Skip to Content

UK Edition. Click here for US version.

SALAMOL STERI-NEB 5MG/2.5ML NEBULISER SOLUTION

Active substance(s): SALBUTAMOL SULPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
What is in this leaflet:
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.

Package Leaflet: Information for the User

5mg /2.5ml Nebuliser Solution

Salbutamol (as sulphate)

REG0068455

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.

PE3060

Salamol Steri-Neb

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.

1. What Salamol Steri-Neb is and what it is used for
2. What you need to know before you take Salamol
Steri-Neb
3. How to take Salamol Steri-Neb
4. Possible side effects
5. How to store Salamol Steri-Neb
6. Contents of the pack and other information

1. What Salamol Steri-Neb is and what it
is used for
Your medicine is called Salamol Steri-Neb
5mg/2.5ml Nebuliser Solution which is a beta2agonist which helps to manage asthma by dilating
(opening up) the airways (or air passages) in the
lungs.
Salamol is used to treat:
l acute severe asthma
l long-term bronchospasm (narrowing of the tubes
to the lungs caused by muscle spasm)
that doesn’t respond to conventional treatment.

2. What you need to know before you
take Salamol Steri-Neb
Do not take Salamol Steri-Neb:
l if you are allergic to salbutamol sulphate or any
of the other ingredients of this medicine (listed in
section 6).
l for the management of premature labour.
Warnings and precautions
Talk to your doctor or pharmacist before you
start to take this medicine:
l if you suffer from thyroid problems
l if you have high blood pressure
l if you are diabetic
l if you have a history of heart disease, irregular or
fast heartbeat or angina
l if you have a condition known as glaucoma
(raised pressure in your eyes)
l if you suffer from hypoxia (deficiency of oxygen
in the tissues)­.
Taking your medicine may lead to low ­
potassium levels in your blood, so your doctor may
want you to have regular blood tests to monitor
this.
Other medicines and Salamol Steri-Neb
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Version 3.3

Approved

Do not take Salamol Steri-Neb if you are taking
the following:
l propranolol or any other non selective beta
blocking drug
Talk to your doctor or pharmacist if you are
taking any of the following:
l steroids such as prednisolone
l diuretics (water tablets usually used to treat high
blood pressure)
l other sympathomimetic drugs such as
Metaraminol or Xanthine derivatives such as
aminophylline or theophylline (drugs used to
improve breathing for people with asthma)
l you are using nebulised anticholinergic drugs
(such as Ipratropium bromide) to treat your
asthma; make sure the mist does not get in your
eyes. This can be prevented by using a mouth
piece instead of a face mask or goggles.
Salamol Steri-Neb with food, drink and alcohol
l You can use Salamol Steri-Neb at any time of
day, with or without food.
Pregnancy, breast-feeding and fertility
l If you are pregnant, planning to become pregnant
or are breast-feeding, ask your doctor for advice
before taking any medicine.
Driving and using machines
l Salamol Steri-Neb is not expected to affect your
ability to drive or operate machinery.

3. How to take Salamol Steri-Neb
Always take Salamol Steri-Neb exactly as your
doctor or pharmacist has told you. You should
check with your doctor or pharmacist if you are not
sure.
You must only use Salamol 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 take
your medicine.
Use in children and adolescents
The recommended dose is:
l Adults including the Elderly and children/
infants over 18 months
2.5mg taken up to three or four times a day. Your
doctor may increase this to 5mg up to three or four
times a day.
Children should be supervised by an adult when
they are using a nebuliser.
l Infants under 18 months
1.25mg (0.25mg/kg) up to four times a day. Your
Page 1 of 3

