Phospho-soda 24.4g/10.8g Oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium phosphate dibasic dodecahydrate; Sodium phosphate dibasic dihydrate

Available from:

Casen-Recordati S.L.

ATC code:

A06AD

INN (International Name):

Sodium phosphate dibasic dodecahydrate; Sodium phosphate dibasic dihydrate

Dosage:

24.4/10.8 gram(s)

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Osmotically acting laxatives

Authorization status:

Marketed

Authorization date:

1998-07-06

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHOSPHO-SODA 24.4 G / 10.8 G ORAL SOLUTION
Sodium Dihydrogen Phosphate Dihydrate / Disodium Phosphate
Dodecahydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Phospho-soda is and what it is used for
2.
What you need to know before you take Phospho-soda
3.
How to take Phospho-soda
4.
Possible side effects
5.
How to store Phospho-soda
6.
Contents of the pack and other information
1.
WHAT PHOSPHO-SODA IS AND WHAT IT IS USED FOR
Phospho-soda is a bowel cleanser that acts by increasing the water
content of your stools. It is a solution
which you take by mouth and it comes in packs containing two 45 ml
bottles. Each bottle contains one dose
which must be diluted with water before use (see Section 3).
You need to take Phospho-soda in order to clean your bowel (also
called large intestine or colon) before your
endoscopy, bowel surgery or X-ray examination. It is important that
your bowel is completely empty so that
the doctors can see it clearly.
Phospho-soda is not a treatment for constipation.
Phospho-soda is indicated in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHOSPHO-SODA
DO NOT TAKE PHOSPHO-SODA IF YOU:

are allergic to disodium phosphate dodecahydrate, sodium dihydrogen
phosphate dihydrate or any of
the other ingredients of this medicine (listed in section 6);

are under the age of 18 years;

feel sick or are vomiting, or are suffering from abdominal pains;

have kidney disease;

suffer from symptomatic heart disease;

have an abnormal build up of fluid

Summary of Product characteristics

Health Products Regulatory Authority
27 June 2022
CRN00CZX8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phospho-soda 24.4g/10.8g Oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
per 45ml doseper 1ml
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dodecahydrate
24.4 g
0.542 g
10.8 g
0.24 g
Excipient(s) with known effect: Ethanol, Sodium, Sodium benzoate (E
211).
Phospho-soda contains 29mg of ethanol per dose.
Each 45ml bottle contains 5.0 g sodium and 15 mg of sodium benzoate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
Clear colourless solution with a ginger-lemon odour, free from
precipitation and turbidity.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a bowel cleanser in preparing the patient for colon surgery, or for
preparing the colon for x-ray or for endoscopic
examination.
Bowel cleansing agents are not to be considered as treatments for
constipation.
Phospho-soda is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Two separate doses of Phospho-soda are provided to adults.
_Elderly patients:_
Phospho-soda should be used with caution in elderly patients. No dose
adjustment is necessary in this group of patients (see
section 4.4).
_ _
_Patients with renal impairment_:
Phospho-soda is contraindicated in patients with renal impairment (see
section 4.3)
_Patients with hepatic impairment:_
The safety and efficacy of Phospho-soda in patients with hepatic
impairment has not been established Phospho-soda is
contraindicated in patients with ascites (see 4.3).
Health Products Regulatory Authority
27 June 2022
CRN00CZX8
Page 2 of 9
_Paediatric population:_
Phospho-soda is contraindicated in children below 18 years (see
section 4.3).
Method of administration
The taking of Phospho-soda should be started the day before the
hospital appointment.
For hospital appointments before 12 noon the dosage instructions for
morning appointments should be followed and for
appointments after 12 noon the dosage i