Spiriva 18 microgram, inhalation powder, hard capsule

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Tiotropium

Предлага се от:

IMED Healthcare Ltd.

АТС код:

R03BB; R03BB04

INN (Международно Name):

Tiotropium

дозиране:

18 microgram(s)

Лекарствена форма:

Inhalation powder, hard capsule

Терапевтична област:

Anticholinergics; tiotropium bromide

Дата Оторизация:

2006-11-27

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA® 18 MICROGRAM, INHALATION POWDER, HARD CAPSULE
TIOTROPIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What SPIRIVA 18 micrograms is and what it is used for
2. What you need to know before you use SPIRIVA 18 micrograms
3. How to use SPIRIVA 18 micrograms
4. Possible side effects
5. How to store SPIRIVA 18 micrograms
6. Contents of the pack and other information
1. WHAT SPIRIVA 18 MICROGRAMS 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
SPIRIVA18 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 use it once a day.
For correct

Данни за продукта

Health Products Regulatory Authority
09 October 2020
CRN009XJ3
Page 1 of 2
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 with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule
_Product imported from Bulgaria, France, Italy, Romania, Spain and the
UK:_
Light green hard capsules containing the inhalation powder with the
product code TI 01 and company logo printed on the
capsule.
4 CLINICAL PARTICULARS
As per PA0775/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0775/002/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate (which may contain small amounts of milk proteins)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strips and outer carton of the product as marketed in
the country of origin.
After first opening of the blister use within the next 9 days.
Discard the HandiHaler device 12 months after first use.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
09 October 2020
CRN009XJ3
Page 2 of 2
Cardboard box containing HandiHaler device and 3 blister strips (3 x
10 capsules)
Cardboard box containing 3 blister strips (3 x 10 capsules)
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUM