Spiriva 18 microgram, inhalation powder, hard capsule

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Tiotropium
Available from:
IMED Healthcare Ltd.
ATC code:
R03BB; R03BB04
INN (International Name):
Tiotropium
Dosage:
18 microgram(s)
Pharmaceutical form:
Inhalation powder, hard capsule
Therapeutic area:
Anticholinergics; tiotropium bromide
Authorization number:
PPA1463/142/001
Authorization date:
2006-11-27

Read the complete document

Package leaflet: Information for the user

Spiriva® 18 microgram, inhalation powder, hard capsule

tiotropium

Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet:

1. What SPIRIVA 18 micrograms is and what it is used for

2. What you need to know before you use SPIRIVA 18 micrograms

3. How to use SPIRIVA 18 micrograms

4. Possible side effects

5. How to store SPIRIVA 18 micrograms

6. Contents of the pack and other information

1. What Spiriva 18 micrograms is and what it is used for

SPIRIVA 18 microgram helps people who have chronic obstructive pulmonary disease (COPD) to breathe more

easily. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD is

associated with the conditions chronic bronchitis and emphysema. As COPD is a chronic disease you should take

SPIRIVA 18 microgram every day and not only when you have breathing problems or other symptoms of COPD.

SPIRIVA 18 microgram 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 18 microgram can also help you when you have on-going

shortness of breath related to your disease and will help you to minimise the effects of the disease on your

everyday life. It also helps you to be active longer. Daily use of SPIRIVA18 microgram will also help to prevent

sudden, short-term worsening of your COPD symptoms which may last for several days. The effect of this

medicine lasts for 24 hours, so you only need to use it once a day. For correct dosing of SPIRIVA 18 microgram

please see section 3. How to use SPIRIVA 18 microgram and the instructions for use provided on the other side

of the leaflet.

2. What you need to know before you use SPIRIVA 18 microgram

Do not use SPIRIVA 18 microgram

if you are allergic (hypersensitive) to tiotropium, its active ingredient, or to any other ingredients of this

medicine (listed in section 6).

if you are allergic (hypersensitive) to atropine or substances related to it, e.g. ipratropium or oxitropium.

Warnings and precautions

Talk to your doctor or pharmacist before using SPIRIVA 18 microgram

Talk to your doctor if you suffer from narrow angle glaucoma, prostate problems or have difficulty passing

urine.

If you have problems with your kidneys, please consult your doctor.

SPIRIVA 18 microgram is indicated for maintenance treatment of your chronic obstructive pulmonary

disease, it should not be used to treat a sudden attack of breathlessness or wheezing.

Immediate allergic reactions such as rash, swelling, itching, wheezing or breathlessness may occur after

administration of SPIRIVA 18 microgram. If this occurs, please consult your doctor immediately.

Inhaled medicines such as SPIRIVA 18 microgram may cause tightness of the chest, coughing, wheezing or

breathlessness immediately after inhalation. If this occurs, please consult your doctor immediately.

Take care not to let the inhalation powder enter your eye as this may result in precipitation or worsening of

narrow-angle glaucoma, which is a disease of the eyes. Eye pain or discomfort, blurred vision, seeing halos

around lights or coloured images in association with red eyes may be signs of an acute attack of narrow-angle

glaucoma. Eye symptoms may be accompanied by headache, nausea or vomiting. You should stop using

tiotropium bromide and immediately consult your doctor, preferably an eye specialist, when signs and

symptoms of narrow-angle glaucoma appear.

Dry mouth, which has been observed with anti-cholinergic treatment, may in the long term be associated with

dental caries. Therefore, please remember to pay attention to oral hygiene.

In case you have suffered from a myocardial infarction during the last 6 months or from any unstable or life

threatening irregular heart beat or severe heart failure within the past year, please, inform your doctor. This is

important to decide if Spiriva is the right medicine for you to take.

Do not use SPIRIVA 18 microgram more frequently than once daily.

Children and adolescents

Spiriva 18 microgram is not recommended for children and adolescents under 18 years.

Other medicines and Spiriva 18 microgram

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including

medicines available without prescription.

Please tell your doctor or pharmacist if you are using/have used similar medicines for your lung disease, such as

ipratropium or oxitropium.

