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SPIRIVA 18 MICROGRAM INHALATION POWDER HARD CAPSULES

Active substance(s): TIOTROPIUM

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CUSTOMER:

Waymade

PRODUCT:

Spiriva 10mcg powder

CODE:

6464/2223H

PRE-PRESS NO.:

02 1808

ARTWORKER:

DT

DATE OF PROOF:

28/04/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

«PAdBì

PROOF HISTORY:
v.1 - waymade - 28/04/14

Leaflet Flat Size = 296 x 600
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 4

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.

Pg 1

SPIRIVA® 18 microgram INHALATION POWDER, HARD CAPSULE
(Tiotropium bromide monohydrate)
Patient Information Leaflet
The above product is called Spiriva 18 microgram inhalation powder, hard capsule but will be referred to as
Spiriva 18 microgram throughout this leaflet.
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.
What is in this leaflet:
1. What Spiriva 18 microgram is and what it is used for
2. What you need to know before you take Spiriva 18 microgram
3. How to take Spiriva 18 microgram
4. Possible side effects
5. How to store Spiriva 18 microgram
6. Contents of the pack and other information

Blister handling

1. WHAT SPIRIVA 18 MICROGRAM 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.

Separate the blister strips by tearing along the perforation.

A

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 Spiriva 18 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 take it once a day. For correct dosing of Spiriva 18
microgram please see section 3. How to take Spiriva 18 microgram and the instructions for use provided on
the other side of the leaflet.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPIRIVA 18 MICROGRAM
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.

B

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 18 microgram
• 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?
Do not take Spiriva 18 microgram
You should not use Spiriva 18 microgram if you are allergic (hypersensitive) to tiotropium, its active
ingredient or to lactose monohydrate which contains milk protein.
You should also not use Spiriva 18 microgram if you are allergic (hypersensitive) to atropine or substances
related to it, e.g. ipratropium or oxitropium

Remove capsule.
Spiriva 18 microgram contain only a small amount of powder so
that the capsule is only partially filled.

C

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 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.
• Do not take 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
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 18 microgram 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.
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.
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.

3. HOW TO TAKE SPIRIVA 18 MICROGRAM
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 (18 micrograms of tiotropium) once a day. Do
not take more than the recommended dose.
Spiriva 18 microgram 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 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 on the
other side of 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 take 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 take 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 taking Spiriva 18 microgram
Before you stop taking Spiriva 18 microgram, you should talk to your doctor or your pharmacist. If you stop
taking 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.

Pg 2 !

CUSTOMER:

Waymade

PRODUCT:

Spiriva 10mcg powder

CODE:

6464/2223H

PRE-PRESS NO.:

02 1808

ARTWORKER:

DT

DATE OF PROOF:

28/04/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 28/04/14

«PAdBì
Leaflet Flat Size = 296 x 600
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

Pg 3

HandiHaler®
Instructions for use

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

Dear Patient,
The HandiHaler® enables you to inhale the medicine contained in the Spiriva 18 microgram capsule - that
your physician has prescribed for your breathing problems.

Evaluation of the side effects is based on the following frequencies:
Common:
Uncommon:
Rare:
Not known:

affects 1 to 10 patients in 100
affects 1 to 10 patients in 1,000
affects 1 to 10 patients in 10,000
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:






















Remember to carefully follow your doctor’s instructions for using
Spiriva 18 microgram.
The HandiHaler® is especially designed for Spiriva 18 microgram
capsule.
You must not use it to take any other medication. You can use your
HandiHaler® for up to one year to take your medication.

The HandiHaler®
*
$
"
!
#

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 heartbeat (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

Dust cap
Mouthpiece
Base
Piercing button
Centre chamber

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

1

Open the dust cap completely by pulling it upwards.
Then open the mouthpiece by pulling it upwards.

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.

2

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 18 MICROGRAM
Spiriva 18 microgram inhalation powder, hard capsule should not be stored above 25°C.
Do not use after the expiry date printed on the carton or blister label. The expiry date refers to the last day of
that month.
Do not place in the sun or on radiators. Do not freeze.
Once you have taken your first capsule from your blister strip you must continue to take the capsules for the
next 9 days, one capsule a day, from the same strip.
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.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only
keep the medicine if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of
your pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Spiriva 18 microgram contains:
Each capsule contains 18 micrograms of the active ingredient tiotropium (as the bromide monohydrate).

Remove a Spiriva 18 microgram 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.

3

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

Spiriva 18 microgram inhalation powder hard capsule also contains the following:
Lactose monohydrate, gelatin and black printing ink.

4

What Spiriva 18 microgram looks like and contents of the pack.
Spiriva 18 microgram is a light-green gelatin capsule that contains a white powder for inhalation and is
marked ‘TI 01’ on the cap with a logo on the body for use in a grey circular plastic HandiHaler® device.
Spiriva 18 microgram inhalation powder, hard capsule is available in the following packs:
A pack contains 30 capsules.
A pack containing 30 capsules and a Handihaler.
Marketing Authorisation Holder and Manufacturer
POM

UXt{ž

PL No: 6464/2223

This product is manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, D-55216 Ingelheim am
Rhein, Germany and procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR

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.

Leaflet revision and issue date (Ref.) 28.04.2014

5

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

Breathe out completely.
Important: Please avoid breathing into the mouthpiece at any time.

6

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.

7

Open the mouthpiece again. Tip out the used capsule and dispose.
Close the mouthpiece and dust cap for storage of your HandiHaler®
device.

8
Pg 3 !

Pg 4 !

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.

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