SPIOLTO RESPIMAT INHALATION SOLUTION 2.5 microgram2.5 microgram per actuation

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

OLODATEROL HYDROCHLORIDE 0.002736 mg/actuation EQV OLODATEROL; TIOTROPIUM BROMIDE MONOHYDRATE 0.003124 mg/actuation EQV TIOTROPIUM

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

R03AL06

Pharmaceutical form:

SOLUTION

Composition:

OLODATEROL HYDROCHLORIDE 0.002736 mg/actuation EQV OLODATEROL 0.0025 mg/actuation; TIOTROPIUM BROMIDE MONOHYDRATE 0.003124 mg/actuation EQV TIOTROPIUM 0.0025 mg/actuation

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2016-01-20

Patient Information leaflet

gji
Abcd
gji
gji



gji
gji
gji
gji
gji






gji
•




gji









gji








gji
gji

Summary of Product characteristics

CCDS 0287-05 27082019
Abcd
SPIOLTO
RESPIMAT
COMPOSITION
The SPIOLTO
RESPIMAT
is a soft mist inhaler delivering tiotropium + olodaterol inhalation
solution.
The delivered dose is 2.5 microgram tiotropium and 2.5 microgram
olodaterol per puff (2 puffs comprise
one medicinal dose) and is equivalent to 3.124 microgram tiotropium
bromide monohydrate and 2.7
microgram olodaterol hydrochloride.
(INN = tiotropium bromide) (INN
= olodaterol)
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipients**: Benzalkonium chloride, disodium edetate, water,
purified, 1 M hydrochloric acid (for pH adjustment)
INDICATIONS
SPIOLTO
RESPIMAT
is indicated as a maintenance bronchodilator treatment to relieve
symptoms in
adult patients with chronic obstructive pulmonary disease (COPD).
DOSAGE AND ADMINISTRATION
The recommended dose for adults 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
(see Instructions for Use).
Elderly
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.
SPIOLTO
RESPIMAT
contains
tiotropium,
which
is
a
predominantly
renally
excreted
drug.
For
patients with moderate to severe impairment (creatinine clearance ≤
50 ml/min, see SPECIAL
WARNINGS AND PRECAUTIONS and PHARMACOKINETICS).
CCDS 0287-05 27082019
Paediatric population
There
is
no
relevant
use
of
SPIOLTO
RESPIMAT
in
the
paediatric
population
in
COPD.
The safety and effectiveness of SPIOLTO
RESPIMAT
in the paediatric populatio