Sirkava 18 microgram, inhalation powder, hard capsule

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIOTROPIUM BROMIDE

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

R03BB04

INN (International Name):

TIOTROPIUM BROMIDE 18 µg

Pharmaceutical form:

INHALATION POWDER HARD CAPSULE

Composition:

TIOTROPIUM BROMIDE 18 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Authorization date:

2019-06-25

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Sirkava 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 Sirkava is and what it is used for
2.
What you need to know before you use Sirkava 18 microgram
3.
How to use Sirkava 18 microgram
4.
Possible side effects
5.
How to store Sirkava 18 microgram
6.
Contents of the pack and other information
1.
WHAT SIRKAVA IS AND WHAT IT IS USED FOR
Sirkava 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 Sirkava 18 microgram every day and not only when you have
breathing problems or other
symptoms of COPD.
Sirkava 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 Sirkava 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 Sirkava 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 do

Summary of Product characteristics

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sirkava 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.
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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 Sirkava 18 microgram in children and
adolescents has not been