Monday 18 June 2012

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






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


terbutaline sulphate



Read all of this leaflet carefully before you start having this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or nurse.

  • 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.



In this leaflet:


  • 1. What Bricanyl Injection is and what it is used for

  • 2. Before you have Bricanyl Injection

  • 3. How to have Bricanyl Injection

  • 4. Possible side effects

  • 5. How to store Bricanyl Injection

  • 6. Further information




What Bricanyl Injection is and what it is used for


Bricanyl Injection contains a medicine called terbutaline sulphate. 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).

  • It is also used in pregnancy to prevent early delivery of the baby (premature labour).



Before you have Bricanyl Injection



Do not have Bricanyl Injection if:


  • You are allergic (hypersensitive) to terbutaline sulphate or any of the other ingredients of Bricanyl Injection (listed in Section 6: Further information).



Take special care with Bricanyl Injection


Check with your doctor or nurse before having Bricanyl Injection 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 having Bricanyl Injection.

  • 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 nurse before having Bricanyl Injection.




Taking other medicines


Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. Bricanyl Injection can affect the way that some medicines work and some medicines can have an effect on Bricanyl Injection.


In particular, tell your doctor or nurse 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 known as diuretics (such as frusemide).



Pregnancy and breast-feeding


Talk to your doctor before having Bricanyl Injection if you are pregnant, might become pregnant or are breast-feeding.




Driving and using tools and machines


Bricanyl Injection is not likely to affect you being able to drive or use any tools or machines.





How to have Bricanyl Injection


You will be given Bricanyl Injection by a doctor.



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.



For prevention of premature labour


  • 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. The infusion will then be continued
      for another 12 hours. Your doctor will usually ask you to lie on your side during the infusion.
    • or under the skin four times a day for a few days.

  • You will then be given tablets for as long as is needed to prolong the pregnancy.




Possible side effects


Like all medicines, Bricanyl Injection 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 (affects more than 1 in 10 people)


  • Trembling or shaking.

  • Headache.


Common (affects less than 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".



The following effects have sometimes been seen but it is not known exactly how often they happen:


  • 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".



Other possible side effects when used to prevent premature labour:



Very common (affects more than 1 in 10 people)


  • Fast heart beats.

  • Trembling or shaking.

  • Headache.

  • Feeling sick (nausea).


Common (affects less than 1 in 10 people)


  • Pounding heart beats (palpitations).

  • Low levels of potassium in your blood which may cause muscle weakness, thirst, or "pins and needles".



The following effects have sometimes been seen but it is not known exactly how often they happen:


  • An increased tendency to bleeding in connection with Caesarean section.

  • Unusual or irregular heartbeats.

  • Chest pain (due to heart problems such as angina). Tell your doctor or midwife if you develop this symptom whilst receiving treatment with Bricanyl Injection, but do not stop using this medicine unless told to.

  • 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.

  • High levels of sugar (glucose) and/or lactic acid in your blood.

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.




How to store Bricanyl Injection


  • The doctor and hospital pharmacist are responsible for storing, using and disposing of Bricanyl Injection correctly.

  • Keep in a safe place, out of the reach and sight of children.

  • Do not store above 25°C. Keep containers in the outer carton.

  • Do not use Bricanyl Injection after the expiry date printed on the packaging. The expiry date refers to the last day of that month.



Further information



What Bricanyl Injection contains


The active substance is terbutaline sulphate. There is 0.5 mg of terbutaline sulphate per millilitre (ml).


The other ingredients are sodium chloride, 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



AstraZeneca AB

S-151 85

Södertälje

Sweden



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.



Leaflet prepared: December 2008


Bricanyl is a trademark of the AstraZeneca group of companies.


© AstraZeneca 2008


RSP 08 0077a



68 035 97.28





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