Skip to Content

YANIMO RESPIMAT 2.5 MICROGRAM / 2.5 MICROGRAM INHALATION SOLUTION

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Pacckage leaflet: Informatiion for the user
u
Yanim
mo Respimaat 2.5 microggram/2.5 miicrogram, in
nhalation so
olution
tiotrropium/olodaaterol

This m
medicine is subject
s
to addditional mon
nitoring. Thiss will allow quick
q
identiffication of neew safety
informattion. You can
n help by repporting any side
s effects you
y may get. See the end of section 4 for how
to reportt side effectss.
Read alll of this leafflet carefullyy before you
u start taking this mediccine becausee it contains
im
mportant infformation foor you.
K
Keep this leafflet. You mayy need to reaad it again.
Iff you have anny further quuestions, ask your doctor or pharmacisst.
Thhis medicinee has been prrescribed for you only. Do
D not pass it on to otherss. It may harm
m them,
evven if their siigns of illnesss are the sam
me as yours.
Iff you get anyy side effects,, talk to yourr doctor or phharmacist. This includes any possiblee side
efffects not listted in this leaaflet. See secction 4.

What iss in this leafllet
1. What Yanimo Resspimat is andd what it is used
u
for
2. What you need to know beforee you take Yanimo
Y
Respiimat
3. How tto take Yanim
mo Respimaat
4. Possibble side effeccts
5. How tto store Yaniimo Respimaat
6. Conteents of the paack and otherr informationn

1.

W
What Yanimo Respimat is and whatt it is used foor

Y
Resp
pimat is
What Yanimo
Yanimo Respimat coontains two active
a
substaances called ttiotropium annd olodaterol. These beloong to a
group off medicines called
c
long-aacting bronchhodilators. Tiotropium beelongs to thee subgroup off
anticholinergics; oloodaterol belonngs to the su
ubgroup of loong acting beeta2 agonistss.
What Yanimo
Y
Resp
pimat is used
d for
h
chronic obstructive pulmonary
p
d
disease
(COP
PD) to
Yanimo Respimat heelps adult paatients who have
breathe m
more easily. COPD is a long-term
l
lunng disease thhat causes shhortness of brreath and couughing.
The term
m COPD is associated
a
wiith the condittions chronicc bronchitis and
a emphyseema.
Yanimo Respimat heelps to open your airways and make it
i easier to geet air in and out of the lunngs.
Regular use of Yanim
mo Respimaat can also heelp you whenn you have onn-going shorrtness of breaath
related tto your diseaase, and will help
h to minim
mise the effeects of the disease on youur everyday life.
l
As COP
PD is a long-tterm disease you should take Yanimoo Respimat every
e
day and
d not only when you
have breeathing probllems or otherr 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)
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.
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.
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.
If any of the following occurs, please stop using this medicine and consult your doctor immediately.

 Immediate allergic reactions to Spiolto Respimat are rare (they may affect up to 1 in 1,000
people). These reactions may occur individually or as part of a severe allergic reaction
(anaphylactic reaction) after administration of Spiolto Respimat. These include rash, nettle
rash (urticaria), swelling of the mouth and face, sudden difficulties in breathing
(angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your
blood pressure or light headedness).
 As with all inhaled medications, tightness of the chest, associated with coughing, wheezing or
breathlessness may occur immediately after inhalation (paradoxical bronchospasm).
 seeing halos around lights or coloured images in association with red eyes (glaucoma). The
frequency cannot be estimated from the available data.
 blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus
paralytic). The frequency cannot be estimated from the available data.
Other possible side effects:
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
high blood pressure (hypertension)
irregular heart beat (atrial fibrillation)
faster heart beat (tachycardia)
feeling your heartbeat (palpitations)
cough
hoarseness (dysphonia)
constipation

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

nasopharyngitis
blurred vision
rapid heartbeat (supraventricular tachycardia)
inflammation of the larynx (laryngitis)
sore throat (pharyngitis)
nosebleed (epistaxis)
fungal infections of the mouth and throat (oropharyngeal candidiasis)
inflammation of the gums (gingivitis)
feeling sick (nausea)
itching (pruritus)
joint pain (arthralgia)
back pain
difficulties passing urine (urinary retention)
infections of the urinary tract
painful urination (dysuria)

Not known (frequency cannot be estimated from the available data)
- tightness of the chest, associated with coughing, wheezing or breathlessness immediately after
inhalation (bronchospasm)
- seeing halos around lights or coloured images in association with red eyes (glaucoma)
- increase of the measured eye pressure
- inflammation in sinuses (sinusitis)
- blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus
paralytic)
- heart burn (gastrooesophageal reflux disease)
- difficulties swallowing (dysphagia)
- inflammation of the tongue (glossitis)
- inflammation of the mouth (stomatitis)
- dental caries
- infections or ulcerations of the skin
- dryness of the skin
- swelling of joint
- depletion of body water (dehydration)
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).
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.

