Lupin-Tiotropium: Uses, Side Effects and Dosage

What is LUPIN-TIOTROPIUM used for?

LUPIN-TIOTROPIUM 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).

LUPIN-TIOTROPIUM 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 LUPIN-TIOTROPIUM work?

LUPIN-TIOTROPIUM 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 LUPIN-TIOTROPIUM?

Medicinal ingredient: Tiotropium bromide monohydrate.

Non-medicinal ingredients: Lactose monohydrate (which contains milk protein).

LUPIN-TIOTROPIUM comes in the following dosage forms:

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

Do not use LUPIN-TIOTROPIUM if:

• you are allergic to tiotropium bromide, atropine or its derivatives (such as ipratropium), or to other ingredients in LUPIN-TIOTROPIUM. 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 LUPIN-TIOTROPIUM. 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). LUPIN-TIOTROPIUM 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 LUPIN-TIOTROPIUM 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: LUPIN-TIOTROPIUM can cause dizziness or blurred vision. Before you drive or do tasks that require special attention, wait until you know how you respond to LUPIN-TIOTROPIUM.

Monitoring: Your healthcare professional might monitor your health throughout your treatment with LUPIN-TIOTROPIUM. 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 LUPIN-TIOTROPIUM:

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

How to take LUPIN-TIOTROPIUM:

• LUPIN-TIOTROPIUM has been prescribed for you and should not be given to other people. Take LUPIN-TIOTROPIUM 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 LupinHaler inhalation device only. Do NOT swallow the capsule! The LupinHaler device is especially designed for LUPIN-TIOTROPIUM and must not be used with any other capsules. Likewise, you should not take your LUPIN-TIOTROPIUM capsules with any inhalation device other than the LupinHaler.
• Before starting your treatment with LUPIN-TIOTROPIUM, be certain that you are completely familiar with the use and proper care of the LupinHaler device.

LupinHaler Inhalation Device:

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

How to Use the LupinHaler Inhalation Device and LUPIN-TIOTROPIUM:

Preparation:

	Remember to carefully follow the doctor's instructions for using LUPIN-TIOTROPIUM. The LupinHaler is specially designed for LUPIN-TIOTROPIUM capsules and must not be used to take any other medication. Discard the LupinHaler 12 months after first use.

	The LupinHaler device parts: Dust cap (lid) Mouthpiece Mouthpiece grip Base Green Piercing button Centre chamber Air Intake vents
	1. After removing LupinHaler device from the pouch: Open the dust cap (lid) by pressing the green piercing button completely in and letting go.
	2. To expose the mouthpiece, open the dust cap (lid) completely by pulling it upwards away from the base.
	3. Lift the mouthpiece away from the base by gripping and squeezing the mouthpiece grip firmly between the thumb and fore finger and lifting up. The centre chamber is now visible.

Blister handling:

Administration:

	5. Close the mouthpiece firmly against the transparent base until you hear a click. Leave the dust cap (lid) open.
	6. Hold the LupinHaler device with the mouthpiece upwards and press the 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.
	7. Breathe out completely. Important: Do not breathe into the mouthpiece at any time.
	8. Raise the LupinHaler to your mouth and close your lips tightly around the mouthpiece. Keep your head in an upright position and breathe in slowly and deeply but at a rate sufficient to hear or feel the capsule vibrate. Breathe in until your lungs are full; then hold your breath as long as comfortable and at the same time take the LupinHaler out of your mouth. Resume normal breathing. To ensure complete inhalation of the capsule contents, repeat steps 7 and 8 once again.
	9. Open the mouthpiece again. Tip out the used capsule and dispose. As the empty capsule may still contain some powder, it should be disposed of carefully. Do not touch the used capsules. If the dry powder gets on your hands, make sure you wash your hands thoroughly. Close the mouthpiece and dust cap for storage of the LupinHaler device.

Cleaning your LupinHaler:

Clean the LupinHaler once a month. Open the dust cap and mouthpiece. Then insert your thumb nail immediately below the green piercing button and lever the button up (as shown). Alternatively, firmly grip the green piercing button between your thumb and fore finger and lift it up. Rinse the inhaler completely with warm water to remove any powder. Dry the LupinHaler thoroughly by tipping excess of water out on a paper towel and air-dry afterwards, leaving the dust cap, mouthpiece and base open. It takes 24 hours to air dry, so clean it right after the use and it will be ready for the next dose. If needed, the outside of the mouthpiece may be cleaned with a moist but not wet tissue. Do not place the LupinHaler device in the dishwasher.

If you have any questions about LUPIN-TIOTROPIUM or the LupinHaler device, contact your healthcare professional.

Usual dose:

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

Overdose:

Symptoms of an overdose with LUPIN-TIOTROPIUM 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 LUPIN-TIOTROPIUM?

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

Side effects of LUPIN-TIOTROPIUM 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;

If you think you, or a person you are caring for, have taken too much LUPIN-TIOTROPIUM, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

• 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.

Storage:

• Store LUPIN-TIOTROPIUM capsules and LupinHaler device between 15-25°C. Do not freeze. Protect from moisture.
• Your capsules should always be stored in the blister strips and only removed from the blister immediately before use. If more than one capsule is accidently exposed to air, discard the exposed unused capsule.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health- products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

• Do not store LUPIN-TIOTROPIUM capsules inside the LupinHaler device.
• Keep out of reach and sight of children.

If you want more information about LUPIN-TIOTROPIUM:

• 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); or by calling at: 1-844-587- 4623.

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Last Approved: May 10, 2023