Spiriva 18 microgram inhalation powder, hard capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tiotropium bromide

Available from:

Primecrown 2010 Limited

ATC code:

R03BB; R03BB04

INN (International Name):

Tiotropium bromide

Dosage:

18 microgram(s)

Pharmaceutical form:

Inhalation Powder, Capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Anticholinergics; tiotropium bromide

Authorization status:

Authorised

Authorization date:

2012-08-17

Summary of Product characteristics

Health Products Regulatory Authority
19 November 2019
CRN009GHP
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spiriva 18 microgram inhalation powder, hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 22.5 microgram tiotropium bromide monohydrate
equivalent to 18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the
HandiHaler device) is 10 microgram tiotropium.
Excipient: Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
_Product imported from the UK and France:_
Light green hard capsules with the product code TI 01 and company logo
printed on the capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tiotropium is indicated as a maintenance bronchodilator treatment to
relieve symptoms of 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 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 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:
There is no relevant use in the paediatric population (below 18 years)
in the indication stated under section 4.1.
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 othe