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BRALTUS 10 MICROGRAM PER DELIVERED DOSE INHALATION POWDER HARD CAPSULE

Active substance(s): TIOTROPIUM BROMIDE

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TEVA UK Ref:

231-30-21403-B LEA TIOTROPIUM (BRALTUS ZONDA) 10mcg INHAL CAPS TUK
Version:

5

Children and adolescents
Braltus should not be used in children and
adolescents under the age of 18 years.
Other medicines and Braltus
Tell your doctor or pharmacist if you are
Package leaflet:
taking, have recently taken or might take any
Information for the patient
other medicines, including any other inhalers
and medicines bought over the counter from
the pharmacy.
Please tell your doctor or pharmacist if you are
taking/have taken similar medicines for your
lung disease, such as ipratropium or oxitropium.
10 microgram per delivered dose
No specific side effects have been reported
inhalation powder, hard capsule
when this medicine has been taken together
tiotropium
with other products used to treat COPD such
as reliever inhalers, e.g. salbutamol,
Read all of this leaflet carefully before
methylxanthines, e.g. theophylline and/or oral
you start taking this medicine because it
and inhaled steroids e.g. prednisolone.
contains important information for you.
Pregnancy and breast-feeding
− Keep this leaflet. You may need to read it
If you are pregnant or breast-feeding, think
again.
you may be pregnant or are planning to have
− If you have any further questions, ask
a baby, ask your doctor or pharmacist for
your doctor, pharmacist or nurse.
advice before taking this medicine. You should
− This medicine has been prescribed for
not take this medicine unless specifically
you only. Do not pass it on to others. It
recommended by your doctor.
may harm them, even if their signs of
Driving and using machines
illness are the same as yours.
The occurrence of dizziness, blurred vision, or
− If you get any side effects, talk to your
headache may influence the ability to drive
doctor, pharmacist or nurse. This includes
and use machinery.
any possible side effects not listed in this
leaflet. See section 4.
Braltus contains lactose
Lactose is a type of sugar found in milk. If you
What is in this leaflet
have been told by your doctor that you have
1. What Braltus is and what it is used for
an allergy to some sugars, contact your doctor
2. What you need to know before you take
before using this inhaler. Lactose may contain
Braltus
very small amounts of milk protein, which may
3. How to take Braltus
cause reactions in those who have severe
4. Possible side effects
hypersensitivity or allergy to milk proteins.
5. How to store Braltus
6. Contents of the pack and other information When taken according to the dose
recommendation of one capsule once a day,
each dose supplies up to 18 mg of lactose
1. What Braltus is and what it is used for
monohydrate.
Braltus contains the active substance
tiotropium. Tiotropium helps people who have 3. How to take Braltus
chronic obstructive pulmonary disease (COPD) Always take this medicine exactly as your
to breathe more easily. COPD is a chronic lung doctor has told you. Check with your doctor or
pharmacist if you are not sure.
disease that causes shortness of breath and
coughing. The term COPD is associated with
The recommended dose is to inhale the
the conditions chronic bronchitis and
contents of one capsule once daily with the
emphysema. As COPD is a chronic disease you Zonda inhaler. One capsule provides the
should take this medicine every day and not
required daily dose of tiotropium (a delivered
only when you have breathing problems or
dose of 10 micrograms of tiotropium); do not
other symptoms of COPD.
take more than the recommended dose.
Braltus is a long-acting bronchodilator that
You should try to take the capsule at the same
helps to open your airways and makes it easier time every day. This is important because this
to get air in and out of the lungs. Regular use
medicine is effective over 24 hours.
of this medicine can also help you when you
The capsules are only for inhalation and not
have on-going shortness of breath related to
your disease and will help you to minimise the for oral intake.
Do not swallow the capsules.
effects of the disease on your everyday life. It
also helps you to be active longer. Daily use of The Zonda inhaler, which you should put the
this medicine will also help to prevent sudden, Braltus capsule into, makes holes in the
capsule and allows you to breathe in the
short-term worsening of your COPD
symptoms which may last for several days. The powder. The capsules must only be inhaled
using the Zonda inhaler. Do not use any other
effect of this medicine lasts for 24 hours, so
inhalers to take Braltus capsules.
you only need to take it once a day.
Make sure you know how to use the Zonda
This medicine should not be used as a rescue
inhaler properly. The instructions for use of the
therapy for the treatment of unexpected
Zonda inhaler are provided on the other side
tightness of the chest, coughing or sudden
of this leaflet. If you have any problems using
attacks of breathlessness or wheezing. Please
use a fast-acting ‘reliever’ (rescue) inhaler, such the Zonda inhaler, ask your doctor, pharmacist
or nurse to show you how it works.
as salbutamol instead. Please keep this
‘reliever’ inhaler with you at all times.
If necessary, you may wipe the mouthpiece of
your Zonda inhaler after use with a dry cloth
2. What you need to know before you take
or tissue.
Braltus
Make sure you do not blow into the Zonda
