Skip to Content

TERBUTALINE SULFATE 2.5MG/ML NEBULISER SOLUTION

Active substance(s): TERBUTALINE SULFATE / TERBUTALINE SULFATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Terbutaline Sulfate 2.5mg/ml Nebuliser Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
•K
 eep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• T his 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.
What is in this leaflet:
1. What Terbutaline Sulfate Nebuliser Solution is and what it is used for
2. What you need to know before you use Terbutaline Sulfate Nebuliser Solution
3. How to use Terbutaline Sulfate Nebuliser Solution
4. Possible side effects
5. How to store Terbutaline Sulfate Nebuliser Solution
6. Contents of the pack and other information
1. What Terbutaline Sulfate Nebuliser Solution is and what it
is used for
Terbutaline Sulfate Nebuliser Solution 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.
Terbutaline Sulfate Nebuliser Solution helps to make breathing easier in
patients who have asthma, bronchitis and other chest illnesses.
2. What you need to know before you use Terbutaline Sulfate
Nebuliser Solution
Do not use Terbutaline Sulfate Nebuliser Solution:
• If you are allergic to terbutaline sulfate or any of the other ingredients
of this medicine (listed in section 6).
• If you have a heart condition called cardiomyopathy (this is when your
heart does not work properly due to inflammation of the heart muscles).
Warnings and precautions
Talk to your doctor or pharmacist before using Terbutaline Sulfate
Nebuliser Solution if any of the following apply to you:
• If you have diabetes
• If you have an overactive thyroid gland
• If you have a heart condition, abnormal heart rhythm, or disease of the
heart
• If you have high blood pressure
• If you have low levels of potassium in the blood (hypokalaemia).
Other medicines and Terbutaline Sulfate Nebuliser Solution
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines including:
•M
 edicines for treating high blood pressure such as propranolol
•O
 ther medicines which help you to breathe.
If you are already taking other medicines prescribed by your doctor for
your asthma, make sure you keep taking these unless your doctor tells
you otherwise.
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 or pharmacist 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
If you are taking high doses of this medicine, you should not drive or use
machinery.
If you are unsure, talk to your doctor.

3. How to use Terbutaline Sulfate Nebuliser Solution
Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Adults (including the elderly):
The recommended dose is one or two ampoules (5mg or 10mg) taken two
to four times each day.
Children weighing more than 25 kg:
The recommended dose is one ampoule (5mg) taken two to four times
each day.
This medicine is not recommended for children weighing less than 25 kg.
General instructions:
Open each foil sachet one at a time and use all the ampoules inside
before opening the next foil sachet. Always return any remaining
ampoules to the foil sachet and place the sachet back in the carton after
use. Since the ampoules do not contain a preservative, it is important to
use them as soon as they are opened.
Instructions for use:
1 DETACH
1. Prepare your power-operated nebuliser following
HERE
the manufacturer’s instructions and/or the dosing
instructions given by your doctor.
2. Take a strip of ampoules from the foil sachet.
Remove one or two ampoules (depending on your
dose) and put the rest back in the foil sachet and
Diagram 1
replace the foil sachet in the carton. [Diagram
1]. Never use an ampoule that has been opened
already or if the solution is discoloured.
3. Hold the ampoule upright and open it by twisting 2
off the top. [Diagram 2]
TWIST
4. Unless otherwise instructed by your doctor,
squeeze all of the liquid from the plastic ampoule
into the nebuliser chamber.
5. Throw away the plastic ampoule.
6. Turn on the nebuliser and breathe in the “mist”
Diagram 2
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.
7. 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.
8. You must wash your nebuliser, face mask and/or mouthpiece in warm
soapy water and rinse well after each use.

Terbutaline 2.5mg/ml 20 2ml Ampoules PIL - UK (Breath)
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0646

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
04.04.17
18.05.17
S.Anson

Date sent:
04.04.17
Date received: 06.04.17

Dimensions:
200 x 280
Min Body Text Size: 9pts
Supplier:
Laboratoire Unither

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

In most people, Terbutaline Sulfate Nebuliser Solution gives relief of
wheezing and chest tightness for up to 6 hours. After using your nebuliser
a few times, you will know how long the effects normally last for you.

5. How to store Terbutaline Sulfate Nebuliser Solution
Keep out of the sight and reach of children.

Contact your doctor immediately if:
•Y
 ou are not getting as much relief from your current dose
•Y
 our breathing is getting worse
•Y
 our chest feels tight.

Do not use after the expiry date which is stated on the carton, foil sachet
and ampoule after “Exp”. The expiry date refers to the last day of that
month.

These are signs that your condition is not being controlled and you may
need different or additional treatment.

Store the ampoules in their foil sachet and their original carton. Each
ampoule should be opened immediately before use and any solution
remaining after use should be thrown away.

If you use more Terbutaline Sulfate Nebuliser Solution than you
should you may feel shaky, anxious or dizzy, get a headache or cramps
and feel that your heart is beating faster or more irregularly than usual.

Once the foil sachet has been opened, the ampoules inside should be
used within 6 months.

Call your doctor immediately or go to the nearest hospital casualty
department. If you feel shaky you should not drive. Take this leaflet or an
ampoule of your medicine with you so that the hospital will know what
you have taken.
If you forget to use Terbutaline Sulfate Nebuliser Solution
If you forget to take your Terbutaline sulfate 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 have any further questions on the use of this medicine, ask your
doctor or pharmacist.
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, face or lips, rash or itching (especially affecting
your whole body), low blood pressure (fainting on standing/ light
headedness/dizziness), collapse.
Rarely, inhaled drugs such as terbutaline 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 been reported. If they do occur, they
usually go away within the first week of starting treatment. Tell your
doctor if any of these side effects become troublesome:

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 Terbutaline Sulfate Nebuliser Solution contains
• T he active substance is terbutaline sulfate
• T he other ingredients are sodium chloride, disodium edetate, water for

injections and sulphuric acid.

Terbutaline Sulfate Nebuliser Solution contains 5mg of terbutaline sulfate
(2.5mg/ml) as the active substance in each 2ml ampoule.
What Terbutaline Sulfate Nebuliser Solution looks like and
contents of the pack
Your medicine comes in the form of plastic ampoules containing 2ml of
a colourless to yellow solution to be nebulised (made into a fine mist for
inhalation).
Each carton contains 20 ampoules in foil wrapped strips of 5 or 10.
Marketing Authorisation Holder:
Breath Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS,
United Kingdom.
Manufacturer:
Laboratoire Unither,
Espace lndustriel Nord, 151 rue André Durouchez - CS 28028,
80084 AMIENS CEDEX 2, France.
This leaflet was last revised in May 2017

• T rembling or shaking
•H
 eadache
•N
 ausea (feeling sick)
•C
 ramps or feeling tense
•M
 outh and throat irritation.

Rarely, you may experience muscle weakness, thirst and pins and needles
(caused by the effects of low levels of potassium in the blood).
Changes in sleeping patterns and changes in behaviour, such as agitation,
hyperactivity and restlessness have sometimes been seen.
Rarely, fast heart beats occur with medicines of this type. Other heart
problems such as unusual heartbeats have also occurred, although this is
usually only seen in susceptible patients.
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 Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
BBBA0646

Terbutaline 2.5mg/ml 20 2ml Ampoules PIL - UK (Breath)
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0646

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
04.04.17
18.05.17
S.Anson

Date sent:
04.04.17
Date received: 06.04.17

Dimensions:
200 x 280
Min Body Text Size: 9pts
Supplier:
Laboratoire Unither

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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