SPIRIVA 2.5 MICROGRAMS Inhalation solution

Содержание инструкции

1. Spiriva Respimat 2.5 micrograms, inhalation solution
   1. What is Spiriva Respimat and what is it used for
   2. What you need to know before using Spiriva Respimat
   3. How to use Spiriva Respimat
   4. Possible side effects
   5. How to store Spiriva Respimat
   6. Contents of the pack and other information

Spiriva Respimat 2.5 micrograms, inhalation solution

tiotropium

Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Spiriva Respimat is and what it is used for
• 2. What you need to know before you use Spiriva Respimat
• 3. How to use Spiriva Respimat
• 4. Possible side effects
• 5. How to store Spiriva Respimat
• 6. Contents of the pack and other information

1. What is Spiriva Respimat and what is it used for

Spiriva Respimat helps people affected by chronic obstructive pulmonary disease (COPD) or asthma to
breathe more easily. COPD is a chronic lung disease that causes shortness of breath and cough. The
term COPD is associated with chronic conditions of bronchitis and emphysema. Asthma is a chronic
disease, characterized by inflammation and narrowing of the airways.
Because COPD and asthma are chronic diseases, Spiriva Respimat must be used every day and
not only when breathing difficulties or other symptoms occur. When used to treat asthma,
Spiriva Respimat must be used in addition to so-called inhaled corticosteroids and long-acting beta-2-
agonists.
Spiriva Respimat is a long-acting bronchodilator that dilates the bronchi and facilitates
breathing. Regular use of Spiriva Respimat can also be helpful when shortness of breath
develops associated with the disease and to minimize the effects of the disease on daily life. Daily use of
Spiriva Respimat helps to prevent the sudden short-term worsening of symptoms of
COPD, which can last for several days.
For the correct dosage of Spiriva Respimat, please refer to paragraph 3 “How to use Spiriva Respimat” and

2. What you need to know before using Spiriva Respimat

Do not use Spiriva Respimat

• if you are allergic (hypersensitive) to tiotropium or to 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.
Talk to your doctor if you suffer from closed-angle glaucoma, prostate problems or difficulty in
urination.
If you suffer from kidney problems, consult your doctor.
When using Spiriva Respimat, be careful that the product does not enter your eyes. If this should
happen, it may cause eye pain or discomfort, blurred vision, seeing halos
around lights or colored images associated with eye redness (i.e. closed-angle glaucoma). The
eye symptoms may be accompanied by headache, nausea or vomiting. Rinse your eyes with
warm water, stop taking tiotropium bromide and consult your doctor immediately for
further advice.
If your breathing gets worse immediately after using the inhaler or if you experience
skin irritation, swelling or itching, stop using it and inform your doctor immediately.
Dry mouth, which has been observed with treatment with anticholinergics, may be associated with dental caries in the long term.
Therefore, pay adequate attention to oral hygiene.
Spiriva Respimat is indicated for the maintenance treatment of chronic obstructive pulmonary disease or asthma. Do not use this medicine for the treatment of sudden attacks of shortness
of breath or wheezing.
For these cases, your doctor must have prescribed another inhaler (“rescue medicine”). Follow the
doctor's instructions.
If Spiriva Respimat has been prescribed for you for asthma, it must be added to inhaled corticosteroids and long-acting beta-2-agonists. Continue to take the inhaled corticosteroids as prescribed by your doctor, even if you feel better.
If you have had a myocardial infarction in the last 6 months or any form of
life-threatening or unstable irregular heartbeat or severe heart failure in the past
year, tell your doctor. This information is important to establish whether Spiriva Respimat is the
right medicine for you.
Do not use Spiriva Respimat more than once a day.
Contact your doctor also if you feel that your breathing has worsened.
If you suffer from cystic fibrosis, tell your doctor because Spiriva Respimat may worsen the symptoms
of your cystic fibrosis.

Children and adolescents
Spiriva Respimat is not recommended in children and adolescents under 18 years of age.

