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TERBUTALINE SULPHATE NEBULISER SOLUTION 2.5MG/ML

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Terbutaline Sulphate 2.5mg/ml Nebuliser Solution
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.
In this leaflet:
1. What Terbutaline Sulphate Nebuliser Solution is and what it is used for
2. Before you use Terbutaline Sulphate Nebuliser Solution
3. How to use Terbutaline Sulphate Nebuliser Solution
4. Possible side effects
5. How to store Terbutaline Sulphate Nebuliser Solution
6. Further information
1. WHAT TERBUTALINE SULPHATE NEBULISER SOLUTION IS AND
WHAT IT IS USED FOR
Terbutaline Sulphate 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 Sulphate Nebuliser Solution helps to make breathing easier in
patients who have asthma, bronchitis and other chest illnesses.
2. BEFORE YOU USE TERBUTALINE SULPHATE NEBULISER
SOLUTION

3. HOW TO USE TERBUTALINE SULPHATE NEBULISER SOLUTION
Always use Terbutaline Sulphate 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.
Children weighing more than 25 kg:
The usual dose is one ampoule (5mg) taken two to four times each day.
This medicine is not recommended for children weighing less than 25 kg.

Do not use Terbutaline Sulphate Nebuliser Solution:
• If you are allergic (hypersensitive) to terbutaline sulphate
• If you are allergic to any of the other ingredients of Terbutaline Sulphate
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).

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.

Take special care with Terbutaline Sulphate 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).

Instructions for use:
1 DETACH
1. Prepare your power-operated nebuliser
HERE
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
your dose) and put the rest back in the foil
Diagram 1
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,
squeeze all of the liquid from the plastic
ampoule into the nebuliser chamber.
Diagram 2
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.

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.

In most people, Terbutaline Sulphate 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.
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.

5. HOW TO STORE TERBUTALINE SULPHATE NEBULISER SOLUTION
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.
Store the ampoules in their foil sachet and their original carton.

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 Sulphate 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

Terbutaline Sulphate Nebuliser Solution contains 5mg of terbutaline
sulphate (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 Sulphate 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 Sulphate Nebuliser Solution 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).
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, Unit 2, Eastman Way, Stevenage,
Hertfordshire, SG1 4SZ, U.K.
Manufacturer:
Laboratoire Unither, ZI Longpré, 10 rue André Durouchez,
80084 AMIENS Cedex 2, France.
This leaflet was last approved in 09/2009.

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.
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.

Item code

Pharmacode

If you forget to use your Terbutaline Sulphate Nebuliser Solution
If you forget to take your Terbutaline sulphate 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.

What Terbutaline Sulphate Nebuliser Solution contains
• The active substance is terbutaline sulphate
• The other ingredients are sodium chloride, disodium edetate, water for
injections and sulphuric acid.

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Further information

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