What Spiriva Respimat is used for and how to use it
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Spiriva Respimat - Consumer Medicine Information

Manufacture: Boehringer Ingelheim Pharmaceuticals, Inc.
Country: Canada
Condition: COPD, Maintenance
Class: Anticholinergic bronchodilators
Form: Liquid solution, Inhaler
Ingredients: tiotropium bromide monohydrate, benzalkonium chloride, disodium edetate, hydrochloric acid and purified water

Tiotropium Bromide Monohydrate Inhalation Solution

About this medication

What the medication is used for

COPD

SPIRIVA RESPIMAT is used long term to help open the airways of people with breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). It is also used to reduce the likelihood of “flare-ups” in people with COPD. In COPD, a “flare-up” is when your condition is getting worse. You will know you are having a “flare-up” if two of the following symptoms get worse for more than two days:

  • Unusual increase in the severity of breathlessness; cough, wheezing, or fatigue;
  • Unusual colour, amount or thickness of mucus;
  • Tightness in the chest or symptoms of a cold.

Asthma

SPIRIVA RESPIMAT is used only as add-on therapy to an inhaled corticosteroid and a long-acting beta agonist when those medications are not adequate to control your asthma.

When used to treat asthma, you should use SPIRIVA RESPIMAT in addition to another anti-asthma inhaler as prescribed by your doctor.

What it does

SPIRIVA RESPIMAT contains tiotropium which belongs to a group of medicines called bronchodilators. SPIRIVA RESPIMAT helps the muscles around the airways in your lungs stay relaxed making it easier for air to get in and out of the lungs. When you inhale it, it helps you breathe more easily.

In COPD patients, it also helps to prevent flare-up symptoms, such as wheezing, cough, chest tightness and shortness of breath.

When it should not be used

Do not take SPIRIVA RESPIMAT:

  • if you are allergic to ipratropium bromide or other drugs which are anticholinergic (contain atropine or its derivatives) or to any component of SPIRIVA RESPIMAT;
  • without also taking an inhaled corticosteroid and a long-acting beta-agonist if you are being treated for asthma.
  • if you are under 18 years of age.

SPIRIVA RESPIMAT is not a rescue medicine and should not be used on as needed basis for treating sudden breathing problems during exacerbations (flare-ups or asthma attack) of the disease. Your doctor may give you other medicine to use for sudden breathing problems.

What the medicinal ingredient is

Tiotropium bromide monohydrate

What the non-medicinal ingredients are

Benzalkonium chloride, disodium edetate, hydrochloric acid and purified water.

What dosage forms it comes in

Inhalation Solution

Each puff delivers 2.5 mcg tiotropium from the mouthpiece (as tiotropium bromide monohydrate).

The inhaler enables you to inhale the medicine contained in a cartridge. The cartridge contains 60 puffs (equal to 30 medicinal doses ) or 28 puffs (equal to 14 medicinal doses) available after preparing the inhaler for first use. There is enough medicine for 30 days or 14 days when it is used as 2 puffs once a day.

Warnings and precautions

The solution is intended for inhalation only. Avoid getting the mist into your eyes. This may result in eye pain and/or discomfort, temporary blurring of vision, and/or coloured images in association with red eyes. Should any of these symptoms develop, consult a doctor immediately.

BEFORE you use SPIRIVA RESPIMAT talk to your doctor or pharmacist if:

  • you are pregnant or intend to become pregnant;
  • you are breast-feeding;
  • you are using any medications including eye drops, other bronchodilators or medications you can buy without a prescription;
  • you have any other medical problems such as difficult urination or enlarged prostate;
  • you have eye problems, such as glaucoma, or eye pain;
  • you have any allergies to food or drugs;
  • you have kidney disease;
  • you have unstable heart disease;
  • you have any other medical problems.

SPIRIVA RESPIMAT is indicated for the treatment of COPD and asthma. Do not use this medicine to treat a sudden attack of breathlessness or wheezing. 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 for your asthma, it should be added on to your inhaled corticosteroid and a long-acting beta-agonist medications. Continue taking your other medications as prescribed by your doctor, even if you feel better.

Your doctor will recommend when and how you should use SPIRIVA RESPIMAT. You must follow any other direction that your doctor has given you for the treatment and/or monitoring of your condition.

Contact your doctor immediately if:

  • you require more than one dose (2 actuations) per day to relieve your breathing problems;
  • your shortness of breath becomes worse;
  • you don’t get the same benefit from your medicine as you did before;
  • you have breathing difficulties and chest pain;
  • you experience difficulty with urination.

