Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
What Spiolto Respimat is
Spiolto 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 beta? agonists.
What Spiolto Respimat is used for
Spiolto 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.
Spiolto Respimat helps to open your airways and make it easier to get air in and out of the lungs. Regular use of Spiolto 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 Spiolto Respimat every day and not only when you have breathing problems or other symptoms of COPD.
Do not take 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 substances related to it, e.g. ipratropium or oxitropium
Warnings and precautions
Talk to your doctor or pharmacist before taking Spiolto
Respimat
- if you have asthma (you should not take Spiolto 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.
- incase 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 Spiolto Respimat
- Stop taking the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after taking 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 Spiolto 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 taking Spiolto Respimat and immediately consult your doctor for further advice.
Spiolto 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 Spiolto Respimat together with certain medicines containing long-acting &-adrenergic agonists, like salmeterol or formoterol.
If you regularly take certain medicines called short-acting f8-adrenergic agents, like salbutamol, continue to take 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 Spiolto Respimat more frequently than once daily.
Children and adolescents Spiolto Respimat should not be given to children or adolescents (below the age of 18 years).
Other medicines and Spiolto 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:
- any medicines that may be similar to Spiolto Respimat (contain similar active substances, such as anticholinergic drugs or &-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 Spiolto 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 take these medicines together with Spiolto 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 take 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 Spiolto Respimat, do not drive or use any tools or machines.
Spiolto 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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Spiolto Respimat is for inhalation use only. Dosage The recommended dose is:
Spiolto Respimat is effective for 24 hours so you will need to take Spiolto 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 Spiolto Respimat 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 Spiolto Respimat in the paediatric population (under 18 years).
If you take more Spiolto 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 Spiolto 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 Spiolto Respimat
Before you stop taking Spiolto Respimat, you should talk to your doctor or your pharmacist. If you stop taking Spiolto 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occurs, please stop taking 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). 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 Spiolto 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 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.
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.
What Spiolto 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 Spiolto Respimat looks like and contents of the pack
Spiolto 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
Spiolto Respimat is:
Boehringer Ingelheim International GmbH Binger Strafse 173
55216 Ingelheim am Rhein
Germany
The manufacturer for Spiolto Respimat is:
Boehringer Ingelheim Espana, SA
c/ Prat de la Riba, 50
08174 Sant Cugat del Vallés (Barcelona) Spain
This medicine is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following name:
Austria, Liechtenstein, Belgium, Luxembourg, Cyprus, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Malta, United Kingdom (Northern Ireland), Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Spiolto Respimat
Finland: Inspiolto Respimat
Bulgaria: Cnuonto Pecnumat
This leaflet was last revised in 07/2024.
Ingelheim
Instructions on how to use the Respimat re-usable inhaler
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 Spiolto Respimat. You will need to use this inhaler only ONCE A DAY. Each time you use it take TWO PUFFS.
Respimat® Cap
Cartridge
Mouthpiece Air vents — Dose-release —
@)
button = = = Safety catch
Cartridge
counter Dose
| Clear base Indicator
¢ If Spiolto Respimat has not been used for more than 7 days release one puff towards the ground.
¢ If Spiolto 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.
@ \ Boehringer lh
Remove clear base
* Keep the cap closed. ¢ Press the safety catch while pulling off the clear base with your other hand.
Insert cartridge
¢ Insert the cartridge into the inhaler. ¢ Place the inhaler on a firm surface and push down firmly until it clicks into place.
Track cartridge and put the clear base back
¢ Mark the check-box on inhaler's label to track the number of cartridges.
¢ Put the clear base back into place until it clicks.
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.
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).
Doserelease button
Safety catch
Clear base
"CLICK"
Put back clear base
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 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.
Air vent
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.
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 Spiolto Respimat has been used up too early.
Did you use Spiolto 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 Spiolto Respimat is working? Once you have prepared Spiolto Respimat for use, no testspraying 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.
My Spiolto Respimat doesn't spray.
Did you insert a cartridge? If not, insert
a cartridge. Once your Spiolto 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 Spiolto 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 or remaining doses is reduced.
Was the cap open when you replaced the cartridge? Close the cap, then replace the cartridge.
Ingelheim
Instructions on how to use the Respimat re-usable inhaler
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 Spiolto Respimat. You will need to use this inhaler only ONCE A DAY. Each time you use it take TWO PUFFS.
