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IPRATROPIUM BROMIDE 250 MICROGRAMS/ML NEBULISER SOLUTION

Active substance(s): IPRATROPIUM BROMIDE

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Package leaflet: Information for the user

Ipratropium Bromide 250 micrograms/1ml Nebuliser Solution
Ipratropium Bromide 500 micrograms/2ml Nebuliser Solution
Ipratropium Bromide
Read all of this leaflet carefully before you start taking 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 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 or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ipratropium Bromide Nebuliser Solution is and what it is used for
2. What you need to know before you take Ipratropium Bromide Nebuliser
Solution
3. How to take Ipratropium Bromide Nebuliser Solution
4. Possible side effects
5. How to store Ipratropium Bromide Nebuliser Solution
6. Contents of the pack and other information
1.

What Ipratropium Bromide Nebuliser Solution is and what it is used for

Ipratropium belongs to a group of medicines called “bronchodilators” which help to
open up the air passages in your lungs so that you can breathe more easily.
This medicine helps to make breathing easier in patients with asthma and other
breathing difficulties such as chronic obstructive pulmonary disease.
Ipratropium Bromide Nebuliser Solution can be used at the same time as medicines
called beta2-agonist bronchodilators (‘relievers’), for example salbutamol.
2.
What you need to know before you take Ipratropium Bromide Nebuliser
Solution

Do not take Ipratropium Bromide Nebuliser Solution
 If you are allergic to ipratropium bromide, a related medicine called atropine or
any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Ipratropium Bromide Nebuliser Solution
 if you suffer from cystic fibrosis
 if you have a condition which makes passing urine difficult
 if you suffer from raised pressure in the eyes (glaucoma), as you will need to
make sure the mist does not get into your eyes



if you are a man suffering from prostate problems

Other medicines and Ipratropium Bromide Nebuliser Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines as they may interact with Ipratropium Bromide Nebuliser Solution.
Tell your doctor if you are taking or have taken any of the following medicines:
 medicines called xanthines such as theophylline
 other medicines containing bronchodilators (which also help you to breathe
more easily), such as salbutamol or terbutaline
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this medicine.
If you become pregnant whilst taking this medicine you should tell your doctor as
soon as possible.
Driving and using machines
Ipratropium Bromide Nebuliser Solution has no known effects on the ability to drive
and use machines.
3.

How to take Ipratropium Bromide Nebuliser Solution

Always use this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Your doctor may tell you to use your nebuliser at regular times each day or only when
you are wheezy or short of breath.
Adults, the elderly and children over 12 years
The recommended dose is 250-500 micrograms (1-2ml of solution) three or four
times a day. For acute attacks of breathlessness use 500 micrograms (2ml) of
solution.
Use in children
Children 6-12 years
The recommended dose is 250 micrograms (1ml). The time between doses should
be decided by the doctor.
Children up to 5 years
This medicine should only be used for acute attacks of breathlessness in children up
to 5 years.
The recommended dose is 125-250 micrograms (0.5-1ml solution). The time between
doses should be decided by the doctor but there should be at least 6 hours between
doses.
In all cases, if breathlessness persists or becomes worse, tell your doctor.

General instructions:
Ipratropium Bromide Nebuliser Solution should be used with a suitable nebuliser. The
“mist” produced is then inhaled through a face mask or mouthpiece. Your doctor will
advise you on choosing an appropriate nebuliser and how it should be used.
Sometimes, this medicine is given using an intermittent positive pressure ventilator,
in which case treatment will be started by your specialist.
Instructions for use:
1. Prepare your nebuliser following the manufacturer’s instructions and/or the
dosing instructions given by your doctor. Make sure it is clean.
2. Take a strip of ampoules from the foil sachet. Remove one or two ampoules
(depending on your dose) (Diagram 1) and put the rest back in the foil sachet
and replace the foil sachet in the carton. Never use an ampoule that has been
opened already or if the solution is discoloured.

