Spiolto Respimat 2.5micrograms/dose / 2.5micrograms/dose inhalation solution cartridge with device

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Olodaterol hydrochloride; Tiotropium bromide

Saatavilla:

Boehringer Ingelheim Ltd

ATC-koodi:

R03AL06

INN (Kansainvälinen yleisnimi):

Olodaterol hydrochloride; Tiotropium bromide

Annos:

2.5microgram/1dose ; 2.5microgram/1dose

Lääkemuoto:

Inhalation solution

Antoreitti:

Inhalation

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 03010400; GTIN: 5012816099111

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIOLTO
® RESPIMAT
®
2.5 MICROGRAM/2.5 MICROGRAM,
INHALATION SOLUTION
tiotropium/olodaterol
This medicine is subject to additional monitoring.
This will allow quick identification of new safety
information. You can help by reporting any side
effects you may get. See the end of section 4 for how
to report side effects.
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 rela

Valmisteyhteenveto

OBJECT 1
SPIOLTO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM,
INHALATION SOLUTION
Summary of Product Characteristics Updated 04-Apr-2017 | Boehringer
Ingelheim Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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.
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 pa