2.5 micrograms/2.5 micrograms per puff inhalation liquid, solution
tiotropium/olodaterol
What Spiolto Respimat is and what it is used for
What Spiolto Respimat is
Spiolto Respimat contains the two active substances tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics (smooth muscle relaxants). Olodaterol belongs to the subgroup of long-acting beta-2 agonists (agents that stimulate beta-2 receptors ).
What Spiolto Respimat is used for
Spiolto Respimat helps adult patients with chronic obstructive pulmonary disease (COPD) to 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 ).
Spiolto Respimat helps open your airways and makes it easier to get air in and out of the lungs. Regular use of Spiolto Respimat can also help when you have ongoing shortness of breath due to your illness, and help reduce the impact of the illness on your daily life. Because COPD is a long-term disease, you should take Spiolto Respimat every day, not just when you have breathing problems or other symptoms of COPD.
Tiotropium and olodaterol contained in Spiolto Respimat may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Spiolto Respimat
Do not use Spiolto 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 similar substances, e.g. ipratropium or tiotropium.
Warnings and precautions
Talk to your doctor or pharmacist before using Spiolto Respimat
- if you have asthma (you should not use Spiolto Respimat to treat asthma )
- if you have heart problems
- if you have high blood pressure
- if you have epilepsy
- if you have a specific thyroid problem called thyrotoxicosis
- if you have an abnormal enlargement of an artery, called an aneurysm
- if you have diabetes
- if you have severe liver disease
- if you have kidney disease
- in the event of a planned operation
- if you have an eye problem with narrow-angle glaucoma
- if you have problems with the prostate or have difficulty emptying the bladder
During treatment with Spiolto 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 becomes difficult or you experience a skin rash, swelling, or itching immediately after inhalation, stop using Spiolto 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 linked to low potassium levels in the blood (see section 4).
When taking Spiolto Respimat, be careful not to get the inhalation liquid in your eyes. This can cause pain or discomfort in the eyes, blurred vision, and visual phenomena associated with red eyes (ie narrow-angle glaucoma ). Symptoms from the eyes may be accompanied by headache, nausea, or vomiting. Clean the eyes with lukewarm water and stop using Spiolto Respimat and immediately contact your doctor for advice.
Spiolto 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 Spiolto 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.
Dry mouth, observed during treatment with anticholinergic drugs, can lead to cavities in the teeth during long-term treatment. Therefore, be careful with oral hygiene.
Do not use Spiolto Respimat more often than once a day.
Children and young people
Spiolto Respimat should not be given to children or adolescents (under 18 years).
Other medicines and Spiolto 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 similar to Spiolto Respimat (contain similar active substances, such as anticholinergic medicines or beta-adrenergic agents). It may increase your risk of side effects.
- medicines called beta-blockers are used for high blood pressure or other heart problems (such as propranolol), or the eye disease glaucoma (such as timolol ). This may result in a reduced effect of Spiolto Respimat.
- medicines that lower the potassium level in the blood. These include:
- cortisone (so-called steroids, for example, prednisolone ),
- diuretics (water tablets),
- and medicines for breathing problems such as theophylline.
If you use these medicines together with Spiolto 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), which are used to treat neurological or psychiatric disorders such as Parkinson’s disease or depression. Simultaneous use of these medicines increases the risk of you getting 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. You should not use this medicine unless your doctor has specifically recommended it.
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 or have blurred vision while taking Spiolto Respimat, do not drive or use 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.
Spiolto 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 take Spiolto Respimat
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Spiolto Respimat is intended for inhalation only.
Dosage
The recommended dose is:
Spiolto 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.
Because COPD is a long-term disease, Spiolto 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 for Spiolto Respimat in children (under 18 years).
Make sure you know how to use Spiolto Respimat inhaler correctly. Instructions for use for the Spiolto Respimat inhaler can be found on the back of this leaflet.
If you have taken too much Spiolto 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 dry mouth, constipation, difficulty emptying the bladder, blurred vision, chest pain, high or low blood pressure, fast or irregular heartbeats or palpitations, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremors, muscle cramps, nausea, tiredness, feeling unwell, low levels of potassium in the blood (which can cause symptoms such as muscle twitching, muscle weakness or abnormal heart rhythm), high blood sugar, or too acidic blood (which can cause symptoms such as nausea, vomiting, weakness, muscle cramps, and faster breathing ).
If you forget to take Spiolto 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 Spiolto Respimat
Before you stop using Spiolto Respimat, talk to your doctor or pharmacist. If you stop using Spiolto 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.
If any of the following occur, stop using this medicine and contact your doctor immediately.
- Immediate hypersensitivity reactions to Spiolto Respimat are rare (may affect up to 1 in 1,000 users). These reactions may occur as a single reaction or as part of a severe allergic reaction ( anaphylactic reaction ) after the administration of Spiolto Respimat. These include skin rash, hives ( urticaria ), swelling of the mouth and face, sudden difficulty in breathing ( angioneurotic edema), or other hypersensitivity reactions (such as a sudden drop in blood pressure or feeling faint).
