2.5 micrograms per puff inhalation liquid, solution
olodaterol
What Striverdi Respimat is and what it is used for
Striverdi Respimat helps people with chronic obstructive pulmonary disease (COPD) breathe easier. COPD is a long-term lung disease that causes shortness of breath and coughing. The diagnosis of COPD is also associated with long-term bronchial catarrh ( chronic bronchitis ) and enlarged lung sacs ( emphysema ). Because COPD is a long-term disease, you should use Striverdi Respimat every day, not just 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 agonists) that helps open your airways and makes it easier to get air in and out of the lungs. Regular use of Striverdi Respimat can also help when you experience a period of shortness of breath due to your illness, and help you reduce the impact of the illness on your daily life.
What you need to know before you use Striverdi Respimat
Do not use 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 using Striverdi Respimat if:
– you have asthma (you should not use Striverdi Respimat for the treatment of asthma ).
– you have heart problems.
– you have high blood pressure.
– you have epilepsy.
– you have a specific problem with the thyroid gland called thyrotoxicosis.
– you have abnormal enlargement of an artery called an aneurysm.
– you have diabetes.
– you have severely impaired liver function as Striverdi Respimat has not been studied in this patient group.
– you have severely impaired kidney function as there is limited experience with the use of Striverdi Respimat for this patient group.
– in the event of a planned operation.
During treatment with Striverdi Respimat
– Stop using the medicine and contact your doctor immediately if you feel chest pressure, cough, wheezing, or shortness of breath immediately after using the medicine. This may be a sign of a condition called bronchospasm (see section 4).
– If breathing worsens or you experience a skin rash, swelling, or itching immediately after inhalation, stop using Striverdi Respimat and contact a doctor immediately (see section 4).
– If you experience any side effects affecting the heart (increased heart rate, increased blood pressure, and/or increase in symptoms such as chest pain), contact your doctor immediately (see section 4).
– If you experience muscle twitching, muscle weakness, or abnormal heart rhythm, consult your doctor as these symptoms may be related to low potassium levels in the blood (see section 4).
Striverdi Respimat should be used for the maintenance treatment of chronic obstructive pulmonary disease. It should not be used to treat sudden attacks of shortness of breath or wheezing.
Do not use Striverdi Respimat together with certain medicines that contain long-acting beta-agonists , such as salmeterol or formoterol.
If you regularly take medicines called short-acting beta-agonists , such as salbutamol, continue taking them only to relieve acute symptoms such as shortness of breath.
Children and young people
Striverdi Respimat should not be given to children or adolescents (under 18 years of age).
Other medicines and Striverdi Respimat
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
In particular, you should tell your doctor if you use:
– Certain medicines for breathing problems are similar to Striverdi Respimat (long-acting beta-agonists ). It may increase your risk of side effects.
– Medicines called beta-blockers are used for high blood pressure or heart problems (such as propranolol), or the eye disease glaucoma (such as timolol ). This may result in a reduced effect of Striverdi Respimat.
– Medicines that lower the potassium level in the blood. These include:
- steroids (eg prednisolone ),
- diuretics (water tablets),
- medicines for breathing problems such as theophylline. If you use these medicines together with Striverdi Respimat, you may experience symptoms such as muscle twitching, muscle weakness, or abnormal heart rhythm.
– Medicines called tricyclic antidepressants or MAO inhibitors (such as selegiline or moclobemide), are used to treat neurological or psychiatric disorders such as Parkinson’s disease or depression; the use of these medicines will increase the likelihood that you will have side effects that affect your heart.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
No studies have been carried out regarding the effect on the ability to drive vehicles and use machines. If you feel dizzy while taking Striverdi Respimat, avoid driving or using any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Striverdi Respimat contains excipients
Striverdi Respimat contains benzalkonium chloride
This medicine contains 0.0011 mg benzalkonium chloride per puff. Benzalkonium chloride can cause wheezing and difficulty breathing (bronchial spasm), especially if you have asthma.
How to use Striverdi Respimat
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Striverdi Respimat is intended for inhalation only.
Dosage
The recommended dose is:
Striverdi Respimat is effective for 24 hours and therefore only needs to be used ONCE PER DAY, if possible at the same time. For each use, take TWO PUFFS.
As COPD is a long-term disease, Striverdi Respimat should be used every day and not only for breathing problems. Do not use more than the recommended dose.
Use for children and adolescents
There is no relevant use of Striverdi Respimat in children under 18 years of age.
Make sure you know how to use the Striverdi Respimat inhaler correctly. The instructions for use for Striverdi Respimat can be found further down in this leaflet.
If you have used too much Striverdi Respimat
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
You may be at higher risk of side effects such as chest pain, high or low blood pressure, fast or irregular heartbeat or the sensation of palpitations, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremors, dry mouth, muscle cramps, nausea, tiredness, feeling unwell, low levels of potassium (which can cause symptoms such as muscle twitching, muscle weakness or abnormal heart rhythm) high blood sugar, or too much acid in the blood (which can cause symptoms such as nausea, vomiting, weakness, muscle cramps, and faster breathing).
