Spiriva

Main information

  • Trade name:
  • Spiriva Respimat Solution for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Spiriva Respimat Solution for Inhalation
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL20091850
  • Last update:
  • 28-05-2018

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

SPIRIVA

RESPIMAT

SOLUTION FOR INHALATION

Tiotropium (2.5 microgram)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What SPIRIVA RESPIMAT is used

How SPIRIVA RESPIMAT works

Before you use SPIRIVA

RESPIMAT

How to use SPIRIVA RESPIMAT

While you are using SPIRIVA

RESPIMAT

Side effects

Storage and Disposal of SPIRIVA

RESPIMAT

Product Description

Manufacturer and Product

Registration Holder

Date of revision

What SPIRIVA RESPIMAT is used

for

Spiriva Respimat helps people who have

chronic obstructive pulmonary disease

(COPD) or asthma to breathe more

easily. COPD is a long-term lung disease

that causes shortness of breath and

coughing. The term COPD is associated

with the inflammation of the mucous

membrane in the airway tubes and the

condition in which the air sacs of the

lungs are damaged and enlarged, causing

breathlessness. Asthma is a long-term

disease characterised by airway

inflammation and narrowing of the

airways. When used to treat asthma you

should use Spiriva Respimat in addition

to so-called inhaled corticosteroids and

long-acting ß2 agonists and you

experienced one or more severe

exacerbations in the previous year.

How SPIRIVA RESPIMAT works

Spiriva Respimat is a long-acting

bronchodilator that helps to open your

airways and makes it easier to get air in

and out of the lungs. Regular use of

Spiriva Respimat can also help you when

you have on-going shortness of breath

related to your disease, and will help to

minimise the effects of the disease on

your everyday life. Daily use of Spiriva

Respimat will also help to prevent any

sudden, short-term worsening of your

COPD symptoms which may last for

several days.

For correct dosing of Spiriva Respimat

please see section. How to use Spiriva

Respimat and the instructions for use

provided on the other side of the leaflet.

Before you use SPIRIVA RESPIMAT

When you must not use it

You should not use SPIRIVA REPIMAT

if you are allergic (hypersensitive) to

tiotropium, its active ingredient or

inactive ingredient listed under section

Product Description.

You should not use SPIRIVA

RESPIMAT if you are allergic

(hypersensitive) to atropine or substances

related to it, e.g. ipratropium or

oxitropium.

You should not use SPIRIVA

RESPIMAT on infants or children and

adolescents below 18 years.

Do not take SPIRIVA RESPIMAT if you

are pregnant, trying to get pregnant or

think you may be pregnant.

Do not take SPIRIVA RESPIMAT if you

are breast-feeding. Ask your doctor or

pharmacist for advice before taking any

medicine.

Before you start use it

Before you use SPIRIVA RESPIMAT,

talk to your doctor or pharmacist if you:

are suffering from seeing halos around

lights or coloured images in association

with red eyes, enlarged prostate or

bladder-neck obstruction (have difficulty

passing urine)

have any kidney problems

Taking other medicines

Please inform your doctor or pharmacist

if you are taking, or have recently taken,

any other medicines, even those not

prescribed.

Please tell your doctor or pharmacist if

you are taking/have taken similar

medicines for your lung disease, such as

ipratropium or oxitropium.

No interaction side effects have been

reported when SPIRIVA RESPIMAT

has been taken together with other

products used to treat COPD and asthma.

How to use SPIRIVA RESPIMAT

Spiriva Respimat is for inhalation use

only.

The instructions for use of the Spiriva

Respimat inhaler are provided on the

other side of this leaflet.

If you have any problems using

SPIRIVA RESPIMAT, ask your doctor,

nurse or pharmacist to show you how it

works

How much to use

The recommended dose is:

Each time you use it take TWO PUFFS.

When to use it

Always take this medicine exactly as

your doctor has told you.

Spiriva Respimat is effective for 24

hours so you will need to use Spiriva

Respimat only ONCE A DAY, if

possible at the same time of the day.

Check with your doctor or pharmacist if

you are not sure.

How long to use it

As COPD and asthma are long-term

diseases take Spiriva Respimat every day

and not only when you experience

breathing problems. Do not take more

than the recommended dose

Before you stop taking SPIRIVA

RESPIMAT, you should talk to your

doctor or your pharmacist.

