Yanimo Respimat

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

OLODATEROL, TIOTROPIUM BROMIDE

Disponible desde:

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

Código ATC:

R03AL

Designación común internacional (DCI):

OLODATEROL 2.5 µg TIOTROPIUM BROMIDE 2.5 µg

formulario farmacéutico:

INHALATION VAPOUR, SOLUTION

Composición:

OLODATEROL 2.5 µg TIOTROPIUM BROMIDE 2.5 µg

tipo de receta:

POM

Área terapéutica:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Estado de Autorización:

Withdrawn

Fecha de autorización:

2015-06-30

Información para el usuario

R1h/J/PI/1
PACKAGE LEAFLET: INFORMATION FOR THE USER
YANIMO 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 Yanimo Respimat is and what it is used for
2. What you need to know before you take Yanimo Respimat
3. How to take Yanimo Respimat
4. Possible side effects
5. How to store Yanimo Respimat
6. Contents of the pack and other information
1.
WHAT YANIMO RESPIMAT IS AND WHAT IT IS USED FOR
WHAT YANIMO RESPIMAT IS
Yanimo 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 YANIMO RESPIMAT IS USED FOR
Yanimo 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.
Yanimo Respimat helps to open your airways and make it easier to get
air in and out of the lungs.
Regular use of Yanimo 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 the
disease on your everyday life.
As COPD is a long-term disease you should take Yanimo Respimat every
day and not only when you
have breathing problems or other symptoms of COPD.

Ficha técnica

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YANIMO RESPIMAT 2.5 MICROGRAM/
2.5 MICROGRAM, INHALATION SOLUTION
Malta
Tiotropium + olodaterol
SUMMARY OF PRODUCT CHARACTERISTICS
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
Yanimo 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
Yanimo 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.
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_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 Yanimo Respimat at the recommended dose.
_Hepatic impairment and Renal impairment _
Yanimo 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 Yanimo
Respimat at the recommended
dose.
There are no data available for use of olodaterol in patients with
s