2.5 micrograms per puff, inhalation liquid, solution
tiotropium
What Spiriva Respimat is and what it is used for
Spiriva Respimat helps people with chronic obstructive pulmonary disease (COPD) or asthma to breathe easier. COPD is a long-term lung disease that can cause shortness of breath and cough. The diagnosis of COPD is also associated with long-term bronchial catarrh ( chronic bronchitis ) and enlarged lung sacs ( emphysema ). Asthma is a long-term disease in which inflammation of the airways and narrow airways are typical of the disease. Because COPD and asthma are long-term illnesses, you should use Spiriva Respimat every day, not just when you have breathing problems or other symptoms. If you use Spiriva Respimat to treat asthma, you should use it together with a so-called inhaled corticosteroid and long-acting beta-2 agonist.
Spiriva Respimat is a long-acting bronchodilator medicine that helps open your airways and makes it easier to get air in and out of the lungs. Regular use of Spiriva Respimat can also help when you get a period of breathlessness due to your disease and helps you reduce the disease’s impact on your daily life. Daily use of Spiriva Respimat will also help prevent sudden, short-term worsening of COPD symptoms, which can last for several days.
For the correct dosage of Spiriva Respimat, see section 3, How to use Spiriva Respimat, and the instructions for use on the back of the leaflet.
What you need to know before you use Spiriva Respimat
Do not use Spiriva Respimat
- 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 similar substances, eg ipratropium or tiotropium.
Warnings and precautions
Talk to your doctor or pharmacist before using Spiriva Respimat.
Talk to your doctor if you have narrow-angle glaucoma, prostate problems, or difficulty emptying the bladder.
Consult your doctor if you have kidney problems.
When using Spiriva Respimat, be careful not to get the inhalation liquid in the 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 tiotropium bromide and contact your doctor immediately for advice.
If breathing becomes difficult or you develop a rash, swelling, or itching immediately after inhalation, stop using Spiriva Respimat and contact a doctor immediately.
Dry mouth, observed during treatment with anticholinergic drugs, can lead to dental caries during long-term treatment. Therefore, be careful with oral hygiene.
Spiriva Respimat is intended for the maintenance treatment of your COPD disease or your asthma. Do not use this medicine to treat sudden attacks of shortness of breath or wheezing or wheezing. Your doctor should have given you another inhaled medicine (“emergency medicine”) to relieve acute symptoms. Follow the instructions your doctor has given you.
If you have been prescribed Spiriva Respimat for your asthma, you should use it together with an inhaled corticosteroid and long-acting beta-2 agonist. Continue to use the inhaled corticosteroid as prescribed by your doctor, even if you feel better.
If you have had a heart attack in the last 6 months or suffered from unstable or life-threatening heart rhythm disturbances or severe heart failure in the last year, tell your doctor. It is important to decide whether Spiriva Respimat is the right medicine for you.
Do not use Spiriva Respimat more often than once a day.
If breathing worsens, contact a doctor.
Tell your doctor if you have cystic fibrosis because Spiriva Respimat may worsen your symptoms of cystic fibrosis.
Children and young people
Spiriva Respimat is not recommended for children under 6 years of age.
Other medicines and Spiriva Respimat
Tell your doctor or pharmacist if you are using, have recently used, or might be using any other medicines, including non-prescription medicines.
Tell the doctor or pharmacist if you are using/have used similar anticholinergic medicines for your lung disease, eg ipratropium or tiotropium.
No specific side effects have been reported when Spiriva Respimat has been used together with other medicines used in the treatment of COPD, such as bronchodilators for inhalation (eg salbutamol ), methylxanthines (eg theophylline), antihistamines, expectorants (eg ambroxol). , leukotriene receptor antagonists (eg montelukast), chromones, anti- IgE treatment (eg omalizumab), and/or inhaled or oral steroids (eg budesonide, prednisolone ).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
You should only use this medicine if your doctor has specifically recommended it.
Driving ability and use of machinery
No studies have been carried out regarding the impact on driving and handling machinery. If dizziness or blurred vision occurs, it may affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 your doctor or pharmacist if you are unsure.
Spiriva Respimat contains benzalkonium chloride
This medicine contains 0.0011 mg benzalkonium chloride per puff. Benzalkonium chloride can cause wheezing and difficulty breathing (bronchial spasm), especially if you have asthma.
