Spiriva 18microgram inhalation powder capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Tiotropium bromide

Tillgänglig från:

Boehringer Ingelheim Ltd

ATC-kod:

R03BB04

INN (International namn):

Tiotropium bromide

Dos:

18microgram

Läkemedelsform:

Inhalation powder

Administreringssätt:

Inhalation

Klass:

No Controlled Drug Status

Receptbelagda typ:

Caution - AMP level prescribing advised

Produktsammanfattning:

BNF: 03010200; GTIN: 5012816081017 5012816081161

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA
®
18 MICROGRAM,
INHALATION POWDER,
HARD CAPSULE
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 18 microgram is and what it is used for
2. What you need to know before you use SPIRIVA 18
microgram
3. How to use SPIRIVA 18 microgram
4. Possible side effects
5. How to store SPIRIVA 18 microgram
6. Contents of the pack and other information
1. WHAT SPIRIVA 18 MICROGRAM IS AND WHAT IT IS USED FOR
SPIRIVA 18 microgram helps people who have chronic
obstructive pulmonary disease (COPD) to breathe more
easily. COPD is a chronic lung disease that causes shortness
of breath and coughing. The term COPD is associated with
the conditions chronic bronchitis and emphysema. As COPD
is a chronic disease you should take SPIRIVA 18 microgram
every day and not only when you have breathing problems or
other symptoms of COPD.
SPIRIVA 18 microgram 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 18 microgram
can also help you when you have on-going shortness of
breath related to your disease and will help you to minimise
the effects of the disease on your everyday life. It also helps
you to be active longer. Daily use of SPIRIVA 18 microgram
will also help to prevent sudden, short-term worsening of
your COPD symptoms which may last for several days. The
effect of this medicine lasts for 24 hours, so you only need to
use it once a day. For correct dosing of

Produktens egenskaper

OBJECT 1
SPIRIVA 18 MICROGRAM INHALATION POWDER, HARD
CAPSULE
Summary of Product Characteristics Updated 15-Mar-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
SPIRIVA
®
18 microgram, inhalation powder, hard capsule
2. Qualitative and quantitative composition
Each capsule contains 22.5 microgram tiotropium bromide monohydrate
equivalent to 18 microgram
tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the
HandiHaler
®
device) is 10 microgram
tiotropium.
Excipient with known effect:
Each capsule contains 5.5 milligram of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder, hard capsule.
Light green hard capsules containing the inhalation powder with the
product code TI 01 and company
logo printed on the capsule.
4. Clinical particulars
4.1 Therapeutic indications
Tiotropium is indicated as a maintenance bronchodilator treatment to
relieve symptoms of 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 recommended dosage of tiotropium bromide is inhalation of the
contents of one capsule once daily
with the HandiHaler device at the same time of day.
The recommended dose should not be exceeded.
Tiotropium bromide capsules are only for inhalation and not for oral
intake.
Tiotropium bromide capsules must not be swallowed.
Tiotropium bromide should only be inhaled with the HandiHaler device.
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 impairment (creatinine clearance ≤ 50 ml/min) see
section 4.4 and section 5.2.
Hepatically impaired patients can use tiotropium bromide at the
recommended dose (see section 5.2).
Paediatric population
_COPD_
There is no relevant use in the paediatric population (below 18 years)
in the indication stated