PACKAGE LEAFLET: INFORMATION FOR THE USER
Spiriva® Respimat® re-usable
2.5 microgram, inhalation solution
tiotropium
▼ 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.
What is in this leaflet
- What SPIRIVA RESPIMAT re-usable is and what it is used for
- What you need to know before you use SPIRIVA RESPIMAT re-usable
- How to take SPIRIVA RESPIMAT re-usable
- Possible side effects
- How to store SPIRIVA RESPIMAT re-usable
- Contents of the pack and other information
- Marketing Authorisation Holder and Manufacturer
- Product registration number
- Date of revision
Instructions for Use Videos
Preparation for first use
Daily use
When to replace your Respimat inhaler
How to replace a cartridge
1. What SPIRIVA RESPIMAT re-usable is and what it is used for
What SPIRIVA RESPIMAT re-usable is
SPIRIVA RESPIMAT re-usable contains the active substance called tiotropium. Tiotropium belongs to a group of medicines called long-acting bronchodilators and to the subgroup of anticholinergics.
What SPIRIVA RESPIMAT re-usable is used for
SPIRIVA RESPIMAT re-usable is used to make breathing easier for patients with:
- Chronic obstructive pulmonary disease (COPD)
as a maintenance treatment in relieving symptoms in adult patients with (COPD). - Asthma
as a maintenance treatment in patients aged 6 years and older with moderate to severe asthma, on top of other medications which may be prescribed by your doctor
COPD is a long-term lung disease with common symptoms such as shortness of breath, persistent cough with mucus, wheezing and chest tightness. The term COPD is associated with the conditions chronic bronchitis and emphysema.
Asthma is a long-term disease characterised by airway inflammation and narrowing of the airways.
SPIRIVA RESPIMAT re-usable is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs.
As COPD and asthma are long-term diseases you should use SPIRIVA RESPIMAT re-usable every day and not only when you have breathing problems or other symptoms.
When used to treat asthma you should use SPIRIVA RESPIMAT re-usable in addition to so-called inhaled corticosteroids and long-acting ß2 agonists.
Daily use of SPIRIVA RESPIMAT re-usable will also help to prevent any sudden, short-term worsening of your COPD symptoms which may last for several days. This will 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.
For correct dosing of SPIRIVA RESPIMAT re-usable please see section 3. How to use SPIRIVA RESPIMAT re-usable and the Handling Instructions at the end of the leaflet.
2. What you need to know before you use SPIRIVA RESPIMAT re-usable
Do not use SPIRIVA RESPIMAT re-usable
- if you are allergic (hypersensitive) to tiotropium or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic (hypersensitive) to atropine or substances related to it, e.g. ipratropium or oxitropium
Warnings and precautions
Talk to your doctor or pharmacist before using SPIRIVA RESPIMAT re-usable
Talk to your doctor if you have, or have had, any of the following medical conditions;
- high pressure in the eye (narrow angle glaucoma)
- kidney or liver problems
- prostate problems
- difficulty in passing urine.
In case you have suffered from a heart attack (myocardial infarction) during the last 6 months or from any unstable or life threatening irregular heart beat or severe heart failure within the past year, please inform your doctor. This is important to decide if Spiriva is the right medicine for you to take.
When taking SPIRIVA RESPIMAT re-usable 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 using tiotropium bromide and immediately consult your doctor for further advice.
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.
Dry mouth which has been observed with anticholinergic treatment may in the long term be associated with dental caries. Therefore, please remember to pay attention to oral hygiene.
Do not use this medicine to treat a sudden attack of breathlessness or wheezing (acute episodes of bronchospasm). Your doctor should have given you another inhaler (“rescue medication”) for this. Please follow the instructions your doctor has given you.
If you have been prescribed SPIRIVA RESPIMAT re-usable for your asthma it should be added on to your anti-inflammatory therapies that include an inhaled corticosteroid and long-acting ß2 agonists. Continue taking the inhaled corticosteroid as prescribed by your doctor, even if you feel better.
Do not take SPIRIVA RESPIMAT re-usable more frequently than once daily.
You should also contact your doctor if you feel that your breathing is worsening.
Children and adolescents
For Asthma:
SPIRIVA RESPIMAT re-usable is not recommended for children under 6 years.
For Chronic obstructive pulmonary disease (COPD):
SPIRIVA RESPIMAT re-usable is not recommended for use in children and adolescents below 18 years
Other medicines and SPIRIVA RESPIMAT re-usable
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
In particular, please tell your doctor or pharmacist if you are using/have used anticholinergic drugs, e.g. ipratropium or oxitropium.