Other medicines and Spiriva Respimat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
In particular, tell your doctor or pharmacist if you are taking or have taken anticholinergic medicines, such as ipratropium or oxitropium.
No adverse interaction effects have been reported following the use of Spiriva Respimat in
combination with other medicines used for the treatment of COPD such as inhaled medicines that relieve symptoms (like salbutamol), methylxanthines (like theophylline), antihistamines,
mucolytics (like ambroxol), leukotriene modifiers (like montelukast), chromones, anti-IgE treatments (like omalizumab) and/or steroids administered orally or by inhalation (like budesonide,
prednisolone).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
You should not use this medicine unless specifically prescribed by your doctor.

Driving and using machines
Studies on the effects on the ability to drive and operate machines have not been conducted.
The onset of dizziness or blurred vision may affect the ability to drive
vehicles and operate machines.

Spiriva Respimat contains benzalkonium chloride
This medicine contains 0.0011 mg of benzalkonium chloride per actuation.
Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you suffer
from asthma.

3. How to use Spiriva Respimat

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Spiriva Respimat is for inhalation use only.
The recommended dose for adults is:
Spiriva Respimat is effective for 24 hours, therefore you will need to use Spiriva Respimat only ONCE
A DAY, if possible at the same time. Each time you must take TWO PUFFS.
Since COPD and asthma are chronic diseases, use Spiriva Respimat every day and not only when
breathing problems occur. Do not take higher doses than recommended.
The use of Spiriva Respimat is not recommended in children and adolescents under 18 years of age
due to the lack of safety and efficacy data.
Make sure you know how to use Spiriva Respimat correctly. Instructions for using Spiriva

If you use more Spiriva Respimat than you should
If you take more than two puffs of Spiriva Respimat in one day, seek immediate medical attention.
You may be at increased risk of developing undesirable effects such as dry mouth,
constipation, difficulty urinating, increased heartbeat or blurred vision.

If you forget to use Spiriva Respimat
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. Take
the next dose as usual.

If you stop using Spiriva Respimat
Before stopping treatment with Spiriva Respimat, talk to your doctor or pharmacist. If
you stop treatment with Spiriva Respimat, the signs and symptoms of COPD may worsen.
If you have any doubts about 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.
The assessment of 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: the frequency cannot be estimated from the available data
___________________________________________________________________________
_______
The side effects described below have been reported by patients taking this medicine, and are listed by frequency, divided into common, uncommon, rare or not known.

With Spiriva Respimat, immediate allergic reactions such as skin rash, hives, swelling of the mouth and face or sudden difficulty breathing (angioedema) or other hypersensitivity reactions (such as sudden decrease in blood pressure or dizziness) may occur, which occur individually or as part of a severe allergic reaction (anaphylactic reaction).
Also, as can happen with all other medicines administered by inhalation, some patients may experience unexpected chest tightness, cough, shortness of breath or wheezing immediately after inhalation (bronchospasm).
If any of these effects occur, contact 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. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse..
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spiriva Respimat

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 package and on the label
of the inhaler. The expiry date refers to the last day of that month.
Do not freeze.
Shelf life after opening
Replace the cartridge no later than 3 months after insertion.
Do not use the Respimat reusable inhaler for more than one year.
Recommended use: 6 cartridges per inhaler
Note: The operation of the Respimat reusable inhaler has been tested for 540 actuations
(corresponding to 9 cartridges).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Spiriva Respimat contains
The active ingredient is tiotropium. The released dose is 2.5 micrograms of tiotropium per actuation (2
actuations constitute the dosage of the medicine) and are equivalent to 3.124 micrograms of tiotropium
bromide monohydrate. The released dose is the dose available to the patient after passage through
the mouthpiece.
The other ingredients are benzalkonium chloride, sodium edetate, purified water and hydrochloric acid 3.6%
as a pH adjuster.

