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ATROVENT INHALER CFC-FREE 20 MICROGRAMS PER METERED DOSE PRESSURISED INHALATION SOLUTION

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Atrovent® Inhaler CFC-Free 20 micrograms
per metered dose pressurised inhalation,
solution
(ipratropium bromide)
The name of this product is Atrovent® Inhaler CFC-Free 20
micrograms per metered dose pressurised inhalation, solution but
will be referred to as ATROVENT Inhaler CFC-FREE throughout this
leaflet.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What ATROVENT Inhaler CFC-FREE is and what it is used for
2. Before you use ATROVENT Inhaler CFC-FREE
3. How to use ATROVENT Inhaler CFC-FREE
4. Possible side effects
5. How to store ATROVENT Inhaler CFC-FREE
6. Further information
1. WHAT ATROVENT INHALER CFC-FREE IS AND WHAT IT IS
USED FOR
The name of your medicine is ATROVENT Inhaler CFC-FREE. This
is an inhaler and contains a medicine called ipratropium bromide.
This belongs to a group of medicines called bronchodilators. It is
used to make breathing easier for people with asthma or ‘chronic
obstructive pulmonary disease’ (COPD), often referred to as chronic
bronchitis. You may have difficulty breathing, shortness of breath,
wheezing or tightness in your chest.
ATROVENT works by opening up your airways.
2. BEFORE YOU USE ATROVENT INHALER CFC-FREE
Do not use ATROVENT if:
• You are allergic (hypersensitive) to ipratropium or any of the other
ingredients in ATROVENT. (Listed in section 6: Further
information)
• You are allergic to similar medicines which contain atropine or
medicines like atropine
• You are pregnant, think you are pregnant, likely to get pregnant or
are breast-feeding
Do not use if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before using ATROVENT.
Take special care with ATROVENT
Check with your doctor or pharmacist before using this medicine if:
• You have glaucoma, or have been told that you may develop it
• You have problems passing water (urine)
• You are a man who has prostate problems
• You have cystic fibrosis
If you are not sure if any of these apply to you, talk to your doctor or
pharmacist before using ATROVENT.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including any inhalers and
medicines obtained without a prescription. This includes herbal
medicines. This is because ATROVENT can affect the way some
other medicines work. Also some other medicines can affect the way
ATROVENT works. In particular, tell your doctor or pharmacist if you
are taking/ have taken any of the following medicines:
• Other inhalers to help you to breathe more easily such as the
reliever inhaler salbutamol
• Medicines called ‘xanthines’ to help your breathing such as
theophylline and aminophylline
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using ATROVENT.
Pregnancy and breast-feeding
Do not use ATROVENT if you are pregnant, think you are pregnant,
likely to get pregnant or are breast-feeding.
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or blurred vision
while taking ATROVENT. If this happens do not drive or use any
tools or machines.

Operations
If you attend a hospital appointment or are admitted to hospital be
sure to take your inhaler(s) and any other medicines (in their
packaging if possible) with you. Some gases used in operations
(anaesthetic gases) may affect how your inhaler works. If you are
about to have surgery, make sure you mention that you are taking
ATROVENT to the doctor, dentist or anaesthetist.
3. HOW TO USE ATROVENT INHALER CFC-FREE
Always use ATROVENT exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Follow these instructions to get the best results. If anything is
unclear after reading this leaflet, ask your doctor or pharmacist. You
may notice that this CFC-Free inhaler tastes slightly different from
the last CFC-containing inhaler you used. This is normal. The inhaler
is still as safe and will work as well as your last one.
How much to use
Adults (including the elderly)
• One or two puffs to be inhaled three or four times daily
• Sometimes, in early treatment, up to four puffs at a time may be
taken
Children 6-12 yrs
• One or two puffs to be inhaled three times daily
Children under 6 yrs
• One puff to be inhaled three times daily
When children are using this medicine they must be supervised by a
responsible adult.
Do not use more than your doctor has told you
See your doctor straight away if:
• You feel that your inhaler is not working as well as usual
• You need to use the inhaler more than your doctor has
recommended
Your doctor may need to check how well your medicine is working.
In some cases your doctor may need to change your medicine.
Testing Your Inhaler
To make sure that your inhaler is working, test fire it twice into the air
before using it for the first time and whenever your inhaler has not
been used for 3 days or more.
How to use your inhaler
Read through numbers 1 to 6 first, before starting to use your
inhaler.
Remove the cap from the
mouthpiece.
Hold the inhaler as shown in the
picture (with the arrow on the
label pointing upwards) and
breathe out gently.