No specific side effects have been reported when SPIRIVA 18 microgram has been used together with other

products used to treat COPD such as reliever inhalers, e.g. salbutamol, methylxanthines, e.g. theophylline and/or

oral and inhaled steroids e.g. prednisolone.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding or think you may be pregnant, or you are planning to have a baby, ask your

doctor or pharmacist for advice before taking this medicine.

You should not use this medicine unless specifically recommended by your doctor.

Driving and using machines

The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery.

Spiriva 18 microgram contains lactose monohydrate

When taken according to dosage recommendations, one capsule once a day, each dose supplies up to 5.5 mg

lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, or an

allergy to milk proteins (which may be contained in small amounts in the ingredient lactose monohydrate),

contact your doctor before taking this medicinal product.

3. How to use Spiriva 18 microgram

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

The recommended dose is to inhale the contents of 1 capsule (18 micrograms of tiotropium) once a day. Do not

use more than the recommended dose.

Spiriva 18 microgram is not recommended for children and adolescents under 18 years.

You should try to use the capsule at the same time every day. This is important because Spiriva 18 microgram is

effective over 24 hours.

The capsules are only for inhalation and not for oral intake. Do not swallow the capsules.

The HandiHaler device, which you should put the Spiriva capsule into, makes holes in the capsule and allows you

to breathe in the powder.

Make sure that you have a HandiHaler and that you can use it properly. The instructions for use of the HandiHaler

are provided on the other side of this leaflet.

Make sure that you do not blow into the HandiHaler.

If you have any problems using the HandiHaler, ask your doctor, nurse or pharmacist to show you how it works.

You should clean your HandiHaler once a month. Cleaning instructions for the HandiHaler are provided in this

leaflet.

When taking Spiriva 18 microgram, take care not to let any of the powder enter your eyes. If any powder does

get into your eyes you may get blurred vision, eye pain and/or red eyes, you should wash your eyes in warm water

immediately. Then talk to your doctor immediately for further advice.

If you feel that your breathing is worsening, you should tell your doctor as soon as possible.

If you use more Spiriva 18 microgram than you should

If you inhale from more than 1 capsule of SPIRIVA 18 microgram in a day, you should talk to your doctor

immediately. You may be at a higher risk of experiencing a side effect such as dry mouth, constipation,

difficulties passing urine, increased heart beat, or blurred vision.

If you forget to use Spiriva 18 microgram

If you forget to take a 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.

If you stop using Spiriva 18 microgram

Before you stop using SPIRIVA 18 microgram, you should talk to your doctor or your pharmacist. If you stop

using SPIRIVA 18 microgram the signs and symptoms of COPD may worsen.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects described below have been experienced by people taking this medicine and they are listed

according to frequency as either common, uncommon, rare or not known.

Common (may affect up to 1 in 10 people):

dry mouth: this is usually mild

Uncommon (may affect up to 1 in 100 people):

dizziness

headache

taste disorders

blurred vision

irregular heart beat (atrial fibrillation)

inflammation of the throat (pharyngitis)

hoarseness (dysphonia)

cough

heart burn (gastro-oesophageal reflux disease)

constipation

fungal infections of the oral cavity and throat (oropharyngeal candidiasis)

rash

difficulties passing urine (urinary retention)

painful urination (dysuria)

Rare (may affect up to 1 in 1,000 people):

difficulty in sleeping (insomnia)

seeing halos around lights or coloured images in association with red eyes (glaucoma)

increase of the measured eye pressure

irregular heart beat (supraventricular tachycardia)

faster heart beat (tachycardia)

feeling your heart beat (palpitations)

tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation

(bronchospasm)

nosebleed (epistaxis)

inflammation of the larynx (laryngitis)

inflammation of the sinuses (sinusitis)

blockage of intestines or absence of bowel movements (intestinal obstruction including ileus paralytic)

inflammation of the gums (gingivitis)

inflammation of the tongue (glossitis)

difficulties swallowing (dysphagia)

inflammation of the mouth (stomatitis)

feeling sick (nausea)

hypersensitivity, including immediate reactions

serious allergic reaction which causes swelling of the face or throat (angioedema)

nettle rash (urticaria)

itching (pruritus)

infections of the urinary tract

Not known (frequency cannot be estimated from the available data):

depletion of body water (dehydration)

dental caries

severe allergic reaction (anaphylactic reaction)

infections or ulcerations of the skin

dryness of the skin

swelling of joints

Serious side effects include allergic reactions which cause swelling of the face or throat (angioedema) or other

hypersensitivity reactions (such as sudden reduction of your blood pressure or dizziness) may occur individually

or as part of severe allergic reaction (anaphylactic reaction) after administration of Spiriva 18 microgram. In

addition, in common with all inhaled medicines, some patients may experience an unexpected tightness of the

chest, coughing, wheezing or breathlessness immediately after inhalation (bronchospasm). If any of these occur,

please consult your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in

this leaflet. You can also report side effects directly via: HPRA Pharmacovigilance, Website: www.hpra.ie.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Spiriva 18 microgram

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister foil. The expiry date

refers to the last day of that month.

