Cleenema Ready-to-Use 21.4g / 9.4g Enema

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium dihydrogen phosphate dihydrate; Disodium phosphate dodecahydrate

Available from:

Casen-Recordati S.L.

ATC code:

A06AG; A06AG01

INN (International Name):

Sodium dihydrogen phosphate dihydrate; Disodium phosphate dodecahydrate

Dosage:

21.4/9.4 gram(s)

Pharmaceutical form:

Rectal solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Enemas; sodium phosphate

Authorization status:

Marketed

Authorization date:

1995-02-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
CLEENEMA READY-TO-USE 21.4G/9.4G ENEMA
Sodium Dihydrogen Phosphate Dihydrate / Disodium Phosphate
Dodecahydrate
_ _
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 Cleenema Ready-to-Use Enema is and what it is used for.
2.
What you need to know before you use Cleenema Ready-to-Use Enema.
3.
How to use Cleenema Ready-to-Use Enema.
4.
Possible side effects.
5.
How to store Cleenema Ready-to-Use Enema.
6.
Contents of the pack and other information.
1.
WHAT CLEENEMA READY-TO-USE ENEMA IS AND WHAT IT IS USED FOR
Cleenema Ready-to-Use Enema is a bowel cleanser that 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 USE CLEENEMA READY-TO-USE ENEMA_ _
_ _
DO NOT USE CLEENEMA 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 know as megacolon).
-
Have a
NARROWING OR INCOMPLETE OPENING
of the anus or rectum.
-
Have a
BLOCKAGE
of the lower colon (Hirschsprung’s diseas

Summary of Product characteristics

Health Products Regulatory Authority
09 August 2022
CRN00D10V
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cleenema Ready-to-Use 21.4g / 9.4g Enema
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 118ml dose delivers the equivalent of 21.4 g (18.1% w/v) Sodium
Dihydrogen Phosphate Dihydrate and 9.4 g (8.0% w/v)
Disodium Phosphate Dodecahydrate.
Contains 4.4 g Sodium per 118ml delivered dose.
Excipients: contains 70mg benzalkonium chloride per 118ml delivered
dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal Solution (Enema)
Clear, colourless, odourless solution, free from precipitate and
turbidity.
4 CLINICAL PARTICULARS
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 and before radiological examinations of the
lower bowel.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults 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).
Elderly patients: 1 bottle (118ml delivered dose) no more than once
daily or as directed by a physician. Cleenema Ready to Use
enema should be used with caution in the elderly (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).
Cleenema 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.
Administration of more than one enema in a 24 hour period can be
harmful. Unle