Yanimo Respimat 2.5 microgram / 2.5 microgram inhalation solution – patient leaflet, side effects, dosage

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 beta₂ 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)

• 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 (liver) disease.
  • if you have renal (kidney) disease.
  • 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:

  • steroids (e.g. prednisolone),
  • diuretics (water tablets),

  • 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.

Yanimo Respimat contains Benzalkonium chloride

This medicine contains 0.0011 mg benzalkonium chloride in each actuation.

Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you have asthma.

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 Yanimo 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 Yanimo 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). The frequency cannot be estimated from the available data.
• 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:

Uncommon (may affect up to 1 in 100 people)

• faster heart beat (tachycardia)
• dizziness
• headache
• cough
• hoarseness (dysphonia)
• dry mouth

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

• irregular heart beat (atrial fibrillation)
• rapid heartbeat (supraventricular tachycardia)
• feeling your heartbeat (palpitations)
• high blood pressure (hypertension)
• difficulties passing urine (urinary retention)
• infections of the urinary tract
• painful urination (dysuria)
• sore throat (pharyngitis)
• inflammation of the larynx (laryngitis)
• inflammation of the gums (gingivitis)
• inflammation of the mouth (stomatitis)
• fungal infections of the mouth and throat (oropharyngeal candidiasis)
• nosebleed (epistaxis)
• difficulty in sleeping (insomnia)

• blurred vision

  • tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
  • constipation
  • feeling sick (nausea)
  • itching (pruritus)
  • joint pain (arthralgia)
  • swelling of joint
  • back pain

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

• increase of the measured eye pressure
• nasopharyngitis
• inflammation in sinuses (sinusitis)
• difficulties swallowing (dysphagia)
• inflammation of the tongue (glossitis)
• heart burn (gastrooesophageal reflux disease)
• dental caries
• infections or ulcerations of the skin
• dryness of the skin
• 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 via the Yellow Card Scheme at

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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.

In-use shelf-life

Exchange the cartridge latest three months after insertion. Do not use the Respimat re-usable inhaler for more than one year.

Recommended use: 6 cartridges per inhaler

Note: The functioning of the RESPIMAT re-usable inhaler has been demonstrated in tests for 540 actuations (corresponding to 9 cartridges).

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 re-usable inhaler and

1 cartridge, providing 60 puffs (30 medicinal doses)

Triple pack: 1 Respimat re-usable inhaler and

3 cartridges, providing 60 puffs (30 medicinal doses) each

Single refill pack: 1 cartridge, providing 60 puffs

(30 medicinal doses)

Triple refill pack: 3 cartridges, providing 60 puffs

(30 medicinal doses) each

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 Belgium, Luxembourg: Yanimo Respimat

2,5 microgrammes/ 2,5 microgrammes/ inhalation, solution à inhaler

Bulgaria: Yanimo Respimat

Янимо Респимат

Cyprus, Greece: Yanimo Respimat Czech Republic: Yanimo Respimat Denmark: Yanimo Respimat Finland: Yanimo Respimat

2.5 mikrog/2.5 mikrog inhalaationeste, liuos Germany: Yanimo Respimat

2,5 Mikrogramm/

2,5 Mikrogramm pro Hub Lösung zur Inhalation Hungary: Yanimo Respimat

2,5 mikrogramm/

2,5 mikrogramm inhalációs oldat

Iceland: Yanimo Respimat UK: Yanimo Respimat Italy: Yanimo Respimat

2,5 microgrammi/ 2,5 microgrammi, soluzione per inalazione Netherlands: Yanimo Respimat

2,5 microgram/

2,5 microgram, inhalatieoplossing

Norway: Yanimo Respimat

Poland: Yanimo Respimat Portugal: Yanimo Respimat Romania: Yanimo Respimat

2,5 micrograme/

2,5 micrograme soluţie de inhalat

Slovakia: Yanimo Respimat Spain: Yanimo Respimat

2,5 microgramos/

2,5 microgramos solución para inhalación Sweden: Yanimo Respimat

This leaflet was last revised in 07/2020.

Yanimo® Respimat®

2.5 microgram/2.5 microgram, inhalation solution

tiotropium/olodaterol

abcd

Yanimo® Respimat® 2.5 microgram/2.5 microgram,

inhalation solution

tiotropium/olodaterol

abcd

Example

MASS E: 1,0 mm

MASS G: 0,65 mm

Introduction

• If not been used for more than 7 days release one puff towards the ground.
• If not been used for more than 21 days repeat steps 4 to 6 under ‘Prepare for use’ until a cloud is

visible. Then repeat steps 4 to 6 three more times.

How to care for your Yanimo Respimat re-usable

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 re-usable inhaler

performance.

If necessary, wipe the outside of your Yanimo Respimat re-usable inhaler with a damp cloth.

Read these Instructions for Use before you start using Yanimo Respimat re-usable.

Respimat is an inhaler device that generates a spray for inhalation.

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

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 and will

deliver 60 puffs (30 doses).

Did you use Respimat re-usable

as indicated (two puffs/once

daily)? Respimat will last 30 days

if used at two puffs once daily.

Did you spray in the air often to

check whether the Respimat

re-usable is working? Once

you have prepared Respimat

re-usable, no test-spraying is

required if used daily.

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 dose-release 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).

Was the cap open when you

replaced the cartridge? Close

the cap, then replace the

cartridge.

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 clear base loose and

does the dose indicator on

your cartridge display

a white arrow on a red

background? Your cartridge

is used up. Insert a new

cartridge.

Did you insert a cartridge?

If not, insert a cartridge. Once

your Respimat re-usable is

assembled, do not remove the

clear base or the cartridge until

the cartridge is used up.

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 use”.

Does the dose indicator on

your cartridge display a white

arrow on a red background?

Your cartridge is used up. Insert

a new cartridge. Dose-

release

button Steps 4-6 x3

Mouthpiece

Air vents

Dose-release

button

Safety catch

Clear base

Respimat® Cartridge

Cap

Cartridge

counter

Dose

Indicator

Front Back

Boehringer Ingelheim

Pharma GmbH & Co. KG

D - 55216 Ingelheim

Germany