Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

OLODATEROL, TIOTROPIUM BROMIDE

Доступна с:

Boehringer Ingelheim International GmbH Binger Strasse 173, 55216 Ingelheim am Rhein, Germany

код АТС:

R03AL06

ИНН (Международная Имя):

OLODATEROL 2.5 µg TIOTROPIUM BROMIDE 2.5 µg

Фармацевтическая форма:

INHALATION VAPOUR, SOLUTION

состав:

OLODATEROL 2.5 µg TIOTROPIUM BROMIDE 2.5 µg

Тип рецепта:

POM

Терапевтические области:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Статус Авторизация:

Authorised

Дата Авторизация:

2015-06-24

тонкая брошюра

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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
relat

Характеристики продукта

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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.
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_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.
For patients with moderate to severe impairment (creatinine clearance

50 ml/min) see 4.4 and 5.2.
Spiolto Respimat co