Tuesday, October 25, 2016

Bricanyl Respules 2.5 mg / ml Nebuliser Solution





Bricanyl Respules 2.5 mg/ml Nebuliser Solution



terbutaline sulphate




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



  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • 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 pharmacist.




In this leaflet:



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

2. Before you use Bricanyl Respules

3. How to use Bricanyl Respules

4. Possible side effects

5. How to store Bricanyl Respules

6. Further information






What Bricanyl Respules are and what they are used for



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.

  • 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.




Before you use Bricanyl Respules




Do not use Bricanyl Respules if:



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




Take special care with Bricanyl Respules



Check with 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.





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 can affect the way that some medicines work and some medicines can have an effect
on Bricanyl.



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).




Pregnancy and breast-feeding



  • Talk to your doctor before using Bricanyl Respules if you are pregnant, might become pregnant or are breast-feeding.

  • If you become pregnant while you are using Bricanyl Respules, talk to your doctor straight away.




Driving and using tools and machines



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






How to use Bricanyl Respules



Always use Bricanyl Respules exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.



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 usual 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.





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.





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 have a double dose to make up for a forgotten dose.




Stopping Bricanyl Respules



Do not stop taking your medicine without first discussing it with your doctor.






Possible side effects



Like all medicines, Bricanyl Respules 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 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.




Other possible side effects



Very Common (affects more than 1 in 10 people)



  • Trembling or shaking.

  • Headache.

Common (affects less than 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’.

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 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.



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 pharmacist.





How to store Bricanyl Respules



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

  • Once you have opened a single Respule, it should be used within 12 hours. 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 Bricanyl Respules after the expiry date printed on the packaging.




Further information




What Bricanyl Respules contain



The active substance is terbutaline sulphate. Each Bricanyl Respule contains 5 mg of the active ingredient, terbutaline sulphate (equivalent to 2.5 mg/ml).



The other ingredients are sodium chloride, disodium edetate, hydrochloric acid and water.





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.



Bricanyl Respules are available in boxes of 20.





Marketing Authorisation Holder and Manufacturer



The Marketing Authorisation for Bricanyl Respules is held by




AstraZeneca UK Ltd

600 Capability Green

Luton

LU1 3LU

UK



Bricanyl Respules are 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 Respules 2.5 mg/ml Nebuliser Solution



Reference number 17901/0114



This is a service provided by the Royal National Institute of Blind People.





Leaflet prepared: September 2009



Bricanyl and Respules are trade marks of the AstraZeneca group of companies.



© AstraZeneca 2009



RSP 09 0063





6804062.28






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