Once you have taken your first capsule from the blister strip you must continue to take the capsules for the next 9

days, one capsule a day, from the same blister.

Discard the HandiHaler device 12 months after first use.

Do not store above 25°C.

Do not freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Spiriva 18 microgram

contains

The active substance is tiotropium. Each capsule contains 18 micrograms of the active ingredient tiotropium (as

bromide monohydrate). During inhalation, 10 microgram tiotropium are delivered from the mouthpiece of the

HandiHaler. The other ingredient is lactose monohydrate (which may contain small amounts of milk proteins).

What Spiriva 18 microgram looks like and contents of the pack

The capsules are light green hard capsules with the product code TI 01 and company logo printed on the capsule.

The HandiHaler device is light grey with ‘HandiHaler’ printed on the front. The HandiHaler device comprises of

a dust cap, mouthpiece, piercing button and centre chamber.

Spiriva combopack is available in packs containing 30 capsules and 1 HandiHaler device.

Spiriva refills is available in packs containing 30 capsules.

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany.

Repackaged by

Cast Healthcare Ltd, Unit E The Business Centre, 5-7 Tobermore Road, Draperstown, Magherafelt, BT45 7AG,

UK or IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest Business Park, Ballycoolin, Dublin 15,

Ireland.

Parallel Product Authorisation holder

IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest Business Park, Ballycoolin, Dublin 15, Ireland.

This medicinal product is authorised in the member States of the EEA under the following names:

Austria, Liechtenstein

Spiriva 18 Microgramm Kapseln mit Inhalationspulver

Belgium

Spiriva – 18 mcg poudre pour inhalation en gélule

Bulgaria

СПИРИВА 18 микрограма прах за инхалация, твърди капсули

Cyprus

Spiriva Κóνις για εισπνοή, σκληρό καψάκιο 18mcg

Czech Republic

Spiriva 18 μg prášek k inhalaci v tvrdých tobolkách

Denmark

Spiriva, inhalationspulver i kapsler 18 mikrogram

Estonia

SPIRIVA, Inhalatsioonipulber kõvakapslis 18mcg

Finland

SPIRIVA 18 mikrog inhalaatiojauhe, kapseli, kova

France

SPIRIVA 18 microgrammes, poudre pour inhalation en gélule

Germany

Spiriva 18 Microgramm Kapsel mit Inhalationspulver

Greece

Spiriva Κόνις για εισπνοή, σκληρό καψάκιο INHPD.CAP 18mcg/CAP

Hungary

Spiriva 18 mikrogramm inhalációs por kemény kapszulában

Iceland

Spiriva 18 míkrógrömm, innöndunarduft, hart hylki

Ireland, Malta, UK

Spiriva 18 microgram inhalation powder, hard capsule

Italy

SPIRIVA 18 microgrammi, polvere per inalazione, capsula rigida

Latvia

Spiriva 18 mikrogrami, inhalācijas pulveris cietās kapsulā

Lithuania

Spiriva 18 mikrogramų įkvepiamieji milteliai, (kietosios kapsulės)

Luxembourg

SPIRIVA GELULES 18 MCG

Netherlands

Spiriva 18 microgram, inhalatiepoeder in harde capsules

Norway

SPIRIVA inhalasjonspulver, hard kapsel 18 mikrog

Portugal

SPIRIVA, PÓ PARA INALAÇÃO, CÁPSULA DURA 0,018 mg

Romania

SPIRIVA 18 micrograme capsule cu pulbere de inhalat

Slovakia

Spiriva 18 mikrogramov, inhalačný prášok v tvrdej kapsule

Slovenia

SPIRIVA 18 mikrogramov prašek za inhaliranje, trde kapsule

Spain

SPIRIVA 18 microgramos, polvo para inhalación

Sweden

Spiriva, inhalationspulver, hård kapsel 18 mikrog

HandiHaler

®

instructions for use:

Dear Patient,

The HandiHaler enables you to inhale the medicine contained in the Spiriva capsule – that your physician has

prescribed for your breathing problems.

