Striverdi Respimat 2.5 micrograms inhalation solution – patient leaflet, side effects, dosage

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 take 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 taking Striverdi Respimat if you:

• have asthma (you should not take 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 taking 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 taking 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 take Striverdi 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 take 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 taking:

• certain medicines for breathing problems that are similar to this medicine (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 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 take 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 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.

  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.

  Striverdi 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 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 take 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.

Make sure that you know how to use your Respimat re-usable inhaler properly. The instructions on how to use the Respimat re-usable inhaler are provided at the end of this leaflet, see ‘Instructions on how to use the Respimat re-usable inhaler’.

Use in children and adolescents

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

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 taking 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 via the Yellow Card Scheme Website: 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 Striverdi 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 cartridge 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 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.

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 Striverdi Respimat is:

Boehringer Ingelheim International GmbH Binger Straße 173

55216 Ingelheim am Rhein

Germany

The manufacturer for Striverdi Respimat is:

Boehringer Ingelheim Pharma GmbH & Co. KG Binger Straße 173

55216 Ingelheim am Rhein

Germany

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Liechtenstein, Belgium, Luxembourg, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Malta, United Kingdom (Northern Ireland), Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Striverdi Respimat

Bulgaria: Стриверди Респимат

This leaflet was last revised in 07/2024.

Striverdi® Respimat® 2.5 microgram,

inhalation solution

olodaterol

abcd

Striverdi® Respimat® ^{2.5 microgram,}

inhalation solution

olodaterol

abcd

p2e:

130802

Example

MASS E: 1,0 mm

MASS G: 0,65 mm

• 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

use’ until a cloud is visible. Then repeat steps 4 to 6 three more times.

How to care for your Respimat re-usable 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 your Respimat re-usable inhaler

performance.

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

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).

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

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

One cartridge delivers multiple doses. The Respimat re-usable inhaler allows for the replacement

of the cartridge, and can be used with up to 6 cartridges.

Read these instructions 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.

My Striverdi Respimat doesn’t spray.

Did you insert a cartridge? If not, insert

a cartridge. Once your Striverdi RESPIMAT 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.

My Striverdi 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

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). The dose counter will count each

incomplete turn and the number of remaining

doses is reduced.

Was the cap open when you replaced the

cartridge? Close the cap, then replace the

cartridge.

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.

Are you replacing the cartridge? The new

cartridge will stick out more than the very first

cartridge. Insert it until it clicks, then replace

the clear base.

I cannot press the dose-release button.

Did you put the clear base back? If not, put the

clear base back to unlock the inhaler. The

Respimat re-usable inhaler only functions with

the clear base in place.

Did you turn the clear base? If not, turn the

clear base in a continuous movement until it

clicks (half a turn).

Does the dose indicator on your cartridge

display a white arrow on a red background?

Your cartridge is used up. Insert a new cartridge

and put the clear base back.

It is difficult to remove the cartridge after

it is used up.

Pull and turn the cartridge at the same time.

I cannot turn or put the clear base back.

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 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.

My Striverdi Respimat has been used up

too early.

Did you use Striverdi Respimat as indicated

(two puffs/once daily)? Each cartridge will last

30 days if used at two puffs once daily.

Did you spray in the air often to check whether

Striverdi Respimat is working? Once you have

prepared Striverdi Respimat for use, no test-

spraying is required if used daily.

Did you take off and put the clear base multiple

times back? Do not remove the clear base

before the cartridge is used up. Each time

you take off the clear base without cartridge

exchange, the dose counter records one puff

and the remaining doses are reduced.