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IPRAMOL STERI-NEB 0.5MG/2.5MG PER 2.5ML NEBULISER SOLUTION

Active substance(s): IPRATROPIUM BROMIDE / SALBUTAMOL / SALBUTAMOL SULPHATE

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PE2850

IPRAMOL STERI-NEB
0.5MG / 2.5 MG
PER 2.5ML NEBULISER
SOLUTION
Ipratropium bromide
and salbutamol
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. 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 Ipramol Steri-Neb ampoules are and what
they are used for
2. What you need to know before you use Ipramol
Steri-Neb ampoules
3. How to use Ipramol Steri-Neb ampoules
4. Possible side effects
5. How to store Ipramol Steri-Neb ampoules
6. Contents of the pack and other information
IPRAMOL STERI-NEB AMPOULES ARE
 1 WHAT

AND WHAT THEY ARE USED FOR

Your medicine is called Ipramol Steri-Neb
ampoules 0.5mg / 2.5mg per 2.5 ml Nebuliser
Solution. The active ingredients are ipratropium
bromide and salbutamol. Ipratropium bromide and
salbutamol both belong to a group of medicines
called bronchodilators, which help to improve
your breathing by opening up your airways.
This is achieved by preventing the contraction
of the smooth muscles surrounding the airways,
therefore allowing the airways to remain open.
Ipratropium bromide acts by blocking the nerve
signals that go to the muscles surrounding the
airways, and salbutamol acts by stimulating
specific receptors in the muscles.
Ipramol Steri-Neb is used to treat breathing
problems in people with long-standing breathing
difficulties in an illness called ‘chronic obstructive
pulmonary disease’ or ‘COPD’. Ipramol will relieve
wheezing, shortness of breath and chest tightness
by opening up your airways.
YOU NEED TO KNOW BEFORE YOU USE
 2 WHAT

YOUR IPRAMOL STERI-NEB AMPOULES

Do not use Ipramol Steri-Neb ampoules:
• if you are allergic (hypersensitive) to ipratropium
or salbutamol or any of the other ingredients in
this medicine (listed in section 6).
• if you are allergic to medicines that contain
atropine or medicines like atropine.
• If you suffer from abnormal heart
rhythms including fast heart beat (called
‘tachyarrhythmia’).
• If you have an enlarged heart or a condition
known as hypertrophic obstructive
cardiomyopathy, where wall between the two
sides of heart becomes thicker and blocks the
blood flow.
If you are not sure, talk to your doctor or
pharmacist before using Ipramol.
Warnings and precautions
Talk to your doctor or pharmacist before using
Ipramol:

• if you suffer from or think you may suffer from
an eye condition known as glaucoma (increased
pressure in the eyes) or if you suffer from any
other eye conditions. Your doctor may advise
you to protect your eyes when using Ipramol
Steri-Neb ampoules;
• if you are male and you know that you have
an enlarged prostate or if you have problems
passing urine (water);
• if you have had a recent heart attack (myocardial
infarction); if you have problems with your
arteries or get pain in your legs when you walk;
• if you have a history of heart disease, irregular
heart rhythm or angina (please tell your doctor
before starting this medication);
• if you have diabetes;
• if you have an overactive thyroid gland;
• if you suffer from cystic fibrosis;
• if you have been told that you have a tumour of
the adrenal gland called pheochromocytoma.
Children and adolescents
Ipramol is not recommended in children 12 years
of age and younger, as safety and efficacy have not
been established in this age group.
Other medicines and Ipramol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Certain medicines may interact with Ipramol
Steri-Neb and may worsen side effects or reduce
the effect of Ipramol Steri-Neb. You must always
tell your doctor if you are taking any of the
following medicines:
• other asthma medicines, including inhalers and
tablets for asthma and including treatments
known as “relievers” such as salbutamol
and “preventers” such as beclometasone
dipropionate. These may increase the effect of
Ipramol Steri-Neb and increase the severity of
side effects;
• beta-blockers i.e. medicines that are commonly
used to treat heart conditions such as chest pain
that occurs on exertion (called angina pectoris),
irregular heart beats or arrhythmias and high
blood pressure (called hypertension). They
include drugs such as propranolol. These drugs
oppose the ‘airway opening’ effects of Ipramol;
• certain drugs to treat depression (such “antidepressants” are drugs that are prescribed for
patients suffering from depression and anxiety).
This class of drug includes medicines such as
monoamine oxidase inhibitors (e.g. phenelzine)
or tricyclic antidepressants (e.g. amitriptyline);
• digoxin (for heart problems) may cause heart
rhythm problems when given with Ipramol
Steri-neb;
• diuretics (“water tablets”) and steroid tablets
(these are medicines that reduce inflammation
such as prednisolone). These drugs may
increase the risk of low potassium levels;
• anaesthetic agents may increase the
susceptibility of the effects of salbutamol on the
heart – you will be monitored closely or your
doctor might decide to discontinue Ipramol
Steri-Neb if you are going to have an operation.
If you are going to have a general anaesthetic in
hospital, please tell the anaesthetist what drugs
you are taking.
If you have to provide a urine sample as part of a
routine sport drug test, tell the person giving the
test that you are taking Ipramol because it contains
salbutamol, which may lead to a positive test
result.

