BRICANYL 0.3 MG/ML SYRUP
Active substances: TERBUTALINE SULPHATE
- PDF options:
- View fullscreen
- Download PDF
PDF Transcript
Package leaflet: Information for the user
Bricanyl® 0.3 mg/ml Syrup
terbutaline sulfate
Read all of this leaflet carefully before you start taking 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.
What is in this leaflet
1. What Bricanyl Syrup is and what it is used for
2. What you need to know before you take Bricanyl Syrup
3. How to take Bricanyl Syrup
4. Possible side effects
5. How to store Bricanyl Syrup
6. Contents of the pack and other information
1.
What Bricanyl Syrup is and what it is used for
Bricanyl Syrup 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.
Bricanyl Syrup is used for the regular treatment of breathing disorders such as asthma. It
helps to relieve tightening of the chest and difficulty breathing (bronchospasm). 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.
2.
What you need to know before you take Bricanyl Syrup
Do not take Bricanyl Syrup:
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 taking Bricanyl Syrup if:
You are pregnant and you have had problems with your pregnancy.
You are diabetic. If so, you may need some additional blood sugar tests when you start
taking Bricanyl Syrup.
You have a history of heart disease, irregular heart rhythm or angina.
You have an overactive thyroid gland.
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 1 of 5
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Bricanyl Syrup.
Other medicines and Bricanyl Syrup
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 Syrup can affect the way that some medicines work and some medicines can have an
effect on Bricanyl Syrup.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Steroid medicines (such as prednisolone).
Xanthine medicines (such as theophylline or aminophylline).
Beta-blocker medicines (such as atenolol or propranolol), including eye drops (such as
timolol).
Water tablets, also know as diuretics (such as frusemide).
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 taking this medicine.
Bricanyl should be used with caution at the end of pregnancy since it relaxes the womb.
Driving and using machines
Bricanyl Syrup is not likely to affect you being able to drive or use machines.
Bricanyl Syrup contains ethanol (alcohol) and sorbitol
This medicine contains small amounts of ethanol (alcohol). It contains less than 100 mg per
dose.
This medicine contains sorbitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3.
How to take Bricanyl Syrup
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure. The instructions on the label should remind you of
what the doctor said. Do not stop taking your medicine without first discussing it with your
doctor.
For asthma and breathing problems
The recommended starting dose for adults and the elderly is two 5 ml spoonfuls three times a
day. Your doctor may then increase the dose to three 5 ml spoonfuls three times a day if
necessary.
Use in children
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 2 of 5
The dose for children depends on the child’s weight. The doctor will work out the correct
dose. This is usually 0.25 ml per kg body weight three times a day. For example, if a child
weighs 20 kg the dose will be 5 ml three times a day.
Contact your doctor straight away if:
Your breathing is getting worse.
You often wake up at night with asthma.
You start getting chest tightness.
You are not getting relief from your current dose.
These signs could mean your asthma is not being controlled and you may need different
or additional treatment straight away.
If you take more Bricanyl Syrup than you should
If you have accidentally taken too much of this medicine, contact your doctor or pharmacist
for advice.
If you forget to take Bricanyl Syrup
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for
the next dose, wait until then and take the next dose as normal. Do not take a double dose to
make up for a forgotten dose.
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.
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, stop taking Bricanyl Syrup and see a doctor straight
away.
Sudden wheezing soon after taking your dose of Bricanyl Syrup. It is not known exactly
how often this happens. If this happens to you, stop taking Bricanyl Syrup and use
your ‘reliever inhaler’ straight away. See your doctor as soon as possible as you may
need to have your treatment changed.
Other possible 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 heart beat (palpitations).
Cramp or feeling tense.
Low levels of potassium in your blood which may cause muscle weakness, thirst, or ‘pins
and needles’.
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 3 of 5
Not known (frequency cannot be estimated from the available data)
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 Syrup, 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.
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5.
How to store Bricanyl Syrup
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton and label after
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines that you no longer use. These measures will help protect the
environment.
6.
Contents of the pack and other information
What Bricanyl Syrup contains
The active substance is terbutaline sulfate. Each 5 ml spoonful contains 1.5 mg of terbutaline
sulfate (equivalent to 0.3 mg/ml).
The other ingredients are citric acid, disodium edetate, ethanol (see section 2 “Bricanyl Syrup
contains ethanol (alcohol) and sorbitol”), glycerol, sodium hydroxide, sorbitol (see section 2
“Bricanyl Syrup contains ethanol (alcohol) and sorbitol”), sodium benzoate, essence of raspberry,
and water.
What Bricanyl Syrup looks like and contents of the pack
Bricanyl Syrup is a clear, colourless, raspberry flavoured aqueous syrup. The syrup is
available in bottles of 100 ml, 300 ml and 1 litre.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Bricanyl Syrup are held by AstraZeneca UK Limited, 600
Capability Green, Luton, LU1 3LU, UK.
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 4 of 5
Bricanyl Syrup is manufactured by Takeda Pharma Sp. z o.o., ul. Księstwa Łowickiego 12,
99 - 420 Łyszkowice, Poland.
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 0. 3 mg/ml Syrup
Reference number
17901/0111
This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in: February 2017.
Bricanyl is a trade mark of the AstraZeneca group of companies.
