Striverdi Respimat 2.5 Microgram Inhalation Solution
PATIENT INFORMATION LEAFLET 2828
16.05.16[2]
Striverdi® Respimat® 2.5 microgram, inhalation solution
(olodaterol hydrochloride)
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section
4.
Your medicine is available using the above name but will be referred to as Striverdi Respimat throughout this leaflet
What is in this leaflet
1. What Striverdi Respimat is and what it is used for
2. What you need to know before you take Striverdi Respimat
3. How to take Striverdi Respimat
4. Possible side effects
5. How to store Striverdi Respimat
6. Contents of the pack and other information
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 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 this medicine for 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 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 worst 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).
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 use Striverdi Respimat together with certain medicines containing long-acting U-adrenergic agonists, like salmeterol or formoterol.
If you regularly take certain medicines called short-acting U-adrenergic agents, like salbutamol, continue to use 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 using:
• certain medicines for breathing problems that are similar to this medicine (U-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 use these medicines together with this medicine you may experience symptoms of muscle spasms, 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 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.
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 use 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.
Use in children and adolescents
There is no relevant use of this medicine in the paediatric population (under 18 years).
Make sure that you know how to use your Striverdi
Respimat inhaler properly. The instructions for use of the Striverdi
Respimat inhaler are provided on the other side of this leaflet.
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 using 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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Striverdi Respimat
Keep out of the sight and reach of children.
Do not use Striverdi Respimat after the expiry date which is stated on the carton and on the inhaler label. The expiry date refers to the last day of the month.
Striverdi Respimat inhaler should be discarded at the latest 3 months after first use (see Instructions for Use overleaf)
Do not freeze.
If the medicines become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Striverdi Respimat contains:
The active substance is olodaterol hydrochloride.
The delivered dose is 2.5 microgram olodaterol (as hydrochloride) per puff (2 puff comprise one medicinal dose).
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 is composed of one cartridge with a clear colourless solution for inhalation and one Respimat inhaler which is plastic with a yellow cap, light grey mouthpiece and clear body. The cartridge has to be inserted into the inhaler before the first use.
Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)
Manufacturer and Product Licence Holder
Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany and is procured from the EU by Product Licence holder Star Pharmaceuticals Ltd.,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM PL 20636/2828
Leaflet revision and issue date (Ref) 16.05.16[2]
Striverdi and Respimat are trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG
3 Replace clear base
• Put the clear base back into place until it clicks.
4 Turn
Striverdi® Respimat® Inhaler
Instructions for Use Introduction
Striverdi Respimat (olodaterol). Read these Instructions for Use 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.
CAP
MOUTHPIECE AIR VENT
DOSE-
RELEASE
BUTTON
SAFETY CATCH
CLEAR BASE
PIERCING ELEMENT
CARTRIDGE
• 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 first Use' until a cloud is visible. Then repeat steps 4 to 6 three more times.
• Do not touch the piercing element inside the clear base.
How to care for your Striverdi Respimat
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 Striverdi Respimat inhaler performance. If necessary, wipe the outside of your Striverdi Respimat inhaler with a damp cloth.
When to get a new Striverdi Respimat
• Your Striverdi Respimat inhaler contains 60 puffs (30 doses) if used as indicated (two puffs/ once daily).
• The dose indicator shows approximately how much medication is left.
• When the dose indicator enters the red area of the scale you need to get a new prescription; there is approximately medication for 7 days left (14 puffs).
• Once the dose indicator reaches the end of the red scale, your Striverdi Respimat locks automatically - no more doses can be released.
At this point, the clear base cannot be turned any further.
• Striverdi Respimat should be discarded three months after you have prepared it for first use, even if it has not been fully used or used at all.
Prepare for first use 1 Remove clear base
• Keep the cap closed.
• Press the safety catch while firmly pulling off the clear base with your other hand.
2 Insert cartridge
• Insert the narrow end of the cartridge into the inhaler.
• Place the inhaler on a firm surface and push down firmly until it clicks into place.
• 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.
Your inhaler is now ready to use. These steps will not affect the number of doses available. After preparation your inhaler will be able to 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
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._
L_
Answers to Common Questions
Is it 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.
Did you insert the cartridge with the wide end first? Insert the cartridge with the narrow end first.
I cannot press the dose-release button.
Did you turn the clear base? If not, turn the clear base in a continuous movement until it clicks (half a turn).
Is the dose indicator on the Striverdi Respimat pointing to zero? The
Striverdi Respimat inhaler is locked after 60 puffs (30 medicinal doses). Prepare and use your new Striverdi Respimat inhaler.
I cannot turn the clear base.
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 dose indicator on the Striverdi Respimat pointing to zero? The
Striverdi Respimat inhaler is locked after 60 puffs (30 medicinal doses). Prepare and use your new Striverdi Respimat inhaler.
The dose indicator on the Striverdi Respimat reaches zero too soon.
Did you use Striverdi Respimat as indicated (two puffs/Once daily)?
Striverdi Respimat will last 30 days if used at two puffs once daily.
Did you turn the clear base before you inserted the cartridge? The
dose indicator counts each turn of the clear base regardless whether a cartridge has been inserted or not.
Did you spray in the air often to check whether the Striverdi Respimat is working? Once you have prepared Striverdi Respimat, no test-spraying is required if used daily.
Did you insert the cartridge into a used Striverdi Respimat? Always insert a new cartridge into a NEW Striverdi Respimat.
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).
My Striverdi Respimat doesn’t spray.
Did you insert a cartridge? If not, insert a cartridge.
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 first Use”.
Is the dose indicator on the Striverdi Respimat pointing to 0? If the
dose indicator points to 0, you have used up all your medication and the inhaler is locked.
Once your Striverdi Respimat is assembled, do not remove the clear base or the cartridge. Always insert a new cartridge into a NEW Striverdi Respimat.