Description of the appearance of Spiriva Respimat and contents of the pack
Spiriva Respimat 2.5 micrograms consists of a cartridge containing the inhalation solution and
a Respimat inhaler. The cartridge must be inserted into the inhaler before first use.
Single pack: 1 reusable Respimat inhaler and 1 cartridge providing 60 actuations (30 doses
of medicine)
Triple pack: 1 reusable Respimat inhaler and 3 cartridges providing 60 actuations (30 doses
of medicine) each
Refill single pack: 1 cartridge providing 60 actuations (30 doses of medicine)
Refill triple pack: 3 cartridges providing 60 actuations (30 doses of medicine) each
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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
Boehringer Ingelheim España, SA
c/ Prat de la Riba, 50
08174 Sant Cugat del Vallès (Barcelona)
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria, Liechtenstein: Spiriva Respimat 2,5 Mikrogramm - Lösung zur Inhalation
Belgium, Luxembourg: Spiriva Respimat 2,5 microgrammes, solution à inhaler
Bulgaria: Спирива Респимат 2,5 микрограма, разтвор за инхалация
Cyprus, Greece: Spiriva Respimat 2.5 μικρογραμμάρια, εισπνεόμενο διάλυμα
Czech Republic: Spiriva Respimat 2,5 mikrogramu, roztok k inhalaci
Denmark: Spiriva Respimat Inhalationsvæske, opløsning 2,5 microgram
Estonia: Spiriva Respimat inhalatsioonilahus 2,5µg/annuses
Finland: Spiriva Respimat 2.5 mikrog inhalaationeste, liuos
France: Spiriva Respimat 2,5 microgrammes/dose, solution pour inhalation
Germany: Spiriva Respimat 2,5 Mikrogramm Lösung zur Inhalation
Hungary: Spiriva Respimat 2,5 mikrogramm inhalációs oldat
Iceland: Spiriva Respimat 2.5 mikróg/skammt
Ireland, Malta,
United Kingdom: Spiriva Respimat 2.5 microgram, inhalation solution
Italy: Spiriva Respimat 2,5 microgrammi, soluzione per inalazione
Latvia: Spiriva Respimat 2,5 mikrogrami šķīdums inhalācijām
Lithuania: Spiriva Respimat 2,5 mikrogramo/išpurškime įkvepiamasis tirpalas
Netherlands: Spiriva Respimat 2,5 microgram, inhalatieoplossing
Norway: Spiriva Respimat 2,5 mikrogram inhalasjonsvæske, oppløsning
Poland: Spiriva Respimat 2,5 mikrograma/dawkę odmierzoną, roztwór do inhalacji
Portugal: Spiriva Respimat 2.5 mg/dose, Solução para inhalção por nebulizaão
Romania: Spiriva Respimat 2,5 micrograme soluţie de inhalat
Slovakia: Spiriva Respimat sol ihl 2,5 µg/1 dávka
Slovenia: Spiriva Respimat 2,5 mikrogramov raztopina za inhaliranje
Spain: Spiriva Respimat 2,5 microgramos, solución para inhalación
Sweden: Spiriva Respimat 2,5 mikrogram, inhalationsvätska, lösning

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SPIRIVA RESPIMAT
Instructions for Use
Introduction
Read these instructions for use before starting to use the reusable Spiriva Respimat.
You will need to use this inhaler only ONCE A DAY. Each time take TWO
ACTUATIONS.

• If not used for more than 7 days, release one actuation into the air.
• If not used for more than 21 days, repeat steps 4 to 6 of the “Preparation for use” paragraph until a cloud is visible. Then repeat steps 4 to 6 three more times.

Maintenance of the reusable Spiriva Respimat
Clean the mouthpiece, including the metal part inside, only with a damp cloth or tissue,
at least once a week.
Any slight discolouration of the mouthpiece does not affect the efficiency of the reusable
Spiriva Respimat inhaler.
If necessary, clean the outside of the reusable Spiriva Respimat inhaler with a damp cloth.

When to replace the inhaler
When you have used an inhaler with 6 cartridges, you need to obtain a new pack of
reusable Spiriva Respimat containing an inhaler.

