Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Tiotropium; Olodaterol

Tilgængelig fra:

Boehringer Ingelheim International GmbH

ATC-kode:

R03BB; R03BB54

INN (International Name):

Tiotropium; Olodaterol

Dosering:

2.5 µg/2.5 microgram(s)

Lægemiddelform:

Inhalation solution

Indgivelsesvej:

Inhalation

Enheder i pakken:

1, 2, 3, 8 single packages, each containing 1 Respimat inhaler and one 1 cartridge, providing 60 puffs

Recept type:

Product subject to prescription which may be renewed (B)

Fremstillet af:

Boehringer Ingelheim Pharma GmbH & Co. KG

Terapeutisk gruppe:

Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics

Terapeutisk område:

Anticholinergics; Anticholinergics

Terapeutiske indikationer:

It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Autorisation status:

Marketed

Autorisation dato:

2015-06-19

Indlægsseddel

R1g/IE MT/PI/WS566 dated 12/08/2022
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIOLTO
® RESPIMAT
® 2.5 MICROGRAM/2.5 MICROGRAM, INHALATION SOLUTION
tiotropium/olodaterol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Spiolto Respimat is and what it is used for
2. What you need to know before you take Spiolto Respimat
3. How to take Spiolto Respimat
4. Possible side effects
5. How to store Spiolto Respimat
6. Contents of the pack and other information
1.
WHAT SPIOLTO RESPIMAT IS AND WHAT IT IS USED FOR
WHAT SPIOLTO RESPIMAT IS
Spiolto Respimat contains two active substances called tiotropium and
olodaterol. These belong to a
group of medicines called long-acting bronchodilators. Tiotropium
belongs to the subgroup of
anticholinergics; olodaterol belongs to the subgroup of long acting
beta
2
agonists.
WHAT SPIOLTO RESPIMAT IS USED FOR
Spiolto Respimat helps adult patients who have chronic obstructive
pulmonary disease (COPD) to
breathe more easily. COPD is a long-term lung disease that causes
shortness of breath and coughing.
The term COPD is associated with the conditions chronic bronchitis and
emphysema.
Spiolto Respimat helps to open your airways and make it easier to get
air in and out of the lungs.
Regular use of Spiolto Respimat can also help you when you have
on-going shortness of breath
related to your disease, and will help to minimise the effects of the
disease on your everyday life.
As COPD is a long-term disease you should take Spiolto Respimat every
day and not only when you
have

Produktets egenskaber

Health Products Regulatory Authority
16 January 2023
CRN00CR24
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 microgram tiotropium (as bromide
monohydrate) and 2.5 microgram olodaterol (as hydrochloride)
per puff.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipient with known effect: This medicine contains 0.0011 mg
benzalkonium chloride in each actuation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Spiolto Respimat is indicated as a maintenance bronchodilator
treatment to relieve symptoms in adult 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
cartridge can only be inserted and used in the Respimat inhaler.
Two puffs from the Respimat inhaler comprise one medicinal dose.
_Adults_
The recommended dose is 5 microgram tiotropium and 5 microgram
olodaterol given as two puffs from the Respimat inhaler
once daily, at the same time of the day.
The recommended dose should not be exceeded.
_Elderly population_
Elderly patients can use Spiolto Respimat at the recommended dose.
_Hepatic impairment and Renal impairment_
Spiolto Respimat contains tiotropium which is a predominantly renally
excreted drug and olodaterol, which is predominantly
metabolized in the liver.
_Hepatic impairment_
Patients with mild and moderate hepatic impairment can use Spiolto
Respimat at the recommended dose.
There are no data available for use of olodaterol in patients with
severe hepatic impairment.
_Renal impairment_
Renally impaired patients can use Spiolto Respimat at the recommended
dose.
Health Products Regulatory Authority
16 January 2023
CRN00CR24
Page 2 of 20