Zoralone

Main information

  • Trade name:
  • Zoralone Forte Syrup Sugar Free
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zoralone Forte Syrup Sugar Free
    Malaysia
  • Language:
  • English

Other information

Status

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

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

Consumer Medication Information Leaflet (RiMUP)

ZORALONE FORTE SYRUP SUGAR FREE

Prednisolone Sodium Phosphate (5mg/ml)

1

What is in this leaflet

What Zoralone Forte is used

How Zoralone Forte works

Before you use Zoralone Forte

How to use Zoralone Forte

While you are using Zoralone

Forte

Side effects

Storage

Disposal

Zoralone Forte

Product description

Manufacturer

Product

Registration Holder

Date of Revision

This leaflet answers some common

questions about Zoralone Forte. It

does not contain all the information

that is known about Zoralone Forte.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits. Your doctor or pharmacist

has weighed the risks of you taking

Zoralone Forte against the benefits

they expect it will have for you.

Keep

this

leaflet

with

the

medicine. You may need to read it

again.

What Zoralone Forte is used for

Zoralone

Forte

used

treatment of many conditions:

asthma

Allergic disorders

Fever due to inflammation that

develop

after

bacteria

infection

Rheumatoid arthritis (joint pain

and inflammation)

Inflammatory skin disease

Zoralone

Forte

also

used

reduce

symptoms

skin

inflammation

(such

swelling,

redness, pain, tenderness or itching).

How Zoralone Forte works

It works by entering inflammatory

cells and blocking the inflammatory

reaction.

Ask your doctor if you have any

questions

about

why

Zoralone

Forte has been prescribed for you.

Your doctor may have prescribed it

another

reason.

There

evidence that it is addictive.

Before you use Zoralone Forte

-When you must not use it

Do not take Zoralone Forte if:

You are allergic to Prednisolone

or glucocorticoids or to any of the

ingredients listed at the end of this

leaflet.

have

current

serious

uncontrolled

infection,

including

fungal infections.

have

stomach

ulcer,

osteoporosis

(brittle

bone),

psychoses

(mental

disorder),

severe

psychoneurosis

(mental

disorder),

acute

bacterial

infection, certain viral infections

example

varicellla

herpes

genitalis and glaucoma (increased

pressure in the eye).

Do

not

take

Zoralone

Forte

to

treat any other complaints unless

your doctor has instructed you to

do so.

-Before you start to use it

Tell your pharmacist or doctor if

you are allergic to other medicines

foods, dyes or preservatives.

Please inform doctor if you have:

tuberculosis (bacteria infections

that mainly affect the lungs)

high blood pressure

sugar in the urine

low potassium blood level

gastric discomfort

mental changes

Your doctor may stop gradually,

increase

dosage

or

restart

the

glucocorticoid therapy according

to your conditions.

Your doctor

may

arrange

some

tests

before

prescribing prednisolone because

glucocorticoid

may

mask

some

signs

of

infections

and

new

infections may appear.

While on glucocorticoid therapy,

you should not be vaccinated with

live vaccine. If you are pregnant,

trying

to

become

pregnant

or

breastfeeding, you must tell your

doctor

before

you

start

the

treatment.

-Taking other medicines

Tell your doctor or pharmacist if

you

are

taking

any

other

medicines, including any that you

get

without

a

prescription

from

pharmacy, supermarket or health

food shop.

Zoralone Forte should only be given

under

your

doctor's

supervision.

Please inform your doctor if you are

taking:

barbiturates-a

type

sedative medicine

phenylbutazone-analgesic

(pain relief)

phenytoin-treat seizures

rifampicin-antibiotic

bacteria infection

anticoagulant-prevent

blood clots

diuretics-promotes

secretion of water from the

body

Consumer Medication Information Leaflet (RiMUP)

2

-Use in children

If possible, children should not be

exposed

common

childhood

illnesses

such

chickenpox

measles while they are taking this

medicine.

