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BRICANYL INJECTION 0.5 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): TERBUTALINE SULPHATE

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Package leaflet: Information for the user

28044575

Bricanyl Injection 0.5 mg/ml, solution for injection or infusion
®

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 nurse.
• If you get any of the side effects, talk to your doctor or
nurse, this includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet
1. What Bricanyl Injection is and what it is used for
2. What you need to know before you use Bricanyl Injection
3. How to use Bricanyl Injection
4. Possible side effects
5. How to store Bricanyl Injection
6. Contents of the pack and other information

If you are not sure if any of the above apply to you, talk to
your doctor or nurse before using Bricanyl Injection.
Your doctor will monitor your heart and your unborn baby.
Your doctor may also take blood tests to monitor for
changes in your blood (see section 3).
Other medicines and Bricanyl Injection
Tell your doctor, nurse or pharmacist if you are taking, have
recently taken, or might take any other medicines, including
medicines obtained without a prescription. This includes
herbal medicines. Bricanyl Injection can have an effect on
the way some medicines work, and some medicines can
effect how Bricanyl Injection works.
In particular, tell your doctor, nurse or pharmacist if you are
taking:
• Medicines for an irregular or fast heartbeat (such as
digoxin).
• Other beta-blocker medicines (such as atenolol or
propranolol), including eye drops (such as timolol).
• Xanthine medicines (such as theophylline or aminophylline).
• Steroid medicines (such as prednisolone)
• Water tablets, also known as diuretics (such as
frusemide).
• Medicines for diabetes to reduce your blood sugar (such
as insulin, metformin, or glibenclamide).
If you are scheduled for surgery with general anaesthetics
it is important that you inform your doctor of all medicines
you use, including Bricanyl. Your doctor will stop the
administration of Bricanyl Injection 6 hours before surgery
whenever possible to protect you from adverse effects
(e.g. irregular heart beat or bleeding of your womb).
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 taking this medicine.
Driving and using machines
Bricanyl Injection is not likely to affect you being able to
drive or use any tools or machines.
Bricanyl Injection contains sodium
This medicinal product contains less than 1 mmol sodium
(23 mg) per 1ml, i.e. essentially sodium-free.

1. What Bricanyl Injection is and what it is used for
Bricanyl Injection contains a medicine called terbutaline
sulfate. This belongs to a group of medicines called
beta‑agonists. These work by relaxing certain muscles. For
example, they open up the airways in the lungs or relax the
muscles of the womb (uterus) during pregnancy.
• Bricanyl Injection is used for breathing disorders such
as asthma. It helps to relieve tightening of the chest and
difficulty breathing (bronchospasm).
• Bricanyl Injection is also used in women who have
unexpectedly gone into early labour (premature labour)
between 22nd and 37th week of gestation, to provide a
short delay in the early delivery of the baby. You will
receive Bricanyl Injection for a maximum of 48 hours.
This will give your doctor or midwife time to take extra
measures that will improve the health of your baby.
2. What you need to know before you use
Bricanyl Injection
Do not use Bricanyl Injection:
• If you are allergic (hypersensitive) to terbutaline sulfate
or any of the other ingredients of this medicine (listed in
section 6).
Do not use Bricanyl Injection (in the treatment of
premature labour):
• If you are less than 22 weeks pregnant.
• If you suffer from or have a known risk of developing
ischaemic heart disease (disease characterised by
reduced blood supply to your heart muscle, causing
symptoms such as chest pain (angina)).
• If you have ever experienced miscarriage in the first two
trimesters of your pregnancy.
• If you are pregnant and you or your baby have certain
conditions when prolongation of your pregnancy would
be dangerous (such as severe high blood pressure,
infection of the womb, bleeding, placenta is covering the
birth canal or is detaching, or your baby has died inside
the womb).
• If you suffer from heart disease with palpitations (for
example heart valve disorder) or longstanding lung
disease (for example chronic bronchitis, emphysema)
causing an increase of blood pressure to your lungs
(pulmonary hypertension).
Warnings and precautions
Talk to your doctor or nurse before using Bricanyl Injection:
• If you have had any problems with your pregnancy.
• If you are diabetic. If so, you may need some additional
blood sugar tests when you are given Bricanyl Injection.
• If you have an overactive thyroid gland.
• If you have a history of heart disease characterised by
breathlessness, palpitations or angina (see Do not use
Bricanyl Injection if).
Warnings and precautions (in the treatment of
premature labour):
Talk to your doctor or nurse before using Bricanyl Injection:
• If during pregnancy, your waters have broken.
• If you have too much fluid in the lungs causing
breathlessness (pulmonary oedema).
• If you have high blood pressure.

