Document: leaflet MAH BRAND_PL 14598-0101 change

• leaflet MAH BRAND_PL 14598-0101
• leaflet MAH BRAND_PLPI 27777-0019

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PACKAGE LEAFLET: INFORMATION FORTHE USER

Spiolto® Respimat®

2.5 microgram/2.5 microgram, inhalation solution

tiotropium/olodaterol

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 Spiolto Respimat is and what it is used for

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

3.    Howto take Spiolto Respimat

4.    Possible side effects

5.    How to store Spiolto Respimat

6.    Contents of the pack and other information

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

What Spiolto Respimat is

Spiolto Respimat contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long acting beta₂ agonists.

What Spiolto Respimat is used for

Spiolto Respimat helps adult patients 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.

Spiolto Respimat helps to open your airways and make it easier to get air in and out of the lungs. Regular use of Spiolto Respimat 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. As COPD is a long-term disease you should take Spiolto Respimat every day and not only when you have breathing problems or other symptoms of COPD.

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

Do not use Spiolto Respimat

-    if you are allergic to tiotropium or olodaterol or any of the 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 Spiolto Respimat

-if you have asthma (you should not use Spiolto Respimat for the treatment of asthma).

-if you have diseases of the heart.

-if you have high blood pressure.

-if you have epilepsy.

-if you have a specific thyroid gland problem called thyrotoxicosis.

-if you have an abnormal widening of an artery called aneurysm.

-if you have diabetes.

-if you have severe hepatic impairment.

-if you have renal impairment.

-in case of a planned surgery.

-if you have an eye problem called narrow-angle glaucoma.

-if you have prostate problems or have difficulty passing urine.

During treatmentwith Spiolto 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).

When taking Spiolto Respimat take care not to let any spray enter your eyes. This may result in eye pain or discomfort, blurred vision, seeing halos around lights or coloured images in association with red eyes (i.e. narrow angle glaucoma). Eye symptoms may be accompanied by headache, nausea or vomiting. Wash your eyes in warm water, stop using Spiolto Respimat and immediately consult your doctor for further advice.

Spiolto 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 Spiolto Respimat together with certain medicines containing long-acting p-adrenergic agonists, like salmeterol orformoterol.

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

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.

Do not take Spiolto Respimat more frequently than once daily.

Children and adolescents

Spiolto Respimat should not be given to children or adolescents (below the age of 18 years).

Other medicines and Spiolto 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:

-    any medicines that may be similar to Spiolto Respimat (contain similar active substances, such as anticholinergic drugs or p-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 Spiolto Respimat

-    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 Spiolto Respimat you may experience symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.

-    medicines called tricyclic antidepressants or monoamine oxidase (MAO) inhibitors (like selegiline or moclobemide), that are used to treat neurological or psychiatric disorders like Parkinson's disease or 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, thinkyou 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

No studies on the effects on the ability to drive and use machines have been performed. If you feel dizzy or if blurred vision occurs while taking Spiolto Respimat, do not drive or use any tools or machines.

3. How to take Spiolto Respimat

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

Spiolto Respimat is for inhalation use only.

Dosage

The recommended dose is: Spiolto Respimat is effective for 24 hours so you will need to use Spiolto Respimat 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 Spiolto Respimat 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 Spiolto Respimat in the paediatric population (under 18 years).

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

If you take more Spiolto Respimat than you should

You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, blurred vision, chest pain, high or low blood pressure, faster or irregular heartbeat or feeling of heart beat, dizziness, nervousness, difficulty in sleeping, anxiety, headache, shaking, 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 Spiolto 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 Spiolto Respimat

Before you stop taking Spiolto Respimat, you should talk to your doctor or your pharmacist. If you stop taking Spiolto Respimat the signs and symptoms of COPD may worsen.

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

4. Possible side effects

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

Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of the mouth and face or sudden difficulties in breathing (angioneurotic oedema) 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 Spiolto Respimat. If any of these occur, please stop using this medicine and consult your doctor immediately.

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

Common (may affect up to 1 in 10 people)

-    dry mouth

Uncommon (may affect up to 1 in 100 people)

-    dizziness

-    difficulty in sleeping (insomnia)

-    headache

-    hypertension

-    irregular heart beat (atrial fibrillation)

-    feeling your heartbeat (palpitations)

-    faster heart beat (tachycardia)

-    cough

-    constipation

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

-    nasopharyngitis

-    sore throat (pharyngitis)

-    inflammation of the larynx (laryngitis)

-    inflammation of the gums (gingivitis)

-    hoarseness (dysphonia)

-    nosebleed (epistaxis)

-    fungal infections of the oral cavity and throat (oropharyngeal candidiasis)