Driving and Using Machines
You may feel dizzy, or have difficulty in focusing or
experience blurred vision while taking Ipramol. If it
occurs do not drive or use tools or machines.
TO USE IPRAMOL STERI-NEB AMPOULES
 3 HOW


Ipramol Steri-Neb ampoules are for inhalation use
after nebulisation.
Always use Ipramol Steri-Neb exactly as described
in this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or nurse if you are
not sure.
The recommended dose for adults and children
over 12 years of age is the contents of one
ampoule, three or four times a day.
Elderly patients should take the usual adult dose.
Ipramol Steri-Neb ampoules are not recommended
for children under 12 years of age.
The label will tell you how much to take and how
often to take it.
Never use more medicine than your doctor has
told you to. Tell your doctor if your breathing
problems get worse or your medicine does
not provide as much relief from your breathing
problems as before or if you are using your blue
short-acting “reliever” inhaler more often than is
usual for you.
Instructions for Use
• Prepare your nebuliser for use according to the
manufacturer’s instructions and advice from
your doctor.
• Carefully remove an ampoule from the labelled
strip by twisting and pulling. Never use an
ampoule that has been opened already or if the
solution is discoloured (diagram A).
• Hold the ampoule upright and twist off the cap
(diagram B).
• Squeeze the contents into the reservoir of your
nebuliser (diagram C).
• Follow the manufacturer’s instructions and the
advice from your doctor on how to assemble
and how to use your nebuliser.
• After you have used your nebuliser, throw
away any solution that is left in the reservoir.
Any solution left in the ampoule should also be
thrown away.
• Clean your nebuliser thoroughly according to
the manufacturer’s instructions. It is important
that the nebuliser is kept clean.
A

B

C

Ipramol with food and drink
Food and drink have no influence on Ipramol
Steri-Neb
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
might be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Ipramol Steri-Neb should not be used during
pregnancy or breast feeding unless your doctor
decides that the benefits to the mother outweigh
the risk to the baby.

Do not dilute the solution or mix it with other
medicines, unless your doctor tells you to.
The single dose ampoules of Ipramol Steri-Nebs
do not contain preservatives and therefore it is
important to use the contents immediately after
opening. A new ampoule must be used each time
you use Ipramol Steri-Nebs in your nebuliser.

Partly used, opened or damaged ampoules should
be discarded. You should never use an ampoule,
which has been opened earlier.
It is important that you follow these instructions in
order to avoid any contamination of the nebuliser
solution within the ampoules.
Do not swallow the solution or use it in injections.
Do not allow the solution or mist to enter your
eyes.
If you use more Ipramol Steri-Neb ampoules than
you should
If you have taken a slightly larger dose than usual,
you may notice a faster heart beat (palpitations) or
tremor. Other symptoms might include chest pain,
changes in blood pressure, flushing, restlessness
or dizziness. These effects usually wear off in a
few hours. The level of potassium in your blood
may fall and the doctor may want to monitor
the potassium in your blood by taking a blood
test to measure the levels from time to time. Tell
your doctor if you are worried by any of these
symptoms or if they persist.
If you have taken more medicine than you should
have taken, tell your doctor immediately or go to
the nearest hospital. If you need to visit a doctor or
need to go into hospital then you should take all of
your medicines with you, including any you may
have bought without a prescription; these should
be in their original packaging if at all possible. Take
this leaflet with you to show the doctor.
If you forget to use Ipramol Steri-Neb Ampoules
If you forget to take a dose at the right time, take it
as soon as you remember.
Do not take a double dose to make up for a
forgotten dose.
If you stop using Ipramol Steri-Neb
You should not stop taking Ipramol Steri-Neb
without prior discussion with your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
 4 POSSIBLE SIDE EFFECTS

Occurrence rates for Side effects
Uncommon: may affect up to 1 in 100 people
• headaches
• palpitations or fast heartbeat
• dryness of the mouth
• nausea (feeling sick)
• cough
• speech difficulties
• dizziness
• increased blood pressure
• feeling nervousness
• tremor
Rare: may affect up to 1 in 1,000 people
• allergic reactions including swelling of the
tongue, lips and face
• breathing difficulties and shortness of breath
• sweating
• flushing
• reduced blood pressure
• vomiting (being sick)
• upset stomach / upset bowels (including
intestinal blockage)
• difficulty in passing urine (water)
• itching
• rashes
• muscular pains, weakness and cramps
• memory disorders
• anxiety and depression
• eye pain or other problems with the eyes
including blurring of vision, excessive dilation
of the pupil of the eye and glaucoma (increased
pressure in the eyes)
• low potassium levels in your blood
Although it is not known exactly how often this
happens, some people might experience chest pain
(due to problems such as angina). Tell your doctor
as soon as possible if you develop these symptoms
whilst receiving treatment with Ipramol, but do not
stop using this medicine unless told to do so.
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.

