Inspiolto Respimat: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

INSPIOLTO RESPIMAT is a combination of two medicines that are used to make breathing easier for people who experience breathing difficulties due to a lung disease called Chronic Obstructive Pulmonary Disease or COPD (including chronic bronchitis and emphysema).

What it does:

INSPIOLTO RESPIMAT contains two active ingredients: Tiotropium, a long-acting muscarinic antagonist (LAMA), and Olodaterol, a long-acting beta₂-adrenergic agonist (LABA).

Tiotropium and olodaterol relax the muscles in the walls of small airways in the lungs. Both of these medicines work together to help open the airways and make it easier for air to get in and out of the lungs. When taken as prescribed, tiotropium and olodaterol help keep the airways open, which can help prevent shortness of breath and wheezing.

When it should not be used:

Do not use INSPIOLTO RESPIMAT:

• if you have asthma;
• to treat sudden symptoms of COPD;
• if you are allergic to tiotropium bromide, ipratropium bromide or other anticholinergic drugs (containing atropine or its derivatives);
• if you are allergic to olodaterol hydrochloride or other drugs containing a beta agonist;
• if you are allergic to any of the non-medicinal ingredients in the formulation;
• if you are less than 18 years of age.

What the medicinal ingredients are:

Tiotropium Bromide Monohydrate and Olodaterol Hydrochloride

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 (as tiotropium bromide monohydrate) and 2.5 mcg olodaterol (as olodaterol hydrochloride) from the mouthpiece.

INSPIOLTO RESPIMAT is supplied in a carton containing one INSPIOLTO RESPIMAT cartridge and one INSPIOLTO RESPIMAT inhaler.

The INSPIOLTO RESPIMAT cartridge is only intended for use with the INSPIOLTO RESPIMAT inhaler.

WARNINGS AND PRECAUTIONS

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BEFORE you use INSPIOLTO RESPIMAT talk to your doctor, nurse or pharmacist if you:

• have heart problems, such as rapid or irregular heartbeat or abnormal electrical signal called “prolongation of the QT interval”;
• have high blood pressure;
• have seizures;
• have thyroid problems;
• have diabetes;
• are taking similar medicines for your lung disease;
• have been told you react strongly to sympathomimetic amines (a class of drugs that includes LABA drugs) or if you are allergic to ipratropium bromide or other drugs which are anticholinergic (contain atropine or its derivatives);
• are taking any medications including eye drops, this includes those you can buy without a prescription;
• have any other medical problems such as difficulty with urination or enlarged prostate;
• have eye problems, such as glaucoma, or eye pain;
• have any allergies to food or drugs;
• have kidney disease;

• are pregnant or planning to become pregnant. It is not known if INSPIOLTO RESPIMAT can harm your unborn baby;

• are breastfeeding. It is not known if INSPIOLTO RESPIMAT passes into your milk and if it can harm your baby.

During the treatment with INSPIOLTO RESPIMAT, tell your doctor immediately or get emergency medical care if you experience any of the following symptoms:

• Tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (signs of bronchospasm).
• Difficulties in breathing or swallowing, swelling of tongue, lips and face, hives or itching, skin rash (signs of
• hypersensitivity reaction). Do not use INSPIOLTO RESPIMAT again before speaking with your doctor.
• Your COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during your treatment.
• Pain or difficulty with urination.

Other warnings you should know about

Treatment of COPD: INSPIOLTO RESPIMAT does not relieve sudden symptoms of COPD. Always have a short-acting bronchodilator medicine with you to treat acute symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.

Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you have asthma.

Driving and using machines: Caution is required when driving a car or operating machinery as dizziness and blurred vision may occur with the use of INSPIOLTO RESPIMAT. If you experience dizziness, you should avoid driving or operating machinery.

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.

The following may interact with INSPIOLTO RESPIMAT:

• antidepressants, in particular tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs);
• medicines similar to INSPIOLTO RESPIMAT (other short- or long-acting muscarinic antagonists such as ipratropium, tiotropium, glycopyrronium, aclidinium, umeclidinium) used for your lung disease, as an overdose may result;
• medicines that decrease the level of potassium in your blood. These include diuretics (also known as “water pills” and are used to treat high blood pressure e.g. hydrochlorothiazide), other bronchodilators such as methylxanthines (e.g. theophylline) or steroids (e.g. prednisolone);
• beta-blockers used in the treatment of high blood pressure or other heart problems (e.g. propranolol) or in the treatment of glaucoma (e.g. timolol).

PROPER USE OF THIS MEDICATION

• Read the Instructions for use before using INSPIOLTO RESPIMAT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor, nurse or pharmacist about your medical condition or your treatment.
• Always use the new INSPIOLTO RESPIMAT inhaler that is provided with each new prescription.

• Do not stop using INSPIOLTO RESPIMAT or other medicines

  • to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • Do not spray into eyes.

  • Call your healthcare provider or get emergency medical care right away if:

    • your breathing problems worsen with INSPIOLTO RESPIMAT;
    • you need to use your rescue medicine more often than usual;
    • your rescue inhaler medicine does not work as well for you at relieving your symptoms.

Usual Adult Dose:

The recommended dose of INSPIOLTO RESPIMAT is 2 puffs (5 mcg tiotropium and 5 mcg olodaterol), once daily at the same time of the day, every day.