Respimat® Cap
Cartridge
Mouthpiece Air vents — Dose-release —
@)
button = = = Safety catch
Cartridge
counter Dose
| Clear base Indicator
¢ If Spiolto Respimat has not been used for more than 7 days release one puff towards the ground.
¢ If Spiolto 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.
@ \ Boehringer lh
Remove clear base
* Keep the cap closed. ¢ Press the safety catch while pulling off the clear base with your other hand.
Insert cartridge
¢ Insert the cartridge into the inhaler. ¢ Place the inhaler on a firm surface and push down firmly until it clicks into place.
Track cartridge and put the clear base back
¢ Mark the check-box on inhaler's label to track the number of cartridges.
¢ Put the clear base back into place until it clicks.
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.
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).
Doserelease button
Safety catch
Clear base
"CLICK"
Put back clear base
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 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.
Air vent
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.
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 Spiolto Respimat has been used up too early.
Did you use Spiolto 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 Spiolto Respimat is working? Once you have prepared Spiolto Respimat for use, no testspraying 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.
My Spiolto Respimat doesn't spray.
Did you insert a cartridge? If not, insert
a cartridge. Once your Spiolto 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 Spiolto 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 or remaining doses is reduced.
Was the cap open when you replaced the cartridge? Close the cap, then replace the cartridge.
Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution comes as solution containing 2.5 microgram/2. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution is olodaterol hydrochloride.
Medicines with the same active substance include: Striverdi Respimat 2.5 microgram, solution for inhalation. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Spiolto Respimat is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Posology
The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler.
Two puffs from the Respimat inhaler comprise one medicinal dose.
Adults
The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day.
The recommended dose should not be exceeded.
Elderly population
Elderly patients can use Spiolto Respimat at the recommended dose.
Hepatic impairment and Renal impairment
Spiolto Respimat contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.
Hepatic impairment
Patients with mild and moderate hepatic impairment can use Spiolto Respimat at the recommended dose.
There are no data available for use of olodaterol in patients with severe hepatic impairment.
Renal impairment
Renally impaired patients can use Spiolto Respimat at the recommended dose.
For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min) see 4.4 and 5.2.
Spiolto Respimat contains olodaterol. There is limited experience with the use of olodaterol in patients with severe renal impairment.
Paediatric population
There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years).
Method of administration
This medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat re-usable inhaler. Respimat is an inhaler device that generates a spray for inhalation. It is meant for use by a single patient and intended for multiple doses delivered by one cartridge.
The Respimat re-usable inhaler allows for replacement of the cartridge, and can be used with up to 6 cartridges.
Patients should read the instructions on how to use the Respimat re-usable inhaler before they start using Spiolto Respimat.
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health care professional.
Instructions for handling and use of the Respimat re-usable inhaler
The patient will need to use this inhaler only ONCE A DAY. Each time used take TWO PUFFS.
• If Spiolto Respimat has not been used for more than 7 days release one puff towards the ground.
• If Spiolto 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 the 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 the Respimat re-usable inhaler performance.
If necessary, wipe the outside of the Respimat re-usable inhaler with a damp cloth.
When to replace the inhaler
When the patient has used an inhaler with 6 cartridges, get a new Spiolto Respimat pack containing an inhaler. Do not use the Respimat re-usable inhaler for more than one year, after having inserted the first cartridge.
Prepare for use
| 1. Remove clear base • Keep the cap closed. • Press the safety catch while pulling off the clear base with the other hand. |
|
| 2. Insert cartridge • Insert the cartridge into the inhaler. • Place the inhaler on a firm surface and push down firmly until it clicks into place. |
|
| 3. Track cartridge and put the clear base back • Mark the check-box on inhaler's label to track the number of cartridges. • 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. The inhaler is now ready to use and will 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 the lips around the mouthpiece without covering the air vents. Point the Inhaler to the back of the throat. • While taking a slow, deep breath through the mouth, PRESS the dose-release button and continue to breathe in slowly for as long as comfortable. • Hold the breath for 10 seconds or for as long as comfortable. • Repeat TURN, OPEN, PRESS for a total of 2 puffs. • Close the cap until the inhaler is used again. |
|
When to replace the Spiolto Respimat cartridge
The dose indicator shows how many puffs remain in the cartridge.
