquid stools and should be encouraged to drink clear liquids to help prevent dehydration, especially patients with conditions that may predispose to dehydration or those taking medications which may decrease glomerular filtration rate, such as diuretics, angiotensin converting enzyme inhibitors (ACE-Is, e.g. enlaparil, ramipril, lisinopril), angiotensin receptor blockers (ARBs, e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan) or non-steroidal anti-inflammatory drugs (NSAIDs).
Since Cleen Ready-to-Use Enema contains sodium phosphates, there is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium and consequently hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia may occur with clinical signs like tetany and renal failure. Electrolyte shifts are of particular concern in children with megacolon or any other condition where there is retention of enema solution, and in patients with co-morbidities. That is why Cleen Ready-to-Use Enema should be used with caution in: elderly or debilitated patients and in patients with uncontrolled arterial hypertension, ascites, heart disease, rectal mucosal changes (ulcers, fissures), colostomy patients who are taking diuretics or other medications which may affect electrolyte levels, who are taking medications known to prolong the QT interval (such as amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide), or pre-existing electrolyte imbalance such as hypocalcaemia, hypokalaemia, hyperphosphataemia, hypernatraemia. Use also with caution in patients who are taking medications known to affect renal perfusion or function, or hydration status. Where electrolyte disorders are suspected and in patients who may experience hyperphosphataemia, electrolyte levels should be monitored before and after administration of Cleen Ready-to-Use Enema.
The product should be used with caution in patients with impaired renal function, when the clinical benefit is expected to outweigh the risk of hyperphosphataemia.
Repeated and prolonged use of Cleen Ready-to-Use Enema is not recommended as it may cause habituation. Administration of more than one enema in a 24 hour period can be harmful. Unless directed by a physician Cleen Ready-to-Use Enema should not be used for more than one week.
Cleen Ready-to-Use Enema should be administered according to the instructions for use and handling (see section 4.2). Patients should be warned to stop administration if resistance is encountered as forced administration of the enema may cause injury. Rectal bleeding after using Cleen Ready-to-Use Enema may indicate a serious condition. If this occurs, administration must be discontinued immediately and the condition of the patient assessed by a physician.
In general, evacuation occurs approximately 5 minutes after Cleen Ready-to-Use Enema administration; therefore, retention times over 5 minutes are not recommended. If evacuation does not occur after using Cleen Ready-to-Use Enema or if the retention time lasts for more than 10 minutes, serious side effects could occur. No further administrations should be given and the condition of the patient should be assessed by a physician who will decide if laboratory tests should be completed in order to detect possible electrolyte abnormalities and to minimize the risk of severe hyperphosphatemia (see sections 4.8 and 4.9).
This medicine contains benzalkonium chloride which is an irritant and may cause skin reactions.
Keep all medicines out of the sight and reach of children.
4.5. Interaction with other medicinal products and other forms of interaction
Use with caution in patients taking calcium channel blockers, diuretics, lithium treatment or other medications that might affect electrolyte levels as hyperphosphataemia, hypocalcaemia, hypokalaemia, hypernatraemic dehydration and acidosis may occur (see section 4.4).
No other sodium phosphate preparations including sodium phosphate oral solution or tablets should be given concomitantly (see section 4.3).
As hypernatraemia is associated with lower lithium levels, concomitant use of Cleen Ready-to-Use Enema and lithium therapy could lead to a fall in serum lithium levels with a lessening of effectiveness.
4.6. Fertility, pregnancy and lactation
As there is no relevant data available to evaluate the potential for foetal malformation or other foetotoxic effects when administered during pregnancy Cleen Ready-to-Use Enema should only be used as directed by a physician at the time of delivery or postpartum.
As sodium phosphate may pass into the breast milk, it is advised that breast milk is expressed and discarded for at least 24 hours after receiving the Cleen Ready-to-Use Enema.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Cleen Ready-to-Use Enema is well tolerated when used as indicated. However, adverse events possibly associated with the use of Cleen Ready-to-Use Enema have been infrequently reported. In some cases, adverse events may occur, especially if the enema is misused.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Organized by MedDRA System Organ Class the undesirable effects are listed below using the following frequency classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data):
Immune System Disorders:
Very rare: Hypersensitivity e.g. urticaria.
Skin and subcutaneous tissue disorders
Very rare: blister, pruritus, stinging.
Metabolism and nutrition disorders
Very rare: dehydration, hyperphosphataemia, hypocalcaemia, hypokalaemia, hypernatremia, metabolic acidosis.
Gastrointestinal disorders:
Very rare: nausea, vomiting, abdominal pain, abdominal distension, diarrhoea, gastrointestinal pain, anal discomfort and proctalgia.
General disorders and administration site conditions:
Very rare: rectal irritation, pain, stinging, chills.
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.
4.9. Overdose
There have been fatalities when Cleen Ready-to-Use Enema has been administered in excessive doses or retained, used in children or used in obstructed patients.
Hyperphosphataemia, hypocalcaemia, hypernatraemia, hypernatraemia dehydration, hypokalemia, hypovolemia, acidosis and tetany may occur in overdose or retention.
Recovery from the toxic effects can normally be achieved by rehydration. Treatment of electrolyte imbalance may require immediate medical intervention with appropriate electrolyte and fluid replacement therapy.
💬 Ask about this leaflet
Ask anything about Cleen Ready-to-Use Enema. 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.