No interaction side effects have been reported when SPIRIVA RESPIMAT re-usable has been used with other products used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline), antihistamines, mucolytics (e.g. ambroxol), leukotriene modifiers (e.g. montelukast), cromones, anti-IgE treatment (e.g. omalizumab) and/or inhaled or oral steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not use this medicine unless specifically recommended by your doctor.
Driving and using machines
No studies on the effects and the ability to drive and use machines have been performed. In case dizziness or blurred vision occurs the ability to drive and use machinery may be influenced.
SPIRIVA RESPIMAT re-usable 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 use SPIRIVA RESPIMAT re-usable
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
SPIRIVA RESPIMAT re-usable is for inhalation use only.
As COPD and asthma are long-term diseases use SPIRIVA RESPIMAT re-usable every day and not only when you experience breathing problems. Do not use more than the recommended dose.
Make sure that you know how to use your SPIRIVA RESPIMAT re-usable inhaler properly. The Handling Instructions of the SPIRIVA RESPIMAT re-usable inhaler are provided at the end of this leaflet.
Asthma:
The recommended dose for patients 6 years and older is:
SPIRIVA RESPIMAT re-usable is effective for 24 hours so you will need to use SPIRIVA RESPIMAT re-usable only ONCE A DAY, if possible at the same time of the day.
Each time you use it take TWO PUFFS
SPIRIVA RESPIMAT re-usable is not recommended for use in children below 6 years due to lack of data on safety and efficacy.
Chronic obstructive pulmonary disease (COPD):
The recommended dose for patients 18 years and older is:
SPIRIVA RESPIMAT re-usable is effective for 24 hours so you will need to use SPIRIVA RESPIMAT re-usable only ONCE A DAY, if possible at the same time of the day.
Each time you use it take TWO PUFFS.
SPIRIVA RESPIMAT re-usable is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
If you use more SPIRIVA RESPIMAT re-usable than you should
If you use more SPIRIVA RESPIMAT re-usable than two puffs in one day talk to your doctor immediately. You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, increased heart beat or blurred vision.
If you forget to use SPIRIVA RESPIMAT re-usable
If you forget to take a dose (TWO PUFFS ONCE A DAY), take it as soon as you remember but do not take two doses at the same time or on the same day.
Then take your next dose as usual.
If you stop using SPIRIVA RESPIMAT re-usable
Before you stop using SPIRIVA RESPIMAT re-usable, you should talk to your doctor or your pharmacist. If you stop using SPIRIVA RESPIMAT re-usable the signs and symptoms of COPD and asthma 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.
Evaluation of the side effects is based on the following frequencies:
| Common: may affect up to 1 in 10 people |
| Uncommon: may affect up to 1 in 100 people |
| Rare: may affect up to 1 in 1,000 people |
| Not known: frequency cannot be estimated from the available data |
The side effects described below have been experienced by people taking this medicine and they are listed according to frequency as either common, uncommon, rare or not known.
| Side effect | Frequency COPD | Frequency Asthma |
| Dry mouth | Common | Uncommon |
| Hoarseness (dysphonia) | Uncommon | Uncommon |
| Cough | Uncommon | Uncommon |
| Headache | Uncommon | Uncommon |
| Inflammation of the throat (pharyngitis) | Uncommon | Uncommon |
| Painful urination (dysuria) | Uncommon | Not known |
| Dizziness | Uncommon | Uncommon |
| Fungal infections of the oral cavity and throat (oropharyngeal candidiasis) | Uncommon | Uncommon |
| Difficulties passing urine (urinary retention) | Uncommon | Not known |
| Constipation | Uncommon | Rare |
| Rash | Uncommon | Uncommon |
| Itching (pruritus) | Uncommon | Rare |
| Increase of the measured eye pressure | Rare | Not known |
| Serious allergic reaction which causes swelling of the mouth and face or throat (angioneurotic oedema) | Rare | Rare |
| Difficulty in sleeping (Insomnia) | Rare | Uncommon |
| Irregular heart beat (atrial fibrillation, Supraventricular tachycardia) | Rare | Not known |
| Feeling your heartbeat (palpitations) | Rare | Uncommon |
| Nosebleed (epistaxis) | Uncommon | Rare |
| Inflammation of the tongue (glossitis) | Rare | Not known |
| Faster heart beat (tachycardia) | Rare | Not known |
| Tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm) | Rare | Uncommon |
| Difficulties swallowing (dysphagia) | Rare | Not known |
| Seeing halos around lights or coloured images in association with red eyes (glaucoma) | Rare | Not known |
| Blurred vision | Rare | Not known |
| Inflammation of the larynx (laryngitis) | Rare | Not known |
| Dental caries | Rare | Not known |
| Inflammation of the gums (gingivitis) | Rare | Rare |
| Nettle rash (urticaria) | Rare | Rare |
| Infections or ulcerations of the skin | Rare | Not known |
| Dryness of the skin | Rare | Not known |
| Infections of the urinary tract | Rare | Rare |
| Heart burn (gastro-oesophageal reflux disease) | Rare | Not known |
| Hypersensitivity, including immediate reactions | Not known | Rare |
| Inflammation of the mouth (stomatitis) | Not known | Rare |
| Depletion of body water (dehydration) | Not known | Not known |
| Inflammation in sinuses (sinusitis) | Not known | Not known |
| Blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic) | Not known | Not known |
| Feeling sick (nausea) | Not known | Not known |
| Severe allergic reaction (anaphylactic reaction) | Not known | Not known |
| Swelling of joint | Not known | Not known |
Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of the mouth and face or sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or dizziness) may occur individually or as part of severe allergic reaction (anaphylactic reaction) after administration of SPIRIVA RESPIMAT re-usable.
