Rexolone

Main information

  • Trade name:
  • Rexolone Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Rexolone Syrup
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL20013122
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

REXOLONE SYRUP

Prednisolone (3mg/5ml)

1

What is in this leaflet

What Rexolone is used for

How Rexolone works

Before you use Rexolone

How to use Rexolone

While you are using Rexolone

Side effects

Storage and disposal of Rexolone

Product description

Manufacturer and Product

Registration Holder

Date of revision

What Rexolone is used for

treatment

adrenal

insufficiency, immunosuppressant, anti-

inflammatory and suppressive treatment

of allergic reaction.

How Rexolone works

Rexolone

contains

Prednisolone

active ingredient. It works by entering

inflammatory

cells

blocking

inflammatory reaction.

Before you use Rexolone

- When you must not use it

Do not use:

in individuals with gastric ulceration,

psychoses (mental health) and severe

psychoneurosis

(mental

health),

osteoporosis

(brittle

bone),

acute

infections, and vaccination with live

vaccines.

presence

congestive

heart

failure or high blood pressure, diabetes,

epilepsy

(seizures),

increased

pressure,

infectious

diseases,

herpes simplex (eye infection), chronic

kidney failure and uremia (excess of

waste products in the blood) in elderly

persons.

have

tuberculosis

(bacterial

infections that mainly affects the lungs)

if you have hypersensitivity to any of

the ingredient of Rexolone.

-Before you start to use it

Use in children

Long term use of corticosteroids may

suppress growth and development of the

children

adolescent

should

undertake

with

caution.

Growth

retardation

irreversible,

prolonged or continuous treatment rarely

given.

Children may be at increased risk

of developing osteoporosis (brittle bone),

death of thigh bone tissue, damage to

eye’s optic nerve or clouding of the eye’s

natural lens during prolonged therapy.

Pregnancy and lactation

Talk to you doctor before taking this

medicine

pregnant,

might

become pregnant or are breastfeeding.

Corticosteroids crosses placenta. Weigh

benefits against potential hazards to the

mother and fetus.

Corticosteroids appear in breast milk and

could

suppress

growth,

interfere

with

internal

corticosteroids

production

cause unwanted effects in the nursing

infant.

Withdrawal

Withdrawal

must

always

gradual,

tapered

over

weeks

months

depending on dosage and duration of

therapy.

Too rapid reduction of dosage,

following a prolonged course (7 days or

more),

lead

acute

adrenal

insufficiency,

blood

pressure

death.

-Taking other medicines

Inform your doctor or pharmacist before

taking this medicines, including any that

you get without a prescription from your

pharmacy, supermarket or health food

shop.

Some

medicines

Rexolone

interfere with each other. They may be

affected by Rexolone or may affect how

well it works especially:

Barbiturates, carbamazepine,

phenytoin, primidone and rifampicin

(medicine for seizures)

Potassium-depleting diuresis, such as

thiazides or furosemide (medicine for

high blood pressure)

Nonsteroidal Antiinflammatory Drugs

(NSAIDs) (reduce inflammation, pain

and fever)

Antidiabetics (stabilize and control

blood glucose levels amongst people

with diabetes)

Antihypertensive (treat high blood

pressure)

Anticoagulants (prevent blood clots)

Salicylates (reduce pain and fever).

Antimuscarinics

(treatment

digestive system)

How to use Rexolone

-How much to use

Always use Rexolone exactly as your

doctor has prescribed. You should check

with

your

doctor

pharmacist

doubt.

The usual dose:

Adult

Initially: 10-20mg (16.7-33.3ml) daily,

once or in divided doses (severe disease,

up to 60mg daily in divided doses).

Maintenance:

2.5-15mg

(4.17-25ml)

daily, once or in divided doses.

Children

Initially:

0.2-2mg/kg

(0.33-3.33ml/kg)

body weight daily in divided doses.

Tapering: Gradually reduce by 2.5mg

(4.17ml) to maintenance.

-When to use it

directed

your

doctor

pharmacist.

-How long to use it

Continue taking Rexolone as your doctor

recommended.

-If you forget to use it

Consult your doctor or pharmacist on

what you should do if you forget to use

Take the missed dose as soon as you

remember. If it is almost time for your

next dose, wait until then to take the

medicine and skip the missed dose. Do

not take a double dose to make up for the

missed dose.

