VENTOLIN NEBULES 2.5MG

Active substance: SALBUTAMOL SULPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
2

Package Leaflet: Information for the User

Ventolin® Nebules® 2.5 mg
and 5 mg
salbutamol sulfate
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 Ventolin Nebules are and what they are used for
2 What you need to know before you use Ventolin Nebules
3 How to use Ventolin Nebules
4 Possible side effects
5 How to store Ventolin Nebules
6 Contents of the pack and other information
1 What Ventolin Nebules are and what they are used for
Ventolin Nebules contain a medicine called salbutamol. This
belongs to a group of medicines called fast-acting bronchodilators.
• Bronchodilators help the airways in your lungs to stay open. This
makes it easier for air to get in and out.
• They help to relieve chest tightness, wheezing and cough.
Ventolin Nebules are used to treat breathing problems in people
with asthma and other chest illnesses. They are usually given to
people who suffer quite badly from these conditions when other
forms of treatment do not help enough. Ventolin Nebules are also
given to treat severe attacks of asthma.
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 Ventolin Nebules
Do not use Ventolin Nebules if:
• you are allergic to salbutamol sulfate or any of the other
ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Ventolin
Nebules if:
• your asthma is active (for example you have frequent symptoms or
flare ups or limited physical ability). Your doctor may start or increase
a medicine to control your asthma such as an inhaled corticosteroid.
• you have high blood pressure
• you are diabetic
• you have an overactive thyroid gland
• you have a history of heart problems such as an irregular or fast
heartbeat or angina
• you use another nebuliser solution e.g. ipratropium bromide, make
sure the mist does not get in your eyes. This can be prevented by
using a mouthpiece instead of a face mask or goggles.
• you are taking xanthine derivatives (such as theophylline) or
steroids to treat asthma.
• you are taking water tablets (diuretics), sometimes used to treat
high blood pressure or a heart condition.
• If you have taken other drugs used to relieve stuffy nose (such as
ephedrine or pseudoephedrine) or other medicines used to treat
asthma,
Other medicines and Ventolin Nebules
Tell your doctor, nurse 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.
Remember to take this medicine with you if you go to hospital.
In particular tell your doctor, nurse or pharmacist if you are taking:
• medicines for an irregular or fast heartbeat
• other medicines for your asthma.

10000000121337

Ventolin Nebules with food and drink
You can use Ventolin Nebules at any time of day, with or without food.
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, nurse or pharmacist
for advice before taking this medicine.
Driving and using machines
Ventolin Nebules are not likely to affect you being able to drive or
use any tools or machines.
You should not drive or use machinery while using the nebuliser as
this makes the mist for you to inhale.

GSK-AUS-Boronia-AUBOR
United Kingdom-GBR
Ventolin Nebules
1

3 How to use Ventolin Nebules
Always use this medicine exactly as your doctor has told you. Check
with your doctor, nurse or pharmacist if you are not sure.
Using this medicine
• do not inject or swallow the liquid. Ventolin 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 or mouthpiece
• 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, adolescents aged 12 years and over and children 4 to
11 years of age
• The usual starting dose is 2.5 mg up to four times daily.
Increased to 5 mg up to four times daily if required.

K

LFT013

Front
Page 1 of 2

your Nebules are in a foil tray. Do not open the foil
tray until you need to use them
open the foil tray by lifting the foil lid at the red
arrow and peeling it back
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

Boronia - Additional Artwork Information Panel
Component Name

VENTOLIN NEBS 20’s LEAFLET UK/CY

Component No.

10000000121337

Site Change No.

201129269, 201129270

Specification No.

return the remaining Nebules to the foil tray, cover the
tray with the foil lid and place the tray back in the box
hold the top of the Nebule you have just removed.
Twist the body to open it

BLFT002

Note to Supplier: N/A

put the open end of the Nebule into the nebuliser bowl
and squeeze slowly. Make sure that all the contents are
emptied into the nebuliser

assemble the nebuliser and use it as directed

V2
10000000121337

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9.0pt
Leading: 9.7pt
Horizontal Scale: 100%
Smallest text size: 9.0pt
Microtext: N

