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

Active substance: IPRATROPIUM BROMIDE

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Patient Information Leaflet

Atrovent® Inhaler CFC-Free 20 micrograms /
actuation pressurised inhalation, solution
(ipratropium bromide)
The name of your medicine is Atrovent Inhaler CFC-Free 20 micrograms,
but will be referred to as Atrovent Inhaler CFC-Free throughout the
remainder of the 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.

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

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.

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



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.

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.

PP1/1303/V3

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.

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.
Keep inhaler in outer carton.
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
A pressurised metered dose inhaler with a metal canister covered with
clear plastic body with a white mouthpiece and a green dust cover.
Each inhaler contains 200 actuations (puffs). Each actuation (puff)
contains 20 micrograms of ipratropium bromide (as the monohydrate).
Also contains: 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 CFCFree 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.
Each carton contains one inhaler.
Atrovent Inhaler CFC-Free 20 micrograms is manufactured by
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173,
55216 Ingelheim am Rhein, Germany. Procured from within the EU.
Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.
Atrovent Inhaler CFC-Free 20 micrograms / actuation pressurised
inhalation, solution
PL 20774/1303
Atrovent Inhaler CFC-Free is a registered trademark of Boehringer
Ingelheim Pharma GmbH & Co. KG
nd

Date of preparation 2 November 2012

POM

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.

PP1/1303/V2

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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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