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YANIMO RESPIMAT 2.5 MICROGRAM / 2.5 MICROGRAM INHALATION SOLUTION

Active substance(s): OLODATEROL HYDROCHLORIDE / TIOTROPIUM BROMIDE MONOHYDRATE

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Package leaflet: Information for the user
Yanimo 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 Yanimo Respimat is and what it is used for
2. What you need to know before you take Yanimo Respimat
3. How to take Yanimo Respimat
4. Possible side effects
5. How to store Yanimo Respimat
6. Contents of the pack and other information

1.

What Yanimo Respimat is and what it is used for

What Yanimo Respimat is
Yanimo 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 beta 2 agonists.
What Yanimo Respimat is used for
Yanimo 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.
Yanimo Respimat helps to open your airways and make it easier to get air in and out of the lungs.
Regular use of Yanimo 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 Yanimo 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 Yanimo Respimat

Do not use Yanimo Respimat
if you are allergic to tiotropium or olodaterol or any of the other ingredients of this medicine
(listed in section 6)

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-

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 Yanimo Respimat

-

if you have asthma (you should not use Yanimo 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 treatment with Yanimo 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 Yanimo 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 Yanimo Respimat and immediately consult your
doctor for further advice.
Yanimo 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 Yanimo Respimat together with certain medicines containing long-acting ß-adrenergic
agonists, like salmeterol or formoterol.
If you regularly take certain medicines called short-acting ß-adrenergic agents, like salbutamol,
continue to use these only to relieve acute symptoms like breathlessness.

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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 Yanimo Respimat more frequently than once daily.

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

Other medicines and Yanimo 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 Yanimo Respimat (contain similar active substances, such as
anticholinergic drugs or ß-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 Yanimo Respimat

-

medicines that lower the amount of potassium in your blood. These include:
o steroids (e.g. prednisolone),
o diuretics (water tablets),
o medicines for breathing problems such as theophylline.
If you use these medicines together with Yanimo 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, 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
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 Yanimo Respimat, do not drive or use any
tools or machines.
3.

How to take Yanimo Respimat

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Yanimo Respimat is for inhalation use only.

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

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

If you take more Yanimo 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 Yanimo 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 Yanimo Respimat
Before you stop taking Yanimo Respimat, you should talk to your doctor or your pharmacist. If you
stop taking Yanimo 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.
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 Yanimo 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.

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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)

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- 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 Yanimo 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
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
email: medsafety@hpra.ie
Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
5.

How to store Yanimo 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.
Yanimo 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.

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6.

Contents of the pack and other information

What Yanimo 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 Yanimo Respimat looks like and contents of the pack
Yanimo 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 Yanimo Respimat is:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
The manufacturer for Yanimo Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria, Liechtenstein:

Yanimo Respimat 2,5 Mikrogramm/2,5 Mikrogramm – Lösung zur
Inhalation

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Belgium, Luxembourg:
Bulgaria:
Cyprus, Greece:
Croatia
Czech Republic:
Denmark:
Estonia:
France:
Germany:
Hungary:
Iceland:
Ireland, Malta, UK:
Italy:
Latvia:
Lithuania:
Netherlands:
Norway:
Poland:
Portugal:
Romania:
Slovakia:
Slovenia:
Spain:
Sweden:

Yanimo Respimat 2,5 microgrammes/2,5 microgrammes/
inhalation, solution à inhaler
Yanimo Respimat Янимо Респимат
Yanimo Respimat
Yanimo Respimat 2,5 mikrograma/ 2,5 mikrograma, otopina
inhalata
Yanimo Respimat 2,5 mikrogramů/2,5 mikrogramů
Yanimo Respimat
Yanimo Respimat
Yanimo Respimat 2,5 microgrammes/2,5 microgrammes/dose,
solution à inhaler
Yanimo Respimat 2,5 Mikrogramm/2,5 Mikrogramm pro Hub,
Lösung zur Inhalation
Yanimo Respimat 2,5 mikrogramm/2,5 mikrogramm inhalációs
oldat
Yanimo Respimat
Yanimo Respimat
Yanimo Respimat 2,5 microgrammi/2,5 microgrammi,soluzione
per inalazione
Yanimo Respimat 2,5 mikrogrami/2,5 mikrogrami šķīdums
inhalācijām
Yanimo Respimat 2,5 mikrogramo/2,5 mikrogramo/išpurškime
įkvepiamasis tirpalas
Yanimo Respimat 2,5 microgram/2,5 microgram,
inhalatieoplossing
Yanimo Respimat
Yanimo Respimat
Yanimo Respimat
Yanimo Respimat 2,5 micrograme/2,5 micrograme soluţie de
inhalat
Yanimo Respimat
Yanimo Respimat 2,5 mikrogramov/2,5 mikrogramov/vdih
raztopina za inhaliranje
Yanimo Respimat 2,5 microgramos/2,5 microgramos solución
para inhalación
Yanimo Respimat

This leaflet was last revised in 06/2015.

