Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
27-04-2024
Summary of Product characteristics
(SPC)
27-04-2024
Active ingredient:
Tiotropium (as bromide monohydrate), olodaterol (as hydrochloride)
Available from:
Boehringer Ingelheim International GmbH
ATC code:
R03AL06
INN (International Name):
Tiotropium (as bromide monohydrate), olodaterol (as hydrochloride)
Dosage:
2.5 microgram/2.5 microgram per puff
Pharmaceutical form:
Inhalation solution
Administration route:
Inhalation
Units in package:
Single, double, triple, eight packs, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Boehringer Ingelheim Pharma GmbH & Co. KG
Therapeutic group:
Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics
Therapeutic indications:
It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
Authorization status:
Authorised
Authorization date:
2015-06-16
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIOLTO®
abcd
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
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Summary of Product characteristics
Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution
Summary of Product Characteristics Updated 29Jun2015 | Boehringer Ingelheim Limited
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 patients with severe hepatic impairment.
_Re
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