S10/UK/PI/2

Package leaflet: Information for the user

Srivasso 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 Srivasso 18 microgram is and what it is used for

2.    What you need to know before you useSrivasso 18 microgram

3.    How to use Srivasso 18 microgram

4.    Possible side effects

5.    How to store Srivasso 18 microgram

6.    Contents of the pack and other information

1. What Srivasso 18 microgram is and what it is used for

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

Srivasso 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 Srivasso 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 Srivasso 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 use it once a day.

2. What you need to know before you use Srivasso 18 microgram Do not use Srivasso 18 microgram

-    if you are allergic to tiotropium or any other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before using Srivasso 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.

-    Srivasso 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 Srivasso 18 microgram. If this occurs, please consult your doctor immediately.

-    Inhaled medicines such as Srivasso 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 Srivasso is the right medicine for you to take

-    Do not use Srivasso 18 microgram more frequently than once daily.

Children and adolescents

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

Other medicines and Srivasso 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 Srivasso 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, think you may be pregnant or 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.

Srivasso 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, contact your doctor before taking this medicinal product.

3. How to use Srivasso 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.

Srivasso 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 Srivasso 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 Srivasso capsule into, makes holes in the capsule and allows you to breathe in the powder.

Make sure that you have an 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 Srivasso 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 Srivasso 18 microgram than you should

If you inhale from more than 1 capsule of Srivasso 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 Srivasso 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 Srivasso 18 microgram

Before you stop taking Srivasso 18 microgram, you should talk to your doctor or your pharmacist.

If you stop taking Srivasso 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 (gastrooesophageal 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 Srivasso 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 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 Srivasso 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.

Do not store above 25°C.

Do not freeze.

Once you have taken your first capsule from the blister you must continue to take the capsules for the next 9 days, one capsule a day, from the same blister.

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 Srivasso 18 microgram contains

-    The active substance is tiotropium. Each capsule contains 18 micrograms of the active ingredient tiotropium (as bromide monohydrate). The delivered dose (the dose that leaves the mouthpiece of the HandiHaler device) is 10 microgram tiotropium.

-    The other ingredient is lactose monohydrate

What Srivasso 18 microgram looks like and contents of the pack

Srivasso 18 microgram inhalation powder, hard capsule is a light green hard capsule containing the inhalation powder, with the product code TI 01 and company logo printed on the capsule.

The product is available in the following packs:

A pack containing 30 capsules A pack containing 60 capsules A pack containing 90 capsules A pack containing 10 capsules and 1 HandiHaler A pack containing 30 capsules and 1 HandiHaler

Hospital pack: Bundle pack containing 5 cardboard boxes of 30 capsules plus HandiHaler device Hospital pack: Bundle pack containing 5 cardboard boxes of 60 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder for Srivasso 18 microgram is:

Boehringer Ingelheim International GmbH Binger StraBe 173 D-55216 Ingelheim am Rhein Germany

The manufacturer for Srivasso 18 microgram and the HandiHaler device is:

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger StraBe 173

D-55216 Ingelheim am Rhein

Germany

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

Srivasso 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation

Srivasso - 18 mcg poudre pour inhalation en gelule

CpnBaco 18 MHKporpaMa npax 3a HHxaaa^a, TBnpgn Kancyan

Srivasso Kovn; yia eicnvop, cK^ppo KayaKio 18mcg

Srivasso 18 pg prasek k inhalaci v tvrdych tobolkach

Srivasso, inhalationspulver i kapsler 18 mikrogram

Srivasso 18 mikrog inhalaatiojaue, kapseli, kova

Srivasso 18 microgrammes, poudre pour inhalation en gelule

Srivasso 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation

Srivasso Kovi^ yia eicrcvop, cK^ppo KayaKio INHPD.CAP 18mcg/CAP

Srivasso 18 mikrogramm inhalacios por kemeny kapszulaban

Srivasso 18 mikrogromm, innondunarduft, hart hylki

Srivasso 18 microgram inhalation powder, hard capsule

Srivasso 18 microgrammi, polvere per inalazione, capsula rigida

Srivasso 18 mikrogrami, inhalacijas pulveris cietas kapsula

Srivasso 18 mikrogramp jkvepiamieji milteliai (kietosios kapsules)

Srivasso GELULES 18 MCG

Srivasso 18 microgram, inhalatiepoeder in harde capsules Srivasso inhalasjonspulver, hard kapsel 18 mikrog

Srivasso, 18 pg/dawk§ inhalacyjnp, proszek do inhalacji w kapsulkach twardych

Srivasso, PO PARA INALACAO, CAPSULA DURA 0,018 mg

Srivasso 18 micrograme capsule cu pulbere de inhalat

Srivasso 18 mikrogramov, inhalacny prasok v tvrdej kapsule

Srivasso 18 mikrogramov prasek za inhaliranje, trde kapsule

Srivasso, inhalationspulver, hard kapsel 18 mikrog

This leaflet was last revised in 09/2015.

HandiHaler instructions for use:

Dear Patient,

The HandiHaler enables you to inhale the medicine contained in the Srivasso capsule - that your physician has prescribed for your breathing problems.

Remember to carefully follow your doctor’s instructions for using Srivasso. The HandiHaler is especially designed for Srivasso. 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

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

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

3. Remove a Srivasso 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.

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 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.

A. Separate the blister strips by tearing along the perforation.

B. 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.

Srivasso capsules contain only a small amount of powder so that the capsule is only partially filled. CE mark

Manufacturer of the HandiHaler device:

Boehringer Ingelheim Pharma GmbH & Co. KG

D-55216 Ingelheim am Rhein

Germany

9