In addition, in common with all inhaled medicines, some patients may experience an unexpected tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (bronchospasm). If any of these occur, please consult your doctor immediately.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store SPIRIVA RESPIMAT re-usable
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 inhaler label. The expiry date refers to the last day of the month.
Do not store above 30ºC
Do not freeze.
SPIRIVA RESPIMAT re-usable inhaler should be discarded at the latest 3 months after first use.
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 SPIRIVA RESPIMAT re-usable contains
The active substance is tiotropium. The delivered dose is 2.5 microgram tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate. 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 3.6% for pH adjustment.
What SPIRIVA RESPIMAT re-usable looks like and contents of the pack
SPIRIVA RESPIMAT re-usable 2.5 microgram is composed of one cartridge with inhalation solution and one Respimat re-usable 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)
Single refill pack: 1 cartridge providing 60 puffs (30 medicinal doses)
7. Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder for SPIRIVA RESPIMAT re-usable is:
Boehringer Ingelheim Singapore Pte Ltd
128 Beach Road
#11-01 Guoco Midtown,
Singapore 189773
The manufacturer for SPIRIVA RESPIMAT re-usable is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Or
Boehringer Ingelheim España, S.A.
c/ Prat de la Riba, 50
08174 Sant Cugat del Vallès
(Barcelona)
Spain
8. Product registration number
SIN 15885P
9. Date of revision
30 May 2024
Spiriva® Respimat® re-usable
HANDLING INSTRUCTIONS
SPIRIVA RESPIMAT re-usable (Tiotropium Bromide)
Read these Handling Instructions before you start using SPIRIVA RESPIMAT re-usable
Children should use SPIRIVA RESPIMAT re-usable with an adult’s assistance
You will need to use this inhaler only ONCE A DAY. Each time you use it take TWO PUFFS.
- If not been used for more than 7 days release one puff towards the ground.
- If not been used for more than 21 days repeat steps 4 to 6 until a cloud is visible. Then repeat steps 4 to 6 three more times.
How to care for your SPIRIVA RESPIMAT re-usable
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 SPIRIVA RESPIMAT re-usable inhaler performance. If necessary, wipe the outside of your SPIRIVA RESPIMAT re-usable inhaler with a damp cloth.
When to replace the inhaler
When you have used an inhaler with 6 cartridges, get a new SPIRIVA RESPIMAT re-usable 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 first use
1. Remove clear base
- Keep the cap closed.
- Press the safety catch while pulling off the clear base with your 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 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.
Your 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 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.
- Repeat Turn, Open, Press for a total of 2 puffs.
- Close the cap until you use your inhaler again.
When to replace your Respimat inhaler
How to replace a cartridge
When to replace the SPIOLTO RESPIMAT re-usable cartridge
The dose indicator shows how many puffs remain in the cartridge.
60 Puffs remaining
Less than 10 puffs remaining. Obtain a new cartridge
Your cartridge is used up. Turn the clear base to loosen it. Your 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.
Answers to Common Questions
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.
Did you put the clear base back?
If not, put the clear base back to unlock the inhaler. The Respimat re-usable 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.
Pull and turn the cartridge at the same time.
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.
Did you use RESPIMAT re-usable as indicated (two puffs/once daily)?
RESPIMAT re-usable will last 30 days if used at two puffs once daily.
Did you spray in the air often to check whether the RESPIMAT re-usable is working?
Once you have prepared RESPIMAT re-usable, 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.
Did you insert a cartridge?
If not, insert a cartridge. Once your RESPIMAT re-usable 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.
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.
