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PACKAGE LEAFLET: INFORMATION FOR THE USER

Striverdi® Respimat®

2.5 microgram, inhalation solution

olodaterol

^This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

1.    What Striverdi Respimat is and what it is used for

2.    What you need to know before you take Striverdi Respimat

3.    How to take Striverdi Respimat

4.    Possible side effects

5.    How to store Striverdi Respimat

6.    Contents of the pack and other information

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Striverdi® Respimat® 2.5 microgram, inhalation solution

olodaterol

1. What Striverdi Respimat is and what it is used for

Striverdi Respimat helps people who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term 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 long-term disease you should take this medicine every day and not only when you have breathing problems or other symptoms of COPD.

Striverdi Respimat contains the active substance olodaterol which is a long-acting bronchodilator (long acting beta 2 agonist) that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of this medicine can also help you when you have on-going shortness of breath related to your disease, and will help to minimise the effects of the disease on your everyday life.

2. What you need to know before you take Striverdi Respimat

Do not use Striverdi Respimat

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

Warnings and precautions

Talk to your doctor or pharmacist before using

Striverdi Respimat if you:

-    have asthma (you should not use this medicine for the treatment of asthma)

-    have diseases of the heart

-    have high blood pressure

-    have epilepsy

-    have a specific thyroid gland problem called thyrotoxicosis

-    have an abnormal widening of an artery called aneurysm

-    have diabetes

-    have severe liver problems as this medicine has not been studied in this patient population

-    have severe kidney problems as there is limited experience with this medicine in this patient population

-    are due to have a planned surgery

During treatment with Striverdi Respimat

-    Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of

a condition called bronchospasm (see section 4).

-    If your breathing has got worse or if you experience rash, swelling or itching directly after using your inhaler, stop using it and tell your doctor immediately (see section 4).

-    If you experience any side effects affecting your heart (increase in pulse rate, increase in blood pressure and/or increase in symptoms like chest pain), tell your doctor immediately (see section 4).

-    If you experience muscle spasm, muscle weakness or abnormal heart rhythm, consult your doctor as these may be related to low blood levels of potassium (see section 4).

Striverdi Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease. It should not be used to treat a sudden attack of breathlessness or wheezing.

Do not use Striverdi Respimat together with certain medicines containing long-acting B-adrenergic agonists, like salmeterol or formoterol.

If you regularly take certain medicines called shortacting B-adrenergic agents, like salbutamol, continue to use these only to relieve acute symptoms like breathlessness.

Children and adolescents

This medicine should not be given to children or

adolescents (below the age of 18 years).

Other medicines and Striverdi Respimat

Please tell your doctor or pharmacist if you are taking,

or have recently taken any other medicines.

In particular, please tell your doctor if you are using:

-    certain medicines for breathing problems that are similar to this medicine (B-adrenergic agents). You may be more likely to get side effects.

-    medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). This may result in loss of the effect of this medicine.

-    medicines that lower the amount of potassium in your blood. These include:

•    steroids (e.g. prednisolone),

•    diuretics (water tablets),

•    medicines for breathing problems such as theophylline. If you use these medicines together with this medicine you may experience symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.

-    medicines called tricyclic antidepressants or MAO inhibitors (like selegiline or moclobemide), that are used to treat neurological or psychiatric disorders like Parkinson’s disease depression; the use of these drugs will increase the likelihood that you get side effects affecting your heart.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. If you feel dizzy while taking this medicine, do not drive or use any tools or machines.

3. How to take Striverdi Respimat

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Striverdi Respimat is for inhalation use only.

Dosage

The recommended dose is:

Striverdi Respimat is effective for 24 hours so you will need to use this medicine only ONCE A DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS.

As COPD is a long-term disease take this medicine every day and not only when you experience breathing problems. Do not take more than the recommended dose.

Use in children and adolescents

There is no relevant use of this medicine in the paediatric population (under 18 years).

Make sure that you know how to use your Striverdi Respimat inhaler properly. The instructions for use of the Striverdi Respimat inhaler are provided on the other side of this leaflet.

If you take more Striverdi Respimat than you should

You may be at a higher risk of experiencing a side effect such as chest pain, high or low blood pressure, faster or irregular heartbeat or feeling of heart beat, dizziness, nervousness, difficulty in sleeping, anxiety, headache, shaking, dry mouth, muscle cramps, nausea, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

If you forget to take Striverdi Respimat

If you forget to inhale a dose, inhale just one dose at the usual time the next day.