- As with other inhaled medicines, chest tightness, coughing, wheezing or shortness of breath may occur immediately after inhalation (paradoxical bronchospasm ). Based on the data available, it is not possible to assess how common it is.
- Visual phenomena such as rings of light or colored images associated with red eyes ( glaucoma ) occur in an unknown number of users.
- Blockage in the bowels or failure to have bowel movements (intestinal obstruction including bowel obstruction) occurs in an unknown number of users.
Other possible side effects:
Uncommon (may affect up to 1 in 100 users)
- faster heartbeat ( tachycardia )
- dizziness
- headache
- cough
- hoarseness ( dysphonia )
- dry mouth
Rare (may affect up to 1 in 1,000 users)
- irregular heartbeat ( atrial fibrillation )
- fast heartbeat ( supraventricular tachycardia )
- a heartbeat that can be felt (palpitations)
- high blood pressure ( hypertension )
- difficulty emptying the bladder ( urinary retention )
- urinary tract infections
- pain when emptying the bladder ( dysuria )
- sore throat ( pharyngitis )
- inflammation of the larynx ( laryngitis )
- inflamed gums ( gingivitis )
- inflammation of the oral mucosa (stomatitis)
- fungal infection of the mouth and throat ( oropharyngeal candidiasis)
- nosebleeds ( epistaxis )
- insomnia _ _
- blurred vision
- chest pressure, associated with coughing, wheezing or wheezing or shortness of breath immediately after inhalation ( bronchospasm )
- constipation
- nausea
- itching ( pruritus )
- joint pain ( arthralgia )
- swollen joints
- back pain
Has been reported (occurring in an unknown number of users)
- increased measured pressure in the eye
- Runny nose
- sinusitis ( sinusitis )
- difficulty swallowing ( dysphagia )
- inflammation of the tongue ( glossitis )
- heartburn ( gastroesophageal reflux)
- holes in the teeth ( caries )
- infection or wounds in the skin
- dry skin
- loss of body fluid ( dehydration )
You may also experience side effects known from treating breathing problems with medicines similar to Spiolto Respimat (beta agonists). These can be irregular heartbeats, chest pain, low blood pressure, tremors, nervousness, muscle cramps, tiredness, feeling unwell, and low levels of potassium in the blood (which can cause symptoms such as muscle twitching, muscle weakness, or abnormal heart rhythm), high blood sugar, or too acidic blood (which can cause symptoms such as nausea, vomiting, weakness, muscle cramps and faster breathing).
How to store Spiolto Respimat
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and the inhaler label after EXP. The expiration date is the last day of the specified month.
Do not freeze.
Shelf life after opening:
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 medicine 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 substances are tiotropium and olodaterol. The delivered dose is 2.5 micrograms of tiotropium (as bromide monohydrate) and 2.5 micrograms 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 hydrochloric acid for pH adjustment.
Appearance and package sizes of the medicine
Spiolto Respimat consists of a medicine 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.
The marketing authorization holder for Spiolto Respimat is:
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
Manufacturers of Spiolto Respimat are:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
alternatively
Boehringer Ingelheim España, SA
c/ Prat de la Riba, 50
08174 Sant Cugat del Vallès (Barcelona)
Spain
alternatively
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: Spiolto Respimat 2.5 Microgram/2.5 Microgram – Lösung zur Inhalation
Belgium, Luxembourg: Spiolto Respimat 2.5 microgrammes/2.5 microgrammes/inhalation, solution à inhaler
Bulgaria: Spiolto Respimat Спиолто Респимат
Cyprus, Greece: Spiolto Respimat
Croatia Spiolto Respimat 2.5 micrograms/ 2.5 micrograms, solution inhalation
Czech Republic: Spiolto Respimat
Denmark: Spiolto Respimat
Estonia: Spiolto Respimat
Finland: Inspiolto Respimat 2.5 microg/2.5 microg inhalaationeste, liuos
France: Spiolto Respimat 2.5 microgrammes/2.5 microgrammes/dose, solution à inhaler
Germany: Spiolto Respimat 2.5 Microgram/2.5 Microgram pro Hub, Lösung
zur Inhalation
Hungary: Spiolto Respimat 2.5 micrograms/2.5 micrograms inhalációs oldat
Iceland: Spiolto Respimat
Ireland, Malta, UK: Spiolto Respimat
Italy: Spiolto Respimat 2.5 microgrammi/2.5 microgrammi, soluzione
per inalazione
Latvia: Spiolto Respimat 2.5 micrograms/2.5 micrograms inhalations škidums
Lithuania: Spiolto Respimat 2.5 microgram/2.5 microgram/išpurškime
įkvepiamasis tirpalas
The Netherlands: Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation oplossing
Norway: Spiolto Respimat
Poland: Spiolto Respimat
Portugal: Spiolto Respimat
Romania: Spiolto Respimat 2.5 micrograme/2.5 micrograme soluzione de inhalat
Slovakia: Spiolto Respimat
Slovenia: Spiolto Respimat 2.5 micrograms/2.5 micrograms
Spain: Spiolto Respimat 2.5 microgramos/2.5 microgramos solución para inhalación