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ATROVENT INHALER CFC-FREE 20 MICROGRAMS/ ACTUATION PRESSURISED INHALATION SOLUTION

Active substance: IPRATROPIUM BROMIDE

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Package Leaflet: Information for the user

Atrovent® Inhaler CFC-Free
20 micrograms/actuation
pressurised inhalation
solution

abcd

(ipratropium bromide)
• 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.

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.

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

How much to use

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.

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.

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.

1
2

Hold the inhaler as shown in the picture
(with the arrow on the label pointing
upwards) and breathe out gently.

3

• 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.

4

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.

Remove the cap from the mouthpiece.

1...2...3...
4...5...6...7...
8...9...10

• Hold your breath for as long as is
comfortable.
• If possible hold your breath for 10
seconds.
• Then breathe out slowly.

5

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

6

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.

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.
ATROVENT should not be stored above 25°C. Keep away from
direct sunlight and heat. Protect from frost.
The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C. Do not try to open, puncture or
burn the canister even when apparently empty.
Keep out of the sight and reach of children.
6. FURTHER INFORMATION
What ATROVENT INHALER CFC-FREE contains
Each inhaler contains 200 actuations (200 puffs). Each actuation
(puff) contains 20 micrograms of ipratropium bromide (as the
monohydrate).
The other ingredients are: A new CFC-Free propellant, propellant
HFA 134a (1,1,1,2 - tetrafluoroethane), citric acid anhydrous,
ethanol anhydrous and purified water. ATROVENT Inhaler CFCFree 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
Your medicine is an inhaler, which contains a pressurised
solution for inhalation. Each carton contains one inhaler.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation is held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berks.,
RG12 8YS, United Kingdom.
and the product is manufactured by:
Boehringer Ingelheim Pharma GmbH & Co. KG,
Binger Strasse 173,
55216 Ingelheim am Rhein,
Germany.

This leaflet was revised in November 2010.
© Boehringer Ingelheim Ltd 2010

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
20100518
51054-10

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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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