Tiogiva 18 mikrogram Inhalationspulver, hård kapsel

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

tiotropiumbromid

Available from:

Glenmark Pharmaceuticals Nordic AB

ATC code:

R03BB04

INN (International Name):

tiotropium bromide

Dosage:

18 mikrogram

Pharmaceutical form:

Inhalationspulver, hård kapsel

Composition:

laktosmonohydrat Hjälpämne; propylenglykol Hjälpämne; tiotropiumbromid 21,7 mikrog Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Blister, 30 kapslar (med inhalator); Blister, 60 kapslar (med inhalator); Blister, 90 kapslar (med inhalator); Blister, 30 kapslar; Blister, 60 kapslar; Blister, 90 kapslar

Authorization status:

Godkänd

Authorization date:

2020-12-09

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIOGIVA 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 is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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 every day and not only when you
have breathing problems or
other symptoms of COPD.
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 can
also help you when you have on-
going shortness of breath related to your disease and will help you to
minimize the effects of the
disease on your everyday life. It also helps you to be active longer.
Daily use of 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 please see section 3.
_How t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tiogiva, 18 microgram, inhalation powder, hard capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 21.7 microgram tiotropium bromide equivalent to
18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece) is 10
microgram tiotropium.
Excipient(s) 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.
Transparent colourless hard capsules containing white inhalation
powder with ‘T10’ 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 recommended dosage of tiotropium bromide is inhalation of the
contents of one capsule once
daily with the Dry Powder Inhaler at the same time of
day.
The recommended dose should not be exceeded.
Tiotropium bromide capsules are only for inhalation.
Tiotropium bromide capsules must not be swallowed.
should be inhaled with the Dry Powder
Inhaler.
Special populations
_Elderly Patients_
Elderly patients can use tiotropium bromide at the recommended dose.
_Renal Impairment_
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.
_Hepatic Impairment_
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 18 microgram in children and
adolescents has not been
established. No data are available.
M