How to use Spiriva Respimat
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Spiriva Respimat is intended for inhalation only.
The recommended dose for patients 6 years of age and older are:
Spiriva Respimat is effective for 24 hours and therefore only needs to be used ONCE PER DAY, if possible at the same time. For each use, take TWO PUFFS.
As COPD and asthma are long-term diseases, Spiriva Respimat should be used every day and not only for breathing problems. Do not use more than the recommended dose.
Spiriva Respimat is not recommended for children under 6 years of age because there is no data regarding efficacy and safety.
Make sure you know how to use the Spiriva Respimat inhaler correctly. The instructions for use for Spiriva Respimat can be found on the other side of this leaflet.
If you have used too much Spiriva Respimat
If you use more than 2 puffs of Spiriva Respimat in a day, you should contact your doctor immediately. You may be at higher risk of side effects such as dry mouth, constipation, difficulty emptying the bladder, increased heart palpitations, and blurred vision.
If you have ingested too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Spiriva Respimat
If you forget to take a dose (TWO PUFFS ONCE A DAY), take one dose as soon as you remember, but do not take two doses at the same time or on the same day. Take the next dose as usual.
If you stop using Spiriva Respimat
Before you stop using Spiriva Respimat, talk to your doctor or pharmacist. If you stop using Spiriva Respimat, the symptoms of COPD or asthma 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.
Side effects are evaluated based on the following frequencies:
Common: may affect up to 1 in 10 users
Uncommon: may affect up to 1 in 100 users
Rare: may affect up to 1 in 1,000 users
Has been reported: occurs in an unknown number of users
The side effects described below have been reported by people using the medicine and are listed by frequency as either common, uncommon, rare or reported.
| Side effect | Frequency when used against COPD | Frequency when used against asthma |
| Dry mouth | Usual | Less common |
| Hoarseness ( dysphonia ) | Less common | Less common |
| Cough | Less common | Less common |
| Headache | Less common | Less common |
| Inflammation of the throat ( pharyngitis ) | Less common | Less common |
| Pain when emptying the bladder ( dysuria ) | Less common | Has been reported |
| Dizziness | Less common | Less common |
| Fungal infection of the mouth and throat ( oropharyngeal candidiasis) | Less common | Less common |
| Difficulty emptying the bladder ( urinary retention ) | Less common | Has been reported |
| Constipation | Less common | Rare |
| Rash | Less common | Less common |
| Itching ( pruritus ) | Less common | Rare |
| Increased measured pressure in the eye ( intraocular pressure ) | Rare | Has been reported |
| Severe allergic reactions causing swelling of the face and throat ( angioneurotic edema ) | Rare | Rare |
| Insomnia | Rare | Less common |
| Irregular heartbeats (atrial fibrillation, supraventricular tachycardia ) | Rare | Has been reported |
| A heartbeat that can be felt ( palpitation er) | Rare | Less common |
| Epistaxis ( epistaxis ) | Rare | Rare |
| Inflammation of the tongue | Rare | Has been reported |
| Faster heartbeat ( tachycardia ) | Rare | Has been reported |
| Pressure on the chest, associated with coughing, wheezing or wheezing or shortness of breath immediately after inhalation ( bronchospasm ) | Rare | Less common |
| Difficulty swallowing ( dysphagia ) | Rare | Has been reported |
| Visual phenomena such as rings of light or colored images associated with red eyes ( glaucoma ) | Rare | Has been reported |
| Blurred vision | Rare | Has been reported |
| Inflammation of the larynx ( laryngitis ) | Rare | Has been reported |
| Caries in the teeth | Rare | Has been reported |
| Inflammation of the gums | Rare | Rare |
| Hives ( urticaria ) | Rare | Rare |
| Infection or sores in the skin | Rare | Has been reported |
| Dry skin | Rare | Has been reported |
| Infection in the urinary tract | Rare | Rare |
| Heartburn ( gastroesophageal reflux) | Rare | Has been reported |
| Hypersensitivity, including immediate reactions | Has been reported | Rare |
| Inflammation of the oral mucosa | Has been reported | Rare |
| Loss of body fluids ( dehydration ) | Has been reported | Has been reported |
| Inflammation of the sinuses | Has been reported | Has been reported |
| Blockage in the intestines or failure to have bowel movements (intestinal obstruction incl. bowel obstruction) | Has been reported | Has been reported |
| Nausea | Has been reported | Has been reported |
| Severe allergic reaction ( anaphylactic reaction ) | Has been reported | Has been reported |
| Swollen joints | Has been reported | Has been reported |
Immediate hypersensitivity reactions such as skin rash, hives ( urticaria ), swelling of the mouth and face or sudden difficulty in breathing ( angioneurotic edema), or other hypersensitivity reactions (such as a sudden drop in blood pressure or dizziness) may occur as a single reaction or as part of a severe allergic reaction ( anaphylactic reaction ) after administration of Spiriva Respimat.
