Aerocort

Main information

  • Trade name:
  • Aerocort HFA Metered Dose Inhaler
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Aerocort HFA Metered Dose Inhaler
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL08010691
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

AEROCORT HFA METERED DOSE INHALER

Salbutamol Sulphate/Beclometasone Dipropionate (100mcg/50mcg)

1

What is in this leaflet

What AEROCORT HFA INHALER

is used for

How AEROCORT HFA INHALER

works

Before you use AEROCORT HFA

INHALER

AEROCORT

INHALER

While you are using it

Side effects

Storage

Disposal

of AEROCORT HFA INHALER

Product Description

Manufacturer

Product

Registration Holder

10 Date of Revision

What AEROCORT HFA INHALER

is used for

indicated

treatment

reversible airway obstruction. It is not

intended for use as first-line treatment

but for use once the need for inhaled

corticosteroid

bronchodilator

therapy has been established.

How AEROCORT HFA INHALER

works

Aerocort

Inhaler

contains

different

medicines:

salbutamol

beclometasone.

Beclometasone belongs to a group of

medicines

called

‘corticosteroids’.

works

reducing

preventing

swelling

inflammation

your

lungs.

Salbutamol

belongs

group

medicines called ‘beta2 adrenoceptor

agonists’ or ‘bronchodilators’. It works

relaxing

muscles

your

airways.

This

helps

breathe

more easily.

Before you use AEROCORT HFA

INHALER

-When you must not use it

AEROCORT

INHALER

allergic

(hypersensitive)

beclomethasone,

salbutamol

other

ingredients

listed at the end of this leaflet.

Pregnancy and breastfeeding

AEROCORT

INHALER during premature labour.

Tell your doctor or pharmacist if you

are pregnant, planning to get pregnant

or are breastfeeding. The use of this

medicine should only be considered if

the expected benefit to the mother is

greater than any possible risk to the

foetus.

your

doctor

advice

before

using any medicine.

-Before you start to use it

Tell your doctor if you have any of the

following

being,

have

ever

been,

treated

tuberculosis

(bacterial

infection that mainly affects the lung).

have

overactive

thyroid

gland

Do not stop

treatment abruptly with

your inhaler unless your doctor tells

you to.

AEROCORT HFA INHALER is not

acute

attacks.

acute

attacks, you will require a fast and

short-acting inhaler.

If you have been treated for a long time

with high doses of inhaled steroid, you

may require a course of steroid tablets

or possibly a steroid injection in times

stress.

example,

during

admission to hospital after a serious

accident, before an operation, during

an acute attack of asthma or if you have

chest

infection

other

serious

illness. Your doctor will decide if you

need any extra steroid treatment and

will also advise you as to how long you

need to take the course of steroid

tablets

should

reduce

these as you get better.

-Taking other medicines

Tell your doctor or pharmacist if you

are taking or have recently taken any

other medicines, including medicines

obtained

without

prescription.

Remember to take these medicines and

your inhalers with you if you must go

into hospital.

Tell your doctor, nurse or pharmacist if

you are taking:

Non-selective beta-blocker such

as propranolol

used

high

blood pressure

Steroid medicines

Water tablets (diuretics)

Xanthine derivatives

How

to

use

AEROCORT

HFA

INHALER

-How much to use

Adults

Two inhalations, three or four times

daily,

maximum

dose

inhalations four times a day. The usual

starting

dose

inhalations

three

times a day.

Children

One to two inhalations, two, three or

four times daily, The maximum dose is

2 inhalations four times a day. The

usual starting dose is 2 inhalations two

times a day.

Elderly

There is no need to adjust dose in

elderly if possible, to the lowest dose at

which effective control of asthma is

maintained.

-When to use it

Do not use your inhaler more often than

the doctor told you to.

It is very important that you keep to

your doctor's instructions as to how

many puffs to take and how often to use

your inhaler.

-How long to use it

Continue taking AEROCORT HFA

INHALER for as long as your doctor

recommends

-If you forget to use it

If you forget a dose, take it as soon as

you remember it

However, if it is time for the next

dose, skip the missed dose

Do not take a double dose to make up

for a forgotten dose. If you have any

further questions, ask your doctor or

pharmacist.

-If you use too much (overdose)

Contact your doctor immediately or

go to Emergency Department of your

nearest Hospital, if you think you or

anyone else may have taken too much

of this medicine. Do this even if there

signs

discomfort

poisoning.

need

urgent

medical attention. Taking too much of

this

medicine

cause

hypokalaemia (low blood potassium

level),

suppression

adrenal

function.

