Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution

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Active Ingredient:

tiotropium bromide monohydrate, olodaterol hydrochloride

Company:

Boehringer Ingelheim Limited See contact details

ATC code:

R03AL06

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Prescription only medicine

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Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info

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1. Name of the medicinal product

Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution

2. Qualitative and quantitative composition

The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff.

The delivered dose is the dose which is available for the patient after passing the mouthpiece.

Excipient with known effect: This medicine contains 0.0011 mg benzalkonium chloride in each actuation.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Inhalation solution

Clear, colourless, inhalation solution

4. Clinical particulars

4.1 Therapeutic indications

Spiolto Respimat is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

4.2 Posology and method of administration

Posology

The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler.

Two puffs from the Respimat inhaler comprise one medicinal dose.

Adults

The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day.

The recommended dose should not be exceeded.

Elderly population

Elderly patients can use Spiolto Respimat at the recommended dose.

Hepatic impairment and Renal impairment

Spiolto Respimat contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.

Hepatic impairment

Patients with mild and moderate hepatic impairment can use Spiolto Respimat at the recommended dose.

There are no data available for use of olodaterol in patients with severe hepatic impairment.

Renal impairment

Renally impaired patients can use Spiolto Respimat at the recommended dose.

For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min) see 4.4 and 5.2.

Spiolto Respimat contains olodaterol. There is limited experience with the use of olodaterol in patients with severe renal impairment.

Paediatric population

There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years).

Method of administration

This medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat re-usable inhaler. Respimat is an inhaler device that generates a spray for inhalation. It is meant for use by a single patient and intended for multiple doses delivered by one cartridge.

The Respimat re-usable inhaler allows for replacement of the cartridge, and can be used with up to 6 cartridges.

Patients should read the instructions on how to use the Respimat re-usable inhaler before they start using Spiolto Respimat.

To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health care professional.

Instructions for handling and use of the Respimat re-usable inhaler

The patient will need to use this inhaler only ONCE A DAY. Each time used take TWO PUFFS.

• If Spiolto Respimat has not been used for more than 7 days release one puff towards the ground.

• If Spiolto Respimat has not been used for more than 21 days repeat steps 4 to 6 under 'Prepare for use' until a cloud is visible. Then repeat steps 4 to 6 three more times.

How to care for the Respimat re-usable 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 Respimat re-usable inhaler performance.

If necessary, wipe the outside of the Respimat re-usable inhaler with a damp cloth.

When to replace the inhaler

When the patient has used an inhaler with 6 cartridges, get a new Spiolto Respimat pack containing an inhaler.

Prepare for use

1. Remove clear base • Keep the cap closed. • Press the safety catch while pulling off the clear base with the other hand.
2. Insert cartridge • Insert the cartridge into the inhaler. • Place the inhaler on a firm surface and push down firmly until it clicks into place.
3. Track cartridge and put the clear base back • Mark the check-box on inhaler's label to track the number of cartridges. • Put the clear base back into place until it clicks.
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).
5. Open • Open the cap until it snaps fully open.
6. Press • Point the inhaler toward the ground. • Press the dose-release button. • Close the cap. • Repeat steps 4-6 until a cloud is visible. • After a cloud is visible, repeat steps 4-6 three more times. The inhaler is now ready to use and will deliver 60 puffs (30 doses).

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).

OPEN

• OPEN the cap until it snaps fully open.

PRESS

• Breathe out slowly and fully.

• Close the lips around the mouthpiece without covering the air vents. Point the Inhaler to the back of the throat.

• While taking a slow, deep breath through the mouth, PRESS the dose-release button and continue to breathe in slowly for as long as comfortable.

• Hold the breath for 10 seconds or for as long as comfortable.

• Repeat TURN, OPEN, PRESS for a total of 2 puffs.

• Close the cap until the inhaler is used again.

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