They

suffer

from

more

serious

attacks

these

illnesses if such exposure occurs.

Children should not be vaccinated

with

‘live’

vaccines

against

common childhood illnesses while

they are taking it, as this may result

in severe attacks of these illnesses.

Potentially serious side effects can

occur

children

growing

teenagers

taking

corticosteroids.

Some

these

include slowed growth, osteoporosis

(bone become brittle) and changes

adrenal

glands

(hormone

imbalance).

How to use Zoralone Forte

-How much to use

dose

will

depend

condition

being

treated

your

response

treatment.

Your

initial dose will be maintained or

adjusted

until

satisfactory

response is noted.

For children

with

normal hormone

secretion

, recommended 0.5 to 2mg

per kg daily of prednisolone in 3 or

4 divided doses after meals.

Your doctor will tell you how much

Zoralone Forte to take.

-When to use it

Zoralone

Forte

best

taken

immediately after food.

How often Zoralone Forte can be

taken may vary depending on what

condition is being treated. If you are

taking Zoralone Forte:

Once a day: It is better to be taken at

the same time each day as instructed

by your doctor.

Several times a day: It is better if

have

doses

evenly

spaced throughout the day.

Do not miss any doses and do not

stop taking the medicine even if

you feel better.

-How long to use it

Continue

taking

Zoralone

Forte

for

as

long

as

your

doctor

or

pharmacist tells you.

This will depend on your condition

and on your response to treatment.

Some

people

will

need

this

medicine for only short periods of

time whilst others may require long

term therapy.

-If you forget to use it

Take the missed dose as soon as you

remember. If it is almost time for

your next dose, skip the missed dose

and take the medicine at your next

regularly scheduled time.

Do not try to make up for missed

doses

by

taking

more

than

one

dose at a time.

-If you use too much (overdose)

Immediately

telephone

your

doctor

for

advice

or

go

to

Accident

and

Emergency

at

the

nearest hospital, if you think that

you

or

anyone

else

may

have

taken too much Zoralone Forte.

Do this even if there are no signs

of discomfort or poisoning. Bring

any remaining medicine with you.

While

you

are

using

Zoralone

Forte

-Things you must do

Take

Zoralone

Forte

exactly

as

your doctor has prescribed.

Tell your doctor if your condition

returns

or

becomes

worse

after

your dose of Zoralone Forte has

been

reduced

or

treatment

has

been stopped.

Tell

your

doctor

immediately

if

you become pregnant while taking

Zoralone Forte.

Tell

any

other

doctors,

dentists

and pharmacists who are treating

you that you are taking Zoralone

Forte, especially if you are being

started on any new medicines.

Tell

your

doctor,

surgeon

or

dentist

that

you

are

taking

Zoralone Forte if you are about to

undergo surgery or an operation.

trauma

operation

surgery may mean that your dose of

Zoralone

Forte

need

increased

cover

stressful

period.

Tell your doctor straight away if

you are a diabetic, and you notice

a change in the results of your

blood or urine sugar tests.

This

medicine

affect

your

blood sugar levels as it can affect

the body's ability to handle glucose.

For diabetics, this means that your

diabetes may become more severe.

For others, diabetes may develop for

first

time

while

taking

corticosteroids

such

Zoralone

Forte.

Ask your doctor when and how

you should stop taking Zoralone

Forte.

-Things you must not do

Do

not

give

this

medicine

to

anyone else, even if they have the

same condition as you.

Do not stop taking Zoralone Forte

suddenly unless advised by your

doctor.

Consumer Medication Information Leaflet (RiMUP)

3

Do not have any immunisations

(particularly with ‘live’ vaccines

such

as

measles,

oral

polio

or

yellow

fever)

without

your

doctor's approval while you are

being

treated

with

Zoralone

Forte.

-Things to be careful of

Avoid close contact with anyone

who has a contagious disease such

as measles or chickenpox.

