Package Leaflet: Information for the user

Atrovent® Inhaler CFC-Free

20 micrograms/actuation abcd
pressurised inhalation
solution
(ipratropium bromide)

• Keep this leaflet. You may need to read it again. 3. HOW TO USE ATROVENT INHALER CFC-FREE
• If you have any further questions, ask your doctor or Always use ATROVENT exactly as your doctor has told you.
pharmacist. You should check with your doctor or pharmacist if you are
• This medicine has been prescribed for you. Do not pass it not sure. Follow these instructions to get the best results. If
on to others. It may harm them, even if their symptoms anything is unclear after reading this leaflet, ask your doctor
are the same as yours. or pharmacist.
• If any of the side effects gets troublesome or serious, or if
you notice any side effects not listed in this leaflet, please How much to use
tell your doctor or pharmacist.
Adults (including the elderly)
In this leaflet: • One or two puffs to be inhaled three or four times daily
1. What ATROVENT Inhaler CFC-FREE is and what it is used for • Sometimes, in early treatment, up to four puffs at a time
2. Before you use ATROVENT Inhaler CFC-FREE may be taken
3. How to use ATROVENT Inhaler CFC-FREE
4. Possible side effects Children 6-12 yrs
5. How to store ATROVENT Inhaler CFC-FREE • One or two puffs to be inhaled three times daily
6. Further information
Children under 6 yrs
1. WHAT ATROVENT INHALER CFC-FREE IS AND WHAT IT • One puff to be inhaled three times daily
IS USED FOR
The name of your medicine is ATROVENT Inhaler CFC-FREE. When children are using this medicine they must be
This is an inhaler and contains a medicine called supervised by a responsible adult.
ipratropium bromide. This belongs to a group of medicines
called anticholinergics which act as bronchodilators. It is Do not use more than your doctor has told you
used to make breathing easier for people with asthma or See your doctor straight away if:
‘chronic obstructive pulmonary disease’ (COPD), often • You feel that your inhaler is not working as well as usual
referred to as chronic bronchitis. You may have difficulty • You need to use the inhaler more than your doctor has
breathing, shortness of breath, wheezing or tightness in recommended
your chest. Your doctor may need to check how well your medicine is
working. In some cases your doctor may need to change
ATROVENT works by opening up your airways. your medicine.

2. BEFORE YOU USE ATROVENT INHALER CFC-FREE Testing Your Inhaler

Do not use ATROVENT if: To make sure that your inhaler is working, test fire it twice
• You are allergic (hypersensitive) to ipratropium or any of into the air before using it for the first time and whenever
the other ingredients in ATROVENT. (Listed in section 6: your inhaler has not been used for 3 days or more.
Further information)
• You are allergic to similar medicines which contain How to use your inhaler
atropine or medicines like atropine Read through numbers 1 to 6 first, before starting to use
• You are pregnant, think you are pregnant, likely to get your inhaler.
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 1 Remove the cap from the mouthpiece.
ATROVENT.

Take special care with ATROVENT 2 Hold the inhaler as shown in the picture
Check with your doctor or pharmacist before using this (with the arrow on the label pointing
medicine if: upwards) and breathe out gently.
• 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 • Then straight away, put the mouthpiece
• You have cystic fibrosis 3 in your mouth.
If you are not sure if any of these apply to you, talk to your • Hold the mouthpiece with your lips.
doctor or pharmacist before using ATROVENT. • Start to breathe in slowly and deeply
through your mouth.
Taking other medicines • Press the top of the inhaler firmly. This
Please tell your doctor or pharmacist if you are taking or will release one puff of your medicine.
have recently taken any other medicines, including any • Keep breathing in.
inhalers and medicines obtained without a prescription.
This includes herbal medicines. This is because ATROVENT • Hold your breath for as long as is
can affect the way some other medicines work. Also some 4 1...2...3...
4...5...6...7... comfortable.
8...9...10
other medicines can affect the way ATROVENT works. • If possible hold your breath for 10 seconds.
• Then breathe out slowly.
In particular, tell your doctor or pharmacist if you are
taking/ have taken any of the following medicines:
• Other anticholinergic medicines including those for • If you are having more than one puff, wait at
COPD (e.g. tiotropium), irritable bowel syndrome 5 least 1 minute before the next puff.
(e.g.mebeverine), urinary incontinence (e.g. oxybutynin, • Then repeat steps 2, 3 and 4.
solifenacin) or cough (e.g. dextromethorphan)
• Other inhalers to help you to breathe more easily such as
the reliever inhaler salbutamol
• Medicines called ‘xanthines’ to help your breathing such After use, replace the cap on the mouthpiece.
as theophylline and aminophylline 6
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before using ATROVENT.
The mouthpiece has been designed specially for use with
Pregnancy and breast-feeding this product only. Do not use any other mouthpiece with
Do not use ATROVENT if you are pregnant, think you are the product and do not use the mouthpiece provided here
pregnant, likely to get pregnant or are breast-feeding. with any other product.