3. How to use Bricanyl Injection

1

You will be given Bricanyl Injection by a doctor. You will
never be expected to give yourself this medicine.
For asthma and breathing problems
• You will be given the injection in one of the following ways:
-- under the skin, into a muscle, or into a vein up to
four times a day.
-- or as an infusion (drip) lasting for 8 to 10 hours.
• The doctor will work out the correct dose for you. The
dose for children is worked out from the child’s weight.
To temporarily delay premature labour
You will never be expected to give yourself this medicine. It
will always be given to you by a person who is qualified to
do so after careful consideration of the balance of benefits
of Bricanyl Injection to your baby and the potential untoward
effects the treatment may have on you.
You will be given Bricanyl Injection by a doctor where
facilities are available to continually monitor your health and
that of your baby throughout administration.
• You will be given the injection in one of the following ways:
-- as an infusion (drip). The doctor will gradually increase
the dose until the contractions stop. The doctor will
then gradually reduce the dose to the lowest dose that
stops your contractions. Your doctor will usually ask
you to lie on your side during the infusion.
The following measures will be taken where necessary:
• Blood pressure and heart rate. Your doctor will consider
the lowering of your dose or discontinuing Bricanyl Injection
if your heart rate exceeds 120 beats per minute.

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Uncommon (may affect up to 1 in 100 people)
• Fluid accumulation in the lungs (pulmonary oedema)
which may cause difficulty breathing.
Rare (may affect up to 1 in 1,000 people)
• Unusual or irregular heartbeats.
• High levels of sugar (glucose) and/or lactic acid in
your blood.
• Flushing (reddening) of the face.
Not known (frequency cannot be estimated from the
available data):
• An increased tendency to bleeding in connection with
Caesarean section.
• Coughing or shortness of breath.
• Mouth and throat irritation.
• Changes in sleeping patterns and changes in behaviour,
such as feeling agitated, restless or “hyperactive”.
• Cramp or feeling tense.
Do not be concerned by this list of side effects. You may
not get any of them. 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 nurse.
Reporting of side effects
If you get any side effects, talk to your doctor 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. By reporting side
effects you can help provide more information on the safety
of this medicine.



 lectrocardiography (ECG, electric activity of your heart).
E
Tell your doctor immediately if you experience chest
pain during treatment. If there are changes in ECG
recording and you have chest pain your doctor will stop
the administration of Bricanyl Injection.
• Balance of water and salts in your body. Tell your
doctor immediately if you experience coughing or
shortness of breath during treatment. If any signs
indicate that there is a build-up of fluid in your lungs
(also known as pulmonary oedema) (e.g. coughing
or shortness of breath), your doctor may stop the
administration of Bricanyl Injection.
• Blood sugar level and the occurrence of low body pH
with a build-up of lactate in your blood (also known as
lactic acidosis).
• Blood potassium levels (low potassium levels may be
associated with a risk of irregular heart beat).
If you have any further questions on the use of this
medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
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 exactly how
often this happens. If this happens to you, tell your
doctor or nurse straight away.
• Sudden wheezing soon after being given Bricanyl Injection.
It is not known exactly how often this happens. If this
happens to you, tell your doctor or nurse straight away.
Other possible side effects when used for asthma or
similar conditions:
Very common (may affect more than 1 in 10 people)
• Trembling or shaking.
• Headache.
Common (may affect up to 1 in 10 people)
• Fast heart beats.
• Pounding heart beats (palpitations).
• Cramp or feeling tense.
• Low levels of potassium in the blood which may cause
muscle weakness, thirst, or “pins and needles”.
Rare (may affect up to 1 in 1,000 people)
• 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.
Not known (frequency cannot be estimated from the
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 Injection, 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”.

Important side effects to look out for when treated for
premature labour:
Rare (may affect up to 1 in 1,000 people)
• Chest pain (due to heart problems such as angina).
If this happens to you, tell your doctor or nurse
straight away.
The following side effects have also been observed with
all beta-agonists like Bricanyl Injection when used to delay
premature labour:
Very common (may affect up to 1 in 10 people)
• Fast heart beats.
• Trembling or shaking.
• Headache.
• Feeling sick (nausea).
Common (may affect up to 1 in 10 people)
• Pounding heart beats (palpitations).
• Low blood pressure which may cause light-headedness
or dizziness.
• Low levels of potassium in your blood which may cause
muscle weakness, thirst, or “pins and needles”.

5. How to store Bricanyl Injection
• The doctor and hospital pharmacist are responsible for
storing, using and disposing of this medicine correctly.
• 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 label and carton. The expiry date refers to
the last day of that month.
• Do not store above 25°C. Keep containers in the outer
carton.
6. Contents of the pack and other information
What Bricanyl Injection contains
The active substance is terbutaline sulfate. There is
0.5 mg of terbutaline sulfate per millilitre (ml).
The other ingredients are sodium chloride (see section 2),
hydrochloric acid and water for injection.
What Bricanyl Injection looks like and contents of the pack
Bricanyl Injection is a clear solution for injection. It comes in
glass ampoules containing either 1 ml or 5 ml of solution.
The 1 ml ampoules are available in packs of five. The 5 ml
ampoules are available in packs of ten.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Bricanyl Injection is held
by AstraZeneca UK Limited, 600 Capability Green, Luton,
LU1 3LU, UK.
Bricanyl Injection is manufactured by Cenexi, 52 Rue Marcel
et Jacques Gaucher, 94120 Fontenay sous Bois, France.

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 Injection
Reference number 17901/0112
This is a service provided by the Royal
National Institute of Blind People.
The leaflet was last revised in March 2015
Bricanyl is a trademark of the AstraZeneca group of
companies.
© AstraZeneca 2015
RSP 14 0093a

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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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