Do not take a double dose to make up for a forgotten dose.

If you stop using Striverdi Respimat

Before you stop taking Striverdi Respimat, you should talk to your doctor or your pharmacist. If you stop taking Striverdi Respimat 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.

Stop taking this medicine and tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

-    Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of the mouth and face or sudden difficulties in breathing (angioneurotic oedema)

-    Unexpected tightness of the chest, coughing or wheezing or breathlessness immediately after inhalation (bronchospasm)

The side effects described below have been experienced by people taking this medicine and they are listed according to frequency as either uncommon or rare.

Uncommon (may affect up to 1 in 100 people):

-    Nasopharyngitis (runny nose)

-    Dizziness

-    Rash

Rare (may affect up to 1 in 1,000 people):

-    Arthralgia (joint pain)

-    Hypertension

You may also experience side effects which are known to occur with certain medicines for breathing problems similar to this medicine (beta-adrenergic agents). These may be faster or irregular heartbeat or feeling of heart beat, chest pain, high or low blood pressure, shaking, headache, nervousness, difficulty in sleeping, dizziness, dry mouth, nausea, muscle cramps, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

Malta

ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D’Argens GZR-1368 Gzira

Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Striverdi Respimat

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

Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton and on the inhaler label after EXP. The expiry date refers to the last day of the month. Striverdi Respimat inhaler should be discarded at the latest 3 months after first use.

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 Striverdi Respimat contains

The active substance is olodaterol. The delivered dose is 2.5 microgram olodaterol (as hydrochloride) per puff.

The delivered dose is the dose which is available for the patient after passing the mouthpiece.

The other ingredients are:

Benzalkonium chloride, disodium edetate, purified water, and citric acid (anhydrous)

What Striverdi Respimat looks like and contents of the pack

Striverdi Respimat 2.5 microgram is composed of one cartridge with inhalation solution and one Respimat inhaler. The cartridge has to be inserted into the inhaler before the first use.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder for Striverdi Respimat is:

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

The manufacturer for Striverdi Respimat 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:

This leaflet was last revised in 02/2016.

Introduction

Striverdi Respimat (olodaterol). Read these Instructions for Use before you start using Striverdi Respimat.

You will need to use this inhaler only ONCE A DAY. Each time you use it take TWO PUFFS.

MOUTHPIECE AIR VENT

DOSE-

RELEASE

BUTTON

SAFETY CATCH

CLEAR BASE PIERCING ELEMENT

	CAP
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CARTRIDGE

If Striverdi Respimat has not been used for more than 7 days release one puff towards the ground.

If Striverdi Respimat has not been used for more than 21 days repeat steps 4 to 6 under ‘Prepare for first Use’ until a cloud is visible. Then repeat steps 4 to 6 three more times.

Do not touch the piercing element inside the clear base.

Howto care for your Striverdi Respimat

Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only, at least once a week.

Any minor discoloration in the mouthpiece does not affect your Striverdi Respimat inhaler performance. If necessary, wipe the outside of your Striverdi Respimat inhaler with a damp cloth.

When to get a new Striverdi Respimat

DOSE

INDICATOR

EMPTY

FULL

Your Striverdi Respimat inhaler contains 60 puffs (30 doses) if used as indicated (two puffs/ once daily).

The dose indicator shows approximately how much medication is left.

When the dose indicator enters the red area of the scale you need to get a new prescription; there is approximately medication for 7 days left (14 puffs).

Once the dose indicator reaches the end of the red scale, your Striverdi Respimat locks automatically - no more doses can be released. At this point, the clear base cannot be turned any further.

Striverdi Respimat should be discarded three months after you have prepared it for first use, even if it has not been fully used or used at all.

Remove clear base

Keep the cap closed.

Press the safety catch while firmly pulling off the clear base with your other hand.

Insert cartridge

Insert the narrow end of the cartridge into the inhaler.

Place the inhaler on a firm surface and push down firmly until it clicks into place.

Replace clear base

Put the clear base backinto place

until it clicks.

Turn

Keep the cap closed.

Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).

Open

Open the cap until it snaps fully open.

Press

•    Point the inhaler toward the ground.

•    Press the dose-release button

•    Close the cap.

•    Repeat steps 4-6 until a cloud is visible.

•    After a cloud is visible, repeat steps 4-6 three more times.

Your inhaler is now ready to use. These steps will not affect the number of doses available. After preparation your inhaler will be able to deliver 60 puffs (30 doses).