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IPRAVENT CFC-FREE INHALER 20 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): IPRATROPIUM BROMIDE MONOHYDRATE / IPRATROPIUM BROMIDE MONOHYDRATE / IPRATROPIUM BROMIDE MONOHYDRATE

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Package leaflet: Information for the patient
Ipravent CFC-Free Inhaler 20 micrograms/ actuation
pressurised inhalation, solution
(ipratropium bromide)

• 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 Ipravent Inhaler.
Pregnancy, breast-feeding and fertility
The name of this medicine is ‘Ipravent CFC-Free Inhaler 20 micrograms/
If you are pregnant or breastfeeding, think you may be pregnant or are
actuation pressurised inhalation, solution’ which will be referred to as ‘Ipravent
planning to have a baby, ask your doctor or pharmacist for advice before taking
Inhaler’ throughout this leaflet.
this medicine.
Read all of this leaflet carefully before you start using this medicine
Safety data for its use in pregnancy has not be established. You should consult
because it contains important information for you.
your physician for more than occasional use of Ipravent Inhaler during
- Keep this leaflet. You may need to read it again.
pregnancy.
- If you have any further questions, ask your doctor, pharmacist or asthma
It is not known whether Ipravent Inhaler is excreted in human milk. You
nurse.
should consult your doctor before you regular use Ipravent Inhaler during
- This medicine has been prescribed for you only. Do not pass it on to others. It
breast-feeding.
may harm them, even if their symptoms and signs of illness are the same as
The effect of Ipravent Inhaler on fertility has not been studied and there are no
yours.
fertility data available.
- If you get any side effects, talk to your doctor, pharmacist or asthma nurse.
This includes any possible side effects not listed in this leaflet. See section 4. Driving and using machines
You may feel dizzy, or have difficulty focusing, dilated pupils, blurred vision,
What is in this leaflet
visual halos and/or coloured images, red eyes, eye pain or discomfort when
1. What Ipravent Inhaler is and what it is used for
using Ipravent Inhaler. If any of these symptoms occur do not drive or use any
2. What you need to know before you use Ipravent Inhaler
tools or machines. If your eyes are affected in any way at all do not drive or
3. How to use Ipravent Inhaler
operate machinery and contact your doctor straightaway.
4. Possible side effects
5. How to store Ipravent Inhaler
Operations
6. Contents of the pack and other information
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 (anaesthetics gases) may affect how your
1. What Ipravent Inhaler is and what it is used for
inhaler works. If you are about to have surgery, make sure you mention that
Ipravent Inhaler contains a medicine called ipratropium bromide. This belongs to you are using Ipravent Inhaler to the doctor, dentist or anaesthetist.
a group of medicines called bronchodilators. It is used to make breathing easier
for people with asthma or ‘chronic obstructive pulmonary disease’ (COPD), often Ipravent Inhaler contains ethanol (alcohol)
This medicinal product contains a small amount of ethanol (8.4 mg in one
referred to as chronic bronchitis.
single dose).
If you have asthma or COPD, you may have difficulty in breathing, shortness of
breath, wheezing or tightness in your chest.
3. How to use Ipravent Inhaler
Ipravent Inhaler works by opening up airways.

2. What you need to know before you use Ipravent Inhaler

1

2

3

4

5

1. Stand or sit upright while using the Ipravent Inhaler
2. Remove the mouthpiece cover.
3. Check inside and outside the mouthpiece of the inhaler to make sure that it
is clean and free from dust and dirt and any loose objects before inhaling.
4. Hold the inhaler upright between the thumb(s) on the base of the
mouthpiece and a forefinger (s)/index finger(s) on the top of the inhaler
(the arrow on the base of the container should be pointing upwards) and
breathe out slowly and deeply.
5. Immediately after breathing out place the mouthpiece in your mouth
between your teeth and close your lips around it but do not bite it
6. Breathe in slowly and deeply, through the mouth and immediately after
starting to breathe in press down firmly on the top of the inhaler to release
one actuation (puff) and continue to breathe in steadily and deeply.
7. Hold your breath, remove the inhaler from the mouth and take away the
finger from top of the inhaler. Continue to hold your breath for as long as is
comfortable, for 10 seconds if possible.
8. Breathe out slowly. Do not breathe out into the inhaler.
9. If a second inhalation is required you should wait at least one minute and
then repeat steps 4 to 8.
10. Replace the mouthpiece cover after use.
IMPORTANT
• Do not inhale too quickly, start breathing in as slowly and steadily as
possible just before pressing the inhaler
• Do not rush through the entire procedure
• Elderly patients and patients with weak hands may use the inhaler with both
hands
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.
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Ipravent CFC-Free Inhaler