If you forget to use Striverdi Respimat
If you forget to inhale a dose, inhale a dose at the usual time the next day. Do not take a double dose to make up for a missed dose.
If you stop using Striverdi Respimat
Before you stop using Striverdi Respimat, talk to your doctor or pharmacist. If you stop using Striverdi Respimat, the symptoms of COPD may worsen.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects described below have been reported by people using the medicine and are listed by frequency as either uncommon or rare.
Uncommon (may affect up to 1 in 100 users)
- Nasopharyngitis (runny nose)
- Dizziness
- Rash
Rare (may affect up to 1 in 1,000 users)
- Arthralgia (joint pain)
- Hypertension (high blood pressure )
You may also experience side effects known from the treatment of breathing problems with medicines similar to Striverdi Respimat (beta- agonists ). These can be fast or irregular heartbeats or the feeling of heart palpitations, chest pain, high or low blood pressure, tremors, headache, nervousness, difficulty sleeping, dizziness, dry mouth, nausea, muscle cramps, tiredness, feeling unwell, low levels of potassium (which can cause symptoms such as muscle twitching, muscle weakness or abnormal heart rhythm) high blood sugar, or too much acid in the blood (which can cause symptoms such as nausea, vomiting, weakness, muscle cramps and faster breathing).
Immediate hypersensitivity reactions such as skin rash, hives ( urticaria ), swelling of the mouth and face or sudden difficulty in breathing ( angioneurotic edema) or other hypersensitivity reaction may occur after administration of Striverdi Respimat. If this occurs, stop using Striverdi Respimat and contact your doctor immediately.
In addition, as with other inhaled medicines, some patients may experience unexpected chest pressure, coughing, wheezing, or shortness of breath immediately after inhalation ( bronchospasm ).
How to store Striverdi Respimat
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and label of the inhaler after EXP. The expiration date is the last day of the specified month.
Do not freeze.
Sustainability:
Replace the medication container no later than three months after insertion.
Do not use the same Respimat reusable inhaler for more than one year.
Recommended use: up to 6 containers per inhaler.
Note: Respimat reusable inhaler has been tested with 540 puffs (corresponding to 9 containers) with maintained function.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is olodaterol. The delivered dose is 2.5 micrograms of olodaterol (as hydrochloride) per puff.
The delivered dose is the dose available to the patient after passing through the nozzle.
Other ingredients are:
Benzalkonium chloride, disodium edetate, purified water, and citric acid (anhydrous)
Appearance and package sizes of the medicine
Striverdi Respimat 2.5 micrograms per puff consist of a medicinal container with inhalation solution and a Respimat inhaler. The container must be inserted into the inhaler before first use.
1-pack: 1 Respimat reusable inhaler and 1 medication container, containing 60 puffs (30 medication doses)
3-pack: 1 Respimat reusable inhaler and 3 medication containers, each containing 60 puffs (30 medication doses)
1-pack refill: 1 medication container containing 60 puffs (30 medication doses)
3-pack refill: 3 medication containers containing 60 puffs (30 medication doses) each
Not all pack sizes may be marketed.
Holder of approval for sale and manufacture
The marketing authorization holder for Striverdi Respimat is:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Manufacturers of Striverdi Respimat are:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France
Information provided by
Boehringer Ingelheim AB, Box 92008, 120 06 Stockholm. Phone: 08 – 721 21 00
Email: info.sto@boehringer-ingelheim.com
This medicine is approved in the European Economic Area under the names:
Austria, Liechtenstein: Striverdi Respimat 2.5 Micrograms – Lösung zur Inhalation
Belgium, Luxembourg: Striverdi Respimat 2.5 microgrammes, solution à inhaler
Bulgaria : Стриверди Респимат 2,5 микрограма хород за инхалация
Cyprus, Greece: Striverdi Respimat
Czech Republic: Striverdi Respimat
Denmark: Striverdi Respimat
Estonia: Striverdi Respimat
Finland: Striverdi Respimat 2.5 micron per suihke, inhalationeste, limos
France: Striverdi Respimat 2.5 microgrammes/dose, solution à inhaler
Germany: Striverdi Respimat 2.5 Microgram/Hub Lösung zur Inhalation
Hungary: Striverdi Respimat 2.5 micrograms inhalációs oldat
Iceland: Striverdi Respimat
Ireland, Malta,
United Kingdom: Striverdi Respimat
Italy: Striverdi Respimat 2.5 micrograms, soluzione per inalazione
Latvia: Striverdi Respimat 2.5 micrograms inhalācijas shĂdums
Lithuania: Striverdi Respimat 2.5 micrograms/išpurškime įkvepiamasis tirpalas
Netherlands: Striverdi Respimat 2.5 microgram, inhalation solution
Norway: Striverdi Respimat
Poland: Striverdi Respimat
Portugal: Striverdi Respimat
Romania: Striverdi Respimat 2.5 micrograms sõlu de inhalant
Slovakia: Striverdi Respimat
Slovenia: Striverdi Respimat 2.5 microgram razpotina za inhaliranje
Spain: Striverdi Respimat 2.5 microgramos solución para inhalación