Tiotropium ProPharma Group, 18 microgram, inhalation powder, hard capsule

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Anhydrous Tiotropium Bromide

Disponível em:

ProPharma Group Netherlands B.V.

Código ATC:

R03BB04

DCI (Denominação Comum Internacional):

Anhydrous Tiotropium Bromide

Dosagem:

18 microgram(s)

Forma farmacêutica:

Inhalation powder, hard capsule

Área terapêutica:

tiotropium bromide

Status de autorização:

Not marketed

Data de autorização:

2020-11-27

Folheto informativo - Bula

Version OCT-2020_IE
2 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIOTROPIUM PROPHARMA GROUP, 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 Tiotropium ProPharma Group is and what it is used for
2.
What you need to know before you use Tiotropium ProPharma Group
3.
How to use Tiotropium ProPharma Group
4.
Possible side effects
5.
How to store Tiotropium ProPharma Group
6.
Contents of the pack and other information
1.
WHAT TIOTROPIUM PROPHARMA GROUP IS AND WHAT IT IS USED FOR
Tiotropium ProPharma Group 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 Tiotropium ProPharma Group every day
and not only when you have
breathing problems or other symptoms of COPD.
Tiotropium ProPharma Group 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
Tiotropium ProPharma Group can also
help you when you have on-going shortness of breath related to your
disease and will help you to
minimize the effects of the disease on your everyday life. It also
helps you to be active longer. Daily
use of Tiotropium ProPharma Group will also help to prevent sudden,
short-term worsening of your
COPD symptoms which may last for several days. The e

Características técnicas

Health Products Regulatory Authority
27 November 2020
CRN009CX4
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tiotropium ProPharma Group, 18 microgram, inhalation powder, hard
capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 21.7 microgram tiotropium bromide equivalent to
18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece) is 10
microgram tiotropium.
Excipient(s) with known effect:
Each capsule contains 5.5 milligram of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
Transparent colourless hard capsules containing white inhalation
powder with 'T10' 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 recommended dosage of tiotropium bromide is inhalation of the
contents of one capsule once daily with the Dry Powder
Inhaler at the same time of day.
The recommended dose should not be exceeded.
Tiotropium bromide capsules are only for inhalation.
Tiotropium bromide capsules must not be swallowed.
Tiotropium bromide should only be inhaled with the Dry Powder Inhaler.
Special populations
_Elderly Patients_
Elderly patients can use tiotropium bromide at the recommended dose.
_Renal Impairment_
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.
_Hepatic Impairment_
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.
Health Products Regulatory Authority
27 November 2020
CRN009CX4
Page 2 of 13
_Cysti