Consumer Medication Information Leaflet (RiMUP)

AEROCORT HFA METERED DOSE INHALER

Salbutamol Sulphate/Beclometasone Dipropionate (100mcg/50mcg)

2

While you are using it

-Things you must do

Take you

medicine exactly as

your

doctor

told

you.

Tell

doctors,

dentists

pharmacists

treating

that

taking

AEROCORT

INHALER.

Tell

your doctor immediately if you become

pregnant while taking this medication.

-Things you must not do

Do not take any new medicines without

consulting your doctor

give

AEROCORT

INHALER to anyone else, even if they

have the same symptoms or condition

as you

-Things to be careful of

Driving and using machines

-

If the relief provided by

AEROCORT HFA INHALER last for

less than 3 hours, you are advised to

inform your doctor as this may

indicate worsening of your condition.

-

It is recommended that the height of

children receiving prolonged

treatment with inhaled corticosteroid

is regularly monitored.

-

Use Aerocort Inhaler regularly for

optimum benefit. However, you

should be regularly reassessed so that

your continuing need for

corticosteroid therapy can also be

reviewed.

-

Rinse your mouth immediately with

water after using the inhaler to avoid

development of oral fungal infection

Side effects

Like all medicines, AEROCORT HFA

INHALER

cause

side

effects,

although not everybody gets them.

Tell your doctor straight away if you

notice any of the following serious side

effects – you may need urgent medical

treatment:

Allergic

reactions

signs

include skin rash, itching and nettle

rash. In severe cases, the signs include

swelling of your tongue, lips and face,

sudden difficulties in breathing and a

fall in your blood pressure that may

cause collapse. See your doctor straight

away if you have any of these side

effects.

Inhaled corticosteroids can affect the

normal production of steroid hormones

in your body, particularly if you use

high doses for a long time. The effects

include:

changes

bone

mineral

density

(thinning of the bones).

cataract (clouding of the lens in the

eye).

glaucoma (increased pressure in the

eye)

a slowing of the rate of growth of

children and adolescents.

Suppression

adrenal

gland

small gland next to the kidney).

These effects are much less likely to

happen

with

inhaled

corticosteroids

than with corticosteroid tablets.

Other side effects are

Feeling shaky

Headache

Mouth and throat irritation

Hoarseness

Increased heart rate or uneven heart

beats (palpitations)

also

unusually

levels

potassium

your

blood

(called ‘hypokalemia’).

If this happens, your doctor will keep

checking your potassium levels.

Cramps in muscles

Thrush (a fungal infection) in the

mouth.

Hyperactivity in children

side

effects

gets

troublesome or serious, or if you notice

side

effects

listed

this

leaflet, tell your doctor or pharmacist.

You may report any side effects or

adverse drug reactions directly to the

National

Centre

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

AEROCORT HFA INHALER

Storage

Store below 25

C. Avoid storage in

direct sunlight or heat. Protect from

frost. Keep out of reach of children

Do not

use this

medicine after the

expiry

date

which

stated

carton and the vial label. The expiry

date refers to the last day of the 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

protect

environment

Product description

What it looks like

Aerocort

Inhaler

white

homogeneous suspension aerosol for

inhalation,

propellant

HFA-134a,

supplied in a pressurized container. On

visual examination there should be no

sign of physical damage or leakage.

This is CFC free metered dose inhaler

preparation

Ingredients

-Active ingredient

Beclometasone

Dipropionate

Salbutamol Sulphate

-Inactive ingredients

Ethanol

anhydrous,

Oleic

acid

Tetrafluoroethane

(HFA-134A

propellant)

-MAL Number

:

MAL08010691AZ

Manufacturer

Cipla Ltd, At 344/345,

Kundaim Indl Estate,

Kundaim Goa, 403115 India

Product Registration Holder

Cipla Malaysia Sdn Bhd

Suite 1101, Amcorp Tower,

Amcorp Trade Centre,

18 Persiaran Barat,

46050 Petaling Jaya,

Selangor, Malaysia.

Consumer Medication Information Leaflet (RiMUP)

AEROCORT HFA METERED DOSE INHALER

Salbutamol Sulphate/Beclometasone Dipropionate (100mcg/50mcg)

3

Date of revision

07/08/2017

Serial Number

NPRA(R4/1)070817/00193