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FAVYND 18 MICROGRAM INHALATION POWDER HARD CAPSULE

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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Package leaflet: Information for the user

Favynd®
18 microgram
inhalation powder,
hard capsule

abcd

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 may last for several days. The effect of this medicine lasts
for 24 hours, so you only need to use it once a day.

abcd
tiotropium

Favynd®
18 microgram
inhalation powder,
hard capsule
Package leaflet: Information for the user
PIXXXX-02

Package leaflet: Information for the user

Favynd®
18 microgram
inhalation powder,
hard capsule
tiotropium

abcd

2. What you need to know before you use Favynd
18 microgram
Do not use Favynd 18 microgram
- if you are allergic to tiotropium or any other ingredients of
this medicine (listed in section 6).
- if you are allergic to atropine or substances related to it,
e.g. ipratropium or oxitropium.

- Dry mouth, which has been observed with anti-cholinergic
treatment, may in the long term be associated with dental caries.
Therefore, please remember to pay attention to oral hygiene.
- In case you have suffered from a myocardial infarction during
the last 6 months or from any unstable or life threatening
irregular heart beat or severe heart failure within the past
year, please, inform your doctor. This is important to decide if
Favynd is the right medicine for you to take.
- Do not use Favynd 18 microgram more frequently than once
daily.

Children and adolescents
Favynd 18 microgram is not recommended for children and
adolescents under 18 years.
Other medicines and Favynd 18 microgram
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
available without prescription.
Please tell your doctor or pharmacist if you are using/have used
similar medicines for your lung disease, such as ipratropium or
oxitropium.

No specific side effects have been reported when Favynd 18
microgram has been used together with other products used to
treat COPD such as reliever inhalers, e.g. salbutamol,
methylxanthines, e.g. theophylline and/or oral and inhaled
steroids e.g. prednisolone.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine. You should not use this
medicine unless specifically recommended by your doctor.
Driving and using machines
The occurrence of dizziness, blurred vision, or headache may
influence the ability to drive and use machinery.
Favynd 18 microgram contains lactose monohydrate
When taken according to dosage recommendations, one
capsule once a day, each dose supplies up to 5.5 mg lactose
monohydrate. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to use Favynd 18 microgram
Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
The recommended dose is to inhale the contents of 1 capsule
(18 micrograms of tiotropium) once a day. Do not use more
than the recommended dose.
Favynd 18 microgram is not recommended for children and
adolescents under 18 years.
You should try to use the capsule at the same time every day.
This is important because Favynd 18 microgram is effective
over 24 hours.

Warnings and precautions
Talk to your doctor or pharmacist before using Favynd
18 microgram

The capsules are only for inhalation and not for oral intake.

- Talk to your doctor if you suffer from narrow angle glaucoma,
prostate problems or have difficulty passing urine.
- If you have problems with your kidneys, please consult your
doctor.
- Favynd 18 microgram is indicated for maintenance treatment
of your chronic obstructive pulmonary disease, it should not be
used to treat a sudden attack of breathlessness or wheezing.
- Immediate allergic reactions such as rash, swelling, itching,
wheezing or breathlessness may occur after administration of
Favynd 18 microgram. If this occurs, please consult your
doctor immediately.
- Inhaled medicines such as Favynd 18 microgram may cause
tightness of the chest, coughing, wheezing or breathlessness
immediately after inhalation. If this occurs, please consult your
doctor immediately.
- Take care not to let the inhalation powder enter your eye as
this may result in precipitation or worsening of narrow-angle
glaucoma, which is a disease of the eyes. Eye pain or
discomfort, blurred vision, seeing halos around lights or
coloured images in association with red eyes may be signs of
an acute attack of narrow-angle glaucoma. Eye symptoms
may be accompanied by headache, nausea or vomiting. You
should stop using tiotropium bromide and immediately
consult your doctor, preferably an eye specialist, when signs
and symptoms of narrow-angle glaucoma appear.

The HandiHaler device, which you should put the Favynd
capsule into, makes holes in the capsule and allows you to
breathe in the powder.

Do not swallow the capsules.

Make sure that you have an HandiHaler and that you can use it
properly. The instructions for use of the HandiHaler are
provided on the other side of this leaflet.
Make sure that you do not blow into the HandiHaler.
If you have any problems using the HandiHaler, ask your doctor,
nurse or pharmacist to show you how it works.
You should clean your HandiHaler once a month. Cleaning
instructions for the HandiHaler are provided on the other side
of this leaflet.
When taking Favynd 18 microgram, take care not to let any of
the powder enter your eyes. If any powder does get into your
eyes you may get blurred vision, eye pain and/or red eyes, you
should wash your eyes in warm water immediately. Then talk to
your doctor immediately for further advice.
If you feel that your breathing is worsening, you should tell
your doctor as soon as possible

If you use more Favynd 18 microgram than you should
If you inhale from more than 1 capsule of Favynd 18 microgram
in a day, you should talk to your doctor immediately. You may
be at a higher risk of experiencing a side effect such as dry
mouth, constipation, difficulties passing urine, increased heart
beat, or blurred vision.

