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.

How much to use

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

Children under 6 yrs
• One puff to be inhaled three times daily

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.

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

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

Remove the cap from the mouthpiece.

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

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.

307867-01

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 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.

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 (see
details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
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 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
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 January 2015.
© Boehringer Ingelheim Ltd 2015

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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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