doctor may increase this to 2.5mg up to four times
a day. Your doctor may consider giving the infant
oxygen therapy.
The nebuliser should be operated by an adult.
What to do if you think your medicine is not
working
You should contact your doctor if the dose seems
less effective or is short lasting. You should not
change the dose you take, or how often you take
your medicine without seeking medical advice.
How to use your Salamol Steri-Neb Nebuliser
l Prepare your nebuliser
A
for use according to the
manufacturer’s instructions.
l Remove a Steri-Neb from
the labelled strip by
twisting and pulling
(diagram A).
l Hold the Steri-Neb
upright and twist off the
B
cap (diagram B).
l Squeeze the contents
into the reservoir of your
nebuliser (diagram C).
l Following the
manufacturer’s
instructions, use your
C
nebuliser.
l After you have used your
nebuliser, throw away any
solution that is left
in the reservoir.
l Clean your nebuliser
thoroughly. Do not get
the solution or mist in your eyes.
Do not dilute the solution or mix it with other
medicines, unless your doctor tells you to.
Do not swallow the solution or use it in injections.
If you take more Salamol Steri-Neb than you
should
If you (or someone else) swallow or take a lot of
the solution all together, or if you think a child has
swallowed or taken any of the solution; contact
your nearest hospital casualty department or your
doctor immediately. An overdose is likely to cause a
very rapid heart beat and feeling shaky.
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 take Salamol Steri-Neb
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 taking Salamol Steri-Neb
Do not stop taking 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.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If the following happens, stop taking the
solution and tell your doctor immediately or go to
the casualty department at your nearest hospital:
l an allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in
breathing; skin rash or hives)
l a sudden increase in breathlessness or wheezing,
which may be due to paradoxical bronchospasm
(narrowing of the air passage
or tightening of the chest), low blood pressure
l angioedema, a serious allergic reaction
causing swelling of the face or throat.
These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.
Talk to your doctor as soon as possible:
l if you feel your heart is beating faster or
stronger than usual (palpitations). This is
usually harmless, and usually stops after you have
used the medicine for a while
l if you may feel your heartbeat is uneven or it
gives an extra beat
Do not stop using this medicine unless told to do
so.
Tell your doctor if you have any of the following
side effects which may also happen with this
medicine:
Common (may affect up to 1 in 10 people)
l Feeling shaky
l Headache
Uncommon (may affect up to 1 in 100 people)
l Mouth and throat irritation
l Muscle cramps
Rare (may affect up to 1 in 1,000 people)
l A low level of potassium in your blood
l Increased blood flow to your extremities
(peripheral dilatation)
Very rare (may affect up to 1 in 10,000 people))
l Changes in sleep patterns and changes in
behaviour, such as restlessness and
excitability

Not known (frequency cannot be estimated from
the available data)
l Chest pain, due to heart problems such as angina.
Tell your doctor or pharmacist if this occurs. Do
not stop using this medicine unless told to do so
l A condition known as lactic acidosis which may
cause stomach pain, hyperventilation, shortness
of breath, cold feet and hands, irregular heartbeat
or thirst.
If you think this medicine is not working well
enough for you
If your medicine does not seem to be working
as well as usual, talk to your doctor as soon as
possible. Your chest problem may be getting worse
and you may need a different medicine.
Do not take extra Salamol Steri-Neb unless your
doctor tells you to.
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.

5. How to store Salamol Steri-Neb
Keep this medicine out of the sight and reach 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 this medicine after the expiry date that
is stated on the outer packaging. The expiry date
refers to the last day of that month.
Do not use Salamol Steri-Neb if you notice the
solution is cloudy. Never give it to anyone else.
It may harm them even if they seem to have
the same symptoms as you have.
Do not throw away any 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 Salamol Steri-Neb solution contains:

l The active ingredient is salbutamol sulphate.
l The other ingredients are sodium chloride, dilute

sulphuric acid, and water for injections.

REG0068455

Version 3.3

Approved

Page 2 of 3

Salamol Steri-Neb

Marketing Authorisation holder:
Norton Healthcare Ltd T/A
IVAX Pharmaceuticals UK,
Ridings Point, Whistler Drive, Castleford, West
Yorkshire, United Kingdom, WF10 5HX.
Company responsible for manufacture:
IVAX Pharmaceuticals UK, Aston lane North,
Whitehouse Vale Industrial Estate, Preston Brook,
Runcorn, Cheshire, United Kingdom, WA7 3FA.

5mg /2.5ml Nebuliser Solution

 Marketing Authorisation Holder and
Manufacturer

Salbutamol (as sulphate)

The leaflet was last
updated:
May 2015
PL 00530/0693
84215-C

Package Leaflet: Information for the User

What Salamol Steri-Neb solution looks like
and contents of the pack:
l Each Steri-Neb contains 2.5ml of a solution that
is equivalent to 5mg of Salbutamol (2mg/ml).
There are 20 Steri-Nebs of your medicine in this
pack.
l Strips of 5 Steri-Nebs are packed into foil
laminate pouches, which in turn are packed into
boxes containing 20 and 100 (ampoules).
Not all pack sizes may be marketed.

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-00530-0693-salamol-steri-neb-5mg_2.5ml-nebuliser-solution-s
albutamol-sulphate

APPROVALS
Signed by

Meaning of Signature
Regulatory Affairs Approval

REG0068455

Version 3.3

Approved

Server Date
08-Jan-2016 03:34:41 PM

Page 3 of 3

Expand view ⇕

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.

Hide