• Then straight away, put the
mouthpiece in your mouth.
• Hold the mouthpiece with your
lips.
• Start to breathe in slowly and
deeply through your mouth.
• Press the top of the inhaler
firmly. This will release one
puff of your medicine.
• Keep breathing in.
• Hold your breath for as long
as is comfortable.
• If possible hold your breath for
10 seconds.
• Then breathe out slowly.

• If you are having more than
one puff, wait at least 1 minute
before the next puff.
• Then repeat steps 2, 3 and 4.

After use, replace the cap on the
mouthpiece.

The mouthpiece has been designed specially for use with this
product only. Do not use any other mouthpiece with the product and
do not use the mouthpiece provided here with any other product.
If you find breathing in and pressing the inhaler at the same time
(step 3) difficult you should talk to your doctor or pharmacist, as you
could use a spacer device (Aerochamber Plus™) with your inhaler.
A spacer is a device designed to make step 3 easier. A spacer is
generally a plastic container with a mouthpiece at one end and a
hole for inserting the mouthpiece of the inhaler at the other end. The
puff of medicine from your inhaler is sprayed into the spacer and the
puff of medicine stays there, inside the spacer, until you breathe in
through your mouth from the spacer with the spacer mouthpiece in
your mouth and with your lips closed around it. This means that you
do not have to worry about breathing in and pressing the inhaler at
the same time.
When using your ATROVENT Inhaler CFC-Free take care not to let
any of the spray enter your eyes. If any of the spray accidentally gets
into your eyes you may get painful, stinging or red eyes, dilated
pupils, blurred vision, see colours or lights. If this happens, talk to
your doctor for advice. If you get problems with your eyes at any
other time, talk to your doctor for advice. You may be developing
glaucoma, which will need treatment straight away.
Cleaning
It is important to clean your inhaler regularly. Otherwise it may not
work properly.
• Remove the canister and cap
• Wash and clean the white mouthpiece in warm soapy water
• Rinse in warm water and allow to air-dry without using any heating
system
• Make sure the small hole in the mouthpiece is washed through
thoroughly
• Once the white mouthpiece is dry, replace the canister and the cap
Make sure you do not run out of ATROVENT
The inhaler has been designed to deliver 200 puffs of your medicine.
However, it is not possible to tell when the inhaler is empty and
when the 200 puffs have been used. There may still be a small
amount of fluid left over in the container. Please make sure that your
inhaler is replaced after you have taken 200 puffs (usually after 3-4
weeks of regular use) so that you can be certain that you are getting
the right amount of your medicine in each puff.
If you use more ATROVENT INHALER CFC-FREE than you
should
If you use more of this inhaler than you should, talk to a doctor or go
to a hospital straight away. Take all your inhalers and any other
medicines you are taking (in their packaging if possible) with you. If
you take too much or too many puffs you may get a dry mouth, a
rapid heart rate or blurred vision.
If you forget to take ATROVENT
• If you forget a dose, inhale it as soon as you remember it.
• However, if it is time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you have any further questions, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ATROVENT can cause side effects, although not
everybody gets them.
Tell your doctor straight away if you notice any the following
serious side effects - you may need urgent medical treatment:
• If after taking ATROVENT you are wheezy or have other
difficulties in breathing, do not take any more (unless you have
been told to by your doctor). You may need to take a fast-acting
reliever inhaler such as salbutamol to help your breathing. Your
doctor may decide that you need different medicines to help your
breathing
• Allergic reactions - the signs may include skin rash and itching
(affects less than 1 in 100 people). In severe cases the signs
include swelling of your mouth and face, sudden difficulties in
breathing and reduction of your blood pressure.
Tightening of your throat (affects less than 1 in 100 people)
• Palpitations (fast or uneven heart beats) or quickening of the heart
rate (affects less than 1 in 100 people)
• Increased heart rate or irregular heart rhythm such as atrial
fibrillation (affects less than 1 in 1000 people)
See your doctor straight away if you have any of these side effects.

