Version No: 3

Date: 27.08.2013

Ref.: SPI 18		Not Approved □
Leaflet Date: 26.08.2013 [0054]		Approved □
Leaflet Name: SPIRIVA 18 MICROGRAM INH. POWDER		Date and Signed
Size: 540 x 325 mm Folded to: 90 x 82 mm
No. Colours: 1/1 Colour: Black
Paper: Offset white 50 g/m2
Fonts	ITC Officina Sans std Size. 1 0,6 pt. Diseno realizado a escaia: 100%	Front

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Spiriva®

18 microgram, inhalation powder, hard capsules

(tiotropium bromide)

Your medicine will be referred to as Spiriva Capsules 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 Capsules are and what they are used for

2. What you need to know before you take Spiriva Capsules

3. How to take Spiriva Capsules

4.    Possible side effects

5. How to store Spiriva Capsules

6. Contents of the pack and other information

1.    WHAT SPIRIVA CAPSULES ARE AND WHAT THEY ARE USED FOR

Spiriva Capsules 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 Capsules every day and not only when you have breathing problems or other symptoms of COPD.

Spiriva Capsules are a long-acting broncholidator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of Spiriva Capsules 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 Capsules 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 Capsules please see section 3 'How to take Spiriva Capsules' and the instructions for use provided on the other side of the leaflet.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPIRIVA CAPSULES

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 Capsules.

-    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 are 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 Capsules

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

You should also not use Spiriva Capsules 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 Capsules are 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 Capsules.

If this occurs, please consult your doctor immediately.

-    Inhaled medicines such as Spiriva Capsules 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 Capsules more frequently than once daily.

Children and adolescents

Spiriva Capsules are not recommended for children and adolescents under 18 years.

Other medicines and Spiriva Capsules

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 Capsules 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 Capsules contain 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 CAPSULES

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 Capsules are 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 Capsules are effective over 24 hours.

The capsules are only for inhalation and not for oral intake.

Do not swallow the capsules.

The Handihalef 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 Handihaler⁰ and that you can use it properly. The instructions for use of the Handihaler⁰ are provided on the other side of this leaflet.

Make sure that you do not blow into the Handi haler⁰.

If you have any problems using the Handihaler⁰, ask your doctor, nurse or pharmacist to show you how it works.

You should dean your Handihaled once a month. Cleaning instructions for the Handihaled are provided on the other side of this leaflet.

When taking Spiriva Capsules, 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 Capsules 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 take Spiriva Capsules

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 Capsules

Before you stop taking Spiriva Capsules, you should talk to your doctor or your pharmacist. If you stop taking Spiriva Capsules 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.

Evaluation of the side effects is based on the following frequencies:

Common:    affects    1    to    10    patients in    100

Uncommon:    affects    1    to    10    patients in    1,000

Rare:    affects    1    to    10    patients in    10,000

Not known:    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 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)

-    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 tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm). If this occurs, please consult your doctor immediately.

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

5.    HOW TO STORE SPIRIVA CAPSULES

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

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

•    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 strip.

•    Do not use this medicine after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.

•    If your capsules or Handihaler show signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Spiriva Capsules contains

Each inhalation capsule contains 18 micrograms tiotropium (as bromide monohydrate).

The capsules also contain lactose monohydrate.

What Spiriva Capsules looks like and the contents of the pack

Each light green hard capsule containing a white powder is marked Tl 01' on the cap and the Boehringer logo on the body in black printing ink, is to be used with the grey/green plastic inhaler device.

The capsules contain powder which should be breathed in using the HandiHalef device.

Spiriva Capsules are available in packs containing blister strips of 30 capsules with a HandiHalef device.

The HandiHalef is the device that must be used with Spiriva Capsules.

Who manufactured your medicine

Spiriva Capsules are manufactured by Boehringer Ingelheim Pharma GmbH & Co KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany. Procured from within the EU and repackaged by Product Licence Holder Boticalia Ltd., 27 Acton Park, The Vale, London W3 7QE.

PL 23038/0054

Date: 26.08.2013

Spiriva is a registered trademark of Boeringher Ingelheim