Duolin

Main information

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

Documents

Localization

  • Available in:
  • Duolin Metered Dose Inhaler
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL07082851
  • Last update:
  • 28-05-2018

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

DUOLIN METERED DOSE INHALER

Salbutamol sulphate/Ipratropium bromide (100mcg/20mcg per actuation)

Consumer Medication Information Leaflet (RiMUP)

1

What is in this leaflet

What DUOLIN INHALER is used for

How DUOLIN INHALER works

Before you use DUOLIN INHALER

How to use DUOLIN INHALER

While you are using it

Side effects

Storage

Disposal

DUOLIN

INHALER

Product Description

Manufacturer and

Product

Registration

Holder

10 Date of Revision

What DUOLIN INHALER is used for

The name of your medicine is DUOLIN

INHALER. It is used for the management

of reversible bronchospasm (narrowing of

airways

going

into

lungs)

associated

with

obstructive

airway

disease in people who requires more than

a single bronchodilator (widening of the

airways).

How DUOLIN INHALER works

DUOLIN

INHALER

contains

different medicines called:

Ipratropium bromide and

Salbutamol sulphate

Both belong to a group of medicines

called bronchodilators. They work by

relaxing the muscles around the airways

so that they open and you can breathe

more easily

Before you use DUOLIN INHALER

-When you must not use it

Do not use DUOLIN INHALER if:

allergic

(hypersensitive)

ipratropium or salbutamol or any of the

other ingredients in DUOLIN INHALER.

have

heart

problem

called

‘hypertrophic

obstructive

cardiomyopathy’. This is where the wall

between the two sides of the heart gets

bigger and blocks the blood flow.

You have a very fast heart beat (called

‘tachyarrythmia’)

You are allergic to soya lecithin or

related food products like soyabean and

peanuts.

-Before you start to use it

Check with your doctor or pharmacist

before using this medicine if:

You have glaucoma (increased pressure

inside the eye), or have been told that you

may develop it

You have heart or circulation problems,

or have had a recent heart attack

You have diabetes

You have an over-active thyroid gland

You have ever had something called

‘pheochromocytoma’. (rare tumor of the

adrenal glands)

enlarged

prostate problems

You have cystic fibrosis (progressive,

genetic disease that causes persistent lung

infections and limits the ability to breathe

over time)

If you are not sure if any of these apply to

you, talk to your doctor or pharmacist

before using DUOLIN INHALER.

Pregnancy and breastfeeding

Duolin should not be used in pregnancy,

especially the first trimester or if you are

breastfeeding unless the expected

benefits outweigh any possible risk to the

newborn. Ask your doctor for advice

before taking any medicine

-Taking other medicines

Please tell your doctor or pharmacist if

you are taking or have recently taken any

other

medicines,

including

medicines

obtained

without

prescription.

This

includes

herbal

medicines.

This

because DUOLIN INHALER can affect

some

other

medicines

work.

Also, some other medicines can affect the

DUOLIN

INHALER

works.

Tell

your

doctor

pharmacist

taking any of the following medicines:

Steroid medicines

Water tablets (also called ‘diuretics’)

Medicines

depression

(such

tricyclic antidepressants or monoamine

oxidase inhibitors)

Xanthine

derivatives

(Medicines

help your breathing)

Medicines called ‘anti- cholinergics’.

Medicines called ‘beta blockers’. These

can be used to treat heart

problems, high blood pressure or migraine

Digoxin - used for a fast heart beat or heart

failure

If you are not sure if any of the above apply

to you, talk to your doctor or pharmacist

before using DUOLIN INHALER.

Operations

Some gases used in operations (anaesthetic

gases such as halothane, trichloroethylene

enflurane)

affect

your

medicine works. If you are about to have

surgery, make sure you mention that you are

taking DUOLIN INHALER to the doctor,

dentist or anaesthetist.

How to use DUOLIN INHALER

-How much to use it

Always use DUOLIN INHALER exactly as

your doctor has told you. You should check

with your doctor or pharmacist if you are not

sure. Follow these instructions to get the best

results. If anything is unclear after reading

this leaflet, ask your doctor, pharmacist or

nurse

Adults

(including

the

elderly)

and

children over 12 years:

The recommended dose is 2 inhalations, 4

times a day.