Preparation for use

1. Remove the transparent base Keep the cap closed. Press the safety catch sliding the transparent base with the other hand.	n a d e l
2. Insert the cartridge i Insert the cartridge into the inhaler. l Place the inhaler on a solid surface and push firmly until the cartridge is fully inserted. I a	a
i 3. Track the cartridge z Mark the check box on the inhaler label to keep track of the number of cartridges already used. n Reposition the transparent base g until you hear a click.
A 4. Rotate Keep the cap closed. Rotate the transparent base in the direction of the arrows on the

label until you hear a click (half a turn).	a c o
5. Open Flip open the cap and open completely.	l F a r m
6. Press Exhale slowly and completely. Close your lips around the mouthpiece without covering the ventilation holes. Point the inhaler towards the back of your throat. Inhale slowly and deeply through your mouth, PRESS the dose release button and continue to inhale slowly for as long as possible. Hold your breath for 10 seconds or for as long as possible. Repeat steps ROTATE, OPEN, PRESS for a total of 2 actuations. Close the cap until the next time you use the inhaler. i L a t I a	a n a d e

Daily use

z n ROTATE Keep the cap closed. e ROTATE the transparent base in the direction of the arrows g on the label until you hear a click A
OPEN

Flip open the cap and OPEN completely.

a c o

PRESS Exhale slowly and completely. Close your lips around the mouthpiece without covering the ventilation holes. Point the inhaler towards the back of your throat. Inhale slowly and deeply through your mouth, PRESS the dose release button and continue to inhale slowly for as long as possible. Hold your breath for 10 seconds or for as long as possible. Repeat steps ROTATE, OPEN, PRESS for a total of 2 actuations. Close the cap until the next time you use the inhaler.

a n a d e l F a r m

When to replace the Spiriva Respimat cartridge
The dose indicator shows how many actuations remain in the cartridge.

60 actuations remaining

Less than 10 actuations remaining. Get a new cartridge.

The cartridge is empty. Rotate the transparent base to loosen it. The inhaler is now
in a locked position. Remove the cartridge from the inhaler. Insert a new cartridge
(continue from step 2).

Answers to frequently asked questions
Is it difficult to fully insert the cartridge?
Did you accidentally rotate the transparent 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 protrude more than the first cartridge inserted. Insert it until you hear a
click, then reposition the transparent base.

You cannot press the dose release button.
Did you rotate the transparent base?
If you did not rotate it, rotate the transparent base with a continuous movement until you hear a
click (half a turn).

Does the dose indicator on the cartridge show a white arrow on a red background?
The cartridge is empty. Insert a new cartridge.

It is difficult to remove the cartridge after it has been used up.
Pull and rotate the cartridge at the same time.

You cannot rotate or reposition the transparent base.
Has the transparent base already been rotated?
If the transparent base has already been rotated, follow the steps “OPEN” and “PRESS” in the
“Daily use” paragraph to take the medicine.

The transparent base is loose and the dose indicator on the cartridge shows a white arrow
on a red background?
The cartridge is empty. Insert a new cartridge.

Reusable Respimat has run out too quickly.
Has reusable Respimat been used as indicated (two actuations/once a day)?
Respimat is sufficient for 30 days if used with two actuations once a day.

Have you often released actuations into the air to check the operation of reusable
Respimat?
After preparing reusable Respimat, it is not necessary to release control actuations into the air if
it is used every day.

Reusable Respimat does not release the dose.
Was the cartridge inserted?
If it was not inserted, insert the cartridge. After reusable Respimat has been assembled, do not
remove the transparent base or the cartridge until the cartridge is empty.

Have you repeated the steps ROTATE, OPEN, PRESS less than three times after
inserting the cartridge?
Repeat the steps ROTATE, OPEN, PRESS three times after inserting the cartridge as
shown in steps 4 to 6 of the “Preparation for use” paragraph.

The dose indicator on the cartridge shows a white arrow on a red background?
The cartridge is empty. Insert a new cartridge.

Reusable Respimat automatically releases the dose.
Was the cap open when the transparent base was rotated?
Close the cap, then rotate the transparent base.

Did you press the dose release button when rotating the transparent
base?
Close the cap so that the dose release button is covered, then rotate the transparent
base.

Was the rotation of the transparent base interrupted before hearing a click?
Rotate the transparent base with a continuous movement until you hear a click (half a turn).

Was the cap open when replacing the cartridge?
Close the cap, then replace the cartridge.

Other information
Boehringer Ingelheim Pharma GmbH & Co. KG

• D – 55216 Ingelheim am Rhein Germany

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