Like all medicines Ipramol Steri-Nebs can cause
side effects, although not everybody gets them.

TO STORE IPRAMOL STERI-NEB
 5 HOW

AMPOULES

Some of the side-effects may be serious and
require medical intervention.

Keep this medicine out of the sight and reach of
children.

Serious Side Effects
If your asthma or wheezing gets worse
immediately after inhaling Ipramol Steri-Neb
Nebuliser Solution, or your breathing becomes
more difficult and you become short of breath do
not take any more Ipramol Steri-Nebs but use your
short-acting ‘reliever’ inhaler straightaway. You
should stop using Ipramol Steri-Nebs and should
contact your doctor immediately. Your doctor may
prescribe alternative treatment for your condition.

Do not use Ipramol Steri-Nebs after the expiry date
stated on the carton. The expiry date refers to the
last day of that month.

If you experience eye pain or eye discomfort,
blurred vision or red eyes, or if you see halos
or coloured spots then you should contact your
doctor straightaway as treatment for these
symptoms may be required.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no
longer require. These measures will help protect
the environment.

If you think that you may be allergic to Ipramol
Steri-Neb Nebuliser Solution or if you think you
may be having an allergic reaction to the solution
then you should stop using Ipramol Steri-Neb
Ampoules straightaway and contact your doctor
immediately.
A reduction in the level of potassium
(hypokalaemia) in the blood due to the salbutamol
component of Ipramol Steri-Nebs can occur –
and this may cause muscle weakness, twitching
or abnormal heart rhythm. This is more likely
to happen if you are taking Ipramol Steri-Nebs
with some other asthma treatments, with inhaled
steroids or steroid tablets or with diuretics (“water
tablets”). Your doctor may need to take a blood
test to measure your potassium levels from time to
time.

Keep Ipramol Steri-Neb Ampoules in the box they
came in. Store in original packaging in order to
protect from light. Store below 25°C. Do not freeze.
Do not take this medicine if you notice the solution
is discoloured or cloudy.

OF THE PACK AND OTHER
 6 CONTENTS

INFORMATION

What Ipramol Steri-Neb Ampoules contain
• the active substances are 0.5 milligram of
ipratropium bromide (as the monohydrate) and
2.5 milligrams of salbutamol (as the sulphate)
• the other ingredients are sodium chloride, water
for injections and dilute hydrochloric acid.
What Ipramol Steri-Neb Ampoules look like and
contents of the pack
Each Ipramol Steri-Neb consists of a plastic
ampoule containing a clear solution. Strips of 5
ampoules are packed into foil laminate pouches,
which in turn are packed into cardboard cartons
containing 5, 10, 15, 20, 25, 30, 40, 50 or 60

ampoules and 2 x 30 ampoule-pack, then packed
into a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Norton
Healthcare Ltd T/A IVAX Pharmaceuticals UK,
Ridings Point, Whistler Drive, Castleford, West
Yorkshire, WF10 5HX, United Kingdom
Manufacturer:
IVAX Pharmaceuticals UK, Preston Brook, Runcorn,
Cheshire, WA7 3FA, UK.
This medicinal product is authorised in the
Member States of the EEA under the following
names
Finland Ipramol 0.5mg / 2.5mg per 2.5ml
Sumutinliuos
Ireland Ipramol Steri-Neb 0.5mg / 2.5mg
per 2.5ml Nebuliser Solution
The Netherlands Ipramol 0.5mg / 2.5mg per 2.5
ml Verneveloplossing
Sweden Ipramol 0.5mg / 2.5mg lösning
för nebulisator
United Kingdom Ipramol Steri-Neb 0.5mg / 2.5mg
per 2.5ml Nebuliser Solution
Belgium Nebu-Iprasal 0,5 mg/2,5 mg
verneveloplossing
Germany Ipramol TEVA 0,5 mg + 2,5 mg
/2,5 ml Steri-Neb Lösung für
einen Vernebler
Denmark Ipramol Steri-Neb
Greece Ipramol Steri-Neb 0,5/2,5mg ανά
2,5ml Διάλυμα για Εισπνοή με
Εκνεφωτή
Italy Ipramol 0.5mg / 2.5mg per 2.5ml
Soluzione da nebulizzare
Poland
Ipramol Steri-Neb
Portugal Ipramol 0.5 mg/dose + 2.5 mg/
dose Solução para inalação por
nebulização
Romania Ipratropiu/salbutamol TEVA
0.5/2.5mg per 2.5ml solutie de
inhalat prin nebulizator
This leaflet was last revised on December 2014.
‘Steri-Neb’ is a trademark
‘Ipramol’ is a registered trade mark

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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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