Spiriva Respimat 2.5mcgs Inhalation solution

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

TIOTROPIUM BROMIDE

Tersedia dari:

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

Kode ATC:

R03BB04

INN (Nama Internasional):

TIOTROPIUM BROMIDE 2.5 µg

Bentuk farmasi:

PRESSURISED INHALATION, SOLUTION

Komposisi:

TIOTROPIUM BROMIDE 2.5 µg

Jenis Resep:

POM

Area terapi:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Status otorisasi:

Authorised

Tanggal Otorisasi:

2011-07-28

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA
®
abcd
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
1. WHAT SPIRIVA RESPIMAT IS AND WHAT
IT IS USED FOR
Spiriva Respimat helps people who have chronic
obstructive pulmonary disease (COPD) or asthma 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.
Asthma is a long-term
disease characterised by airway
inflammation and
narrowing of the airways.
As COPD and asthma are long-term diseases you should
use Spiriva Respimat every day and not only when you
have breathing problems or other symptoms. When
used to treat asthma you should use Spiriva Respimat
in addition to so-called inhaled corticosteroids and
long-acting ß
2
agonists.
Spiriva Respimat is a long-acting bronchodilator that
helps to open your airways and makes it easier to get
air in and out of the lungs. Regular use of Spiriva
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. Daily use of Spiriva Respimat will also
help to prevent any sudden, short-t

Karakteristik produk

R1E/MT/SPC/12
SPIRIVA
®
RESPIMAT
®
2.5 MICROGRAM,
INHALATION SOLUTION
Malta
tiotropium
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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
COPD
Spiriva Respimat 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.
R1E/MT/SPC/12
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.
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