If you forget to use Favynd 18 microgram
If you forget to take a dose, take one as soon as you remember
but do not take two doses at the same time or on the same day.
Then take your next dose as usual.

If you stop taking Favynd 18 microgram
Before you stop taking Favynd 18 microgram, you should talk
to your doctor or your pharmacist. If you stop taking Favynd
18 microgram the signs and symptoms of COPD may worsen.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The side effects described below have been experienced by
people taking this medicine and they are listed according to
frequency as either common, uncommon, rare or not known.

Common (may affect up to 1 in 10 people):
- dry mouth: this is usually mild

Uncommon (may affect up to 1 in 100 people):
- dizziness
- headache
- taste disorders
- blurred vision
- irregular heart beat (atrial fibrillation)
- inflammation of the throat (pharyngitis)
- hoarseness (dysphonia)
- cough
- heart burn (gastrooesophageal reflux disease)
- constipation
- fungal infections of the oral cavity and throat (oropharyngeal
candidiasis)
- rash
- difficulties passing urine (urinary retention)
- painful urination (dysuria)

Rare (may affect up to 1 in 1,000 people):
- difficulty in sleeping (insomnia)
- seeing halos around lights or coloured images in association
with red eyes (glaucoma)
- increase of the measured eye pressure
- irregular heart beat (supraventricular tachycardia)
- faster heart beat (tachycardia)
- feeling your heart beat (palpitations)
- tightness of the chest, associated with coughing, wheezing or
breathlessness immediately after inhalation (bronchospasm)
- nosebleed (epistaxis)
- inflammation of the larynx (laryngitis)
- inflammation of the sinuses (sinusitis)
- blockage of intestines or absence of bowel movements
(intestinal obstruction including ileus paralytic)
- inflammation of the gums (gingivitis)
- inflammation of the tongue (glossitis)
- difficulties swallowing (dysphagia)
- inflammation of the mouth (stomatitis)
- feeling sick (nausea)
- hypersensitivity, including immediate reactions
- serious allergic reaction which causes swelling of the face or
throat (angioedema)
- nettle rash (urticaria)
- itching (pruritus)
- infections of the urinary tract


Not known (frequency cannot be estimated from the
available data):
- depletion of body water (dehydration)
- dental caries
- severe allergic reaction (anaphylactic reaction)
- infections or ulcerations of the skin
- dryness of the skin
- swelling of joints
Serious side effects include allergic reactions which cause swelling
of the face or throat (angioedema) or other hypersensitivity
reactions (such as sudden reduction of your blood pressure or
dizziness) may occur individually or as part of severe allergic
reaction (anaphylactic reaction) after administration of Favynd
18 microgram. In addition, in common with all inhaled
medicines, some patients may experience an unexpected
tightness of the chest, coughing, wheezing or breathlessness
immediately after inhalation (bronchospasm). If any of these
occur, please consult your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.
5. How to store Favynd 18 microgram

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated
on the carton and the blister foil. The expiry date refers to the
last day of that month.
Do not store above 25°C.
Do not freeze.
Once you have taken your first capsule from the blister you
must continue to take the capsules for the next 9 days, one
capsule a day, from the same blister.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information

What Favynd 18 microgram contains

- The active substance is tiotropium. Each capsule contains
18 micrograms of the active ingredient tiotropium (as
bromide monohydrate). The delivered dose (the dose that
leaves the mouthpiece of the HandiHaler device) is
10 micrograms tiotropium.
- The other ingredient is lactose monohydrate.
What Favynd 18 microgram looks like and contents of the
pack

Favynd 18 microgram inhalation powder, hard capsule is a light
green hard capsule containing the inhalation powder, with the
product code TI 01 and company logo printed on the capsule.

The product is available in the following packs:
A pack containing 30 capsules
A pack containing 60 capsules
A pack containing 90 capsules
A pack containing 10 capsules and 1 HandiHaler
A pack containing 30 capsules and 1 HandiHaler
Hospital pack: Bundle pack containing 5 cardboard boxes of
30 capsules plus HandiHaler device
Hospital pack: Bundle pack containing 5 cardboard boxes of
60 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder for Favynd 18 microgram is:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany

The manufacturer for Favynd 18 microgram and the HandiHaler
device is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
This medicinal product is authorised in the member States
of the EEA under the following names:
Austria, Liechtenstein

