Skip to Content

SPIRIVA 18MICROGRAM INHALATION POWDER HARD CAPSULES

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
SPIRIVA® 18MICROGRAM
INHALATION POWDER, HARD
CAPSULES
(tiotropium bromide)
Read all of this leaflet carefully before you start taking
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 18microgram throughout this leaflet.
What is in this leaflet:
1. What Spiriva 18microgram is and what it is used for
2. What you need to know before you take Spiriva
18microgram
3. How to take Spiriva 18microgram
4. Possible side effects
5. How to store Spiriva 18microgram
6. Contents of the pack and other information
1. What Spiriva 18microgram is and what it is used for
Spiriva 18microgram 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 18microgram every day and not only when you
have breathing problems or other symptoms of COPD.
Spiriva 18microgram 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 18microgram
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
18microgram 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 take it once a day. For correct dosing
of Spiriva 18microgram please see section 3.’How to take
Spiriva 18microgram’ and the instructions for use provided
on the other side of the leaflet.
2. What you need to know before you take Spiriva
18microgram
Please read the following questions carefully. If you can
answer any of these questions with ‘Yes’ please discuss
this with your doctor before taking Spiriva 18microgram
-

are you allergic to tiotropium, atropine or similar drugs
such as ipratropium or oxitropium or to milk protein?
are you taking any other medicinal products containing
ipratropium or oxitropium?
are you pregnant, do you think you are pregnant, or are
you breast-feeding?
are you suffering from narrow angle glaucoma, prostate
problems or have difficulty passing urine?
do you have any kidney problems?
have you suffered from a myocardial infarction during
the last 6 months or from any unstable or lifethreatening irregular heart beat or severe heart failure
within the past year?

Do not take Spiriva 18microgram
You should not use Spiriva 18microgram if you are allergic
(hypersensitive) to tiotropium, its active ingredient or to
lactose monohydrate which contains milk protein.

You should also not use Spiriva 18microgram if you are
allergic (hypersensitive) to atropine or substances related
to it, e.g. ipratropium or oxitropium
Warnings and precautions
- 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 18microgram 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 18microgram. If this occurs,
please consult your doctor immediately.
- Inhaled medicines such as Spiriva 18microgram 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 narrowangle 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 anticholinergic 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 lifethreatening 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 take Spiriva 18microgram more frequently than
once daily.
Children and adolescents
Spiriva 18microgram is not recommended for children and
adolescents under 18 years.
Other medicines and Spiriva 18microgram
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 specific side effects have been reported when
Spiriva 18microgram has been taken 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.

3. How to take Spiriva 18microgram
Follow your doctor’s instructions about when and how to
take your medicine. If you are unsure ask your doctor or
pharmacist.
The recommended dose is to inhale the contents of
1 capsule (18micrograms of tiotropium) once a day.
Do not take more than the recommended dose.
Spiriva 18microgram is not recommended for children and
adolescents under 18 years.
You should try to take the capsule at the same time every
day. This is important because Spiriva 18microgram 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 18microgram, 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 take more Spiriva 18microgram than you should
If you inhale from more than 1 capsule of Spiriva
18microgram 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 take Spiriva 18microgram
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 taking Spiriva 18microgram
Before you stop taking Spiriva 18microgram, you should
talk to your doctor or your pharmacist. If you stop taking
Spiriva 18microgram 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

Pregnancy and breast-feeding
If you are pregnant or believe you are pregnant, or if you
are breast-feeding, consult with your doctor. You should
not use this medicine unless specifically recommended by
your doctor.

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

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

Common:
Uncommon:
Rare:
Not known:

Spiriva 18microgram contains lactose monohydrate
When taken according to dosage recommendations, one
capsule once a day, each dose supplies up to 5.5mg
lactose monohydrate.

Evaluation of the side effects is based on the following
frequencies:
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
frequency cannot be estimated from the
available data

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:
- Dry mouth: this is usually mild
Uncommon:
- 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:
- 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:
- 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 18microgram. 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, pharmacist
or nurse. 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
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Spiriva 18microgram
Do not take your capsules after the expiry date which is
stated on the box/blisters/label after ‘Exp’. The expiry date
refers to the last day of that month. After opening the blister
strip use capsules within 9 days.
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
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 your doctor tells you to stop taking this medicine, return
any unused capsules to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
If your capsules become discoloured or show any sign of
deterioration, seek the advice of your pharmacist.

6. Contents of the pack and other information
What Spiriva 18microgram contains
Each capsule contains 18micrograms tiotropium (as
bromide monohydrate).
During inhalation, 10micrograms tiotropium are delivered
from the mouthpiece of the HandiHaler®
The capsule also contains the inactive ingredient lactose
monohydrate.
What Spiriva 18microgram 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 No: 18799/1174
POM
Leaflet date: 20.05.2015
Spiriva and HandiHaler are registered trade marks of
Boehringer Ingelheim.
See overleaf for instructions on how to use HandiHaler.

HandiHaler Instructions for use

Blister handling

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

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 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.

Open the dust cap completely 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 medication 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.

Then open the mouthpiece by pulling it upwards.

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.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide