SPIRIVA RESPIMAT 2.5 MICROGRAM SOLUTION FOR INHALATION

Active substance: TIOTROPIUM BROMIDE MONOHYDRATE

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Assessed against the UK PIL dated May 2013

By caroline at 7:40
Spiriva Respimat 2.5 microgram, Solution for Inhalation am, Oct 07, 2013
(tiotropium bromide)
The above product is called Spiriva Respimat 2.5 microgram, Solution for
Inhalation but will be referred to as Spiriva Respimat throughout this Leaflet.
Patient Information Leaflet

Make sure that you know how to use your Spiriva Respimat inhaler properly.
The instructions for use of the Spiriva Respimat inhaler are provided on the
other side of this leaflet.

Read all of this leaflet carefully before you start taking 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.

If you take more Spiriva Respimat than you should
If you take more Spiriva Respimat than two puffs in one day 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.

What is in this leaflet
1) What Spiriva Respimat is and what it is used for.
2) What you need to know before you take Spiriva Respimat
3) How to take Spiriva Respimat
4) Possible side effects
5) How to store Spiriva Respimat
6) Contents of the pack and other information

1) What Spiriva Respimat is and what it is used for
Spiriva Respimat helps people who have chronic obstructive pulmonary
disease (COPD) to breathe more easily. COPD is a long-term 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 longterm disease you should take Spiriva Respimat every day and not only when
you have breathing problems or other symptoms of COPD.
Spiriva Respimat 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
Spiriva Respimat can also help you when you have ongoing shortness of
breath related to your disease, and will help to minimise the effects of the
disease on your everyday life. Daily use of Spiriva Respimat will also help to
prevent any sudden, short-term worsening of your COPD symptoms which
may last for several days.
For correct dosing of Spiriva Respimat please see section 3. How to take
Spiriva Respimat and the instructions for use provided on the other side of the
leaflet.

2) What you need to know before you take Spiriva Respimat
Please read the following questions carefully.
If you can answer any of these questions with ‘Yes’ please discuss this with
your doctor before taking Spiriva Respimat
– are you allergic (hypersensitive) to tiotropium, atropine or similar drugs such
as ipratropium or oxitropium?
– are you taking any other medicinal products containing ipratropium or
oxitropium?
– are you pregnant, do you think you are pregnant, or are you breast-feeding?
– are you suffering from blurred vision, eye pain and/or red eyes, prostate
problems or have difficulty passing urine?
– do you have any kidney problems?
Do not use Spiriva Respimat
– if you are allergic (hypersensitive) to tiotropium, its active ingredient or any
of the other ingredients of this medicine (listed in section 6)
– if you are allergic (hypersensitive) to atropine or substances related to it,
e.g. ipratropium or oxitropium
Warnings and precautions
When taking Spiriva Respimat take care not to let any spray enter your eyes.
This may result in eye pain or discomfort, blurred vision, seeing halos around
lights or coloured images in association with red eyes (i.e. narrow angle
glaucoma). Eye symptoms may be accompanied by headache, nausea or
vomiting. Wash your eyes in warm water, stop using tiotropium bromide and
immediately consult your doctor for further advice.
If your breathing has got worse or if you experience rash, swelling or itching
directly after using your inhaler, stop using it and tell your doctor immediately.
Dry mouth which has been observed with anticholinergic treatment may in the
long term be associated with dental caries. Therefore, please remember to
pay attention to oral hygiene.
Spiriva Respimat is indicated for the maintenance treatment of your chronic
obstructive pulmonary disease. It should not be used to treat a sudden
attack of breathlessness or wheezing.
Make sure your prescriber knows if you have diseases of the heart, in
particular conditions affecting your heartbeat (rhythm disorders). Rhythm
disorders may include irregular heartbeat, too slow heart beat (bradycardia),
or too fast heartbeat (tachycardia). This is important to decide if Spiriva
Respimat is the right medicine for you to take.

If you forget to take Spiriva Respimat
If you forget to take your daily dose (TWO PUFFS ONCE A DAY), don’t
worry. Take it 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 Spiriva Respimat
Before you stop taking Spiriva Respimat, you should talk to your doctor or
your pharmacist. If you stop taking Spiriva Respimat 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, Spiriva Respimat can cause side effects, although not
everybody gets them.
Evaluation of the side effects is based on the following frequencies:
Common:
affects 1 to 10 patients in 100
Uncommon:
affects 1 to 10 patients in 1,000
Rare:
affects 1 to 10 patients in 10,000
Not Known:
frequency cannot be estimated from the available data
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:
– dry mouth: this is usually mild
Uncommon:
– dizziness
– headache
– irregular heart beat (atrial fibrillation, supraventricular tachycardia)
– feeling your heartbeat (palpitations)
– faster heart beat (tachycardia)
– cough
– nosebleed (epistaxis)
– inflammation of the throat (pharyngitis)
– hoarseness (dysphonia)
– constipation
– fungal infections of the oral cavity and throat (oropharyngeal candidiasis)
– difficulties swallowing (dysphagia)
– rash
– itching (pruritus)
– difficulties passing urine (urinary retention)
– painful urination (dysuria)
Rare:
– seeing halos around lights or coloured images in association with red eyes
(glaucoma)
– increase of the measured eye pressure
– blurred vision
– tightness of the chest, associated with coughing, wheezing or
breathlessness immediately after inhalation (bronchospasm)
– inflammation of the larynx (laryngitis)
– heart burn (gastrooesophageal reflux disease)
– dental caries
– inflammation of the gums (gingivitis)
– inflammation of the tongue (glossitis)
– inflammation of the mouth (stomatitis)
– serious allergic reaction which causes swelling of the mouth and face or
throat (angioneurotic oedema)
– nettle rash (urticaria)
– infections or ulcerations of the skin
– dryness of the skin
– infections of the urinary tract
Not known:
– depletion of body water (dehydration)
– difficulty in sleeping (insomnia)
– inflammation in sinuses (sinusitis)
– blockage of intestines or absence of bowel movements (intestinal
obstruction, including ileus paralytic)
– feeling sick (nausea)
– hypersensitivity, including immediate reactions
– swelling of joint

