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IPRATROPIUM STERI-NEB 250 MICROGRAMS/ML NEBULISER SOLUTION

Active substance(s): IPRATROPIUM BROMIDE

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Version 2.4

Approved

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.

·

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 you have any
further questions,
ask your doctor or
pharmacist.

·

Keep this leaflet.
You may need to
read it again.

·

Read all of this leaflet
carefully before you
start using this
medicine.

PE3100

REG0069754

Page 1 of 3

Package Leaflet: Information for the User

Ipratropium Bromide

Nebuliser Solution

Ipratropium Steri-Neb 250 micrograms/ml

DO NOT use Ipratropium Steri-Neb and talk to
your doctor if:
O you are allergic to medicines containing
ipratropium bromide or atropine or any of
the other ingredients listed in section 6 of the
leaflet.
Take special care with and talk to your doctor
before you start to use Ipratropium Steri-Neb
if you:
O suffer from an eye condition called glaucoma
O suffer from an enlarged prostate.
O suffer from cystic fibrosis
Taking or using other medicines
O Ipratropium Steri-Neb can be used in
combination with other medicines for the
treatment of respiratory conditions such
as beta- adrenergic drugs (e.g. salbutamol,
formoterol), theophylline, disodium
cromoglicate and inhaled corticosteroids (e.g.
beclometasone). Talk to your doctor before
you start to use Ipratropium Steri-Neb if you
are using any of these medicines, as your dose
may need to be adjusted.
O Please tell your doctor or pharmacist if you are
taking/using or have recently taken/used any
other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
O If you are pregnant, planning to become

2. Before you use
Ipratropium Steri-Neb

Ipratropium Steri-Neb contains a solution of
ipratropium bromide, which is an anticholinergic
bronchodilator agent that helps to manage
conditions where there is a blockage of the
airways. It works by relaxing the smooth muscles
in the passage of the lungs. This helps to relieve
the narrowing and tightness you feel in your
lungs.
Ipratropium Steri-Neb is used to treat breathing
problems in people with chest illnesses such as
chronic obstructive pulmonary disease (COPD)
and asthma.

1. What Ipratropium Steri-Neb is
and what it is used for

1. What Ipratropium Steri-Neb is and what it
is used for
2. Before you use Ipratropium Steri-Neb
3. How to use Ipratropium Steri-Neb
4. Possible side effects
5. How to store Ipratropium Steri-Neb
6. Further information

In this leaflet

Always use Ipratropium Steri-Neb exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
You must only use Ipratropium Steri-Neb in a
power-operated nebuliser. The nebuliser turns
the solution into a fine mist that you can
breathe in. Delivery of the aerosol may be by
face mask or “T” piece. Read the manufacturer’s
instructions and make sure you know how to use
the nebuliser before you use your medicine.
The usual dose is:
O Adults including the Elderly
0.4 to 2.0ml of solution (100 to 500
micrograms) up to four times a day.
O Children
0.4 to 2.0ml of solution (100 to 500
micrograms) up to three times a day.
What to do if you think your medicine is not
working
O Tell your doctor if your breathing gets worse
or your medicine does not provide as much
relief from your condition as before. You
should NOT change the dose you take, or how
often you use your medicine without seeking
medical advice.
How to use Ipratropium Steri-Neb with your
Nebuliser
O Prepare your nebuliser
A
for use according to
the manufacturer’s
instructions.
O Remove a Steri-Neb
from the labelled strip
by twisting and pulling
(diagram A).
O Hold the Steri-Neb
upright and twist off the B
cap (diagram B).
O Squeeze the contents
into the reservoir of your
nebuliser (diagram C).
O Following the
manufacturer’s
instructions, use your
C
nebuliser.
O After you have used
your nebuliser, throw
away any solution that
is left in the reservoir.
O Clean your nebuliser
thoroughly.

3. How to use Ipratropium
Steri-Neb

pregnant or are breast-feeding, ask your doctor
for advice before using this medicine.
Driving and using machines
O Ipratropium Steri-Neb is not expected to affect
your ability to drive or operate machinery.

