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BRICANYL RESPULES 2.5 MG/ML NEBULISER SOLUTION

Active substance(s): TERBUTALINE SULPHATE / TERBUTALINE SULPHATE / TERBUTALINE SULPHATE

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PS09719

Package leaflet: Information for the user

Bricanyl® Respules® 2.5 mg/ml Nebuliser Solution
terbutaline 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 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 or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.

If you are to undergo surgery with general anaesthetics it is
important that you inform your doctor about all medicine you
use, including Bricanyl to protect you from adverse effects
(e.g. irregular heart beat).
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 or
pharmacist for advice before using this medicine.
• If you become pregnant while you are using Bricanyl Respules,
talk to your doctor straight away.
• If you are using Bricanyl Respules every day rather than as
needed, then Bricanyl Respules should be used with caution
at the end of pregnancy since it relaxes the womb.

What is in this leaflet
1. What Bricanyl Respules are and what they are used for
2. What you need to know before you use Bricanyl Respules
3. How to use Bricanyl Respules
4. Possible side effects
5. How to store Bricanyl Respules
6. Contents of the pack and other information

Driving and using machines
Bricanyl Respules is not likely to affect you being able to drive or
use machines.
3. How to use Bricanyl Respules

1. What Bricanyl Respules are and what they are used for

Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.

Bricanyl Respules contain a medicine called terbutaline. This
belongs to a group of medicines called ‘beta‑agonists’. These
work by relaxing certain muscles and opening up the airways
in the lungs.
• Bricanyl Respules are used for asthma and other breathing
problems where you have a tight chest and difficulty breathing.
• Bricanyl should not be used alone for the regular treatment
of asthma or other breathing conditions. If you are using
Bricanyl every day then your doctor should have also
prescribed you another type of medication such as an
“inhaled corticosteroid”, which helps reduce the swelling and
inflammation in your lungs.
• A Respule is a small plastic container that contains a
liquid. The liquid is put into a machine called a nebuliser.
This machine turns the medicine into a fine mist which you
breathe in through a face mask or mouthpiece.

The solution in a Respule 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 ‘How much to take’.
How much to take
The recommended dose is:
• Adults:
1 to 2 Respules, 2 to 4 times a day
• Children over 8 years: 1 Respule, 2 to 4 times a day
• Younger children are usually prescribed lower doses.
Instructions for using Bricanyl Respules
1. Break off a Respule from the strip. Leave the rest in the foil
envelope.
2. Hold upright. Twist off the top of the Respule to open.
3. Place the open end of the Respule firmly inside the nebuliser
cup. Squeeze slowly to put the liquid in the cup.
4. Throw the empty Respule away. Put the top back on the
nebuliser cup.
5. Connect the top of the cup to the face mask or mouthpiece.
6. Connect the bottom of the cup to the air pump. The air pump
should be connected to the compressor unit.
7. 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 the face mask fits tightly.
8. You will know when your treatment is complete because the
fine mist will stop coming out of your mask or mouthpiece.
9. How long it takes to nebulise all the medicine depends on
the type of equipment you use. It will also depend on the
amount of medicine to be used.
10. After each use, you must wash the nebuliser cup and
mouthpiece (or face mask) in warm soapy water and rinse
well. After washing, dry these parts by turning on the
compressor and allowing air to blow through them.

2. What you need to know before you use Bricanyl Respules
Do not use Bricanyl Respules:
• If you are allergic to terbutaline or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Bricanyl Respules if:
• You have diabetes. If so, you may need some extra blood
sugar tests when you start using Bricanyl Respules.
• You have a history of heart disease, irregular heart rhythm or
angina.
• You have an overactive thyroid gland.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Bricanyl Respules.
Other medicines and Bricanyl Respules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes medicines
that you buy without a prescription and herbal medicines.
Bricanyl Respules can affect the way that some medicines work
and some medicines can have an effect on Bricanyl Respules.

Talk to your doctor straight away if:
• Your breathing is getting worse.
• You often wake at night with asthma.
• You start getting a tight chest.
• You are not getting relief from your current dose.
These are signs that your asthma is not being controlled.
You may need a different or additional treatment
straight away.

In particular, tell your doctor or pharmacist if you are taking any
of the following medicines:
• 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 (also known as
frusemide).

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If you use more Bricanyl Respules than you should
If you use more Bricanyl Respules than you should, contact your
doctor or pharmacist.



If you forget to use Bricanyl Respules
• If you forget to have a dose, have it as soon as you
remember. However, if it is almost 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 Bricanyl Respules
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

Once you have opened a single Respule, any
remaining product cannot be regarded as sterile.
This must be considered if the intention is to use the
remaining content at a later occasion.
Each single Respule should be used within 24 hours after
it is opened. After this time the Respule and any remaining
contents should be thrown away.
Do not store above 30°C. Store Bricanyl Respules in their
original carton and foil, and out of direct sunlight.
Do not use this medicine after the expiry date which is stated
on the label and carton. The expiry date refers to the last day
of that month.
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

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

What Bricanyl Respules contains
The active substance is terbutaline sulfate. Each Bricanyl Respule
contains 5 mg of the active ingredient, terbutaline sulfate (equivalent
to 2.5 mg/ml).
The other ingredients are sodium chloride, disodium edetate,
hydrochloric acid and water.

Important side effects to look out for:
• Allergic reactions. The signs may include a swollen face,
skin rash, breathing problems, low blood pressure (feeling
faint) and collapse. It is not known how often this happens.
If this happens to you, stop using your nebuliser and
see a doctor straight away.
• Sudden wheezing soon after inhaling your dose of
Bricanyl Respules. It is not known how often this happens.
If this happens to you, stop using Bricanyl Respules and
see a doctor straight away.

What Bricanyl Respules look like and the contents of the pack
Respules are single dose plastic units containing 2 millilitres (ml)
of solution.
The solution must be nebulised (made into a fine mist) before it
can be breathed in.

Other possible side effects
Very Common (may affect more than 1 in 10 people)
• Trembling or shaking.
• Headache.

Bricanyl Respules are available in boxes of 20.

Common (may affect up to 1 in 10 people)
• Pounding or rapid heart beats (palpitations).
• Cramp or feeling tense.
• Low levels of potassium in your blood which may cause
muscle weakness, thirst, or ‘pins and needles’.

Bricanyl Respules are manufactured by AstraZeneca AB,
S‑151 85, Södertälje, Sweden.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Bricanyl Respules is held by
AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK.

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
Bricanyl Respules 2.5 mg/ml
Nebuliser Solution
Reference number
17901/0114
This is a service provided by the
Royal National Institute of Blind
People.

Not known (frequency cannot be estimated from
available data)
• Unusual or irregular heart beats.
• Chest pain (due to heart problems such as angina). Tell your
doctor if you develop this symptom whilst receiving treatment
with Bricanyl Respules, 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.
Do not be concerned by this list of side effects. You may not get
any of them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the 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.

This leaflet was last revised in: December 2016.
Bricanyl and Respules are trade marks of the AstraZeneca
group of companies.

5. How to store Bricanyl Respules

© AstraZeneca 2016




RSP 16 0113

Keep this medicine out of the sight and reach of children.
Once a foil envelope has been opened, the Respules inside
should be used within 3 months. Note: It is best to mark the
opening date on the foil envelope to help you remember.

564106-A01
04-03-17
PS09719

Black

Technical Info

AZL032A
7737

Profile

Bricanyl Respules 2.5mg Leaflet:
Patient UK
GP

Body text size

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9.0 pt

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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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