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Instructions for Use
Yanimo Respimat inhaler
How to use your Yanimo Respimat inhaler
This leaflet explains how to use and care for your Yanimo Respimat inhaler. Please read and
carefully follow these instructions. See also section 3. How to take Yanimo Respimat on the other
side of this leaflet.
The Yanimo Respimat inhaler releases medication slowly and gently, making it easy to inhale it into
your lungs.
The Yanimo Respimat inhaler enables you to inhale the medicine contained in a cartridge. The full
cartridge provides 60 puffs (30 medicinal doses). You will need to use this inhaler only ONCE A
DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS. There is
enough medicine for 30 days when it is used according to the directions for use. In the box you will
find the Yanimo Respimat inhaler and the Yanimo Respimat cartridge. Before the Yanimo Respimat
inhaler is used for the first time, the cartridge provided must be inserted.

Yanimo Respimat inhaler and the Yanimo Respimat cartridge

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1) Inserting the cartridge
The following steps 1-6 are necessary before first use:
1

With the light-green cap (A) closed, press the safety catch (E)
while pulling off the clear base (G).

1

2a

2 Take the cartridge (H) out of the box. Push the narrow end of the
cartridge into the inhaler until it clicks into place. The cartridge
should be pushed firmly against a firm surface to ensure that it has
gone all the way in (2b).
The cartridge will not be flush with the inhaler, you will still see
the silver ring of the lower end of the cartridge.
Do not remove the cartridge once it has been inserted into the
inhaler.

2b
3

Replace the clear base (G).
Do not remove the clear base again.

3
2) To prepare the Yanimo Respimat inhaler for first-time use

4

4

Hold the Yanimo Respimat inhaler upright, with the light-green
cap
(A) closed. Turn the base (G) in the direction of the black arrows
on the label until it clicks (half a turn).

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5

Open the light-green cap (A) until it snaps fully open.

6

Point the Yanimo Respimat inhaler towards the ground.
Press the dose release button (D). Close the light-green cap (A).

5

Repeat steps 4, 5 and 6 until a cloud is visible.
Then repeat steps 4, 5 and 6 three more times to ensure the
inhaler is prepared for use.
6
Your Yanimo Respimat inhaler is now ready to use.
These steps will not affect the number of doses available. After
preparation your Yanimo Respimat inhaler will be able to deliver
your 60 puffs (30 medicinal doses).

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Daily use of your Yanimo Respimat inhaler
You will need to use this inhaler ONLY ONCE A DAY.
Each time you use it take TWO PUFFS.
I

Hold the Yanimo Respimat inhaler upright, with the light-green
cap (A) closed, to avoid accidental release of dose. Turn the base
(G) in the direction of the black arrows on the label until it clicks
(half a turn).

II

Open the light-green cap (A) until it snaps fully open. Breathe out
slowly and fully, and then close your lips around the end of the
mouthpiece without covering the air vents (C). Point your Yanimo
Respimat inhaler to the back of your throat.

I

II

While taking in a slow, deep breath through your mouth, press the
dose release button (D) and continue to breathe in slowly for as
long as you can. Hold your breath for 10 seconds or for as long as
comfortable.

III Repeat steps I and II so that you get the full dose.
You will need to use this inhaler only ONCE A DAY.
Close the light-green cap until you use your Yanimo Respimat
inhaler again.
If Yanimo Respimat inhaler has not been used for more than 7 days
release one puff towards the ground. If Yanimo Respimat inhaler has
not been used for more than 21 days repeat steps 4 to 6 until a cloud is
visible. Then repeat steps 4 to 6 three more times.

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When to get a new Yanimo Respimat inhaler

The Yanimo Respimat inhaler contains 60 puffs (30 medicinal doses).
The dose indicator shows approximately how much medication is left.
When the pointer enters the red area of the scale, there is,
approximately, medication for 7 days left (14 puffs). This is when you
need to get a new Yanimo Respimat inhaler prescription.
Once the dose indicator has reached the end of the red scale (i.e. all 30
doses have been used), the Yanimo Respimat inhaler locks
automatically – no more doses can be released. At this point, the base
cannot be turned any further.
At the latest, three months after use the Yanimo Respimat inhaler should
be discarded even if not all medication has been used.

What if….
What if...

Reason

What to do

I can’t turn the base
easily.

a) The Yanimo Respimat inhaler is already
prepared and ready to use.

a) The Yanimo Respimat
inhaler can be used as it is.

b) The Yanimo Respimat inhaler is locked
after 60 puffs (30 medicinal doses).

b) Prepare and use your new
Yanimo Respimat inhaler.

The cap is fully
pulled of and apart
from the inhaler.

While opening the cap it was pulled too
hard.

The cap can easily be attached
again.

I can’t press the dose
release button.

The clear base has not been turned.

Turn the clear base until it
clicks. (half a turn)

The clear base
springs back after I
have turned it.

The clear base was not turned far enough.

Prepare the Yanimo Respimat
inhaler for use by turning the
clear base until it clicks.
(half a turn)

I can turn the clear
base past the point
where it clicks.

Either the dose release button has been
pressed, or the clear base has been turned
too far.

With the light-green cap
closed, turn the base until it
clicks. (half a turn)

How to care for your inhaler
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 the performance of your Yanimo Respimat
inhaler.

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If necessary, wipe the outside of your Yanimo Respimat inhaler with a damp cloth.
Further Information
The Yanimo Respimat inhaler must not be disassembled after inserting the cartridge and replacing the
clear base.
Do not touch the piercing element inside the base.

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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