Do not take Braltus:
inhaler. When taking Braltus, take care not to
− if you are allergic (hypersensitive) to
tiotropium or any of the other ingredients of let any of the powder enter your eyes. If any
powder does get into your eyes, you may get
this medicine (listed in section 6)
− if you are allergic (hypersensitive) to atropine blurred vision, eye pain and/or red eyes; you
should wash your eyes in warm water
or substances related to it, e.g. ipratropium
immediately. Then talk to your doctor
or oxitropium
immediately for further advice.
− if you are allergic (hypersensitive) to lactose
or any other sugars
If you feel that your breathing is worsening,
you should tell your doctor as soon as possible.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
Use in children and adolescents
before taking Braltus:
Braltus should not be used in children and
− if you are taking any other medicinal products adolescents under the age of 18 years.
containing ipratropium or oxitropium
If you take more Braltus than you should
− if you are suffering from narrow angle
If you inhale the contents of more than
glaucoma, prostate problems or have
1 capsule of Braltus in a day, you should talk to
difficulty passing urine
your doctor immediately. You may be at a
− if you have any kidney problems
higher risk of experiencing side effects such as
− if you have suffered from a heart attack
dry mouth, constipation, difficulties passing
(myocardial infarction) during the last 6
urine, increased heart beat, or blurred vision.
months, or from any unstable or
If you forget to take Braltus
life-threatening irregular heart beat or
If you forget to take a dose, take one as soon
severe heart failure in the past year.
as you remember, but do not take two doses
Braltus is indicated for maintenance treatment at the same time or on the same day. Then
of your chronic obstructive pulmonary
take your next dose as usual.
disease; it should not be used to treat a
Do not take a double dose to make up for a
sudden attack of breathlessness or wheezing.
forgotten dose.
Immediate allergic reactions such as rash,
If you stop taking Braltus
swelling, itching, wheezing or breathlessness
Before you stop taking Braltus, you should talk
may occur after administration of Braltus. If
to your doctor or pharmacist. If you stop
this occurs, please consult your doctor
taking this medicine, the signs and symptoms
immediately (see section 4).
of COPD may get worse.
Inhaled medicines such as Braltus may cause
If you have any further questions on the use of
tightness of the chest, coughing, wheezing or this medicine, ask your doctor, pharmacist or
breathlessness (bronchospasm) immediately
nurse.
after inhalation. In such instances you should
immediately use a fast-acting ‘reliever’ inhaler, 4. Possible side effects
Like all medicines, this medicine can cause side
such as salbutamol. If these symptoms occur
stop taking Braltus inhaler and please consult effects, although not everybody gets them.
your doctor immediately.
Serious side effects including allergic
reactions which cause swelling of the face or
Take care not to let the inhalation powder
throat (angioedema) or other hypersensitivity
enter your eyes as this may result in watering
reactions (such as sudden reduction of your
eyes or it may cause narrow-angle glaucoma
blood pressure or dizziness) or increased
or may worsen this condition. Narrow-angle
wheezing and shortness of breath may occur
glaucoma is a disease of the eyes. Eye pain or
discomfort, blurred vision, seeing halos around individually or as part of severe allergic
reaction (anaphylactic reaction) after taking
lights or coloured images in association with
this medicine. Such serious side effects are
red eyes may be signs of an acute attack of
rare. In addition, in common with all inhaled
narrow-angle glaucoma. Eye symptoms may
medicines, some patients may experience
be accompanied by headache, nausea or
vomiting. You should stop using this medicine unexpected tightness of the chest, coughing,
wheezing or breathlessness immediately after
and immediately consult your doctor,
inhalation (known as bronchospasm).
preferably an eye specialist, when signs and
If any of these side effects occur, please
symptoms of narrow-angle glaucoma appear.
The medicine in your inhaler may decrease the consult your doctor immediately.
Do not use your Braltus, inhaler again until
normal secretions (saliva) in your mouth and
make your mouth feel dry. Long-term this may you have seen or at least spoken with, your
be associated with dental caries (tooth decay). doctor. If you are wheezy and short of breath
you should use your fast-acting ‘reliever’
Therefore, please remember to pay attention
(rescue) inhaler straightaway.
to oral hygiene, rinse your mouth out and
Other side effects have been experienced by
brush your teeth regularly.
people taking this medicine, and they are
If you have suffered from a heart attack
listed below according to their frequency.
(myocardial infarction) during the last 6
Common: may affect up to 1 in 10 people
months, or from any unstable or
−Dry mouth: this is usually mild
life-threatening irregular heart beat or severe
heart failure in the past year, please inform
Uncommon: may affect up to 1 in 100 people
your doctor. This is important so that the
− Dizziness
doctor can decide whether or not Braltus is
− Headache
the right treatment for you to take.
− Taste disorders
− Blurred vision
Do not take this medicine more than once
− Irregular heart beat (atrial fibrillation)
daily (see section 3).

