SPIRIVA RESPIMAT Inhalation solution Ref.[51416] Active ingredients: Tiotropium

Posology

The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler (see 4.2).

Two puffs from the Respimat inhaler comprise one medicinal dose.

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

The recommended dose should not be exceeded.

In the treatment of asthma the full benefit will be apparent after several doses of the medicinal product. In adult patients with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (≥800 μg budesonide/day or equivalent) and at least one controller.

Special populations

Geriatric patients can use tiotropium bromide at the recommended dose.

Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min, see 4.4 and 5.2).

Hepatically impaired patients can use tiotropium bromide at the recommended dose (see 5.2).

Paediatric population

Asthma:

The recommended dose for patients 6 to 17 years of age is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day. In adolescents (12-17 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (>800-1600 µg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (400-800 µg budesonide/day or equivalent) with two controllers.

For children (6-11 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (>400 µg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (200-400 µg budesonide/day or equivalent) with two controllers.

The safety and efficacy of Spiriva Respimat in children aged 6-17 years with moderate asthma has not been established. The safety and efficacy of Spiriva Respimat in children below 6 years of age has not been established. Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.

COPD:

There is no relevant use of Spiriva Respimat in children and adolescents below 18 years.

Cystic fibrosis

The efficacy and safety of Spiriva Respimat has not been established (see sections 4.4 and 5.1).

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 Spiriva Respimat.

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

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

Children should use Spiriva Respimat with an adult’s assistance.

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

• 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 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 Spiriva 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.

When to replace the Spiriva Respimat cartridge:

The dose indicator shows how many puffs remain in the cartridge.

60 puffs remaining

Less than 10 puffs remaining. Obtain a new cartridge.

The cartridge is used up. Turn the clear base to loosen it. The inhaler is now in a locked position. Pull off the cartridge from the inhaler. Insert a new cartridge until it clicks (refer to step 2). The new cartridge will stick out more than the very first cartridge (continue with step 3). Remember to put the clear base back to unlock the inhaler.

High doses of tiotropium bromide may lead to anticholinergic signs and symptoms.

However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium bromide in healthy volunteers. Additionally, no relevant adverse effects, beyond dry mouth/throat and dry nasal mucosa, were observed following 14-day dosing of up to 40 microgram tiotropium inhalation solution in healthy volunteers with the exception of pronounced reduction in salivary flow from day 7 onwards.

3 years.

In-use shelf life of the cartridge: 3 months.

In-use shelf life of the inhaler: 1 year.

Recommended use: 6 cartridges per inhaler.

Note: The functioning of the RESPIMAT re-usable inhaler has been demonstrated in tests for 540 actuations (corresponding to 9 cartridges).

Do not freeze.

Type and material of the container in contact with the medicinal product:

Solution filled into a polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. The cartridge is enclosed within an aluminium cylinder.

Each cartridge contains 4 ml inhalation solution.

Pack sizes and devices supplied:

Single pack: 1 Respimat re-usable inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)

Triple pack: 1 Respimat re-usable inhaler and 3 cartridges, providing 60 puffs (30 medicinal doses) each

Single refill pack: 1 cartridge, providing 60 puffs (30 medicinal doses)

Triple refill pack: 3 cartridges, providing 60 puffs (30 medicinal doses) each

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.