Ipravent CFC-Free Inhaler

Do not use Ipravent Inhaler:
• If you are allergic to ipratropium bromide or any of the other ingredients of
this medicine (listed in section 6).
• If you are allergic to similar medicines which contain atropine or medicines
like atropine.
• If you are pregnant, think you are pregnant, are 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 Ipravent Inhaler.
Warnings and precautions
Talk to your doctor or pharmacist or asthma nurse before using Ipravent Inhaler
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
or asthma nurse before using Ipravent Inhaler.
Ipratropium bromide is slow acting drug and therefore you will not get immediate
relief after starting this medicine.
Talk to your doctor, pharmacist, or asthma nurse:
• If you are required to take a fast-acting reliever inhaler such as salbutamol
more frequently than normal or if you are not getting relief from your reliever
inhaler or if your symptoms are getting worse, this may be due to worsening
of asthma and you should see your doctor straightaway.
• If your asthma seems to be getting worse you may have a bacterial infection
and you must see your doctor. Your doctor may prescribe you antibiotics, may
increase the dose of your inhaled corticosteroids and /or may start short
course of oral corticosteroids.
• If you experience allergic reactions like skin rash and itching (urticaria) or a
severe allergic reactions (anaphylaxis) with swelling of your mouth, tongue
and lips and swelling of your face, sudden difficulties in breathing
(bronchospasm) and/or a tightness in your throat you must see your doctor
immediately.
• If you experience sudden difficulty in breathing, increased wheezing or
shortness of breath after taking a dose of Ipravent inhaler you must stop using
your Ipravent Inhaler and not use it again and you must use your fast-acting
reliever inhaler straightaway. You must contact your doctor immediately.
• If any of the spray from the inhaler accidently gets into your eyes you must
contact your doctor or asthma nurse as soon as possible.
Children and adolescents
Ipravent inhaler should not be used in children 12 years of age and
younger or adolescents 13 to 17 years of age.
Other medicines and Ipravent Inhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might use
any other medicines, including any inhalers or medicines obtained without a
prescription. This includes herbal medicines. This is because Ipravent Inhaler
can affect the way some other medicines work. Also some other medicines can
affect the way Ipravent Inhaler works.
In particular, tell your doctor or pharmacist if you are taking/have taken any of
the following medicines:
• Other inhalers to help you breathe more easily such as the reliever inhaler
salbutamol.

Always use Ipravent Inhaler exactly as your doctor has told you. Check with
your doctor if you are not sure.
Use in children
This pressurised metered dose inhaler is not to be used in children 12
years of age and younger or in adolescents 13 to 17 years of age.
Use in adults (including the elderly) with either asthma or COPD
• 1 or 2 puffs to be inhaled three or four times daily.
• However, in early treatment some patients may need up to 4 puffs at a time
to obtain maximum benefit.
Always use this medicine exactly as described in this leaflet or as your doctor,
pharmacist or asthma nurse has told you. Check with your doctor, pharmacist
or asthma nurse if your not sure.
Testing your inhaler
When you use the inhaler for the first time you should test it to check that it
works properly. Also do this if you have not used the inhaler for 3 or more days.
1. Remove the mouthpiece cover by gently pressing the sides with your thumb
and index finger.
2. Point the mouthpiece away from you and press the canister twice (once at a
time) to release two puffs into the air.
How to use your inhaler

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UK

Date: 19/06/2017

Practice in front of a mirror the first few times. If you see “mist” coming from the
top of your inhaler or the sides of your mouth you should start again.
A spacing device may be useful for patients with weak hands, particularly the
elderly and adults who find it difficult to synchronise breathing in and actuation
of the inhaler.
However this Ipravent Inhaler is NOT to be used with ANY spacing device.
If a spacing device is required you will have to have your inhaler treatment changed to an alternative inhaler that can be used with a spacing
device.
If the Inhaler has been exposed to low temperatures, the patient should take the
metal canister out of the plastic case and warm it in their hands for a minimum
of two minutes.
When using your Ipravent Inhaler take care not to let any of the spray
enter your eyes. If any of the spray from the inhaler accidently gets into your
eyes you may get painful eyes, stinging or red eyes, dilated pupils, blurred
vision, see colors or lights or halos around lights. If you get any of the above
side effects, rinse the eye with cold tap water and immediately talk to your
doctor, pharmacist or asthma nurse for further advice.
Cleaning your inhaler
To prevent your inhaler from getting blocked up it should be cleaned at least
once a week.
• Remove the canister and green mouthpiece cover.
• 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 mouthpiece is dry, replace the canister and the mouthpiece cover.
Do not put the metal canister into water.
Do not use more than your doctor has told you to use
See your doctor straightaway if:
• You feel that your inhaler is not working as well as usual.
or
• You need to use the inhaler more than your doctor has recommended.
Your doctor may need to check how well your medicine is working. Your doctor
may need to change your medicine.
Make sure you do not run out of Ipravent Inhaler
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 Ipravent Inhaler than you should
If you use more of this medicine than you should, talk to a doctor or go to a
hospital straightaway. 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 use your Ipravent Inhaler
• If you forget a dose, take 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