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

Yanimo Respimat 2,5 Mikrogramm/2,5 Mikrogramm – Lösung zur
Inhalation
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 mikrog/2.5 mikrog inhalaationeste, liuos
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 02/2017.

---------------------------------------------------------------------------------------------------------------------------

Instructions For Use
Introduction
Yanimo Respimat (tiotropium bromide and olodaterol). Read these Instructions for Use before you
start using Yanimo Respimat.
You will need to use this inhaler only ONCE A DAY. Each time you use it take TWO PUFFS.

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

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

When to get a new Yanimo Respimat

• Your Yanimo 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 Yanimo Respimat locks
automatically – no more doses can be released. At this point, the clear base cannot be turned any
further.
• Yanimo 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.
Prepare for first use
1. Remove clear base
 Keep the cap closed.
 Press the safety catch while firmly
pulling off the clear base with your
other hand.

2. 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.

3. Replace clear base
 Put the clear base back into place
until it clicks.

4. Turn
 Keep the cap closed.
 Turn the clear base in the direction of
the arrows on the label until it clicks
(half a turn).

5. Open
 Open the cap until it snaps fully open.

6. 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).

Daily use
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
 Breathe out slowly and fully.
 Close your lips around the mouthpiece without
covering the air vents. Point your Inhaler to the
back of your throat.
 While taking a slow, deep breath through your
mouth, PRESS the dose-release button and
continue to breathe in in slowly for as long as
comfortable.
 Hold your breath for 10 seconds or for as long
as comfortable.
 Repeat TURN, OPEN, PRESS for a total of 2
puffs.
 Close the cap until you use your inhaler again.

Answers to Common Questions
It is difficult to insert the cartridge deep enough.
Did you accidentally turn the clear base before inserting the cartridge? Open the cap, press the
dose-release button, then insert the cartridge.
Did you insert the cartridge with the wide end first? Insert the cartridge with the narrow end first.
I cannot press the dose-release button.

Did you turn the clear base? If not, turn the clear base in a continuous movement until it clicks (half
a turn).
Is the dose indicator on the Yanimo Respimat pointing to zero? The Yanimo Respimat inhaler is
locked after 60 puffs (30 medicinal doses). Prepare and use your new Yanimo Respimat inhaler.
I cannot turn the clear base.
Did you turn the clear base already?
If the clear base has already been turned, follow steps “OPEN” and “PRESS” under “Daily Use” to
get your medicine.
Is the dose indicator on the Yanimo Respimat pointing to zero? The Yanimo Respimat inhaler is
locked after 60 puffs (30 medicinal doses). Prepare and use your new Yanimo Respimat inhaler.
The dose indicator on the Yanimo Respimat reaches zero too soon.
Did you use Yanimo Respimat as indicated (two puffs/once daily)? Yanimo Respimat will last 30
days if used at two puffs once daily.
Did you turn the clear base before you inserted the cartridge? The dose indicator counts each turn
of the clear base regardless whether a cartridge has been inserted or not.
Did you spray in the air often to check whether the Yanimo Respimat is working? Once you
have prepared Yanimo Respimat, no test-spraying is required if used daily.
Did you insert the cartridge into a used Yanimo Respimat? Always insert a new cartridge into a
NEW Yanimo Respimat.
My Yanimo Respimat sprays automatically.
Was the cap open when you turned the clear base? Close the cap, then turn the clear base.
Did you press the dose-release button when turning the clear base? Close the cap, so the doserelease button is covered, then turn the clear base.
Did you stop when turning the clear base before it clicked? Turn the clear base in a continuous
movement until it clicks (half a turn).
My Yanimo Respimat doesn’t spray.
Did you insert a cartridge? If not, insert a cartridge.
Did you repeat TURN, OPEN, PRESS less than three times after inserting the cartridge? Repeat
TURN, OPEN, PRESS three times after inserting the cartridge as shown in the steps 4 to 6 under
“Prepare for first use”.
Is the dose indicator on the Yanimo Respimat pointing to 0? If the dose indicator points to 0, you
have used up all your medication and the inhaler is locked.
Once your Yanimo Respimat is assembled, do not remove the clear base or the cartridge. Always
insert a new cartridge into a NEW Yanimo Respimat.

Expand Transcript

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.

Hide