Spiriva: Uses, Side Effects and Dosage

What is SPIRIVA used for?

SPIRIVA is used long-term in adults to manage airway blockage from chronic obstructive pulmonary disease (COPD; a lung disease that makes it hard to breathe). This can include chronic bronchitis (inflammation of the lungs) and emphysema (damage to parts of the lung known as alveoli).

SPIRIVA is not a rescue medicine and should not be used on an as needed basis for treating sudden severe symptoms of COPD (e.g., sudden breathing problems). Your healthcare professional may give you other medicines to use for sudden breathing problems.

How does SPIRIVA work?

SPIRIVA belongs to a class of medications known as long-acting muscarinic antagonist (LAMA) bronchodilators, also known as an anticholinergic. It works by relaxing the muscles around the airways in your lungs for 24 hours. When you inhale it, it makes it easier for you to breathe.

What are the ingredients in SPIRIVA?

Medicinal ingredient: Tiotropium bromide monohydrate.

Non-medicinal ingredients: Gelatin, and lactose monohydrate (which contains milk protein).

SPIRIVA comes in the following dosage forms:

Inhalation powder capsules: 18 mcg of tiotropium (as tiotropium bromide monohydrate).

Do not use SPIRIVA if:

• you are allergic to tiotropium bromide, atropine or its derivatives (such as ipratropium), or to other ingredients in SPIRIVA. If you are unsure ask your healthcare professional.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SPIRIVA. Talk about any health conditions or problems you may have, including if you:

• are pregnant or plan to become pregnant;

• are breastfeeding or plan to breastfeed;
• are taking any medications including eye drops, this includes those you can buy without prescription;
• have difficulty urinating, which can include problems caused by an enlarged prostate;
• have eye pain caused by increased pressure in the eyes (narrow-angle glaucoma);
• have problems digesting certain milk sugars (e.g., galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption). SPIRIVA capsules contain lactose, a milk sugar. If you are unsure ask your healthcare professional;
• have kidney problems;
• have or have had heart problems.

Other warnings you should know about:

Eye problems: Avoid getting the SPIRIVA powder into your eyes. This may cause eye pain, discomfort, temporary blurring of vision, and/or coloured images in association with red eyes. These may be signs of acute narrow-angle glaucoma (eye pain caused by increased pressure in the eyes). If you develop any of these symptoms, consult a healthcare professional right away.

Driving and using machines: SPIRIVA can cause dizziness or blurred vision. Before you drive or do tasks that require special attention, wait until you know how you respond to SPIRIVA.

Monitoring: Your healthcare professional might monitor your health throughout your treatment with SPIRIVA. This can include monitoring your kidney and the development of sudden or worsening COPD symptoms.

Contact your healthcare professional immediately if:

• you require more than one dose 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.

See the Serious side effects and what to do about them table below for more information on these and other serious side effects.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SPIRIVA:

• medicines similar to SPIRIVA (other short- or long-acting muscarinic antagonists) used for your lung disease may interact with SPIRIVA and increase the risk of experiencing possible side effects.

How to take SPIRIVA:

• SPIRIVA has been prescribed for you and should not be given to other people. Take SPIRIVA capsules exactly as your healthcare professional tells you to. Do not take more than once a day or exceed the prescribed dose. You should check with your healthcare professional if you are not sure.
• Your healthcare professional may also provide you with an inhaled short-acting bronchodilator for the treatment of COPD symptoms that may occur suddenly.
• The contents of the capsule must be inhaled once daily through the mouthpiece of the HANDIHALER inhalation device only. Do NOT swallow the capsule! The HANDIHALER device is especially designed for SPIRIVA and must not be used with any other capsules. Likewise, you should not take your SPIRIVA capsules with any inhalation device other than the HANDIHALER.
• Before starting your treatment with SPIRIVA, be certain that you are completely familiar with the use and proper care of the HANDIHALER device.