You should also contact your doctor if you feel that your breathing is
worsening.

Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of
the mouth and face or sudden difficulties in breathing (angioneurotic oedema)
or other hypersensitivity reactions may occur after administration of Spiriva
Respimat. If this occurs, please consult your doctor immediately.

If you have cystic fibrosis, tell your doctor because Spiriva Respimat could
make your cystic fibrosis symptoms worse.

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).

Children and adolescents
Spiriva Respimat is not recommended for children and adolescents under 18
years.

If you get any side effects, talk to your doctor or pharmacist. This includes any
side effects not listed in this leaflet.

Do not take Spiriva Respimat more frequently than once daily.

Other medicines and Spiriva Respimat
Please tell your doctor or pharmacist if you are taking, or have recently taken,
any other medicines, including medicines obtained without a prescription.
In particular, please tell your doctor or pharmacist if you are taking/have taken
anticholinergic drugs, e.g. ipratropium or oxitropium.
No interaction side effects have been reported when Spiriva Respimat has
been taken with other products used to treat COPD such as reliever inhalers,
e.g. salbutamol, methylxanthines, theophylline and/or inhaled or oral steroids,
e.g. prednisolone.
Pregnancy and breast-feeding
If you are pregnant or believe you are pregnant, or if you are breast-feeding,
you should not use this medicine unless specifically recommended by your
doctor.
Ask your doctor for advice before taking this medicine.
Driving and using machines
No studies on the effects and the ability to drive and use machines have been
performed. In case dizziness or blurred vision occurs the ability to drive and
use machinery may be influenced.

3) How to take Spiriva Respimat
Always take Spiriva Respimat exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Spiriva Respimat is for inhalation use only.
The usual dose is: Spiriva Respimat is effective for 24 hours so you will need
to use Spiriva Respimat only ONCE A DAY, if possible at the same time of
the day. Each time you use it take TWO PUFFS.
As COPD is a long-term disease take Spiriva Respimat every day and not
only when you experience breathing problems. Do not take more than the
recommended dose.
Spiriva Respimat is not recommended for use in children and adolescents
below 18 years due to lack of data on safety and efficacy.

5) How to store Spiriva Respimat
 Keep all medicines out of the sight and reach of children.
 Do not use Spiriva Respimat after the expiry date which is stated on the
carton and on the inhaler label. The expiry date refers to the last day of the
month. Spiriva Respimat inhaler should be discarded at the latest 3 months
after first use (see Instructions for Use overleaf).
 Do not freeze.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6) Contents of the pack and other information
What Spiriva Respimat contains
The active substance is tiotropium. The delivered dose is 2.5 microgram
tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to
3.124 microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the patient after passing
the mouthpiece.
The other ingredients are:
Benzalkonium chloride, disodium edetate, purified water, and hydrochloric
acid 3.6% for pH adjustment.
What Spiriva Respimat looks like and contents of the pack
Spiriva Respimat is composed of one cartridge and one Respimat inhaler.
Inhaler is plastic with a light green cap, light grey mouthpiece and clear body.
Cartridge with ring sealing and enclosed within an aluminium cylinder. The
cartridge has to be inserted into the inhaler before the first use.
Each single pack has 1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
PL 10383/1993 Spiriva Respimat 2.5 microgram, Solution for Inhalation POM
Who makes and repackages your medicine?
Your medicine is manufactured by Boehringer Ingelheim Pharma GmbH &
Co. KG Binger Strasse 173, D-55216 Ingelheim am Rhein Germany Procured
from within the EU and repackaged by Product Licence Holder Primecrown
Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 02.10.2013

How to use your Spiriva Respimat inhaler

Repeat steps 4, 5 and 6 until a cloud is visible.

This leaflet explains how to use and care for your Spiriva Respimat Inhaler.
Please read and carefully follow these instructions. See also section 3.
How to take Spiriva Respimat Inhaler on the other side of this leaflet.

Then repeat steps 4, 5 and 6 three more times to ensure the inhaler is
prepared for use.