pressure in your eyes (glaucoma), which will need treatment
(straightaway). If your eyes are affected in any way do not drive or
operate machinery.
See your doctor straightaway if you have any of these side effects.
The side effects described below have been experienced by people taking
Ipravent Inhaler and they are listed as either common, uncommon or rare.
Common (may affect up to 1 in 10 people)
• Headache, dizziness
• Dry mouth, feeling sick (nausea), stomach upset or discomfort.
• Cough and throat irritation when you have just used Ipravent Inhaler
Uncommon (may affect up to 1 in 100 people)
• Itching, skin rash.
• Unexpected tightness of the chest, swelling of the throat, dry throat.
• Blurred vision, dilated pupils,increased pressure in the eye (glaucoma),
painful eyes, stinging redness or swelling of the eyes, seeing colors, lights
or halos around lights.
• Diarrhoea, constipation or being sick (vomitting).
• Mouth or lip sores.
• Problems passing water (urine), especially if you already have problems
passing urine.
Rare (may affect up to 1 in 1000 people)
• Difficulty focusing
• Nettle rash (urticaria)
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine.

Do not stop using your Ipravent Inhaler unless your doctor tells you to.

6. Contents of the pack and other information

If you have any further questions on the use of this medicine ask your doctor or
pharmacist or asthma nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor straight away if you notice any of the following serious
side effects – you may need urgent medical treatment:
• If after using Ipravent Inhaler you are wheezy or have other difficulties in
breathing, do not use any more (unless you have been told to by your
doctor). You may need to use 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.
• Paradoxical bronchospasm (may affect up to 1 in 100 people). As with other
inhaled medicines you may experience difficulty in breathing with an
immediate worsening of your wheezing after taking a dose of this medicine.
This is known as paradoxical bronchospasm and will respond to a fast-acting
‘reliever’ inhaler, your ‘blue’ inhaler and should be treated straightaway. You
should stop using Ipravent Inhaler immediately and contact the doctor.
The doctor will want to see you and examine your chest and will probably
prescribe a different inhaler to treat your asthma or COPD or chronic
bronchitis.
• Allergic reactions (may affect up to 1 in 100 people) – the signs may include
skin rash and itching . In severe reactions the signs include swelling of your
mouth (tongue and lips) and face, sudden difficulties in breathing and a fall in
your blood pressure. Tightening of your throat may occur. If allergic reactions
occur, Ipravent should be stopped immediately; do not use your Ipravent
Inhaler again; talk to your doctor or pharmacist straightaway.
• Palpitations (fast or uneven heart beats ) or quickening of the heart rate
(may affect up to 1 in 100 people).
• Increased heart rate or irregular heart rhythm such as atrial fibrillation (may
affect up to 1 in 1000 people).
• If any of the spray from the inhaler accidently gets into your eyes you may
get painful eyes, stinging or red eyes, dilated pupils, blurred vision, see
colors or lights or halos around lights. If this happens, talk to your doctor
immediately for advice. If you get problems with your eyes at any other time
also talk to your doctor for advice. You may be developing increased

5. How to store Ipravent Inhaler
Keep this medicine out of the sight and reach of children
Do not use Ipravent Inhaler after the expiry date which is stated on the carton
and canister label after EXP. The expiry date refers to the last day of that
month.
Ipravent Inhaler should not be stored above 25°C. Keep away from direct
sunlight and heat. Protect from frost.
If the Inhaler has been exposed to low temperatures, the patient should take
the metal canister out of the plastic case and warm it in their hands for a
minimum of two minutes.
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.
Do not throw away any medicines or inhalers via waste water or household
waste. Ask your pharmacist how to throw away medicines and inhalers that
you no longer use. These measures will help protect the environment

What Ipravent Inhaler contains
• The active substance is ipratropium bromide.
One metered dose (ex-valve) contains 20 micrograms ipratropium bromide
(as the monohydrate).This is equivalent to a delivered dose (ex-actuator) of
18 micrograms ipratropium bromide (as the monohydrate). Each canister
contains 200 actuations, each actuation containing 20 micrograms
ipratropium bromide (as the monohydrate).
• The other ingredients are CFC-Free propellant, propellant HFA 134a
(1,1,1,2- tetrafluoroethane), citric acid anhydrous, ethanol anhydrous
and purified water. Ipravent Inhaler does not contain any
chlorofluorocarbon (CFC) propellants.
What Ipravent Inhaler looks like and contents of pack.
Ipravent Inhaler is comprised of a pressurised aluminium canister which
contains pressurised solution for inhalation sealed with a metering valve
made up of a thermoplastic body and a metallic ferrule and spring and a
plastic actuator made up of polypropylene having a white mouthpiece fitted
with a green mouthpiece cover. Each carton contains one inhaler.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Cipla (EU) Limited. Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW,
United Kingdom
Manufacturer:
S&D Pharma CZ, spol. s r.o, Theodor 28, 273 08 Pchery (Pharmos a.s.
facility), Ceská Republika
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY,
United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in 06/2017.

21062283

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Date: 19/06/2017

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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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