SPIOLTO RESPIMAT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OLODATEROL AS HYDROCHLORIDE; TIOTROPIUM BROMIDE AS MONOHYDRATE

Available from:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC code:

R03AL03

Pharmaceutical form:

SOLUTION FOR INHALATION

Composition:

OLODATEROL AS HYDROCHLORIDE 2.5 MCG; TIOTROPIUM BROMIDE AS MONOHYDRATE 2.5 MCG

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY

Therapeutic area:

VILANTEROL AND UMECLIDINIUM BROMIDE

Therapeutic indications:

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

Authorization date:

2021-02-28

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied upon physician’s prescription only
SPIOLTO
® RESPIMAT
®
INHALATION SOLUTION
Each actuation releases:
2.5 microgram tiotropium (as bromide monohydrate)
2.5 microgram olodaterol (as hydrochloride)
2 puffs, comprising one medicinal dose, contain:
5 microgram tiotropium (as bromide monohydrate)
5 microgram olodaterol (as hydrochloride)
Inactive ingredients and allergens in the medicine: see section
'Important information about
some of this medicine's ingredients' in section 2 and section 6
'Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
essential information about this medicine. If you have any further
questions, refer to the
physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Spiolto Respimat is indicated as a maintenance bronchodilator
treatment to relieve
symptoms in patients with chronic obstructive pulmonary disease
(COPD).
THERAPEUTIC GROUP: Long acting bronchodilators. Tiotropium belongs to
the sub-group of
anticholinergics. Olodaterol belongs to the sub-group of long acting
β2 receptor agonists.
More about the medicine
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 medical term COPD describes 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 may help you when you suffer
from persistent
shortness of breath resulting from your illness, and will also help to
minimise the effects of
the disease on your everyday life.
As COPD is a long-term disease you should take Spiolto Respimat eve

Summary of Product characteristics

Spiolto Respimat
Approved prescribing
information
Inhalation solution
May 2019
1
SPIOLTO RESPIMAT
INHALATION SOLUTION
PRESCRIBING INFORMATION
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.
Spiolto Respimat is not indicated to treat asthma.
Spiolto Respimat is not indicated for the treatment of acute
deteriorations of COPD.
_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.
Spiolto Respimat
Approved
prescribing
information
Inhalation solution
May 2019
2
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