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RESPONTIN NEBULES

Active substance(s): IPRATROPIUM BROMIDE

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Package Leaflet: Information for the User

Respontin® Nebules®

GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe

ipratropium bromide

Read all of this leaflet carefully before you start using this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet:
1 What Respontin Nebules are and what they are used for
2 What you need to know before you use Respontin Nebules
3 How to use Respontin Nebules
4 Possible side effects
5 How to store Respontin Nebules
6 Contents of the pack and other information

1 What Respontin Nebules are and what are they
used for
Respontin Nebules contain a medicine called ipratropium. This
belongs to a group of medicines called ‘relievers’ or
bronchodilators. They relax the muscles in the airways of your
lungs. This helps to:
• open your airways
• relieve chest tightness, wheezing and coughing so that you can
breathe more easily.
Respontin Nebules are used to treat:
• asthma
• other breathing difficulties in adults, such as Chronic
Obstructive Pulmonary Disease (COPD).
They are usually given to people who have these conditions when
other treatments have not helped enough.
A Nebule® is a small plastic container that contains a liquid. The
liquid is put into a machine called a nebuliser. This machine makes a
fine mist for you to breathe in through a face mask.

2 What you need to know before you use Respontin
Nebules
Do not use Respontin Nebules if:
• you are allergic to ipratropium bromide or any of the other
ingredients of this medicine (listed in section 6)
• you are allergic (hypersensitive) to atropine.
Do not use if any of the above apply to you. If you are not sure,
talk to your doctor, nurse or pharmacist before using Respontin
Nebules.
Take special care with Respontin Nebules
Talk to your doctor, nurse or pharmacist before using Respontin
Nebules if:
• you have difficulty passing water because your prostate gland
is enlarged
• you have cystic fibrosis
• you suffer from a problem caused by too much pressure in your
eye (glaucoma). You need to make sure the mist from the
nebuliser does not get in your eyes.
If you are not sure if any of the above apply to you, talk to your
doctor, nurse or pharmacist before using Respontin Nebules.
Other medicines and Respontin Nebules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription. This includes herbal medicines. In
particular if you are taking any of the following:
• medicines for breathing problems called ‘beta-agonists’ such
as salbutamol
• medicines for breathing problems called ‘xanthine
preparations’ such as theophylline or aminophylline.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
You may feel dizzy or have difficulty in focusing or have blurred
vision whilst taking Respontin Nebules. If this happens do not
drive or use any tools or machines.

3 How to use Respontin Nebules
Always use this medicine exactly as your doctor has told you.
Check with your doctor, nurse or pharmacist if you are not sure.

United Kingdom-GBR

Using this medicine
• do not inject or swallow the liquid. Respontin Nebules
should only be inhaled using your nebuliser
• do not let the liquid, or the mist produced by the
nebuliser get into your eyes. You can wear glasses or
goggles to protect them
• your doctor, nurse or pharmacist should show you how to use
your medicine
• each small plastic container (Nebule) contains some liquid
• the liquid is put into a nebuliser. This makes a fine mist for you
to breathe in through a face mask
• you must use your nebuliser in a well-ventilated room as some
of the mist will be released into the air and may be breathed in
by others.
Adults (including the elderly) and children over 12 years old
• the usual dose is the contents of 1 to 2 single dose units
(250-500 micrograms), three to four times a day
• for acute attacks of breathlessness use 2 single dose units
(500 micrograms)
• if breathlessness does not go away or gets worse consult your
doctor.
Children 6 to 12 years old
• 1 single dose unit (250 micrograms) up to a total daily dose of
4 single dose units (1 mg)
• the time between doses should be decided by your doctor.
Children 0 to 5 years for treatment of acute asthma only
• ½ to 1 single dose unit (125-250 micrograms) up to a total
daily dose of 4 single dose units (1 mg)
• the time between doses should be not be less than 6 hours.
When children are using this medicine they must be supervised by
a responsible adult.
Do not use your nebuliser to take Respontin Nebules and
‘disodium cromoglycate inhalation solutions’ which have the
preservative ‘benzalkonium chloride’ at the same time.
Using your Nebules
your Nebules are in a foil pack. Do not
open the pack until you need to use them
cut the pack along the dotted line and
take out the Nebules
hold the strip of Nebules in one hand, with your
other hand hold the last Nebule in the row
twist the Nebule downwards and away from you