The Spiriva Respimat Inhaler releases medication slowly and gently, making it
easy to inhale it into your lungs.
The Spiriva Respimat Inhaler enables you to inhale the medicine contained in
a cartridge. The full cartridge provides 60 puffs (30 medicinal doses). You will
need to use this inhaler only ONCE A DAY, if possible at the same time of
the day. Each time you use it take TWO PUFFS. There is enough medicine
for 30 days when it is used according to the directions for use. In the box you
will find the Spiriva Respimat inhaler and the Spiriva Respimat cartridge.
Before the Spiriva Respimat inhaler is used for the first time, the cartridge
provided must be inserted.

Your Spiriva Respimat inhaler is now ready to use.
These steps will not affect the number of doses available. After preparation
your Spiriva Respimat inhaler will be able to deliver your 60 puffs (30
medicinal doses).

Daily use of your Spiriva Respimat inhaler
You will need to use this inhaler only ONCE A DAY. Each time you use it
take TWO PUFFS.

I Hold the Spiriva Respimat inhaler upright, with the green cap (A) closed, to
avoid accidental release of dose. Turn the base (G) in the direction of the red
arrows on the label until it clicks (half a turn).
Spiriva Respimat Inhaler and the Spiriva Respimat cartridge

1) Inserting the cartridge
The following steps 1–6 are necessary before first use:

II Open the green cap (A) until it snaps fully open. Breathe out slowly and
fully, and then close your lips around the end of the mouthpiece without
covering the air vents (C). Point your Spiriva Respimat inhaler to the back of
your throat.

1. With the green cap (A) closed, press the safety catch (E) while pulling off
the clear base (G).

While taking in a slow, deep breath through your mouth, press the dose
release button (D) and continue to breathe in slowly for as long as you can.
Hold your breath for 10 seconds or for as long as comfortable.
III Repeat steps I and II so that you get the full dose.
You will need to use this inhaler only ONCE A DAY.
Close the green cap until you use your Spiriva Respimat inhaler again.
If Spiriva Respimat inhaler has not been used for more than 7 days release
one puff towards the ground. If Spiriva Respimat inhaler has not been used
for more than 21 days repeat steps 4 to 6 until a cloud is visible. Then repeat
steps 4 to 6 three more times.

When to get a new Spiriva Respimat inhaler

2. Take the cartridge (H) out of the box. Push the narrow end of the cartridge
into the inhaler until it clicks into place. The cartridge should be pushed
firmly against a firm surface to ensure that it has gone all the way in (2b).
The cartridge will not be flush with the inhaler, you will still see the silver
ring of the lower end of the cartridge.
Do not remove the cartridge once it has been inserted into the inhaler.

The Spiriva Respimat inhaler contains 60 puffs (30 medicinal doses). The
dose indicator shows approximately how much medication is left. When the
pointer enters the red area of the scale, there is, approximately, medication
for 7 days left (14 puffs). This is when you need to get a new Spiriva
Respimat inhaler prescription.
Once the dose indicator has reached the end of the red scale (i.e. all 30
doses have been used), the Spiriva Respimat inhaler is empty and locks
automatically. At this point, the base cannot be turned any further.
At the latest, three months after use the Spiriva Respimat inhaler should be
discarded even if not all medication has been used.
What if…
What if...
I can’t turn the
base easily.

3. Replace the clear base (G). Do not remove the clear base again.

2) To prepare the Spiriva Respimat inhaler for first-time use
The cap is fully
pulled off and
apart from the
inhaler.
I can’t press the
dose release
button.
The clear base
springs back after
I have turned it.
4. Hold the Spiriva Respimat inhaler upright, with the green cap (A) closed.
Turn the base (G) in the direction of the red arrows on the label until it clicks
(half a turn).

I can turn the
clear base past
the point where it
clicks.

Reason
a) The Spiriva Respimat
inhaler is already
prepared and ready to
use.
b) The Spiriva Respimat
inhaler is locked after 60
puffs (30 medicinal
doses).
While opening the
cap it was pulled too
hard.

What to do
a) The Spiriva Respimat
inhaler can be used as it
is.
b) Prepare and use your
new Spiriva Respimat
inhaler.

The cap can easily be
attached again.

The clear base has not
been turned.

Turn the clear base until
it clicks. (half a turn)

The clear base was not
turned far enough.

Prepare the Spiriva
Respimat inhaler for use
by turning the clear base
until it clicks. (half a
turn)
With the green cap
closed, turn the base
until it clicks. (half a
turn)

Either the dose release
button has been
pressed, or the clear
base has been turned
too far.

How to care for your inhaler
Clean the mouthpiece including the metal part inside the mouthpiece with a
damp cloth or tissue only, at least once a week. Any minor discolouration in
the mouthpiece does not affect the performance of your Spiriva Respimat
inhaler.
If necessary, wipe the outside of your Spiriva Respimat inhaler with a damp
cloth.
5. Open the green cap (A) until it snaps fully open.

Further information
The Spiriva Respimat inhaler must not be disassembled after inserting the
cartridge and replacing the clear base.
Do not touch the piercing element inside the base.

6. Point the Spiriva Respimat inhaler towards the ground. Press the dose
release button (D). Close the green cap (A).

Expand view ⇕

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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