DUOLIN INHALER is not recommended

for children under 12 years.

When to use it

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

Use your inhaler for the duration for which

your doctor has prescribed.

-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.

DUOLIN METERED DOSE INHALER

Salbutamol sulphate/Ipratropium bromide (100mcg/20mcg per actuation)

Consumer Medication Information Leaflet (RiMUP)

2

-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

need

urgent

medical

attention.

Taking

much

cause

lower

potassium

levels

your

blood,

chest

pain, high blood pressure and fast heart

beat

While you are using it

-Things you must do

recommended

dose

does

provide the desired effect, consult your

doctor.

dangerous

exceed

recommended dose. Do not use more than

your doctor has told you. Tell all the

doctors, dentists and pharmacists treating

you that you are taking Duolin Inhaler.

Tell

your

doctor

immediately

become

pregnant

while

taking

this

medication. Consult a doctor immediately

in the event of acute, rapidly worsening

breathing difficulty

-Things you must not do

Do not stop taking the medicine unless

advised by your doctor. Do not take any

new medicines without consulting your

doctor or pharmacist. Do not give Duolin

to anyone else, even if they have the same

symptoms or condition as you

-Things to be careful of

See your doctor straight away if you feel

that your medicine is not working as well

as usual. Your doctor may need to check

how well your medicine is working.

Care must be taken to prevent Duolin

from entering the eye

Side effects

Like all medicines, DUOLIN INHALER

cause

side

effects,

although

everybody gets them.

If after taking DUOLIN INHALER,

you are wheezy or have other difficulties

in breathing, do not take any more (unless

you have been told to by your doctor)

-nervousness

-tremor

-tachycardia (abnormally rapid heart rate)

- dizziness

- palpitations (pounding of heartbeat)

- headache

dryness

mouth,

throat

irritation,

dysphonia (difficulty in speaking)

-paradoxical bronchoconstrictions (rapid

onset

unexpected

narrowing

airways occurring shortly after the use of

a medicine)

-nausea, vomiting, sweating, weakness,

muscle cramps

-high or low blood pressure

-eye complications such as dilation of the

pupil, increased pressure inside the eye,

eye pain & blurred vision if it enters the

eyes

-gastrointestinal disturbance

-urinary retention

-allergic

reactions

such

skin

rash,

itching,

angioedema

(swelling

deeper layers of the skin) of the tongue,

lips,

face,

hives,

laryngospasm

(brief

spasm of the vocal cords)

-anaphylactic reactions (potentially life-

threatening allergic reactions)

-hyperactivity in children

Some of it is just mild side effects, not

necessary need to see doctor.

If any of the side effects gets troublesome

serious,

notice

side

effects not listed in this leaflet, tell your

doctor or pharmacist.

report

side

effects

adverse

drug

reactions

directly

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

DUOLIN

INHALER

-Storage

Store below 30°C. Protect from frost. Do

not use this medicine after the expiry date

which is stated on the carton and the inhaler

label. The expiry date refers to the last day

of the

month. Keep inhaler in the outer

carton to protect from light. Keep out of the

sight and reach of children.

-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

Duolin CFC free inhaler is a one piece filled

metal

container

fitted

with

valve

with

plastic stem. On visual examination. there

should be no sign of physical damage such as

dents, bulged containers bent valve stem and

uneven crimping. A white coloured powder

is obtained after opening the container.

-Ingredients

-Active ingredients: Ipratropium bromide

and Salbutamol sulphate

-Inactive ingredients: Lactose monohydrate

(micronised) and Heptafluoropropane

(HFA- propellant 227)

-MAL Number:

MAL07082851AZ

Manufacturer

Cipla Ltd.

Verna Industrial Estate,

Goa 403722 India

Product Registration Holder

Cipla Malaysia Sdn Bhd

Suite 1101, Amcorp Tower,

Amcorp Trade Centre,

18 Persiaran Barat,

46 050 Petaling Jaya, Selangor, Malaysia.

Date of revision

30/08/2017

Serial Number

NPRA(R4/1)300817/00239