-If you use too much (overdose)

Contact your doctor immediately or go to

Emergency

Department

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.

Taking too much Rexolone may cause:

Acute adrenal insufficiency

due to too

rapid

corticosteriod

withdrawal

after

long term use resulting in fever, muscle

pain,

joint

pain,

reduce

appetite,

nausea,

skin

peeling,

postural

blood

pressure,

dizziness,

fainting,

difficult

breathing

blood

glucose level.

Consumer Medication Information Leaflet (RiMUP)

REXOLONE SYRUP

Prednisolone (3mg/5ml)

2

Cushingoid

changes

from

continued

use of large doses resulting in round,

moon-shaped

face,

central

obesity,

stretch mark, excess body hair, acne,

ecchymosis

discoloration of the skin

resulting from bleeding underneath),

high

blood

pressure,

osteoporosis

(brittle

bone),

myopathy

(muscle

disease), sexual dysfunction, diabetes,

hyperlipidemia

(high

cholesterol),

peptic ulcer (ulcer in the stomach and

small

intestine),

increased

susceptibility

infection

electrolyte and fluid imbalance.

While you are using Rexolone

-Things you must do

Tell

doctors,

dentists

pharmacists treating you that you are

taking Rexolone.

Tell your doctor immediately if you

become

pregnant

while

taking

this

medication.

-Things you must not do

take

more

than

recommended

dose

unless

your

pharmacist or doctor tells you.

Do not take any new medicines without

consulting your doctor or pharmacist.

Do not give Rexolone to anyone else,

even if they have the same symptoms

or condition as you.

-Things to be careful of

careful

driving

operating

machinery

until

know

Rexolone affects you.

Side effects

Like all medicines, Rexolone can cause

side effects, although not everybody gets

them.

If symptoms persist, refer to the doctor.

Tell your doctor

if you notice any of the

following side effects or notice any other

effects not listed:

Metabolic

effects

leading

osteoporosis

(brittle

bone),

nitrogen

depletion and high blood glucose level.

Increase

appetite,

delayed

wound

healing and increased susceptibility to

all kinds of infection.

Cushing's

syndrome,

growth

retardation

children

acute

adrenal

insufficiency

hormonal

disorder that occurs when the adrenal

glands

produce

enough

certain hormone).

Amenorrhoea

(absence

menstrual

periods

woman),

abnormally

increased

sweating,

skin

thinning,

metal and neurological (brain, spine

and nerve) disturbances.

High blood pressure in the skull, acute

inflammation

pancreas,

bone

death,

increasing

clotting

blood

leading

thromboembolism

(formation

blood

clot inside

blood

vessel),

peptic

ulceration

less frequently electrolyte disturbances

(altered

potassium,

magnesium,

chloride, sodium, or calcium levels).

report

side

effects

adverse drug reactions directly to the

National

Centre

Adverse

Drug

Reaction Monitoring by calling Tel: 03-

78835550,

visiting

website

npra.moh.gov.my

(Public Reporting Medicinal

Problems / Side Effects / AEFI / Vaccine

Safety).

Storage and disposal of Rexolone

-Storage

Keep

container

tightly

closed.

Store

below 30°C. Protect from heat and light.

Keep medicine out of reach of children.

-Disposal

Medicines should not be disposed of via

wastewater

household

waste.

your

pharmacist

dispose

medicines

longer

required.

These

measures

will

help

protect

environment.

Product description

-What it looks like

Light pink liquid with raspberry flavour.

Ingredients

-Active ingredient

Each 5ml contains

3 mg Prednisolone

Inactive ingredients

Raspberry Flavour, Carmoisine Supra,

Propylene

Glycol,

Citric

Acid

Anhydrous,

Liquid

Glucose,

Sodium

Benzoate, Sugar Syrup, Purified water.

-MAL number

MAL20013122AZ

Manufacturer and Product

Registration Holder

Pharmaceutical

Industries

Sdn.

Bhd.

Plot 61, Bayan

Lepas Industrial Park

Phase 4, 11900 Penang,

Malaysia.

Date of revision

20/09/2017

Serial Number

NPRA(R4/1)200917/00252