Driving and using machines If you find breathing in and pressing the inhaler at the same
You may feel dizzy, or have difficulty in focusing, or blurred time (step 3) difficult you should talk to your doctor or
vision while taking ATROVENT. If this happens do not drive pharmacist, as you could use a spacer device (Aerochamber
or use any tools or machines. Plus™) with your inhaler. A spacer is a device designed to
make step 3 easier. A spacer is generally a plastic container
Operations with a mouthpiece at one end and a hole for inserting the
If you attend a hospital appointment or are admitted to mouthpiece of the inhaler at the other end. The puff of
hospital be sure to take your inhaler(s) and any other medicine from your inhaler is sprayed into the spacer and
medicines (in their packaging if possible) with you. Some the puff of medicine stays there, inside the spacer, until you
gases used in operations (anaesthetic gases) may affect how breathe in through your mouth from the spacer with the
your inhaler works. If you are about to have surgery, make spacer mouthpiece in your mouth and with your lips closed
sure you mention that you are taking ATROVENT to the around it. This means that you do not have to worry about
doctor, dentist or anaesthetist. breathing in and pressing the inhaler at the same time.

ATROVENT contains alcohol

This medicine contains about 8 mg of alcohol (ethanol) in
each puff. The amount in each puff of this medicine is
equivalent to less than 1 ml beer or 1 ml wine. The small
amount of alcohol in this medicine will not have any
noticeable effects. 307867-15

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When using your ATROVENT Inhaler CFC-Free take care not Reporting of side effects
to let any of the spray enter your eyes. If any of the spray If you get any side effects, talk to your doctor, pharmacist
accidentally gets into your eyes you may get painful, or nurse. This includes any possible side effects not listed in
stinging or red eyes, dilated pupils, blurred vision, see this leaflet. You can also report side effects directly via the
colours or lights. If this happens, talk to your doctor for Yellow Card Scheme at www.mhra.gov.uk/yellowcard or
advice. If you get problems with your eyes at any other time, search for MHRA Yellow Card in the Google Play or Apple
talk to your doctor for advice. You may be developing App Store. By reporting side effects you can help provide
glaucoma, which will need treatment straight away. more information on the safety of this medicine.

Cleaning 5. HOW TO STORE ATROVENT INHALER CFC-FREE

It is important to clean your inhaler regularly. Otherwise it Do not use this medicine after the expiry date which is
may not work properly. stated on the carton and the canister label. The expiry date
refers to the last day of the month.
• Remove the canister and cap
• Wash and clean the white mouthpiece in warm soapy ATROVENT should not be stored above 25°C. Keep away
water from direct sunlight and heat. Protect from frost.
• Rinse in warm water and allow to air-dry without using
any heating system The canister contains a pressurised liquid. Do not expose to
• Make sure the small hole in the mouthpiece is washed temperatures higher than 50°C. Do not try to open, puncture
through thoroughly or burn the canister even when apparently empty.
• Once the white mouthpiece is dry, replace the canister
and the cap Keep out of the sight and reach of children.

Make sure you do not run out of ATROVENT 6. FURTHER INFORMATION

The inhaler has been designed to deliver 200 puffs of your What ATROVENT INHALER CFC-FREE contains
medicine. However, it is not possible to tell when the inhaler Each inhaler contains 200 puffs. Each puff contains
is empty and when the 200 puffs have been used. There may 20 micrograms of ipratropium bromide (as the monohydrate).
still be a small amount of fluid left over in the container.
Please make sure that your inhaler is replaced after you The other ingredients are:
have taken 200 puffs (usually after 3-4 weeks of regular use) HFA 134a (1,1,1,2 - tetrafluoroethane), citric acid
so that you can be certain that you are getting the right anhydrous, ethanol anhydrous and purified water.
amount of your medicine in each puff.
What ATROVENT INHALER CFC-FREE looks like and
If you use more ATROVENT INHALER CFC-FREE than you contents of the pack
should Your medicine is an inhaler, which contains a pressurised
If you use more of this inhaler than you should, talk to a solution for inhalation. Each carton contains one inhaler.
doctor or go to a hospital straight away. Take all your
inhalers and any other medicines you are taking (in their Marketing Authorisation Holder and Manufacturer
packaging if possible) with you. If you take too much or too The Marketing Authorisation is held by:
many puffs you may get a dry mouth, a rapid heart rate or
blurred vision. Boehringer Ingelheim Limited,
Ellesfield Avenue,
If you forget to take ATROVENT Bracknell, Berks.,
• If you forget a dose, inhale it as soon as you remember it. RG12 8YS, United Kingdom.
• However, if it is time for the next dose, skip the missed
dose. and the product is manufactured by:
• Do not take a double dose to make up for a forgotten
dose. Boehringer Ingelheim Pharma GmbH & Co. KG,
If you have any further questions, ask your doctor or Binger Strasse 173,
pharmacist. 55216 Ingelheim am Rhein,
Germany.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ATROVENT can cause side effects, This leaflet was revised in November 2020.
although not everybody gets them.
© Boehringer Ingelheim Ltd 2020
Tell your doctor straight away if you notice any of 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.