FAVYND 18 Microgram Inhalation Powder, Capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TIOTROPIUM BROMIDE MONOHYDRATE

Available from:

Boehringer Ingelheim International GmbH

ATC code:

R03BB04

INN (International Name):

TIOTROPIUM BROMIDE MONOHYDRATE

Dosage:

18 Microgram

Pharmaceutical form:

Inhalation Powder, Capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Anticholinergics

Authorization status:

Authorised

Authorization date:

2015-08-13

Patient Information leaflet

F1/IE/MT/PI/2 
1  

PACKAGE LEAFLET: INFORMATION FOR THE USER 

FAVYND 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 Favynd 18 microgram is and what it is used for 
2. 
What you need to know before you use Favynd 18 microgram 
3. 
How to use Favynd 18 microgram 
4. 
Possible side effects 
5. 
How to store Favynd 18 microgram 
6. 
Contents of the pack and other information 

1. 
WHAT FAVYND 18 MICROGRAM IS AND WHAT IT IS USED FOR 

Favynd 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 use Favynd 18 microgram every day and
not only when you have 
breathing problems or other symptoms of COPD. 

Favynd 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 Favynd 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 Favynd 
18 microgram will also help to prevent sudden, short-term worsening
of your COPD symptoms which�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Favynd 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 approximately 5.5 milligrams 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