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the remaining Nebules to the
5 return
foil pack and replace it in the box
the top of the Nebule you have
6 hold
just removed. Twist the body to open it

end of the Nebule
7 putintothetheopen
nebuliser bowl and squeeze slowly

the nebuliser
8 assemble
and use it as directed

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Diluting your Nebules
You may need to dilute the liquid in the Nebule. This depends on
the nebuliser you use and how long you are meant to inhale for.
• do not dilute the contents of a Nebule unless you are
told to by your doctor
• if your doctor has told you to dilute the solution, empty the
contents of the Nebule into the nebuliser bowl
• add the amount of sterile sodium chloride 0.9% solution your
doctor has told you to use
• put the top on the nebuliser bowl and shake gently to mix the
contents.
If dilution is necessary then only sterile sodium chloride
0.9% solution should be used.
After use
• use a fresh Nebule for each dose. Only open a new one when
you are ready to use it. If there is any liquid left over, throw it
away. Do not save it to use again
• throw away any solution remaining in the nebuliser bowl
• clean your nebuliser in the recommended way.
If you use more Respontin Nebules than you should
If you use more medicine than you should, the following effect
may happen:
• dry mouth
• visual accommodation disturbances
• fast or irregular heart beats.
If you think you have used too much talk to a doctor. Take the
medicine pack with you.
If you forget to use Respontin Nebules
• If you become wheezy, inhale your missed dose
• If you are not wheezy, do not worry, just inhale the next dose
when it is due
• If it is time for your next dose, skip the missed dose, do not use a
double dose (two doses at once) to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask
your doctor, nurse or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop using Respontin Nebules and see a doctor straight
away, if you notice any of the following serious side effects
- you may need urgent medical treatment:
• If after using Respontin Nebules you are wheezy or have other
difficulties in breathing, do not use any more (unless you have
been told to by your doctor).
• Allergic reactions – the signs may include skin rash and itching
(may affect up to 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 (may affect up to 1 in 100 people).
• 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).
Stop using this medicine and see your doctor straight away if you
have any of these side effects.
Other side effects include:
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 Respontin
Nebules.
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, 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 (may affect up to 1 in 1000 people)
• Difficulty focusing.
• Nettle rash (urticaria).
If any of the liquid or mist 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 affected, do not drive or use any tools or machines. If
you get problems with your eyes at any other time, talk to your
doctor for advice.
If the relief of wheezing or chest tightness is not as good
as usual or does not last for as long as usual, tell your
doctor as soon as possible. It may be that your chest condition
is getting worse and perhaps you may need an extra medicine.

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.

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5 How to store Respontin Nebules

United Kingdom-GBR

• Keep this medicine out of the sight and reach of children.
• Keep Respontin Nebules out of the light and in the foil pack.
• When you open a foil pack:
- Note the date
- Add 4 weeks to this date. This is the new `discard after’
date.
- There is a space on the foil pack lid to write the `discard
after’ date.
- Do not use any unused Respontin Nebules from that foil
pack after this `discard after’ date.
- Ask your pharmacist how to dispose of them.
• If the foil pack has not been opened, do not use this medicine
after the expiry date shown on the carton and label after EXP.
The date refers to the last day of that month.
• Store below 25°C (77ºF)
• Do not throw away medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

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6 Contents of the pack and other information

What Respontin Nebules contains
• The active substance is ipratropium bromide.
• The other ingredients are salt (sodium chloride), diluted
phosphoric acid and purified water.
Respontin Nebules are a sterile solution for nebulisation. They
contain 250 micrograms of ipratropium bromide in each ml. The
Nebules come in two different sizes - 1 ml and 2 ml Nebules.
What Respontin Nebules look like and contents of the pack
Each carton contains 4 foil packs of five Nebules.
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer:
Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany
Other Formats:
To listen to or request a copy of this leaflet in Braille, large print
or audio please call, free of charge:

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0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name
Respontin Nebules 250 mcg in 1 ml

Respontin Nebules 500 mcg in 2 ml
Reference number
10949/0275
This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in July 2015
Respontin, Nebule and Nebules are registered trade mark of the
GSK group of companies.
© 2015 GSK group of companies. All rights reserved.

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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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