-    blurred vision

-    rapid heartbeat (supraventricular tachycardia)

-    feeling sick (nausea)

-    joint pain (arthralgia)

-    back pain

-    difficulties passing urine (urinary retention)

-    painful urination (dysuria)

-    hypersensitivity, including immediate reactions

-    serious allergic reaction which causes swelling of the mouth and face or throat (angioneurotic oedema)

-    itching (pruritus)

-    nettle rash (urticaria)

Not known (frequency cannot be estimated from the available data)

-    seeing halos around lights or coloured images in association with red eyes (glaucoma)

-    increase of the measured eye pressure

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

-    inflammation of the tongue (glossitis)

-    dental caries

-    inflammation in sinuses (sinusitis)

-    inflammation of the mouth (stomatitis)

-    difficulties swallowing (dysphagia)

-    heart burn (gastrooesophageal reflux disease)

-    blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic)

-    rash

-    severe allergic reaction (anaphylactic reaction)

-    dryness of the skin

-    infections or ulcerations of the skin

-    depletion of body water (dehydration)

-    infections of the urinary tract

-    swelling of joint

You may also experience side effects which are known to occur with certain medicines for breathing problems similar to Spiolto Respimat (beta-adrenergic agents). These may be irregular heartbeat, chest pain, low blood pressure, shaking, nervousness, 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).

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).

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

We bsi te: www. m h ra .gov. u k/y e 11 owca rd

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

Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Spiolto Respimat

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 on the inhaler label after EXP. The expiry date refers to the last day of the month.

Do not freeze.

Spiolto Respimat inhaler should be discarded at the latest 3 months after first use.

Do not throw away any medicines via wastewater or household waste. Askyour 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 Spiolto Respimat contains

The active substances are tiotropium and olodaterol. The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 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 hydrochloric acid for pH adjustment.

What Spiolto Respimat looks like and contents of the pack

Spiolto Respimat 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.

Single pack: 1 Respimat inhaler and 1 cartridge,

providing 60 puffs (30 medicinal doses) Double pack: 2 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Triple pack: 3 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) Eight pack: 8 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder for Spiolto Respimat is:

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

The manufacturer for Spiolto 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:

Spiolto Respimat 2,5 Mikrogramm/

2.5    Mikrogramm - Losungzur Inhalation

Spiolto Respimat 2,5 microgrammes/

2.5    microgrammes/inhalation, solution a inhaler

Spiolto Respimat Cnno/uo Pecm/iMaT Spiolto Respimat

Spiolto Respimat 2,5 mikrograma/

2.5    mikrograma, otopina inhalata Spiolto Respimat 2,5 mikrogramu/

2.5    mikrogramu Spiolto Respimat Spiolto Respimat

Spiolto Respimat 2,5 microgrammes/

2.5    microgrammes/dose, solution a inhaler

Spiolto Respimat 2,5 Mikrogramm/

2.5    Mikrogramm pro Hub,

Losungzur Inhalation

Spiolto Respimat 2,5 mikrogramm/

2.5    mikrogramm inhalacios oldat Spiolto Respimat

Spiolto Respimat

Spiolto Respimat 2,5 microgrammi/

2.5    microgrammi, soluzione per inalazione

Spiolto Respimat 2,5 mikrogrami/

2.5    mikrogrami skTdums inhalacijam Spiolto Respimat 2,5 mikrogramo/

2.5    mikrogramo/ispurskime jkvepiamasis tirpalas

Spiolto Respimat 2,5 microgram/

2.5    microgram, inhalatieoplossing Spiolto Respimat

Spiolto Respimat Spiolto Respimat Spiolto Respimat 2,5 micrograme/

2.5    micrograme solute de inhalat Spiolto Respimat

Spiolto Respimat 2,5 mikrogramov/

2.5    mikrogramov/vdih raztopina za inhaliranje

Spiolto Respimat 2,5 microgramos/

2.5    microgramos solucion para inhalacion

Spiolto Respimat

This leaflet was last revised in 04/2016.

Boehringer l||||l/ Ingelheim

Spiolto® Respimat®

Instructions For Use

Prepare for first use

Introduction

Spiolto Respimat (tiotropium and olodaterol). Read these Instructions for Use before you start using Spiolto Respimat.

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

CAP

PIERCING ELEMENT

CLEAR BASE

SAFETYCATCH

AIR VENT

DOSE-

RELEASE

BUTTON

MOUTHPIECE

CARTRIDGE

How to care for your Spiolto 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 Spiolto Respimat inhaler performance. If necessary, wipe the outside of your Spiolto Respimat inhaler with a damp cloth.

When to get a new Spiolto Respimat

DOSE

INDICATOR

FULL

EMPTY