ORS B Plus

Main information

  • Trade name:
  • ORS B Plus
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ORS B Plus
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19920763
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

1

ORS B PLUS SACHET

Dextrose Anhydrous/Trisodium Citrate Dihydrate/Potassium Chloride/Sodium Chloride (3375mg/725mg/375mg/650mg)

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What ORS B PLUS is used for

How ORS B PLUS works

Before you use ORS B PLUS

How to use ORS B PLUS

While you are using it

Side effects

Storage and Disposal of ORS B

PLUS

Product Description

Manufacturer and Product

Registration Holder

Date of revision

Serial number

What ORS B PLUS is used for

PLUS

contains

essential

salts

required

body.

used

treatment of replacement of water and

electrolytes

lost

during

moderate

severe diarrhoea.

How ORS B PLUS works

It replaces the water and some important

salts that are lost from the body due to

diarrhoea.

Before you use ORS B PLUS

-When you must not use it

Do not use this medicine if you suffer

from any of the following:

Kidney, liver or heart conditions

Increased body potassium levels

Problems with the amount of salt in

your body

Difficulty in passing urine

High blood pressure

Oedema (swelling of the limbs due to

water retention)

Severe vomiting

Problems

with

products

containing

glucose

Pregnancy and lactation

Do not take ORS B PLUS if you are

pregnant or think you may be pregnant.

Do not take ORS B PLUS if you are breast

feeding. Ask your doctor or pharmacist

for advice before taking any medicine.

-Before you start use it

Tell your doctor or pharmacist if you

are allergic to any medicines.

Tell your doctor and pharmacist what

medications you are taking.

Taking other medicines

Tell your doctor or pharmacist if you are

taking any other medicines including any

that you buy without a prescription from

a pharmacy, medical hall or any other

source.

How to use ORS B PLUS

Always take ORS B PLUS exactly as your

doctor or pharmacist has told you.

Take one sachet and dissolve the contents

in 250ml of cooled boiled water. It is to be

taken orally.

Do not boil the solution and do not use if

the contents in the sachet look wet.

Make and use fresh solutions each day.

Discard unused solution at the end of each

day.

Babies and small children should be given

the solution slowly, in small amounts, as

often as possible during the first 24 hours

of diarrhoea.

PLUS

should

only

reconstituted with water at the volume

stated. Do not increase or decrease the

volume of water used.

-How much to use

Follow all directions given to you by your

doctor

pharmacist

carefully.

They

differ

from

information

contained in this leaflet. If you do not

understand the instructions on the label,

ask your doctor or pharmacist for help.

Children under 2 years:

250mL for the first 2 hours, 3 x 250mL

can be taken a day.

Children 2-5 years:

3 x 250mL for the first 2 hours, 6 x 250

mL can be taken a day.

Adults:

4 x 250mL for the first two hours, 12 x

250mL can be taken throughout the day.

Infants

young

children

should

given small amounts of oral rehydration

fluid administered frequently but slowly

each time.

-When to use it

Use as directed by your doctor or

pharmacist.

-How long to use it

Continue taking your medicine for as

long as your doctor or pharmacist

recommends.

-If you use too much (overdose)

Taking too much of ORS B PLUS may

cause the sodium and potassium level in

the blood to be very high.

Go to the Emergency Department of your

nearest

hospital

think

anyone else may have taken too much of

this medicine. Do this even if there are

no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are using it

-Things you must do

Talk to your doctor or pharmacist if your

symptoms do not improve. Your doctor

will assess your condition and decide if

you should continue to take the medicine.

seeking

other

medical

treatment, tell all the doctors, dentists and

pharmacists that you are taking ORS B

PLUS.

-Things you must not do

Do not stop taking the medicine unless

advised by your doctor or pharmacist.

Do not give ORS B PLUS to anyone else

even if they have the same symptoms or

condition as you.

Side effects

Like all medicines, ORS B Plus can cause

side effects, although not everybody gets

them. However, if you notice anything

unusual,

inform

your

doctor

pharmacist.

Side

effects

reported

include

Hypernatraemia, which is a high sodium

level

blood.

Symptoms

2

Consumer Medication Information Leaflet (RiMUP)

ORS B PLUS SACHET

Dextrose Andhydrous/Trisodium Citrate Dihydrate/Potassium Chloride/Sodium Chloride (3375mg/725mg/375mg/650mg)

hypernatraemia may include restlessness,

weakness,

thirst,

swollen

tongue,

headache and hypotension.

Hyperkalaemia may occur after excessive

intake, after the use of potassium-sparing

diuretics,

renal

failure

acidosis.

Symptoms

include

mental

confusion,

weakness, paralysis, hypotension, heart

block and cardiac arrest.

Other

side

effects

reported

include

nausea, vomiting, diarrhea and abdominal

cramps.

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling Tel: 03-

78835550, or visiting the website

npra.moh.gov.my (Public → Reporting

Medicinal Problems / Side Effects /

AEFI / Vaccine Safety).

Storage and Disposal of ORS B PLUS

-Storage

Keep all medicines out of the sight and

reach of children.

Keep the medicines in a cool dry place

where the temperature stays below 30ºC.

Protect from light.

Do not store in the bathroom or near a sink

or on a window sill.

Do not leave it in the car on hot days.

Heat

dampness

destroy

some

medicines.

Do not take this medicine after the expiry

date stamped on the pack. The expiry date

refers to the last day of that month.

-Disposal

Medicines should not be disposed of via

wastewater or household waste. Ask your

pharmacist how to dispose of medicines

no longer required. These measures will

help to protect the environment.

Product Description

-What it looks like

A white and odourless, crystalline

powder

-Ingredients

-Active

ingredients

Potassium

chloride

375mg,

Dextrose

anhydrous

3375mg, Sodium chloride 650mg and

Sodium citrate 725mg.

MAL number:

MAL19920763XZ

Manufacturer

Pharmaniaga Manufacturing Berhad

(60016-D),

11A, Jalan P/1, Kawasan Perusahaan

Bangi, 43650 Bandar Baru Bangi,

Selangor Darul Ehsan, Malaysia.

Product Registration Holder

Pharmaniaga Manufacturing Berhad

(60016-D),

11A, Jalan P/1, Kawasan Perusahaan

Bangi, 43650 Bandar Baru Bangi,

Selangor Darul Ehsan, Malaysia.

Date of Revision

25/08/2017

Serial Number

NPRA(R4/1)240817/00225