SPIRIVA RESPIMAT may cause dizziness, difficulty in focusing the eye, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Proper use of this medication

SPIRIVA RESPIMAT has been prescribed to treat your current condition. DO NOT give it to other people. Always use SPIRIVA RESPIMAT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Appropriate use of SPIRIVA RESPIMAT includes an understanding of the way it should be administered. Therefore, it is important that you read and understand how to use the inhaler before starting SPIRIVA RESPIMAT therapy.

It is very important that you use SPIRIVA RESPIMAT regularly every day. Do not stop taking SPIRIVA RESPIMAT suddenly even if you feel better.

FOR ORAL INHALATION ONLY

Take care to avoid spraying SPIRIVA RESPIMAT into your eyes.

Usual Adult Dose

COPD

Take 2 puffs once a day, if possible at the same time of the day, every day.

Asthma

Take 2 puffs once a day, if possible at the same time of the day, every day.

In the treatment of asthma, the full benefits will be seen after several doses of SPIRIVA RESPIMAT.

Instructions for use

Please read and carefully follow these instructions.

Each box contains 1 RESPIMAT inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) or 28 puffs (14 medicinal doses) . The colour of the cap of the Respimat inhaler is colour coded to match the cartridge.

Before SPIRIVA RESPIMAT is used for the first time, the cartridge provided must be inserted into the inhaler.

The inhaler and cartridge for SPIRIVA RESPIMAT

1) Inserting the cartridgeThe following steps 1-6 are necessary before first use: 1. With the greencap (A) closed, press the safety catch (E) while pulling off the clear base (G).

The inhaler and cartridge for SPIRIVA RESPIMAT

1) Inserting the cartridge

The following steps 1-6 are necessary before first use:

1. With the green
   cap (A) closed,
   press the safety
   catch (E) while
   pulling off the
   clear base (G).


2. Take the cartridge
   (H) out of the
   box. Push the
   narrow end of
   the cartridge into
   the inhaler until it
   clicks into place
   (2a).


                                         The cartridge
                                         should be pushed
                                         firmly against a
                                         firm surface to
                                         ensure that it has
                                         gone all the way
                                         in (2b).


  The cartridge
  will not be flush
  with the inhaler,
  you will still see
  the silver ring of
  the lower end of
  the cartridge.

                                        Do not remove
                                         the cartridge once
                                         it has been
                                         inserted into the
                                         inhaler.

3. Replace the clear
   base (G).

   Do not remove
   the clear base
   again.




2) Preparing SPIRIVA RESPIMAT for the first time

4. Hold SPIRIVA
   RESPIMAT upright, with
   the green cap (A) closed.
   Turn the clear base (G) in
   the direction of the black
   arrows on the label until it
   clicks (half a turn).




5. Open the green cap (A)
   until it snaps fully open.









6. Point SPIRIVA
   RESPIMAT towards the
   ground. Press the dose
   release button (D). Close
   the green cap (A).



Repeat steps 4, 5 and 6 until a cloud is visible.

Then repeat steps 4, 5 and 6 three more times to ensure the inhaler is prepared for use.

SPIRIVA RESPIMAT is now ready to use.

These steps will not affect the number of doses available. After preparation, your SPIRIVA RESPIMAT will deliver 60 puffs (30 medicinal doses) or 28 puffs (14 medicinal doses).

3) Daily use of your SPIRIVA RESPIMAT inhaler


I    Hold SPIRIVA
     RESPIMAT
     upright, with the
     green cap (A)
     closed, to avoid
     accidental release of
     dose. Turn the clear
     base (G) in the
                                           direction of the
                                           black arrows on the
                                           label until it clicks
                                           half a turn).

II    Open the green cap
     (A) until it snaps
     fully open. Breathe
     out slowly and
     fully, and then close
     your lips around the
     end of the
     mouthpiece without
                                          covering the air
                                          vents (C). Point
                                          SPIRIVA
                                          RESPIMAT to the
                                          back of your throat

                                          While taking in a
                                          slow, deep breath
                                          through your
                                          mouth, press the
                                          dose release button
                                          (D) and continue to
                                          breathe in slowly
                                          for as long as you
                                          can. Hold your
                                          breath for 10
                                          seconds or for as
                                          long as comfortable.

III   Repeat Steps I and II so that you get the full dose.

      You will need to use this inhaler only once a day.

      Close the green cap until you use your SPIRIVA RESPIMAT inhaler again.

Helpful Hints for Daily Dosing

Using the SPIRIVA RESPIMAT inhaler requires 3 simple steps. A helpful way to remember the steps for Daily Dosing is to remember TOP:


Turn the clear base

Open the cap and close your lips around the mouthpiece

Press the dose-release button and inhale


These steps should be performed two times to receive the proper dose of medicine.