© AstraZeneca 2017
RSP 16 0114a
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 5 of 5
Bricanyl® 0.3 mg/ml Syrup
terbutaline sulfate
Read all of this leaflet carefully before you start taking 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.
What is in this leaflet
1. What Bricanyl Syrup is and what it is used for
2. What you need to know before you take Bricanyl Syrup
3. How to take Bricanyl Syrup
4. Possible side effects
5. How to store Bricanyl Syrup
6. Contents of the pack and other information
1.
What Bricanyl Syrup is and what it is used for
Bricanyl Syrup 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.
Bricanyl Syrup is used for the regular treatment of breathing disorders such as asthma. It
helps to relieve tightening of the chest and difficulty breathing (bronchospasm). 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.
2.
What you need to know before you take Bricanyl Syrup
Do not take Bricanyl Syrup:
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 taking Bricanyl Syrup if:
You are pregnant and you have had problems with your pregnancy.
You are diabetic. If so, you may need some additional blood sugar tests when you start
taking Bricanyl Syrup.
You have a history of heart disease, irregular heart rhythm or angina.
You have an overactive thyroid gland.
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 1 of 5
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Bricanyl Syrup.
Other medicines and Bricanyl Syrup
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 Syrup can affect the way that some medicines work and some medicines can have an
effect on Bricanyl Syrup.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Steroid medicines (such as prednisolone).
Xanthine medicines (such as theophylline or aminophylline).
Beta-blocker medicines (such as atenolol or propranolol), including eye drops (such as
timolol).
Water tablets, also know as diuretics (such as frusemide).
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 taking this medicine.
Bricanyl should be used with caution at the end of pregnancy since it relaxes the womb.
Driving and using machines
Bricanyl Syrup is not likely to affect you being able to drive or use machines.
Bricanyl Syrup contains ethanol (alcohol) and sorbitol
This medicine contains small amounts of ethanol (alcohol). It contains less than 100 mg per
dose.
This medicine contains sorbitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3.
How to take Bricanyl Syrup
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure. The instructions on the label should remind you of
what the doctor said. Do not stop taking your medicine without first discussing it with your
doctor.
For asthma and breathing problems
The recommended starting dose for adults and the elderly is two 5 ml spoonfuls three times a
day. Your doctor may then increase the dose to three 5 ml spoonfuls three times a day if
necessary.
Use in children
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 2 of 5
The dose for children depends on the child’s weight. The doctor will work out the correct
dose. This is usually 0.25 ml per kg body weight three times a day. For example, if a child
weighs 20 kg the dose will be 5 ml three times a day.
Contact your doctor straight away if:
Your breathing is getting worse.
You often wake up at night with asthma.
You start getting chest tightness.
You are not getting relief from your current dose.
These signs could mean your asthma is not being controlled and you may need different
or additional treatment straight away.
If you take more Bricanyl Syrup than you should
If you have accidentally taken too much of this medicine, contact your doctor or pharmacist
for advice.
If you forget to take Bricanyl Syrup
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for
the next dose, wait until then and take the next dose as normal. Do not take a double dose to
make up for a forgotten dose.
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.
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, stop taking Bricanyl Syrup and see a doctor straight
away.
Sudden wheezing soon after taking your dose of Bricanyl Syrup. It is not known exactly
how often this happens. If this happens to you, stop taking Bricanyl Syrup and use
your ‘reliever inhaler’ straight away. See your doctor as soon as possible as you may
need to have your treatment changed.
Other possible 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 heart beat (palpitations).
Cramp or feeling tense.
Low levels of potassium in your blood which may cause muscle weakness, thirst, or ‘pins
and needles’.
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 3 of 5
Not known (frequency cannot be estimated from the available data)
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 Syrup, 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.
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5.
How to store Bricanyl Syrup
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton and label after
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines that you no longer use. These measures will help protect the
environment.
6.
Contents of the pack and other information
What Bricanyl Syrup contains
The active substance is terbutaline sulfate. Each 5 ml spoonful contains 1.5 mg of terbutaline
sulfate (equivalent to 0.3 mg/ml).
The other ingredients are citric acid, disodium edetate, ethanol (see section 2 “Bricanyl Syrup
contains ethanol (alcohol) and sorbitol”), glycerol, sodium hydroxide, sorbitol (see section 2
“Bricanyl Syrup contains ethanol (alcohol) and sorbitol”), sodium benzoate, essence of raspberry,
and water.
What Bricanyl Syrup looks like and contents of the pack
Bricanyl Syrup is a clear, colourless, raspberry flavoured aqueous syrup. The syrup is
available in bottles of 100 ml, 300 ml and 1 litre.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Bricanyl Syrup are held by AstraZeneca UK Limited, 600
Capability Green, Luton, LU1 3LU, UK.
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 4 of 5
Bricanyl Syrup is manufactured by Takeda Pharma Sp. z o.o., ul. Księstwa Łowickiego 12,
99 - 420 Łyszkowice, Poland.
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 0. 3 mg/ml Syrup
Reference number
17901/0111
This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in: February 2017.
Bricanyl is a trade mark of the AstraZeneca group of companies.
© AstraZeneca 2017
RSP 16 0114a
UK PIL Bricanyl syrup RSP 16 0114a (based on RSP 15 0027) 18/01/2017 AH
Page 5 of 5
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.