If you stop taking SPIRIVA

RESPIMAT, the signs and symptoms of

COPD may worsen.

If you forget to use it

If you forget to take your daily dose, take

one as soon as you remember but do not

take two doses at the same time or on the

same day. Then take your next dose as

usual

.

2

Consumer Medication Information Leaflet (RiMUP)

If you use too much (overdose)

If you take more SPIRIVA RESPIMAT

than two puffs in one day, you should

talk to your doctor immediately. You

may be at a higher risk of experiencing a

side effect such as dry mouth or throat.

While you are using SPIRIVA

RESPIMAT

Things you must do

Take your medicine exactly as your

doctor has told you.

Tell your doctor immediately if you

become pregnant while taking this

medication

.

If you have been prescribed SPIRIVA

RESPIMAT for your asthma it should be

added on to inhaled corticosteroids and

long-acting ß2 agonists. Continue taking

the inhaled corticosteroids as prescribed

by your doctor, even if you feel better.

Things you must not do

Spiriva Respimat is indicated for the

maintenance treatment of your chronic

obstructive pulmonary disease or asthma.

Do not use this medicine to treat a

sudden attack of breathlessness or

wheezing.

Do not take any new medicines without

consulting your doctor or pharmacist.

Do not take SPIRIVA RESPIMAT more

frequently than once daily.

The Spiriva Respimat

inhaler must not

be disassembled after inserting the

cartridge and replacing the clear base.

Do not touch the piercing element inside

the base.

Things to be careful of

When taking SPIRIVA RESPIMAT, take

care not to let any of the powder enter

your eyes. This may result in eye pain or

discomfort, blurred vision, seeing halos

around lights or coloured images in

association with red eyes (i.e. narrow

angle glaucoma), you should wash your

eyes in warm water immediately. Then

talk to your doctor immediately for

further information.

If you feel that your breathing has got

worse or if you experience rash, swelling

or itching directly after using your

inhaler, stop using it and tell your doctor

immediately.

Dry mouth which has been observed

with anticholinergic treatment may in the

long term be associated with dental

caries. Therefore, please remember to

pay attention to oral hygiene.

This medicine may affect your ability to

drive or use machines. If you feel sick,

dizziness, blurred vision, or headache, do

not drive or use machines and contact

your doctor immediately.

Side effects

Like all medicines, SPIRIVA

RESPIMAT can cause side effects,

although not everybody gets them.

The side effects described below have

been experienced by people taking this

medicine.

Metabolism and nutrition disorders:

dehydration

Nervous system disorders:

dizziness

difficulty in sleeping

Eye disorders:

seeing halos around lights or coloured

images in association with red eyes

pressure within the eye increased

vision blurred

Cardiac disorders:

irregular heart beat

feeling your heartbeat

faster heart beat

Respiratory, thoracic and mediastinal

disorders:

cough

nosebleed

inflammation of the throat

speech disturbance resulting in a hoarse

voice

associated with coughing, wheezing or

breathlessness immediately after

inhalation (bronchospasm)

inflammation of the larynx/voice box

inflammation of the sinuses

Gastro-intestinal disorders:

dry mouth, usually mild

constipation

fungal infections of the oral cavity and

throat (oropharyngeal candidiasis)

difficulties swallowing

heart burn (gastrooesophageal reflux

disease)

inflammation of the gums

inflammation of the tongue

inflammation of the mouth

blockage of intestines or absence of

bowel movements

Skin and subcutaneous tissue disorders,

Immune system disorders:

rash

itching

swelling of the face or throat

(angioedema)

nettle rash

skin infection and skin ulcer

dry skin

hypersensitivity (including immediate

reactions)

Musculoskeletal and connective tissue

disorders:

joint swelling

Renal and urinary disorders:

urinary retention (usually in men with

predisposing factors)

painful urination (dysuria)

urinary tract infection

If any of the side effects gets serious or

,

if you notice any side effects not listed in

this leaflet, please tell your doctor or

pharmacist.

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

SPIRIVA

RESPIMAT

Storage

Keep out of the reach and sight of

children.

Do not store above 30

Do not freeze.

Spiriva Respimat inhaler should be

discarded at the latest 3 months after first

use.

Disposal

Do not use SPIRIVA RESPIMAT after

the expiry date which is stated on the

3

Consumer Medication Information Leaflet (RiMUP)

carton and the blister foil. The expiry

date refers to the last day of that month.