2
Diluting your Nebules
• 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 normal saline 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 normal saline 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 Ventolin Nebules than you should
If you use more than you should, talk to a doctor as soon as possible.
The following effects may happen:
• your heart beating faster than usual
• you feel shaky.
• hyperactivity
These effects usually wear off in a few hours.
If you forget to use Ventolin Nebules
• If you forget a dose, take it as soon as you remember it.
• However, if it is time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop using Ventolin Nebules
Do not stop using Ventolin Nebules without talking to your doctor.
If you have any further questions on the use of this medicine, ask
your doctor, nurse or pharmacist.
4 Possible side effects
If your breathing or wheezing gets worse straight after
taking this medicine, stop using it immediately, and tell your
doctor as soon as possible.
Like all medicines, this medicine can cause side effects, although
not everybody gets them. The following side effects may happen
with this medicine:
Allergic Reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop taking Ventolin and see a
doctor straight away. Signs of an allergic reaction include: swelling
of the face, lips, mouth, tongue or throat which may cause difficulty
in swallowing or breathing, itchy rash, feeling faint and light
headed, and collapse.
Talk to your doctor as soon as possible 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
• you may feel your heartbeat is uneven or it gives an extra beat
• these may affect up to 1 in 10 people.
If any of these happen to you, talk to your doctor as soon as
possible. 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)
• feeling shaky
• headache.
Uncommon (may affect up to 1 in 100 people)
• mouth and throat irritation
• muscle cramps.
Rare (may affect up to 1 in 1,000 people)
• a low level of potassium in your blood
• increased blood flow to your extremities (peripheral dilatation).
Very rare (may affect up to 1 in 10,000 people)
• changes in sleep patterns and changes in behaviour, such as
restlessness and excitability.
The following side effects can also happen but the frequency
of these are not known:
• chest pain, due to heart problems such as angina. Tell your doctor,
nurse or pharmacist if this occurs. Do not stop using this medicine
unless told to do so
• a condition known as lactic acidosis which may cause stomach
pain, hyperventilation, shortness of breath even though there may
be improvement in your wheezing, cold feet and hands, irregular
heartbeat or thirst.
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

10000000121337

By reporting side effects you can help provide more information on
the safety of this medicine.
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 Ventolin unless your doctor tells you to.
5 How to store Ventolin Nebules
• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Store the Nebules in the foil tray inside the carton to protect the
Nebules from light.
• When you open a foil tray:
- note the date of opening
- add 3 months to this date. This will be the ‘discard after’ date
- write the ‘discard after’ date in the space provided on the foil lid
- do not use any unused Ventolin Nebules remaining from that
foil tray after the ‘discard after’ date, return them to your
pharmacist for destruction.
• If the foil tray has not been opened, do not use Ventolin Nebules
after the expiry date, which is stated on the carton, labels and
foil trays after ‘EXP’. The expiry date refers to the last day of that
month.
• If you are told to stop taking this medicine return any unused
Ventolin Nebules to your pharmacist to be destroyed.
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 to protect the environment.
6 Contents of the pack and other information
What Ventolin Nebules contains
• The active substance is salbutamol sulfate.
• Ventolin Nebules 2.5 mg:
each 2.5 ml Nebule contains 2.5 mg of salbutamol (as salbutamol
sulfate).
• Ventolin Nebules 5 mg:
each 2.5 ml Nebule contains 5 mg of salbutamol (as salbutamol
sulfate).
• The other ingredients are salt (sodium chloride), sulfuric acid and
water.
What Ventolin Nebules looks like and contents of the pack
Each foil tray contains 5 Ventolin Nebules.
Each carton contains 20 Ventolin 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:

0800 198 5000 (UK only)

Please be ready to give the following information:
Product name Ventolin Nebules 2.5 mg
Ventolin Nebules 5 mg
Reference number 10949/0085
This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in January 2014
Ventolin, Nebule and Nebules are registered trademarks of the
GlaxoSmithKline group of companies
© 2014 GlaxoSmithKline group of companies. All rights reserved.

V2
10000000121337

GSK-AUS-Boronia-AUBOR
United Kingdom-GBR
Ventolin Nebules
1

K

LFT013

Back
Page 2 of 2

Boronia - Additional Artwork Information Panel
Component Name

VENTOLIN NEBS 20’s LEAFLET UK/CY

Component No.

10000000121337

Site Change No.

201129269, 201129270

Specification No.

BLFT002

Note to Supplier: N/A

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9.0pt
Leading: 9.7pt
Horizontal Scale: 100%
Smallest text size: 9.0pt
Microtext: N

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
(web4)