In addition, as with other inhaled medicines, some patients may experience unexpected pressure in the chest, coughing, wheezing, or shortness of breath immediately after inhalation.
If any of these occur, contact your doctor immediately.
How to store Spiriva Respimat
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Do not freeze.
Sustainability:
Replace the medication container no later than three months after insertion.
Do not use the same Respimat reusable inhaler for more than one year.
Recommended use: up to 6 containers per inhaler.
Note: Respimat reusable inhaler has been tested with 540 puffs (corresponding to 9 containers) with maintained function.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.112
Contents of the packaging and other information
Contents declaration
The active substance is tiotropium. The delivered dose is 2.5 micrograms of tiotropium per puff (2 puffs give one medicinal dose) and corresponds to 3.124 micrograms of tiotropium bromide monohydrate. 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 3.6% hydrochloric acid (for pH adjustment).
Appearance and package sizes of the medicine
Spiriva Respimat 2.5 micrograms per puff consist of a medicinal container with inhalation solution and a Respimat inhaler. The container must be inserted into the inhaler before first use.
1-pack: 1 Respimat reusable inhaler and 1 medication container, containing 60 puffs (30 medication doses)
3-pack: 1 Respimat reusable inhaler and 3 medication containers, each containing 60 puffs (30 medication doses)
1-pack refill: 1 medication container containing 60 puffs (30 medication doses)
3-pack refill: 3 medication containers containing 60 puffs (30 medication doses) each
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
or
Boehringer Ingelheim España, SA
c/ Prat de la Riba, 50
08174 Sant Cugat del Vallès (Barcelona)
Spain
or
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: Spiriva Respimat 2.5 Micrograms – Lösung zur Inhalation
Belgium, Luxembourg: Spiriva Respimat 2.5 microgrammes, solution à inhaler
Bulgaria : Спирива Респимат 2.5 микрограма, хорошо за инхалация
Cyprus , Greece : Spiriva Respimat 2.5 μικρογραμμάρια, εισπνεόμενο προφορία
Czech Republic: Spiriva Respimat
Denmark: Spiriva Respimat Inhalation liquid, solution 2.5 micrograms
Estonia : SPIRIVA RESPIMAT inhalatsionilahus 2.5µg/annuses
Finland: SPIRIVA RESPIMAT 2.5 microg inhalation ester, limos
France : Spiriva Respimat 2.5 microgrammes/dose, solution pour inhalation
Germany : Spiriva Respimat 2.5 Microgram Lösung zur Inhalation
Hungary : Spiriva Respimat 2.5 micrograms inhalációs oldat
Iceland: Spiriva Respimat 2.5 micrograms/dose
Ireland, Malta,
UK (Northern Ireland): Spiriva Respimat 2.5 microgram, inhalation solution
Italy : Spiriva Respimat 2.5 mcg soluzione per inalazione
Latvia: Spiriva Respimat 2.5 micrograms shķidums inhalation
Lithuania: Spiriva Respimat 2.5 micrograms/išpurškime įkvepiamasis tirpalas
The Netherlands : Spiriva Respimat 2.5 microgram, inhalatie oplossing
Norway: Spiriva Respimat 2.5 micrograms inhalation solution, solution
Poland : Spiriva Respimat 2.5 micrograms/dawkę odmierzoną, roztwór do inhalacji
Portugal : Spiriva Respimat 2.5 mg/dose, Solução para inhalção por nebulizaão
Romania: SPIRIVA RESPIMAT 2.5 micrograms sõlu de inhalant
Slovakia : Spiriva Respimat sol ihl 2.5 µg/1 dose
Slovenia : Spiriva Respimat 2.5 micrograms razpotina za inhaliranje
Spain: Spiriva Respimat 2.5 microgramos, solución para inhalación