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

SPIRIVA RESPIMAT 2.5 microgram is

composed of one 4.5ml cartridge with

inhalation solution and one Respimat

inhaler. The cartridge has to be inserted

into the inhaler before the first use.

Single pack: 1 Respimat inhaler and 1

cartrige, providing 60 puffs (30

medicinal doses)

Ingredients

- Active ingredient:

tiotropium bromide .

The delivered dose is 2.5 microgram

tiotropium per puff (2 puffs comprise

one medicinal dose) and is equivalent to

3.124 microgram tiotropium bromide

monohydrate. The delivered dose is the

dose which is available for you after

passing the mouthpiece.

-Inactive ingredients:

Benzalkonium chloride

disodium edetate

purified water

hydrochloric acid 3.6% for pH

adjustment.

MAL number

MAL20091850AZ

Manufacturer

Boehringer Ingelheim Pharma GmbH &

Co. KG

Ingelheim am Rhein

Germany

Boehringer Ingelheim International

GmbH

Ingelheim am Rhein

Product Registration Holder

Boehringer Ingelheim (Malaysia) Sdn.

Bhd.

Suite 15-5 Level 15, Wisma UOA

Damansara II

No. 6 Jalan Changkat Semantan

Damansara Heights

50490 Kuala Lumpur

Malaysia

Date of revision

02/10/2017

Serial Number

NPRA(R4/1)210917/00255

4

Consumer Medication Information Leaflet (RiMUP)

INSTRUCTIONS FOR USE

Spiriva Respimat, Inhalation for

Solution

Remember to carefully follow your

doctor’s instructions for using SPIRIVA

RESPIMAT.

How to care for your SPIRIVA

RESPIMAT

Clean the mouthpiece including the

metal

part

inside

mouthpiece

with a damp cloth or tissue only, at

least once a week.

minor

discoloration

mouthpiece

does

affect

your

SPIRIVA

RESPIMAT

inhaler

performance.

When to get a new SPIRIVA

RESPIMAT

Your SPIRIVA

RESPIMAT

inhaler contains 60 puffs (30

doses) if used as indicated

(two puffs/Once daily).

dose

indicator

shows

approximately

much

medication is left.

When

dose

indicator

enters

area

scale you need to get a new

prescription;

there

approximately

medication

for 7 days left (14 puffs).

Once

dose

indicator

reaches the end of the red

scale,

your

SPIRIVA

RESPIMAT

locks

automatically

more

doses

released.

this

point,

clear

base

cannot be turned any further.

Three months after first use,

SPIRIVA

RESPIMAT

should be discarded even if

it has not been used.

Prepare for first use

1. Remove clear base

Keep the cap closed.

Press the safety catch while firmly

pulling off the clear base with your

other hand.

2. Insert cartridge

Insert

narrow

cartridge into the inhaler.

Place the inhaler on a firm surface

and push down firmly until it snaps

into place.

The cartridge will not be hidden

within the inhaler, you will still see

the silver ring of the lower end of the

cartridge.

Do not remove the cartridge once it

has been inserted into the inhaler.

3. Replace clear base

Do not remove the clear base again.

4. Turn

Keep the cap closed.

Turn the clear base in the direction of

the arrows on the label until it clicks

(half a turn).

5

. Open

Open the cap until it snaps fully open.

6. Press

Point the inhaler toward the ground

Press the dose-release button.

Close the cap.

Repeat steps 4-6 until a cloud is

visible.

After a cloud is visible

, repeat steps

6 three more times.

If Spiriva Respimat inhaler has not

been used for more than 7 days

release one puff towards the ground.

If Spiriva Respimat inhaler has not

been used for more than 21 days

repeat steps 4 to 6.

5

Consumer Medication Information Leaflet (RiMUP)

Daily use

TURN

Keep the cap closed

TURN

the clear base in the direction

of the arrows on the label until it

clicks (half a turn).

OPEN

OPEN

the cap until it snaps fully

open.

PRESS

Breathe out slowly and fully.

Close

your

lips

around

mouthpiece

without

covering

air vents.

While taking a slow, deep breath

through

your

mouth,

PRESS

dose-release button and continue to

breathe in.

Hold your breath for 10 seconds or

for as long as comfortable.

Repeat Turn, Open, Press for a total

of 2 puffs.