Spiriva Respimat 2.5micrograms/dose inhalation solution cartridge with device

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Tiotropium bromide

Disponibil de la:

Boehringer Ingelheim Ltd

Codul ATC:

R03BB04

INN (nume internaţional):

Tiotropium bromide

Dozare:

2.5microgram/1dose

Forma farmaceutică:

Inhalation solution

Calea de administrare:

Inhalation

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 03010200; GTIN: 5012816081024

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA
®
RESPIMAT
®
2.5 MICROGRAM,
INHALATION SOLUTION
tiotropium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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 Spiriva Respimat is and what it is used for
2. What you need to know before you use Spiriva
Respimat
3. How to use Spiriva Respimat
4. Possible side effects
5. How to store Spiriva Respimat
6. Contents of the pack and other information
WHAT SPIRIVA RESPIMAT LOOKS LIKE AND CONTENTS OF
THE PACK
Spiriva Respimat 2.5 microgram is composed of
one cartridge with inhalation solution and one
Respimat inhaler. The cartridge has to be inserted
into the inhaler before the first use.
Single pack:
1 Respimat inhaler and
1 cartridge, providing 60 puffs
(30 medicinal doses)
Double pack:
2 single packages, each
containing 1 Respimat inhaler and
1 cartridge, providing 60 puffs
(30 medicinal doses)
Triple pack:
3 single packages, each
containing 1 Respimat inhaler and
1 cartridge, providing 60 puffs
(30 medicinal doses)
Eight pack:
8 single packages, each
containing 1 Respimat inhaler and
1 cartridge, providing 60 puffs
(30 medicinal doses)
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
The marketing authorisation holder for Spiriva
Respimat is:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
The manufacturer for Spiriva Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
THIS LEAFLET WAS LAST REVISED IN 03/2018.

Caracteristicilor produsului

OBJECT 1
SPIRIVA RESPIMAT 2.5 MICROGRAM, INHALATION
SOLUTION
Summary of Product Characteristics Updated 20-Apr-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Spiriva Respimat 2.5 microgram, inhalation solution
2. Qualitative and quantitative composition
The delivered dose is 2.5 microgram tiotropium per puff (2 puffs
comprise one medicinal dose) and is
equivalent to 3.124 microgram tiotropium bromide monohydrate.
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
COPD
Tiotropium is indicated as a maintenance bronchodilator treatment to
relieve symptoms of patients with
chronic obstructive pulmonary disease (COPD).
Asthma
Spiriva Respimat is indicated as add-on maintenance bronchodilator
treatment in patients aged 6 years
and older with severe asthma who experienced one or more severe asthma
exacerbations in the preceding
year (see sections 4.2 and 5.1).
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 (see 4.2).
Two puffs from the Respimat inhaler comprise one medicinal dose.
The recommended dose for adults is 5 microgram tiotropium given as two
puffs from the Respimat
inhaler once daily, at the same time of the day.
The recommended dose should not be exceeded.
In the treatment of asthma the full benefit will be apparent after
several doses of the medicinal product. In
adult patients with severe asthma, tiotropium should be used in
addition to inhaled corticosteroids (≥ 800
μg budesonide/day or equivalent) and at least one controller.
Special populations
Geriatric patients can use tiotropium bromide at the recommended dose.
Renally impaired patients can use tiotropium bromide at the
recommended dose. For patients with
moderate to severe