URISOL EFFERVESCENT GRANULES IN SACHET

Country: Malaysia

Language: English

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

Active ingredient:

SODIUM BICARBONATE; Tartaric Acid; Citric acid anhydrous; Sodium Citrate Anhydrous

Available from:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

SODIUM BICARBONATE; Tartaric Acid; Citric acid anhydrous; Sodium Citrate Anhydrous

Units in package:

28 Sachets

Manufactured by:

IND-SWIFT LIMITED

Patient Information leaflet

URISOL
_Consumer Medication Information Leaflet (RiMUP)_
(Sodium Bicarbonate 1.76g, Tartaric Acid 890mg, Citric Acid 720mg and
Sodium Citrate 630mg Effervescent Granules Sachet)
1
WHAT IS IN THIS LEAFLET
1.
What Urisol is used for
2.
How Urisol works
3.
Before you use Urisol
4.
How to use Urisol
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Urisol
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS URISOL USED FOR
Indicated for relieving of discomfort
in
mild
urinary
tract
infection;
symptomatic
relief
of
dysuria;
to
enhance
the
action
of
certain
antibiotics
especially
some
sulphonamides;
in
gout
as
urinary
alkalinisers to prevent cystallisation
of urates and dissolution of uric acid
stones.
HOW URISOL WORKS
Pharmacology Class: Urinary and
Gastric Alkalinizer
Sodium bicarbonate acts as urinary
alkaliser by increasing the excretion
of free bicarbonate ions in the urine,
thus
effectively
raising
the urinary
pH.
Sodium
citrate
is
metabolized
to
bicarbonates, which increases urinary
pH by increasing the excretion of free
bicarbonate ions, without producing
systemic alkalosis when administered
in recommended doses.
Sodium Citrate is used to make the
urine
alkaline
in
the
treatment
of
urinary tract infections.
Citric acid increases the secretion of
urine and renders it less acidic. It is
also
used
in
the
preparation
of
effervescent
granules
to
aid
effervescence.
BEFORE YOU USE URISOL
_-When you must not use it _
_ _
Do not give this medicine to children
under 12 years of age unless advised
to do so by a doctor.
Patients should be advised to consult
your
doctor
or
pharmacist
before
using this medicine if you are taking
other medicines or if you have kidney
problems,
heart
problems
or
high
blood pressures.
_-Before you start to use it _
_ _
SPECIAL WARNINGS AND PRECAUTIONS
Do not give this medicine to children
under 12 years of age unless advised
to do so by a doctor.
Patients should be advised to consult
your
doctor
or
pharmacist
be

Summary of Product characteristics

URISOL
(SODIUM BICARBONATE, TARTARIC ACID, CITRIC ACID AND SODIUM CITRATE
EFFERVESCENT GRANULES SACHET)
COMPOSITION:
Each sachet contains:
Sodium Bicarbonate BP
1.76g
Tartaric Acid BP
890mg
Citric Acid Anhydrous BP
720mg
Sodium Citrate Anhydrous USP
630mg
PRESENTATION:
28 Sachets in a Carton
PRODUCT DESCRIPTION:
GRANULES:
White to off white coloured, lemon flavoured granules.
RECONSTITUTED SOLUTION:
The reconstituted solution is clear and lemon flavored.
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS
ATC code: G04BX Other urologicals; Used in the treatment of urological
problems
Sodium Bicarbonate, Tartaric Acid, Citric Acid and Sodium Citrate
Effervescent granules have
gastric antacid as well as urinary alkalinising properties.
Sodium Bicarbonate increases the alkali reserve of the plasma and
increases excretion of urine,
which is rendered less acidic. Sodium Citrate is used to make the
urine alkaline in the treatment
of urinary tract infections. Citric acid increases the secretion of
urine and renders it less acidic. It
is also used in the preparation of effervescent granules to aid
effervescence.
PHARMACOKINETICS AND DRUG METABOLISM
Sodium Citrate and Citric Acid: Sodium citrate is metabolized to
bicarbonates which increases
urinary pH by increasing the excretion of free bicarbonate ions
without producing systemic
alkalosis when administered in recommended doses.
Sodium bicarbonate is excreted through renal and also via lungs by
forming CO2.
Sodium citrate, citric acid and absorbed tartaric acid are excreted
through the urine.
INDICATIONS AND USAGE:
Indicated for relieving of discomfort in mild urinary tract infection;
symptomatic relief of
dysuria; to enhance the action of certain antibiotics especially some
sulphonamides; in gout as
urinary alkalinisers to prevent cystallisation of urates and
dissolution of uric acid stones.
DOSAGE AND ADMINISTRATION:
_ADULTS_:
Dissolve the contents of 1 – 2 sachets in a glass of cold water. It
may be taken 4 times daily for 5
days unless advised to do so by the physician.
_CHILD