HANDIHALER Inhalation Device:

• The HANDIHALER inhalation device enables you to inhale the medicine contained in the SPIRIVA capsule that your healthcare professional has prescribed for your breathing problems.
• After first use, you can use your HANDIHALER device for up to one-year to take your medication before needing a replacement.
• If you are unable to inspire through the HANDIHALER device to make the SPIRIVA capsule vibrate, consult your healthcare professional.

How to Use the HANDIHALER Inhalation Device and SPIRIVA:

Preparation:

1. Become familiar with the HANDIHALER device.

HANDIHALER device parts: Dust cap Mouthpiece Mouthpiece ridge Base Piercing button Centre chamber Air intake vents
2. To release the dust cap, press the green piercing button completely in and let go.
3. Open the dust cap completely by pulling it upwards, then open the mouthpiece by pulling it upwards.
Blister Handling:
4A. The blister card contains two blister strips (5 capsules each) joined along a perforated line. Prior to removing the first capsule from the blister card, separate the SPIRIVA blister strips by tearing along the perforation.
4B. Immediately before use, peel the aluminum back foil until one capsule is fully visible. After opening a strip, the in-use shelf life of the remaining capsules in the strip is 5 days.

4C. Remove one SPIRIVA capsule from the blister. Do not expose more than one capsule. If more than one capsule is exposed, you should discard the exposed unused capsules. Do not store the capsule in the HANDIHALER device. SPIRIVA capsules are partially filled but contain exact amount of medication as declared on the label.
Administration:
5. Place the capsule in the centre chamber. It does not matter which end of the capsule is placed in the chamber.
6. Close the mouthpiece firmly until you hear a click, leaving the dust cap open.
7. Hold the HANDIHALER with the mouthpiece upwards and press the green piercing button completely in only once, and release. This makes holes in the capsule and allows the medication to be released when you breathe in. The piercing of the SPIRIVA capsule may produce small gelatin pieces. Some of these small pieces may pass through the screen of your HANDIHALER device into your mouth or throat when you breathe in your medicine. This is normal. The small pieces of gelatin should not harm you.
8. If you feel that your chest is congested with mucus, try to cough to clear your lungs before you inhale SPIRIVA. Breathe out completely. Important: Do not breathe into the mouthpiece at any time.

Cleaning:

It is important to clean the HANDIHALER once a month as follows:

If you have any questions about SPIRIVA or the HANDIHALER device, contact your healthcare professional.

Usual dose:

One (1) SPIRIVA capsule is to be inhaled once daily, preferably at the same time each day, only with the HANDIHALER inhalation device.

Overdose:

Symptoms of an overdose with SPIRIVA include:

• constipation,
• difficulty urinating,
• dry mouth,
• increased eye pressure or pain,
• eye redness,
• vision changes.

Missed Dose:

If you miss or forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses at the same time or on the same day.

What are possible side effects from using SPIRIVA?

These are not all the possible side effects you may have when taking SPIRIVA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of SPIRIVA may include:

• coughing;
• dry mouth or throat. Check with your healthcare professional if the dry mouth persists;
• bad taste. Check with your healthcare professional if the bad taste persists;
• dizziness;
• hoarse voice;
• itching;
• difficulty in sleeping;
• heartburn;
• constipation. If you experience constipation for a prolonged period of time, tell your healthcare professional;
• sore throat;
• sinus infection;
• inflammation of the mouth, gums and/or tongue;
• nosebleed;
• infections or ulcerations of the skin;
• dry skin;
• swelling of joints;
• dehydration.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store your SPIRIVA capsules and HANDIHALER inhalation device between 15^oC to 25^oC. Protect from freezing, moisture, heat, and sunlight.

• Your capsules should always be stored in the blister strips and only removed from the blister immediately before use. After opening a blister strip, use within 5 days. If more

  • than one capsule is accidently exposed to air, discard the exposed unused capsule.
• Do not store SPIRIVA capsules inside the HANDIHALER device.
• Keep out of reach and sight of children.

If you want more information about SPIRIVA:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s, Boehringer Ingelheim (Canada) Ltd., website (https://www.boehringer-ingelheim.ca), or by calling 1-800-263-5103, ext. 84633.

This information is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.

Last Revised: APR 22, 2022