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TERBUTALINE SULFATE 2.5MG/ML NEBULISER SOLUTION

Active substance(s): TERBUTALINE SULFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Terbutaline Sulfate 2.5mg/ml Nebuliser Solution

Terbutaline Sulfate Nebuliser Solution helps to make breathing easier in
patients who have asthma, bronchitis and other chest illnesses.
2. BEFORE YOU USE TERBUTALINE SULFATE NEBULISER
SOLUTION
Do not use Terbutaline Sulfate Nebuliser Solution:
• If you are allergic (hypersensitive) to terbutaline sulfate
• If you are allergic to any of the other ingredients of Terbutaline Sulfate
Nebuliser Solution (see section 6 Further Information)
• If you have a heart condition called cardiomyopathy (this is when your
heart does not work properly due to inflammation of the heart muscles).
Take special care with Terbutaline Sulfate Nebuliser Solution:
Talk to your doctor 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).
Taking other medicines
Tell your doctor if you are taking any of the following as they may interact
with your medicine:
• Medicines for treating high blood pressure such as propranolol
• Other 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.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, think you are pregnant or are breast-feeding, tell your
doctor before using 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

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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.

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Always use Terbutaline Sulfate Nebuliser Solution exactly as your doctor
has told you. You should check with your doctor or pharmacist if you are
not sure.
Adults (including the elderly):
The usual dose is one or two ampoules (5mg or 10mg) taken two to
four times each day.

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

This medicine is not recommended for children weighing less than 25 kg.

Keep out of the reach and sight of children.
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.

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

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

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.

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.

6. FURTHER INFORMATION
What Terbutaline Sulfate Nebuliser Solution contains
• The active substance is terbutaline sulfate
• The other ingredients are sodium chloride, disodium edetate, water
for injections and sulfuric acid.
Terbutaline Sulfate Nebuliser Solution contains 5mg of terbutaline
sulfate (2.5mg/ml) as the active substance in each 2ml ampoule.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

What Terbutaline Sulfate Nebuliser Solution looks like and
contents of the pack

4. POSSIBLE SIDE EFFECTS

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).

Like all medicines, Terbutaline Sulfate Nebuliser Solution can cause side
effects, although not everybody gets them.

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.

5. HOW TO STORE TERBUTALINE SULFATE NEBULISER SOLUTION

Store the ampoules in their foil sachet and their original carton.

If you forget to use your 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 the one you missed.

Children weighing more than 25 kg:
The usual dose is one ampoule (5mg) taken two to four times each day.

Instructions for use:
1 DETACH
HERE
1. Prepare your power-operated nebuliser
following 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 Diagram 1
your dose) and put the rest back in the foil
sachet and replace the foil sachet in the
carton. [Diagram 1]. Never use an ampoule
2
that has been opened already or if the
TWIST
solution is discoloured.
3. Hold the ampoule upright and open it by
twisting off the top. [Diagram 2]
4. Unless otherwise instructed by your doctor,
Diagram 2
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” 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.

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.

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).
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:
• Trembling or shaking
• Cramps or feeling tense
• Headache
• Mouth and throat irritation
• Nausea (feeling sick)
• Feeling tense.

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 Industriel Nord,
151 rue Andre Durouchez - CS 28028,
80084 AMIENS CEDEX 2, France.
This leaflet was last revised in November 2015

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.

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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.

AAAI5265

Terbutaline 2.5ml/2ml 20 Doses PIL - UK (Arrow)
item no: AAAI5265

dimensions: 200 x 280

print proof no: 4

pharmacode:

origination date: 20.11.15

min pt size: 9

originated by: S.Anson
approved for print/date

colours/plates
1. black
2.
3.
4.
5.
6.

revision date: 02.12.15

Technical Approval

revised by: S.Anson

date sent: 20.11.15

supplier: Laboritoire Unither

technically app. date: 25.11.15

Non Printing Colours
1. Profile
2.

3.

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In this leaflet:
1. What Terbutaline Sulfate Nebuliser Solution is and what it is used for
2. 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. Further information
1. WHAT TERBUTALINE SULFATE NEBULISER SOLUTION IS AND
WHAT IT IS USED FOR

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CODE 39

CODE 39
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Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any 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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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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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