Overdose:

Missed Dose:

If you miss a dose of INSPIOLTO RESPIMAT, take it as soon as you remember. Do not take more than one dose (two puffs) per day. Then take your next dose as usual.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• increase of the measured eye pressure;
• seeing halos around lights or coloured images in association with red eyes;
• blurred vision;
• diarrhea;
• constipation;
• dry mouth;
• inflammation of the mouth, gums and tongue;
• difficulty in swallowing;
• heartburn;
• feeling tired;
• general weakness;
• inflammation of the throat, nasal passages and sinuses;
• common cold;
• fungal infections of the oral cavity and throat;
• depletion of body water;
• back pain;
• swollen and painful joints;
• muscular pain;
• muscle spasms;
• feeling dizzy;
• difficulty sleeping
• cough;
• pain in mouth and throat;
• hoarseness;
• nosebleed;
• sore throat and discomfort when swallowing;
• inflammation/irritation of the vocal chords;
• pain when passing urine;
• inability to empty the bladder;
• rash;
• itching;
• nettle rash;
• infections or ulcerations of the skin;
• dryness of the skin.

If any of these affects you severely, tell your doctor, nurse or pharmacist.

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

HOW TO STORE IT

Store INSPIOLTO RESPIMAT between 15–30°C. Do not freeze your INSPIOLTO RESPIMAT cartridge and inhaler. Keep your INSPIOLTO RESPIMAT cartridge and inhaler out of the sight and reach of children.

Reporting Side Effects

MORE INFORMATION

If you want more information about INSPIOLTO RESPIMAT:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp), the manufacturer’s website (https://www.boehringer-ingelheim.ca), or by calling the manufacturer, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103, ext. 84633.

Last revised: November 14, 2019

INSTRUCTIONS FOR USE

Introduction Read these Instructions for Use before you start using INSPIOLTO RESPIMAT. You will need to use this inhaler only ONCE A DAY. Each time you use it take 2 PUFFS. Each box contains: 1 RESPIMAT inhaler 1 cartridge Each cartridge provides 60 puffs (30 doses). Physician samples and hospital packs provide 28 puffs (14 doses). The colour of the cap of the RESPIMAT inhaler is colour coded to match the cartridge. How to store my INSPIOLTO RESPIMAT inhaler Store INSPIOLTO RESPIMAT (the cartridge and inhaler) between 15-30oC. Do not freeze. Keep out of the sight and reach of children. Do not use your inhaler after the expiry date. Do not touch the piercing element inside the clear base. If you have not used your inhaler in more than: 7 days: release 1 puff towards the ground 21 days: repeat steps 4 to 6 under “Prepare for First Use” until a cloud is visible. Then repeat steps 4 to 6 three more times. How to care for your INSPIOLTO RESPIMAT Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only. You should do this at least once a week. Any minor changes in the colour of the mouthpiece will not affect how your INSPIOLTO RESPIMAT works.

When to get a new INSPIOLTO RESPIMAT Your INSPIOLTO RESPIMAT inhaler contains either 60 puffs (30 doses) or 28 puffs (14 doses) if you use it as directed (2 puffs/once a day). The 28 puff (14 doses) product is for physician samples and the hospital pack. The dose indicator shows you about how much medication is left. When the dose indicator enters the red area of the scale, there is about: 7 days of medication left for the 60 puff product 3 days of medication left for the 28 puff product. You need to get a new prescription or refill your prescription. Once the dose indicator reaches the end of the red scale: Your INSPIOLTO RESPIMAT locks automatically. No more doses can be released. At this point, the clear base cannot be turned any further. You should throw out the INSPIOLTO RESPIMAT when one of the following happens first: 3 months after first use, even if all the medication has not been used, or it locks automatically.

Empty Full Dose Indicator

1	Remove clear base Keep the cap closed. Press the safety catch while firmly pulling off the clear base with your other hand.	Clear base Safety catch
2	Insert cartridge Insert the narrow end of the cartridge into the inhaler. Place the inhaler on a firm surface and push down firmly until it snaps into place. You should hear a “click” when it has gone in all the way.
3	Replace clear base Put the clear base back into place until it “clicks”. Do not remove the clear base again.	Clear base
4	Turn Keep the cap closed. Turn the clear base in the direction of the arrows on the label until it “clicks” (half a turn).	Arrows
5	Open Open the cap until it snaps fully open.	Cap
6	Press Point the inhaler toward the ground. Press the dose-release button. Close the cap. Repeat steps 4 to 6 until a cloud is visible. After a cloud is visible, repeat steps 4 to 6 three more times. Your inhaler is now ready to use. Dose-release button	Steps 4-6 x3

Daily Use
TURN Keep the cap closed. TURN the clear base in the direction of the arrows on the label until it “clicks” (half a turn).	Arrows
OPEN OPEN the cap until it snaps fully open.	Cap
PRESS Breathe out slowly and fully. Close your lips around the mouthpiece without covering the air vents. While taking a slow, deep breath through your mouth, PRESS the dose-release button and continue to breathe in. Hold your breath for 10 seconds or for as long as you feel comfortable. To take your second puff, repeat the 3 steps, TURN, OPEN and PRESS (TOP) one more time. Close the cap.	Air Vent