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

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Package Leaflet: Information for the User ________________________________________________________________________________________

Atrovent® Inhaler CFC-Free 20 micrograms per
metered dose pressurised inhalation solution
(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.
The name of your medicine is Atrovent inhaler cfc-free 20 micrograms
per metered dose pressurised inhalation solution but it will be referred as
Atrovent inhaler cfc-free throughout this leaflet.
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
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 inhaler cfc-free works by opening up your airways.

2. BEFORE YOU USE ATROVENT INHALER CFC-FREE
Do not use Atrovent inhaler cfc-free if:
 You are allergic (hypersensitive) to ipratropium or any of the other
ingredients in Atrovent inhaler cfc-free. (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 inhaler cfc-free.
Take special care with Atrovent inhaler cfc-free
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 inhaler cfc-free.
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 inhaler cfc-free can affect the way some other
medicines work. Also some other medicines can affect the way Atrovent
inhaler cfc-free 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 inhaler cfc-free.
Pregnancy and breast-feeding
Do not use Atrovent inhaler cfc-free if you are pregnant, think you are
pregnant, likely to get pregnant or are breast-feeding.

may affect how your inhaler works. If you are about to have surgery,
make sure you mention that you are taking Atrovent inhaler cfc-free to
the doctor, dentist or anaesthetist.
3. HOW TO USE ATROVENT INHALER CFC-FREE
Always use Atrovent inhaler cfc-free 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
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or blurred vision while
taking Atrovent inhaler cfc-free. 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)

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 inhaler cfc-free
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.

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
Keep 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 canister label. The expiry date refers to the last day of the
month.
Atrovent inhaler cfc-free 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.
6. FURTHER INFORMATION
What Atrovent inhaler cfc-free contains
Each inhaler contains 200 actuations (200 puffs). Each metered dose
contains 20 micrograms of ipratropium bromide (as the monohydrate).
The other ingredients are: A new cfc-free propellant, propellant HFA
134a (norflurane), citric acid anhydrous, ethanol anhydrous and purified
water. Atrovent inhaler cfc-free does not contain any
chlorofluorocarbon (CFC) propellants.

If you forget to take Atrovent inhaler cfc-free
 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.

You may have been prescribed Atrovent inhaler cfc-free as you were
previously being treated with Atrovent inhaler cfc-free. These products
contain the same medicine, ipratropium bromide, but different
propellants. Propellants are ingredients which enable the delivery of the
medicine to the lungs.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Atrovent inhaler cfc-free can cause side effects,
although not everybody gets them.

Atrovent inhaler cfc-free 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 HFA134a which does not damage the ozone layer i.e. Atrovent inhaler cfcfree does not contain any CFCs.
In terms of safety and effectiveness the cfc-free product is the same as
the old CFC-containing product.

Tell your doctor straight away if you notice any the following
serious side effects - you may need urgent medical treatment:
 If after taking Atrovent inhaler cfc-free 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 inhaler cfc-free and they are listed as either common,
uncommon or rare.

What Atrovent inhaler cfc-free looks like and contents of the pack
A white inhaler (mouth piece) with a green cap (embossed on the front
with 'BOEHRINGER INGELHEIM' and the company logo) with a
clear/colourless plastic canister holder, and contains 200 metered doses.
The pump comes in a tamper evident carton.
Product Licence Holder and Manufacturer
This product is procured from within the EU by the Product Licence
Holder: IMED Healthcare Ltd, New Road, Buncrana, Co. Donegal,
Ireland.
Manufactured by: Boehringer Ingelheim Pharma GmbH & Co. KG,
Binger Strasse 173, 55216 Ingelheim am Rhein, Germany.
PL: 40854/0007

POM

This leaflet was revised in November 2012
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 inhaler
cfc-free

© Boehringer Ingelheim Ltd 2010

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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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