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| 60 puffs remaining. |
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| Less than 10 puffs remaining. Obtain a new cartridge. |
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| The cartridge is used up. Turn the clear base to loosen it. The inhaler is now in a locked position. Pull off the cartridge from the inhaler. Insert a new cartridge until it clicks (refer to step 2). The new cartridge will stick out more than the very first cartridge (continue with step 3). Remember to put the clear base back to unlock the inhaler. |
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
History of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium.
Although no formal in vivo drug interaction studies have been performed between Spiolto Respimat and other drugs, inhaled Spiolto Respimat has been used concomitantly with other COPD medicinal products, including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
Anticholinergic agents
The co-administration of tiotropium bromide, one component of Spiolto Respimat, with other anticholinergic containing drugs has not been studied and therefore is not recommended.
Adrenergic agents
Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of Spiolto Respimat.
Xanthine derivatives, steroids or diuretics
Concomitant treatment with xanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate any hypokalemic effect of adrenergic agonists (see section 4.4).
Beta-blockers
Beta-adrenergic blockers may weaken or antagonise the effect of olodaterol. Cardioselective beta-blockers could be considered, although they should be administered with caution.
MAO inhibitors and tricyclic antidepressants, QTc Prolonging drugs
Monamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval may potentiate the action of Spiolto Respimat on the cardiovascular system.
Pharmacokinetic Drug Drug interactions
No relevant effect on systemic exposure to olodaterol has been observed in drug-drug interaction studies with co-administration of fluconazole, used as model inhibitor of CYP2C9.
Co-administration of ketoconazole as potent P-gp and CYP3A4 inhibitor increased systemic exposure to olodaterol by approximately 70%. No dose adjustment of Spiolto Respimat is necessary.
In vitro investigations have shown that olodaterol does not inhibit CYP enzymes or drug transporters at the plasma concentrations achieved in clinical practice.
Pregnancy
Tiotropium
There is a very limited amount of data from the use of tiotropium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see 5.3).
Olodaterol
For olodaterol no clinical data on exposed pregnancies are available. Preclinical data for olodaterol revealed effects typical for beta-adrenergic agonists at high multiples of the therapeutic doses (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Spiolto Respimat during pregnancy.
Like other beta2-adrenergic agonists, olodaterol a component of Spiolto Respimat may inhibit labour due to a relaxant effect on uterine smooth muscle.
Breast-feeding
Clinical data from nursing women exposed to tiotropium and/or olodaterol are not available.
In animal studies for both tiotropium and olodaterol the substances and/or their metabolites have been detected in the milk of lactating rats, but it is not known whether tiotropium and/or olodaterol passes into human breast milk.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Spiolto Respimat should be made taking into account the benefit of breast-feeding to the child and the benefit of Spiolto Respimat therapy to the woman.
Fertility
Clinical data on fertility are not available for tiotropium and olodaterol or the combination of both components. Preclinical studies performed with the individual components tiotropium and olodaterol showed no indication of any adverse effect on fertility (see 5.3).
No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that dizziness and blurred vision have been reported with the use of Spiolto Respimat. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience such symptoms, they should avoid potentially hazardous tasks such as driving or operating machinery.
There is limited information on overdosing with Spiolto Respimat. Spiolto Respimat has been studied up to 5 microgram / 10 microgram (tiotropium/olodaterol) in COPD patients and up to 10 microgram / 40 microgram (tiotropium/olodaterol) in healthy subjects; no clinically relevant effects were observed. An overdose could lead to exaggerated anti-muscarinic effects of tiotropium and/or exaggerated β2 agonists effects of olodaterol.
Symptoms
Overdose of anticholinergic tiotropium
High doses of tiotropium may lead to anticholinergic signs and symptoms.
However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium bromide in healthy volunteers. Additionally, no relevant adverse events, beyond dry mouth/throat and dry nasal mucosa were observed following 14-day dosing of up to 40 microgram tiotropium inhalation solution in healthy volunteers with the exception of pronounced reduction in salivary flow from day 7 onwards.
Overdose of ß2-agonist olodaterol
An overdose of olodaterol is likely to lead to exaggerated effects typical of beta2-adrenergic agonists, e.g. myocardial ischaemia, hypertension or hypotension, tachycardia, arrhythmias, palpitation, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.
Treatment of overdose
Treatment with Spiolto Respimat should be discontinued. Supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective beta-blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm.
Ask anything about Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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