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Finland

France

Germany

Greece

Hungary

Iceland

Ireland, Malta, UK

Italy

Latvia

Lithuania

Luxembourg
Netherlands

Norway

Poland


Portugal

Romania

Slovakia

Slovenia

Sweden


Favynd 18 Mikrogramm
Hartkapseln mit Pulver zur Inhalation
Favynd – 18 mcg poudre pour
inhalation en gélule
Фавинд 18 микрограма
прах за инхалация, твърди капсули
Favynd Κόνις για εισπνοή,
σκληρό καψάκιο 18mcg
Favynd 18 µg prášek k inhalaci
v tvrdých tobolkách
Favynd, inhalationspulver
i kapsler 18 mikrogram
Favynd 18 mikrog inhalaatiojaue,
kapseli, kova
Favynd 18 microgrammes,
poudre pour inhalation en gélule
Favynd 18 Mikrogramm
Hartkapseln mit Pulver zur Inhalation
Favynd Κόνις για εισπνοή,
σκληρό καψάκιο INHPD.CAP 18mcg/CAP
Favynd 18 mikrogramm
inhalációs por kemény kapszulában
Favynd 18 míkrógrömm,
innöndunarduft, hart hylki
Favynd 18 microgram
inhalation powder, hard capsule
Favynd 18 microgrammi,
polvere per inalazione, capsula rigida
Favynd 18 mikrogrami,
inhalācijas pulveris cietās kapsulā
Favynd 18 mikrogramų įkvepiamieji
milteliai (kietosios kapsulės)
Favynd GELULES 18 MCG
Favynd 18 microgram,
inhalatiepoeder in harde capsules
Favynd inhalasjonspulver,
hard kapsel 18 mikrog
Favynd, 18 µg/dawkę inhalacyjną,
proszek do inhalacji w kapsułkach
twardych
Favynd, PÓ PARA INALAÇÃO,
CÁPSULA DURA 0,018 mg
Favynd 18 micrograme
capsule cu pulbere de inhalat
Favynd 18 mikrogramov,
inhalačný prášok v tvrdej kapsule
Favynd 18 mikrogramov
prašek za inhaliranje, trde kapsule
Favynd, inhalationspulver,
hård kapsel 18 mikrog

This leaflet was last revised in 09/2015.

HandiHaler® instructions for use:

Dear Patient,
The HandiHaler enables you to inhale the medicine
contained in the Favynd capsule - that your physician
has prescribed for your breathing problems.

Blister handling

1
To release the dust cap press the piercing button
completely in and let go.

4
Close the mouthpiece firmly until you hear a click,
leaving the dust cap open.

7
Raise the HandiHaler to your mouth and close your lips
tightly around the mouthpiece. Keep your head in an
upright position and breathe in slowly and deeply but
at a rate sufficient to hear or feel the capsule vibrate.
Breathe in until your lungs are full; then hold your
breath as long as comfortable and at the same time
take the HandiHaler out of your mouth.

A
Separate the blister strips by tearing along the
perforation.

Resume normal breathing. Repeat steps 6 and 7 once,
in order to empty the capsule completely.

2
Remember to carefully follow your doctor’s instructions
for using Favynd. The HandiHaler is especially designed
for Favynd. You must not use it to take any other
medicine. You can use your HandiHaler for up to one
year to take your medicine.

Open the dust cap completely by pulling it upwards.
Then open the mouthpiece by pulling it upwards.

5
Hold the HandiHaler device with the mouthpiece
upwards and press the piercing button completely in
only once, and release. This makes holes in the capsule
and allows the medicine to be released when you
breathe in.

8
Open the mouthpiece again. Tip out the used capsule
and dispose. Close the mouthpiece and dust cap for
storage of your HandiHaler device.

B
Peel back foil (only immediately before use) using
the tab until one capsule is fully visible.
In case a second capsule is exposed to air
inadvertently this capsule has to be discarded.

Cleaning your HandiHaler

3
The HandiHaler
1

Dust cap

2

Mouthpiece

3

Base

4

Piercing button

5

Centre chamber

Remove a Favynd capsule from the blister (only
immediately before use, see blister handling) and place
it in the centre chamber ( 5 ), as illustrated. It does not
matter which way the capsule is placed in the chamber.

C

6
Breathe out completely.
Important: Please avoid breathing into the mouthpiece
at any time.

Clean the HandiHaler once a month. Open the dust
cap and mouthpiece. Then open the base by lifting the
piercing button. Rinse the complete inhaler with warm
water to remove any powder. Dry the HandiHaler
thoroughly by tipping excess of water out on a paper
towel and air-dry afterwards, leaving the dust cap,
mouthpiece and base open. It takes 24 hours to air
dry, so clean it right after you have used it and it will
be ready for your next dose. If needed, the outside of
the mouthpiece may be cleaned with a moist but not
wet tissue.

Remove capsule.
Favynd capsules contain only a small amount of
powder so that the capsule is only partially filled.

Manufacturer of the HandiHaler device:
Boehringer Ingelheim
Pharma GmbH & Co. KG
D-55216 Ingelheim am Rhein
Germany

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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