CASEN PHOSPHO-SODA 24.4g10.8g oral solution

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE; DISODIUM PHOSPHATE DODECAHYDRATE

MAH:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN:

SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE; DISODIUM PHOSPHATE DODECAHYDRATE

units_in_package:

45ml ml

manufactured_by:

Casen-Recordati S.L.

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CASEN PHOSPHO-SODA 24.4 G / 10.8 G ORAL SOLUTION
DISODIUM PHOSPHATE DODECAHYDRATE - SODIUM DIHYDROGEN PHOSPHATE
DIHYDRATE
1
WHAT IS IN THIS LEAFLET
1.
What Phospho-soda is used for
2.
How Phospho-soda works
3.
Before you use Phospho-soda
4.
How to use Phospho-soda
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Phospho-
soda
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PHOSPHO-SODA IS USED FOR
Phospho-Soda is a laxative. It is used in
case of severe constipation. You must
also adapt your eating habits if you suffer
from constipation.
Phospho-Soda is used to prepare the
bowel for a surgical procedure or a bowel
examination.
You must talk to a doctor if you do not
feel better or if you feel worse.
HOW PHOSPHO-SODA WORKS
It works by osmotic processes to increase
fluid retention in small bowel lumen.
BEFORE YOU USE PHOSPHO-SODA
-
_When you must not use it _
_ _
Do not use this product if you are
allergic to the active substance or any
of the other ingredients of this
medicine
-
If you suffer from nausea or stomach
ache; in this case there is actually a risk
of kidney failure;
-
If you are younger than 18 years, you
cannot use
Phospho-Soda as bowel
cleansing (but you can use it as
laxative.
_ _
-
In case of:

kidney disease;

overactivity of the parotid glands
(primary hyperparathyroidism)
associated with high
concentrations of calcium in
blood.

symptomatic heart disease;

ascites (fluid accumulation in the
abdominal cavity);

known or suspected occlusion in
the stomach or the bowel;

colon hypertrophy (megacolon);

perforation in the gastrointestinal
tract;

bowel occlusion (ileus);

progressing inflammatory bowel
disease (such as Crohn's disease or
bleeding rectal colitis).
-
Phospho-Soda cannot be used in
combination with other laxatives
containing sodium phosphate.
_ _
_- Before you start to use it _
_ _
Talk to your doctor or pharmacist before
using Phospho-Soda
-

SPC

00000000
CASEN PHOSPHO-SODA 24.4
g
/
10.8
g oral solution
Name & Dosage Form:
CASEN PHOSPHO-SODA 24.4g/10.8g oral solution
Therapeutic Class:
Laxative.
Bowel preparation.
Therapeutic Code:
A06AD17
Description:
Oral solution. Colourless solution with ginger and lime flavour
without precipita
-
tion or impurities.
Names and strengths of Active Ingredients:
Disodium Phosphate dodecahydrate 10.8 g – Sodium dihydrogen
phosphate
dihydrate 24.4 g per 45 mL bottle.
Disodium Phosphate dodecahydrate 0.24 g – Sodium dihydrogen
phosphate
dihydrate 0.542 g per 1 mL.
Pharmacology (Summary of Pharmacodynamics & Pharmacokinetics):
CASEN PHOSPHO-SODA is a saline laxative that works by osmotic
processes to
increase fluid retention in small bowel lumen. The resultant fluid
accumulation in
the ileum causes distention and induces in turn bowel movement and
evacuation.
The start of these peristaltic movements depends on the patient and
occurs 1 to
2 hours after administration.
Administration of oral sodium phosphates solution caused transient
serum elec
-
trolyte shifts in healthy volunteers. An open-label study was
performed with twen-
ty-four healthy adult volunteers who received oral sodium phosphates
solution
to evaluate the time course and degree of electrolyte shifts in two
age and two
gender groups. The study was designed to mimic the bowel preparation
regimen
commonly used prior to colonoscopy, including a clear liquid diet,
timing of sodi
-
um phosphate doses and proper hydration. The followed regimen of 2 x
45 ml of
oral sodium phosphate and additional clear liquids was in line with
the approved
dosing regimen of the product. The study population was balanced for
gender and
age. One-half of the study participants were aged 65 years or older.
Results showed an increase in serum concentrations of sodium and
phosphate
but a decrease of potassium and calcium after each dose.
The mean serum phosphate concentration for all subjects was 3.33 mg/dL
at
baseline, then it peaked at 6.26 mg/dL at hour 3, decreased to 4.70
mg/dL just