27 May 2016

TEVA UK Ref:

231-30-21403-B LEA TIOTROPIUM (BRALTUS ZONDA) 10mcg INHAL CAPS TUK
Version:

5

27 May 2016
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− Sore throat (pharyngitis)
− Hoarseness (dysphonia)
− Cough
− Heart burn (gastrooesophageal reflux
disease)
− Constipation
− Fungal infections of the mouth and throat
(oropharyngeal candidiasis)
− Rash
− Difficulty 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)
− Nettle rash (urticaria)
− Itching (pruritus)
− Infections of the urinary tract
Frequency cannot be estimated from the
available data:
− Depletion of body water (dehydration)
− Tooth decay (dental caries)
− Infections or ulcerations of the skin
− Dryness of the skin
− Swelling of joints
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 Braltus
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 bottle
label after EXP. The expiry date refers to the
last day of that month.
Do not refrigerate or freeze.
Keep the bottle tightly closed. Store in the
original packaging to protect from moisture.
Use the product within 30 days (15 capsule
bottle) or 60 days (30 capsule bottle) of
opening the bottle.
The Zonda inhaler should only be used with
the bottle of capsules provided. Do not reuse
the inhaler for another bottle of capsules.
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 Braltus contains
− The active substance is tiotropium. Each
capsule contains 13 micrograms of the
active ingredient tiotropium (as bromide).
During inhalation, 10 micrograms of
tiotropium are delivered to the patient from
each capsule from the mouthpiece of the
Zonda inhaler and are inhaled into the lungs.
− The other ingredients are lactose
monohydrate (capsule content) and
Hypromellose (capsule shell).
What Braltus looks like and contents of the
pack
Braltus 10 microgram per delivered dose
Zonda Instructions for Use
Dear Patient,

inhalation powder, hard capsule is a colourless
and transparent hard capsule, containing
white powder.
This medicine is provided in bottles, with a
screw-cap closure. The bottle is supplied in a
carton with a Zonda inhaler. The Zonda
Inhaler has a green body and cap with a white
push button.
Braltus is available in packs containing either
15 or 30 capsules and a Zonda inhaler, and in
multipacks containing either 60 capsules (2
packs of 30) and 2 Zonda inhalers or 90
capsules (3 packs of 30) and 3 Zonda inhalers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer:
Laboratorios LICONSA S.A.
Avda. Miralcampo, No 7, Polígono Industrial
Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain
This leaflet was last revised in 05/2016
PL 00289/1870

21403-B

4. Never place a capsule directly into the
mouthpiece.

The Zonda inhaler enables you to inhale the
medicine contained in the Braltus capsule
that your doctor has prescribed for your
breathing problems.
Remember to carefully follow your doctor’s
instructions for using Braltus. The Zonda
inhaler is especially designed for Braltus
capsules: you must not use it to take any
other medication. The capsules must only be
inhaled using the Zonda inhaler. Do not use
any other inhalers to take Braltus capsules.
Each capsule contains only a small amount of
powder. Do not open the capsule or it may
not work.
The Zonda inhaler should only be used with
the bottle of capsules provided. Do not reuse
the inhaler for another bottle of capsules.
Discard the Zonda device after 15 uses (if
used with a 15 capsule bottle) or 30 uses (if
used with a 30 capsule bottle).

9

2. Mouthpiece

2

3. Base

5
3

6. Hold the inhaler with the mouthpiece
upwards, and firmly press the piercing
button completely in only once. Release
the button. This will pierce the capsule
and allows the medication to be released
when you breathe in.

1. Dust cap

Zonda
1

5. Close the mouthpiece until you hear a
click, leaving the cap open.

4

4. Piercing button
5. Centre chamber

1. Pull the cap upwards.
2. Hold the base of the inhaler firmly and
open the mouthpiece by pulling it
upwards, in the direction of the arrow.
3. Remove a Braltus capsule from the bottle
immediately before use and close the
bottle tightly. Place one capsule in the
capsule-shaped compartment in the
base of the inhaler. Do not store the
capsule in the Zonda inhaler.

7. Breathe out fully. It is important to do
this away from the mouthpiece. Avoid
breathing into the mouthpiece at any
time.
8. Place the mouthpiece in your mouth and
keep your head in an upright position.
Close your lips around the mouthpiece
and breathe in slowly and deeply
enough to hear or feel the capsule
vibrating inside the compartment. Hold
your breathe for as long as you
comfortably can whilst taking the inhaler
out of your mouth. Then breathe
normally. Repeat steps 7 and 8 to empty
the capsule completely.
9. After use, open the mouthpiece again,
and tip out the empty capsule. Close the
mouthpiece and cap, and store your
Zonda inhaler.
The Zonda inhaler is a Medical Device (CE)
Manufacturer:
Plastiape S.p.A.
Via 1 Maggio, 8, 23875 Osnago LC, Italy
21403-B

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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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