Like all medicines, Ipratropium Steri-Neb can
cause side effects, although not everybody gets
them.
Most of these are nothing to worry about.
Stop using the solution and tell your doctor
immediately or go to the casualty department at
your nearest hospital if the following happens:
O an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;

4. Possible side effects

Special Precautions for use of Ipratropium
Steri-Neb
O DO NOT dilute the solution or mix it with
other medicines, unless your doctor tells you
to.
O DO NOT swallow the solution or use it in
injections.
O DO NOT get the solution or mist in your eyes.
It is advisable to administer the inhalation
fluid with the use of a mouthpiece. If a
nebuliser mask is used, this should fit the face
well. There have been rare reports of ocular
problems when the spray has entered the eyes.
Patients who are at a high risk of increased
intraocular pressure (glaucoma) should make
sure that they protect their eyes well when
using Ipratropium
Steri-Neb.
If you use more Ipratropium Steri-Neb than
you should
O If you have used a slightly larger dose than
usual, you may notice a faster heart beat
(palpitations). This usually wears off in a few
hours.
O If you (or someone else) swallow or use a lot
of the solution all together, or if you think
a child has swallowed or used any of the
solution contact your nearest hospital casualty
department or your doctor immediately.
In the case of a serious overdose, more rapid
breathing, a high fever, restlessness, confusion,
and hallucinations can occur as well as a faster
heartbeat.
Please take this leaflet, any remaining solution,
and the container with you to the hospital, or
doctor so that they know which solution has
been consumed.
If you forget to use Ipratropium Steri-Neb
O If you forget to take a dose, take one as soon
as you remember, unless it is nearly time to
take the next one. DO NOT take a double
dose to make up for a forgotten dose.
If you stop using Ipratropium Steri-Neb
O DO NOT stop using your medicine without
talking to your doctor first even if you feel
better.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

skin rash or hives)

wheezing, which may be due to paradoxical
bronchospasm (narrowing of the air passage or
tightening of the chest).
These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.
Stop using the solution and tell your doctor if
you suffer from any of the following for more
than a few days.
O a dry mouth.
O constipation and difficulty passing water.
If you notice any of the following symptoms
after the inhalation of Ipratropium Steri-Neb,
you should consult your doctor:
O pain in or painfulness of the eyes, blurred
vision, coloured rings or images together with
red eyes.
The following side effects have been reported at
the approximate frequencies shown:
Common side effects that occurred in less than
one in ten and more than one in one hundred
patients were:
O cough,
O sore throat and hoarseness
O dry mouth
O feeling sick
O headache.
Uncommon side effects that occurred in less
than one in one hundred but more than one in
one thousand patients were:
O palpitations (heart pounding)
O fast heart beat
O skin rash and other allergic reactions.
Rare side effects that occurred in less than
one in one thousand but more than one in ten
thousand patients included:
O blurred vision
O difficulty in urinating.
Other side effects that have been reported in
individual cases include:
O visual disturbances
O dizziness
O stomach disorders
O tightness of the chest causing breathing
difficulties.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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.

O a sudden increase in breathlessness or

REG0069754

Version 2.4

Approved
Marketing Authorisation holder:
Norton Healthcare Ltd T/A
IVAX Pharmaceuticals UK,
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX, United Kingdom

Marketing Authorisation Holder
and Manufacturer

What Ipratropium Steri-Neb solution contains:
O The active ingredient is Ipratropium Bromide
250 micrograms/ml.
The 1ml Steri-Neb contains 250 micrograms
of ipratropium bromide.
The 2ml Steri-Neb contains 500 micrograms
of ipratropium bromide
O The other ingredients are sodium chloride,
water for injections, and dilute hydrochloric
acid to adjust the pH.
What Ipratropium Steri-Neb solution looks like
and contents of the pack:
O Each Ipratropium Steri-Neb is a plastic vial
containing a clear solution.
O Strips of 5 Steri-Nebs are packed into foil
laminate pouches, which in turn are packed
into boxes containing 20 and 100
(Steri-Nebs).
Not all pack sizes may be marketed.

6. Further information

Keep out of the reach and sight of children.
Do not store above 25°C. Do not refrigerate or
freeze. Keep container in outer carton to protect
from light.
For single use only. Use immediately. Discard any
unused portion.
Do not use Ipratropium Steri-Neb after the
expiry date which is stated on the carton and on
each Steri-Neb unit after EXP. The expiry date
refers to the last day of that month.
Do not use Ipratropium Steri-Neb if you notice
the solution is cloudy.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

5. How to store
Ipratropium Steri-Neb

Company responsible for manufacture:
IVAX Pharmaceuticals UK,
Aston Lane North,
Whitehouse Vale Industrial Estate,
Preston Brook, Runcorn,
Cheshire, WA7 3FA,
United Kingdom,
‘Steri-Neb’ is a
trademark

This leaflet was last
revised:
June 2015
PL 00530/0694
231-30-11042-H

Ipratropium Steri-Neb 250 micrograms/ml

Nebuliser Solution

Ipratropium Bromide

Package Leaflet: Information for the User

Page 2 of 3

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00530-0694-ipratropium-250mcg_ml-steri-neb-non-perfor
ated-carton

APPROVALS
Signed by
Vivekananda Bhatlapenumar

REG0069754

Meaning of Signature
Regulatory Affairs Approval

Version 2.4

Approved

Server Date
19-Jun-2015 02:41:47 PM

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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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