Tiotropium Viatris 18 microgram, inhalation powder, hard capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tiotropium

Available from:

Viatris Limited

ATC code:

R03BB04

INN (International Name):

Tiotropium

Pharmaceutical form:

Inhalation powder, hard capsule

Therapeutic area:

tiotropium bromide

Authorization status:

Not marketed

Authorization date:

2019-01-11

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Tiotropium Mylan 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 or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tiotropium Mylan is and what it is used for
2.
What you need to know before you use Tiotropium Mylan 18 microgram
3.
How to use Tiotropium Mylan 18 microgram
4.
Possible side effects
5.
How to store Tiotropium Mylan 18 microgram
6.
Contents of the pack and other information
1.
WHAT TIOTROPIUM MYLAN IS AND WHAT IT IS USED FOR
Tiotropium Mylan 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 Tiotropium Mylan 18 microgram every day and not only
when you have breathing problems
or other symptoms of COPD.
Tiotropium Mylan 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
Tiotropium Mylan 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 Tiotropium Mylan 18
microgram will also help to prevent sudden, short-term worsening of
your COPD symptoms which ma

Summary of Product characteristics

Health Products Regulatory Authority
08 January 2024
CRN00DW4W
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tiotropium Viatris 18 microgram, inhalation powder, hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 21.7 microgram tiotropium bromide anhydrous
equivalent to 18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the
NeumoHaler device) is 12 microgram tiotropium.
Excipient with known effect
Each capsule contains 5.5 mg of lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
White or almost white capsules marked with T18 in black ink on the cap
containing white or almost white powder.
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 NeumoHaler
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 NeumoHaler 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 under section 4.1.
_Cystic fibrosis_
The safety and efficacy of Tiotr