Exposure to such diseases while you

taking

Zoralone

Forte,

particularly if large doses are being

taken, can put you at greater risk of

developing

these

diseases

have not had them before.

Tell your doctor straight away if

you think you have been exposed

to chickenpox or measles.

with

medicine,

should

take

care

when

driving,

operating

machinery

drinking

alcohol

until

know

Zoralone Forte affects you.

signs

symptoms

infections

such

fever

inflammation may be hidden by the

anti-inflammatory

action

Zoralone

Forte.

should

your doctor for medical advice for

any but the most minor infections.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well

while

you

are

taking

Zoralone Forte.

Zoralone Forte

helps

most

people

take

have

unwanted

side

effects

some

people.

medicines

have

side

effects. Sometimes they are serious,

most of the time they are not.

Some

side

effects

only

detected by your doctor. So, when

Zoralone

Forte

taken

long

periods of time it is important to

visit

your

doctor

regularly

check-ups.

Some side effects are as below:

Disturbance

Electrolyte

Balance

Sodium

water

retention with swelling and high

blood

pressure

increased

removal

potassium

with

possibility

blood

potassium level.

Metabolic Effects – Movement

calcium

phosphorous

with osteoporosis (fragile bone)

&

spontaneous

fractures,

nitrogen depletion due to protein

breakdown,

high

blood

sugar

level, increased requirement for

insulin

other

oral

hypoglycemic agents in diabetes.

Gastrointestinal - Stomach ulcer

with

possible

perforation

haemorrhage,

pancreas

inflammation.

Neurological

high

blood

pressure

inside

skull

headache.

Tissue Repair – Delayed wound

healing which able to increased

liability to infection.

Endocrine

Suppression

growth in children.

Musculoskeletal

Muscle

weakness, aseptic necrosis of the

bone (death of bone tissue due to

poor blood supply).

Ophthalmic

such

posterior

subcapsular

cataracts

(clouding

of eye lens), increased pressure

in the eye.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

side

effects,

even

those not mentioned in this leaflet,

tell your doctor or pharmacist.

You may report any side effects or

adverse

drug

reactions

directly

National

Centre

Adverse

Drug

Reaction

Monitoring

calling

Tel:

03-78835550,

visiting

website

portal.bpfk.gov.my

(Consumers

Reporting)

Storage and Disposal of Zoralone

Forte

-Storage

Store below temperature 30°C.

Keep in a cool dry place, protected

from light.

Keep out of reach of children.

-Disposal

Dispose

medicine

after

expiry date.

Consult your pharmacist on how to

dispose of any medicines no longer

required.

Product description

-What it looks like

A clear light brown sugar-free liquid

with

blackcurrant

cream

soda flavour.

Zoralone Forte is packed in 60ml

PET amber bottle.

-Ingredients

Active ingredient:

Each

contains

prednisolone.

Inactive ingredients:

Methylparaben,

Propylparaben,

Disodium

Hydrogen

Phosphate

Dihydrate,

Sodium

Dihydrogen

Phosphate

Dihydrate,

Glycerin,

Disodium

Edetate,

Blackcurrant

FlavourIce Cream Soda Flavour and

Purified Water.

MAL number: MAL11075002A

Manufacturer:

HOE Pharmaceuticals Sdn. Bhd.

Jalan

Sultan

Mohd.

Bandar

Sultan

Suleiman,

42000

Port

Klang,

Selangor,

Malaysia.

Consumer Medication Information Leaflet (RiMUP)

4

Product Registration Holder:

HOE Pharmaceuticals Sdn. Bhd.

Jalan

Sultan

Mohd.

Bandar

Sultan

Suleiman,

42000

Port

Klang,

Selangor,

Malaysia.

Date of revision

25/02/2016

Serial Number:

BPFK(R4/1)301015/00388

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

There are no news related to this product.