Patient leaflet - Terbutaline Sulfate 2.5 mg / ml nebuliser solution
1. What Terbutaline Sulfate Nebuliser Solution is and what it is used for
Terbutaline Sulfate Nebuliser Solution belongs to a group of medicines called ‘beta-agonists’. These work by relaxing certain muscles and opening up the airways in your lungs so that you can breathe more easily.
- Terbutaline Sulfate Nebuliser Solution is used for asthma and other breathing problems where you have a tight chest and difficulty breathing.
- Terbutaline should not be used alone for the regular treatment of asthma or other breathing conditions. If you are using terbutaline daily, your doctor should also have prescribed another type of medication such as an ‘inhaled corticosteroid’, which helps reduce swelling and inflammation in your lungs.
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).
Warnings and precautions
Talk to your doctor or pharmacist before using Terbutaline Sulfate Nebuliser Solution if you have:
- diabetes
- an overactive thyroid gland
- a heart condition, abnormal heart rhythm, or disease of the heart
- 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 medicines that you buy without a prescription. Terbutaline Sulfate Nebuliser Solution can affect the way that some medicines work, and some medicines can have an effect on Terbutaline Sulfate Nebuliser Solution.
Tell your doctor if you are taking:
- Steroid medicines (such as prednisolone)
- Medicines called ‘xanthines’ (such as theophylline)
- Medicines called ‘beta-blockers’ (such as atenolol or propranolol) including eye drops (such as timolol)
- Water tablets (diuretics, such as furosemide).
If you are to undergo surgery with general anaesthetics it is important that you inform your doctor about all medicines you use, including Terbutaline Sulfate Nebuliser Solution.
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 talk to your doctor as soon as possible.
If you use Terbutaline Sulfate Nebuliser Solution daily, it should be used with caution at the end of pregnancy.
Driving and using machines
This medicine is not likely to affect you being able to drive or use machines.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per 2ml ampoule, that is to say essentially ‘sodium-free’.
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.
Terbutaline Sulfate Nebuliser Solution should be used as required rather than regularly.
The solution in an ampoule must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your nebuliser are given after the section ‘General instructions’.
Children under 18 years should only use a nebuliser to take reliever medications under the care of a doctor with expertise in the management of asthma so that deterioration in asthma control can be detected and treated without delay.
Only use the nebuliser recommended by your doctor and supervise your child while they are using the nebuliser.
Seek medical attention right away if your asthma symptoms (cough, breathlessness, wheezing or tight chest) are getting worse, or if you are too breathless to speak, eat or sleep, even if there is short-term recovery following use of prescribed nebulised medication.
You must contact your doctor as soon as possible if you need higher doses of Terbutaline Sulfate Nebuliser Solution than usual to relieve your breathing problems. You may then need extra medication to control your asthma.
If you use Terbutaline Sulfate Nebuliser Solution more than twice a week to treat your asthma symptoms, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that can have serious complications and may be life-threatening or even fatal. You should contact your doctor as soon as possible to review your asthma treatment.
If you use a medicine against inflammation of your lungs daily, e.g. “inhaled corticosteroid”, it is important to continue using it regularly, even if you feel better.
The recommended dose is:
- 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 25kg: The recommended dose is one ampoule (5mg) taken two to four times each day.
- This medicine is not recommended for children weighing less than 25kg.
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.
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 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
1 DETACH
HERE
Diagram 1
BBBB5913
that has been opened already or if the 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.
- 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.
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.
These are signs that your condition is not being controlled and you may need different or additional treatment.
If you use more Terbutaline Sulfate Nebuliser Solution than you should
You may feel sick, shaky, anxious or dizzy, get a headache or cramps and feel that your heart is beating faster or more irregularly than usual.
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 a dose of 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 stop using Terbutaline Sulfate Nebuliser Solution
Do not stop taking your medicine without first discussing it with your doctor.
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.
Stop using this medicine and see your doctor or go to the nearest hospital casualty department immediately if any of the following serious side effects occur.
Not known (frequency cannot be estimated from the available data):
- Allergic reactions. The signs may include a swollen face, skin rash, breathing problems, low blood pressure (feeling faint) and collapse
- Sudden wheezing soon after inhaling your dose of Terbutaline Sulfate Nebuliser Solution.
Other side effects
Very Common (may affect more than 1 in 10 people):
- Trembling or shaking
- Headache.
Common (may affect up to 1 in 10 people):
- Pounding or rapid heartbeats (palpitations)
- Cramps or feeling tense
Low levels of potassium in your blood which may cause muscle
weakness, thirst, or ‘pins and needles’.
Not known (frequency cannot be estimated from available data):
- Unusual or irregular heartbeats
- Chest pain (due to heart problems such as angina). Tell your doctor if you develop this symptom whilst receiving treatment with Terbutaline Sulfate Nebuliser Solution, but do not stop using this medicine unless told to
- Feeling sick (nausea)
- Mouth and throat irritation
- Changes in sleeping patterns and changes in behaviour, such as feeling agitated, restless or hyperactive
- Lactic acidosis is caused by a build-up of lactic acid in your blood. Symptoms of lactic acidosis include recurrent nausea and vomiting, abdominal pain and hyperventilation.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Terbutaline Sulfate Nebuliser Solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Each ampoule should be opened immediately before use and any solution remaining after use should be thrown away.
Once the foil sachet has been opened, the ampoules inside should be used within 6 months.
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
- The active substance is terbutaline sulfate. Terbutaline Sulfate Nebuliser Solution contains 5mg of terbutaline sulfate (2.5mg/ml) as the active substance in each 2ml ampoule.
- The other ingredients are sodium chloride, disodium edetate, water for injections and sulphuric acid.
What Terbutaline Sulfate Nebuliser Solution looks like and contents of the pack
This medicine is a clear, colourless to yellow solution contained within clear plastic single dose ampoules, each containing 2ml of nebuliser 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
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
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 November 2022
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Diagram 2