Diagram 1

Diagram 2

3. Hold the ampoule upright and open it by twisting off the top (Diagram 2).
4. Unless otherwise instructed by your doctor, squeeze all the liquid from the
ampoule into the nebuliser chamber.
5. Throw away the empty plastic ampoule
6. If your doctor has told you to dilute the solution, this should be carried out
using ONLY sterile sodium chloride 0.9% solution. Use the amount which your
doctor has told you to use.
7. Turn on the nebuliser and breathe in the “mist” calmly and deeply using the
face mask or mouthpiece. If you are using a face mask make sure that it is
fitted correctly. Be sure to protect your eyes from the mist produced as it can
cause pain or discomfort if it gets into them. This is especially important if you
suffer from glaucoma. If a lot of the mist gets into your eyes or you start
suffering from eye pain or discomfort after using this medicine you should
contact your doctor or pharmacist.
8. The length of time it takes your nebuliser to turn your medicine into a mist will
depend on the type of equipment you use. You will know when your treatment
is complete because the fine mist will stop coming out of your mask or
mouthpiece.
9. You must wash your nebuliser, face mask and/or mouthpiece in warm soapy
water and rinse well after each use.

Contact your doctor immediately if:
 You are not getting relief from your current dose
 Your breathing is getting worse
 Your chest feels tight
These are signs that your condition is not being controlled and you may need
different or additional treatment.
If you take more Ipratropium Bromide Nebuliser Solution than you should
You may feel that your heart is beating faster than usual or that your breathing
becomes rapid. You may have a high fever, restlessness, confusion or hallucinations.
Call your doctor immediately or go to the nearest hospital casualty department .
Take this leaflet or an ampoule of your medicine with you so that the doctor will know
what you have taken.
If you forget to take Ipratropium Bromide Nebuliser Solution
If you forget to take your Ipratropium Bromide Nebuliser Solution, take the next dose
when it is due, or before you become wheezy.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ipratropium Bromide Nebuliser Solution this may make your
condition worse. Do not stop taking your medicine unless your doctor tells you to do
so.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
All medicines can cause allergic reactions, although serious allergic reactions
are very rare. Tell your doctor immediately if you get any sudden wheeziness,
difficulty in breathing, swelling of the eyelids, tongue, lips or face, rash or
itching (especially affecting your whole body). This is known as ‘angioedema’.
Rarely, inhaled drugs such as Ipratropium Bromide Nebuliser Solution can
cause acute wheezing and/or shortness of breath. If this occurs, stop using
your medicine immediately and seek medical advice.
The following side effects have also been reported:
Common side effects (may affect up to 1 in 10 people)
Headache
Cough
Irritation of the nose and mouth
Dryness of the mouth
Nausea and/or vomiting (feeling or being sick)
Constipation
Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people)
Skin rashes (a rash of red spots or itchy ‘nettle’ rash)
Rapid heartbeat
Blurred vision, difficulty focusing or other visual disturbances
Glaucoma (increased pressure in the eye)
Rare side effects (may affect up to 1 in 1,000 people)
Increased pressure in the eye
Irregular heartbeat
Difficulty passing urine
Pain in the eyes
Widening of the pupils

If any of the solution or mist accidentally gets into your eyes you may experience red
eyes, discomfort or pain in your eyes, blurred vision, or you may see halos or
coloured images.
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.
5.

How to store Ipratropium Bromide Nebuliser Solution

Keep this medicine out of the sight and reach of children.
Do not store your medicine above 25˚C. Store in the original package in order to
protect from light.
Do not use this medicine after the expiry date which is stated on the ampoule label,
foil sachet and carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any cloudiness when the solution is poured
into the nebuliser cup. Discard the solution and wash the nebuliser cup before
selecting a fresh ampoule for use.
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.
6.

Contents of the pack and other information

What Ipratropium Bromide Nebuliser Solution contains
 The active substance is Ipratropium Bromide 250 micrograms/ml (0.025%
w/v).



The other ingredients are sodium chloride, water for injections and
hydrochloric acid

What Ipratropium Bromide Nebuliser Solution looks like and contents of the
pack
Your medicine comes in the form of plastic ampoules containing a clear colourless
solution to be nebulised (made into a fine mist for inhalation).
Two sizes of ampoules are available:
Ampoule containing 1ml of solution (250 micrograms of Ipratropium Bromide)
Ampoule containing 2ml of solution (500 micrograms of Ipratropium Bromide)
The ampoules are packed in strips of 10 inside a foil sachet which are then packed
into a carton. Cartons are available in packs of 20 or 60 ampoules. Not all pack sizes
may be marketed.
Marketing Authorisation Holder:
Breath Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, U.K.
Manufacturer:
Laboratoire Unither, Espace lndustriel Nord, 151 rue André Durouchez- CS 28028,
80084 AMIENS Cedex 2, France
This leaflet was last revised in: March 2016

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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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