Remember to carefully follow your doctor’s instructions for using Spiriva.

The HandiHaler is especially designed for Spiriva. You must not use it to take any

other medicine.

You can use your HandiHaler for up to one year to take your medicine.

The HandiHaler

1. Dust cap

2. Mouthpiece

3. Base

4. Piercing button

5. Centre chamber

To release the dust cap press the piercing button completely in and let go.

Open the dust cap completely by pulling it upwards.

Then open the mouthpiece by pulling it upwards.

Remove a Spiriva

capsule from the blister (only immediately before use, see blister

handling) and place it in the centre chamber (5), as illustrated. It does not matter

which way the capsule is placed in the chamber.

Close the mouthpiece firmly until you hear a click, leaving the dust cap open.

Hold the HandiHaler device with the mouthpiece upwards and press the piercing

button completely in only once, and release. This makes holes in the capsule and

allows the medicine to be released when you breathe in.

Breathe out completely.

Important:

Please avoid breathing into the mouthpiece at any time.

Raise the HandiHaler to your mouth and close your lips tightly around the

mouthpiece. Keep your head in an upright position and breathe in slowly and deeply

but at a rate sufficient to hear or feel the capsule vibrate. Breathe in until your lungs

are full; then hold your breath as long as comfortable and at the same time take the

HandiHaler out of your mouth.

Resume normal breathing. Repeat steps 6 and 7 once, in order to empty the capsule

completely.

Open the mouthpiece again. Tip out the used capsule and dispose. Close the

mouthpiece and dust cap for storage of your HandiHaler device.

Cleaning your HandiHaler

Clean the HandiHaler once a month. Open the dust cap and mouthpiece. Then open

the base by lifting the piercing button. Rinse the complete inhaler with warm water to

remove any powder. Dry the HandiHaler thoroughly by tipping excess of water out on

a paper towel and air-dry afterwards, leaving the dust cap, mouthpiece and base open.

It takes 24 hours to air dry, so clean it right after you have used it and it will be ready

for your next dose. If needed, the outside of the mouthpiece may be cleaned with a

moist but not wet tissue.

Blister handling

Separate the blister strips by tearing along the perforation.

Peel back foil (only immediately before use) using the tab until one capsule is fully

visible.

In case a second capsule is exposed to air inadvertently this capsule has to be

discarded.

Remove capsule.

Spiriva capsules contain only a small amount of powder so that the capsule is only

partially filled.

Spiriva

and HandiHaler

are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.

This leaflet was last revised in April 2021.

Read the complete document

Health Products Regulatory Authority

09 October 2020

CRN009XJ3

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Spiriva 18 microgram, inhalation powder, hard capsule

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 22.5 microgram tiotropium bromide monohydrate equivalent to 18 microgram tiotropium.

The delivered dose (the dose that leaves the mouthpiece of the HandiHaler® device) is 10 microgram tiotropium.

Excipient with known effect:

Lactose monohydrate

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Inhalation powder, hard capsule

Product imported from Bulgaria, France, Italy, Romania, Spain and the UK:

Light green hard capsules containing the inhalation powder with the product code TI 01 and company logo printed on the

capsule.

4 CLINICAL PARTICULARS

As per PA0775/002/001

5 PHARMACOLOGICAL PROPERTIES

As per PA0775/002/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate (which may contain small amounts of milk proteins)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in

the country of origin.

After first opening of the blister use within the next 9 days.

Discard the HandiHaler device 12 months after first use.

6.4 Special precautions for storage

Do not store above 25°C.

Do not freeze.

6.5 Nature and contents of container

Health Products Regulatory Authority

09 October 2020

CRN009XJ3

Page 2 of 2

Cardboard box containing HandiHaler device and 3 blister strips (3 x 10 capsules)

Cardboard box containing 3 blister strips (3 x 10 capsules)

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

IMED Healthcare Ltd.

Unit 625 Kilshane Avenue

Northwest Business Park

Ballycoolin

Dublin 15

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1463/142/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 27

November 2006

10 DATE OF REVISION OF THE TEXT

October 2020

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