Spiriva 18microgram inhalation powder capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Tiotropium bromide
Available from:
CST Pharma Ltd
ATC code:
R03BB04
INN (International Name):
Tiotropium bromide
Dosage:
18microgram
Pharmaceutical form:
Inhalation powder
Administration route:
Inhalation
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 03010200; GTIN: 5055946802350

Package leaflet: Information for the user

Spiriva

®

18microgram inhalation

powder, hard capsules

(tiotropium bromide)

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.

The name of your medicine is Spiriva 18microgram

inhalation powder, hard capsules but will be referred to as

Spiriva throughout this leaflet.

What is in this leaflet:

What Spiriva is and what it is used for

What you need to know before you use Spiriva

How to use Spiriva

Possible side effects

How to store Spiriva

Contents of the pack and other information

1.

What Spiriva is and what it is used for

Spiriva 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 every day and

not only when you have breathing problems or other

symptoms of COPD.

Spiriva 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 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 Spiriva 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 please see

section 3.How to use Spiriva and the instructions for use

provided on the other side of the leaflet.

2.

What you need to know before you use Spiriva

Do not use Spiriva

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

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 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. If this occurs, please consult

your doctor immediately.

Inhaled medicines such as Spiriva 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 more frequently than once daily.

Children and adolescents

Spiriva is not recommended for children and adolescents

under 18 years.

Other medicines and Spiriva

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

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 contains lactose monohydrate

When taken according to dosage recommendations, one

capsule once a day, each dose supplies up to 5.5mg

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

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 (18micrograms of tiotropium) once a day. Do not

use more than the recommended dose.

Spiriva 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 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 on the other

side of this leaflet.

When taking Spiriva, 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 than you should

If you inhale from more than 1 capsule of Spiriva 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

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

Before you stop using Spiriva, you should talk to your

doctor or your pharmacist. If you stop using Spiriva 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)

Sore throat (pharyngitis)

Hoarseness (dysphonia)

Cough

Heart burn (gastrooesophageal reflux disease)

Constipation

Fungal infections of the oral cavity and throat

(oropharyngeal candidiasis)

Rash

Difficulty 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)

Allergic reactions (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)

Tooth decay (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. 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 the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow

Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more

information on the safety of this medicine.

5.

How to store Spiriva

Keep out of the sight and reach of children.

Do not store above 25° C. Do not freeze.

Do not use the capsules after the expiry date which is

stated on the carton and blister labels after ‘Exp’. The

expiry date refers to the last day of that month. After

opening the blister strip use capsules within 9 days.

Once you have taken your first capsule of Spiriva from the

blister strip you must continue to take the capsules for the

next 9 days, one capsule a day, from the same strip.

If the capsules become discoloured or show any signs of

deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop using this

medicine, return any unused medicine to your pharmacist

for safe disposal. Only keep this medicine if your doctor

tells you to.

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.

6.

Contents of the pack and other information

What Spiriva contains

Each capsule contains 18 microgram tiotropium (as

bromide monohydrate) (delivered dose: 10 microgram

tiotropium).

During inhalation, 10micrograms tiotropium are delivered

from the mouthpiece of the HandiHaler

The capsule also contains the inactive ingredient lactose

monohydrate.

What Spiriva looks like and contents of the pack

The capsules are hard light green, hard capsules printed

with the company logo on the cap and 'TI 01' on the body

in black ink. A HandiHaler device is contained in the pack.

The capsules contain powder which should be breathed in

using the HandiHaler

device.

The HandiHaler is the device that must be used with

Spiriva.

The product is available in a pack containing blister strips

of 30 capsules containing powder for inhalation and

1 HandiHaler device.

Manufactured by: Boehringer Ingelheim Pharma GmbH &

Co.KG, Ingelheim am Rhein, Germany.

Procured from within the EU and repackaged by the

Product Licence holder: B&S Healthcare, Unit 4,

Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Spiriva

®

18microgram inhalation powder, hard

capsules; PL 18799/1147

Leaflet date: 21.02.2020

Spiriva and HandiHaler are registered trademarks of

Boehringer Ingelheim Pharma GmbH & Co. KG.

See overleaf for instructions on how to use

HandiHaler.

Blind or partially sighted?

Is this leaflet hard to see or

read?

Call 0208 515 3763 to obtain

the leaflet in a format

suitable for you.

POM

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.

Blister handling

To release the dust cap press the piercing button

completely in and let go.

Close the mouthpiece firmly until you hear a click, leaving

the dust cap open.

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.

Separate the blister strips by tearing along the perforation.

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.

Open the dust cap completely by pulling it upwards.

Then open the mouthpiece by pulling it upwards.

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.

Open the mouthpiece again. Tip out the used capsule and

dispose. Close the mouthpiece and dust cap for

storage of your HandiHaler device.

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.

Cleaning your HandiHaler

The HandiHaler

Dust cap

Mouthpiece

Base

Piercing button

Centre chamber

Remove a Spiriva capsule from the blister (only

immediately before use, see blister handling) and

place it in the centre chamber (

), as illustrated. It does not

matter which way the capsule is placed in the chamber.

Breathe out completely.

Important: Please avoid breathing into the mouthpiece at any

time.

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.

Remove capsule.

Spiriva capsules contain only a small amount of powder so

that the capsule is only partially filled.

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