The side effects described below have been experienced by people
taking ATROVENT and they are listed as either common,
uncommon or rare.
Common (affects less than 1 in 10 people)
• Headache, dizziness
• Dry mouth, feeling sick (nausea), stomach upset or discomfort
• Cough and throat irritation when you have just used ATROVENT
Uncommon (affects less than 1 in 100 people)
• Itching, skin rash
• Unexpected tightness of the chest, swelling of the throat, dry throat
• Blurred vision, dilated pupils, glaucoma, painful, stinging, red or
swelling of the eyes, see colours or lights
• Diarrhoea, constipation or being sick
• Mouth or lip sores
• Problems passing water (urine), especially if you already have
problems passing urine
Rare (affects less than 1 in 1000 people)
• Difficulty focusing
• Nettle rash (urticaria)
If any of the side effects gets troublesome or serious, or if you notice
any side effects not listed in this leaflet, tell your doctor or
pharmacist.
If any of the spray accidentally gets into your eyes you may get
painful, stinging or red eyes, dilated pupils, blurred vision, see
colours or lights. If this happens, talk to your doctor for advice. If you
get problems with your eyes at any other time, talk to your doctor for
advice. You may be developing glaucoma, which will need treatment
straight away. If your eyes are affected in any way do not drive or
operate machinery.
5. HOW TO STORE ATROVENT INHALER CFC-FREE
Do not use this medicine after the expiry date which is stated on the
carton and the canister label. The expiry date refers to the last day of
the month.
Do not store above 25oC. Protect from light and heat. Protect from
frost. The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50oC. Do not pierce the canister.
Keep out of the sight and reach of children.
6. FURTHER INFORMATION
What ATROVENT INHALER CFC-FREE contains
Each metered dose contains 20 micrograms ipratropium bromide (as
the monohydrate).
The other ingredients are: norflurane (HFA 134a), citric acid
anhydrous, ethanol anhydrous and purified water. ATROVENT
Inhaler CFC-Free does not contain any chlorofluorocarbon
(CFC) propellants.
You may have been prescribed ATROVENT Inhaler CFC-Free as
you were previously being treated with ATROVENT Inhaler. These
products contain the same medicine, ipratropium bromide, but
different propellants. Propellants are ingredients which enable the
delivery of the medicine to the lungs.
ATROVENT Inhaler contained chlorofluorocarbons or CFCs as
propellants which are known to damage the ozone layer. Your
ATROVENT Inhaler CFC-Free has been developed to include the
new propellant HFA-134a which does not damage the ozone layer
i.e. ATROVENT Inhaler CFC-Free does not contain any CFCs. In
terms of safety and effectiveness the CFC-Free product is the same
as the old CFC-containing product.
What ATROVENT INHALER CFC-FREE looks like and contents
of the pack
A white inhaler with a green cap (embossed on the front with
‘BOEHRINGER INGELHEIM’ and the company logo). A stainless
steel canister which contains a clear, colourless pressurised solution
for inhalation.
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173,
55216 Ingelheim am Rhein, Germany.
Procured from within the EU by Product Licence holder PilsCo Ltd,
9-15 Springburn Place, East Kilbride, G74 5NU
PL 39467/0099 Atrovent Inhaler CFC-Free 20 micrograms per
metered dose pressurised inhalation, solution
This leaflet was revised 02/10/2013.
© Boehringer Ingelheim Ltd 2010

POM

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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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