Posology : מינונים

4.2    Posology and method of administration

Posology
The medicinal product is intended for inhalation use only.

The recommended dosage of tiotropium bromide is inhalation of the contents of one capsule once daily with the HandiHaler device at the same time of day.
The recommended dose should not be exceeded.
Tiotropium bromide capsules are only for inhalation and not for oral intake.
Tiotropium bromide capsules must not be swallowed.
Tiotropium bromide should only be inhaled with the HandiHaler device.

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 section 4.4 and section 5.2).

Hepatically impaired patients can use tiotropium bromide at the recommended dose (see section 5.2 ).
Paediatric population
COPD
There is no relevant use in the paediatric population (below 18 years) in the indication stated under section 4.1.

Cystic fibrosis
The safety and efficacy of Spiriva 18 microgram in children and adolescents has not been established.
No data are available.

Method of administration:
To ensure proper administration of the medicinal product the patient should be trained how to use the inhaler by the physician or by other healthcare professionals.

Instructions for handling and use:

Remember to carefully follow your doctor’s instructions for using
SPIRIVA. The HandiHaler is especially designed for SPIRIVA. You must not use it to take any other medication. You can use your
HandiHaler for up to one year to take your medication.


The HandiHaler
1    Dust cap
2    Mouthpiece
3    Base
4    Piercing button
5    Centre chamber
1. To release the dust cap press the piercing button completely in and let go.



2. Open the dust cap completely by pulling it upwards.
Then open the mouthpiece by pulling it upwards.



3. Remove a SPIRIVA capsule from the blister (only immediately before use, see blister handling) and place it in the centre chamber (5), as illustrated. It does not matter which way the capsule is placed in the chamber.



4. Close the mouthpiece firmly until you hear a click, leaving the dust cap open.
5. Hold the HandiHaler 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.



6. Breathe out completely.
Important: Please avoid breathing into the mouthpiece at any time.



7. Raise the HandiHaler 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 HandiHaler out of your mouth.
Resume normal breathing.
Repeat steps 6 and 7 once, in order to empty the capsule completely.

8. Open the mouthpiece again. Tip out the used capsule and dispose.
Close the mouthpiece and dust cap for storage of your HandiHaler device.



Cleaning your HandiHaler
Clean the HandiHaler once a month. Open the dust cap and mouthpiece.
Then open the base by lifting the piercing button. Rinse the complete inhaler with warm water to remove any powder. Dry the HandiHaler 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 you used it and it will be ready for your next dose. If needed, the outside of the mouthpiece may be cleaned with a moist but not wet tissue.
Blister handling

A. Separate the blister strips by tearing along the perforation.



B. Peel back foil (only immediately before use) using the tab until one capsule is fully visible.
In case a second capsule is exposed to air inadvertently this capsule has to be discarded.



C. Remove capsule.



SPIRIVA capsules contain only a small amount of powder so that the capsule is only partially filled.