Spiriva 18 microgram inhalation powder, hard capsule

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Tiotropium bromide

可用日期:

Merit Pharmaceuticals Limited

ATC代码:

R03BB; R03BB04

INN（国际名称）:

Tiotropium bromide

剂量:

18 microgram(s)

药物剂型:

Inhalation powder, hard capsule

治疗领域:

Anticholinergics; tiotropium bromide

授权日期:

2012-08-17

资料单张

SPIRIVA
® 18 MICROGRAM, INHALATION POWDER, HARD CAPSULE
tiotropium
This product is known by the above name but will be referred to as
Spiriva 18
microgram throughout this:
PACKAGE LEAFLET INFORMATION FOR THE USER
WHAT IS IN THIS LEAFLET:
1) What Spiriva 18 microgram is and what it is used for
2) What you need to know before you take Spiriva 18 microgram
3) How to take Spiriva 18 microgram
4) Possible side effects
5) How to store Spiriva 18 microgram
6) Contents of the pack and other information
1) WHAT SPIRIVA 18 MICROGRAM IS AND WHAT IT IS USED FOR
Spiriva 18 microgram helps people who have chronic obstructive
pulmonary
disease (COPD) to breathe more easily. COPD is a chronic lung disease
that
causes shortness of breath and coughing. The term COPD is associated
with
the conditions chronic bronchitis and emphysema. As COPD is a chronic
disease you should take Spiriva 18 microgram every day and not only
when
you have breathing problems or other symptoms of COPD.
Spiriva 18 microgram is a long-acting bronchodilator that helps to
open your
airways and makes it easier to get air in and out of the lungs.
Regular use of
Spiriva 18 microgram can also help you when you have on-going
shortness of
breath related to your disease and will help you to minimise the
effects of the
disease on your everyday life. It also helps you to be active longer.
Daily use
of
Spiriva
18
microgram
will
also
help
to
prevent
sudden,
short-term
worsening of your COPD symptoms which may last for several days. The
effect of this medicine lasts for 24 hours, so you only need to take
it once a
day. For correct dosing of Spiriva 18 microgram please see section 3.
How to
take Spiriva 18 microgram and the instructions for use provided on the
other
side of the leaflet.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPIRIVA 18 MICROGRAM
PLEASE READ THE FOLLOWING QUESTIONS CAREFULLY. If you can answer any
of
these questions with “YES” please discuss this with your doctor
BEFORE taking
Spiriva 18 microgram
•
are you allergic to tiotropium, atropine or sim

产品特点

Health Products Regulatory Authority
21 May 2021
CRN00C2S0
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 other hea