If SPIRIVA RESPIMAT has not been used for more than 7 days, release one puff towards the ground.

If SPIRIVA RESPIMAT has 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.

4) When to get a new SPIRIVA RESPIMAT inhaler

     SPIRIVA RESPIMAT
     contains 60 puffs (30
     medicinal doses) or 28
     puffs (14 medicinal
     doses). The dose
     indicator shows
     approximately how much
     medication is left. When
     the pointer enters the red
     area of the scale, there is
                                          medication left

      (30 medicinal doses
     product) or 3 days (14
     medicinal doses
     product). This is when
     you need to get a new
     SPIRIVA RESPIMAT
     prescription.




Once the dose indicator has reached the end of the red scale, all puffs have been used and the RESPIMAT inhaler locks automatically. At this point, the base cannot be turned any further.

At the latest, three months after first use, the SPIRIVA RESPIMAT should be discarded even if not all medication has been used, or when the locking mechanism is enacted, whichever comes first.

How to care for your 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 performance of your SPIRIVA RESPIMAT.

If necessary, wipe the outside of SPIRIVA RESPIMAT with a damp cloth.

Additional information

SPIRIVA RESPIMAT must not be disassembled after inserting the cartridge and replacing the clear base.

Do not touch the piercing element inside the bottom of the clear base.

What if... ReasonWhat to do
I cannot turn
the base easily?
The SPIRIVA
RESPIMAT inhaler
is already prepared
and ready to use.
The SPIRIVA
RESPIMAT inhaler
is locked and all the
medicine has been
used.
The SPIRIVA
RESPIMAT inhaler
can be used as it is.

Prepare and use a
new SPIRIVA
RESPIMAT inhaler.
I cannot press
the dose
release button?

The clear base has
not been turned.
Turn the clear base
until it clicks (half a
turn).
The clear base
springs back
after I have
turned it and a
small amount
of moisture is
released?

The clear base was
not turned far
enough.

Prepare the SPIRIVA
RESPIMAT inhaler
for use by turning the
clear base until it
clicks (half a turn).
I can turn the
clear base past
the point
where it clicks?

Either the dose
release button has
been pressed, or the
clear base has been
turned too far.
With the green cap
closed, turn the clear
base until it clicks
(half a turn).

Overdose

In case of an overdose, immediately contact your doctor, or the Regional Poison Control Center, or go to the nearest hospital emergency department.

Missed dose

If you forget to inhale a dose, inhale the next dose as soon as possible but do not inhale two doses on the same day. Then inhale the next dose as usual.

Side effects and what to do about them

Side effects may include:

  • Cough, dry mouth or throat, bad taste;
  • Dizziness;
  • Hoarse voice;
  • Rash, itching;
  • Difficulty in sleeping;
  • Heartburn;
  • Constipation;
  • Sore throat;
  • Sinus infection;
  • Inflammation of the mouth, gums and/or tongue;
  • Nosebleed;
  • Infections or ulcerations of the skin;
  • Dry skin.

Check with your doctor if the dry mouth or bad taste persists or if you experience constipation for a prolonged period of time.

Serious side effects, how often they happen and what to do about them

Symptom / effectTalk with your doctor or pharmacistStop taking drug and seekimmediate medical help
Only if severIn all case
Uncommon
(< 1/100
patients)
Urinary Retention:difficulty and pain when passing urine, urinating frequently,urination in a weak stream or drips  
Oropharyngeal Candidiasis:fungal infection of the oral cavity and throat  
Skin rash/hives 
ParadoxicalBronchospasm:tightness of the chest associated with coughing, wheezing, or breathlessness immediately after inhalation  
Rare
(<1 /1000
patients)
Serious Allergic Reaction:rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing  
Urinary tract infection  
Difficulty in swallowing  
Fast or irregular heart beat
Eye disorders: new or worsened pressure in your eyes, eye pain or discomfort, blurred vision, seeing halos or rainbows around items or red eyes  
Not KnownSwelling of joints  
Dehydration
Intestinal Obstruction: absence of bowel movements  

This is not a complete list of side effects. For any unexpected effects while taking SPIRIVA RESPIMAT, contact your doctor or pharmacist.

How to store it

Store at room temperature (25°C), excursions permitted to 15-30°C. Do not freeze.

Store out of the sight and reach of children.

SPIRIVA RESPIMAT should be discarded whenever one of the following occurs first:

  • at the latest, three months after you first use it (even if not all medication has been used); 
  • when the locking mechanism is enacted.

Reporting suspected side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701E
                     Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.boehringer-ingelheim.ca or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103 Ext. 84633 (Medical Information).

Please visit our website to see if more up-to-date information has been posted.