CLEEN READY-TO-USE 21.4G / 9.4G ENEMA
Active substance(s): SODIUM ACID PHOSPHATE / SODIUM PHOSPHATE / SODIUM ACID PHOSPHATE / SODIUM PHOSPHATE / SODIUM ACID PHOSPHATE / SODIUM PHOSPHATE
Sodium Dihydrogen Phosphate Dihydrate / Disodium Phosphate Dodecahydrate
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist or doctor if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
• You must talk to a doctor if you do not feel better or if you feel worse
after 7 days.
What is in this leaflet
1. What Cleen Ready-to-Use Enema is and what it is used for.
2. What you need to know before you use Cleen Ready-to-Use Enema.
3. How to use Cleen Ready-to-Use Enema.
4. Possible side effects.
5. How to store Cleen Ready-to-Use Enema.
6. Contents of the pack and other information.
1. What Cleen Ready-to-Use Enema
is and what it is used 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
You must talk to a doctor if you do not feel better or if you feel worse after
2. What you need to know before you
use 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:
– a pierced/damaged or blocked gut
– an active inflammatory bowel disease (such as Crohn’s disease or
• 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.
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
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
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:
• 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
• 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,
• 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 use Cleen Ready-to-Use Enema
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 Readyto-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.
4. Possible side effects
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.
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.
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 Ready-to-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-to-Use 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.
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).
• 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.
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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store 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 25°C.
Do not refrigerate.
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
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-to-Use 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:
If you have any questions or comments about this product, please contact
This leaflet was last revised in December 2013.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.