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Bricanyl Turbohaler 0.5mg/Dose Inhalation Powder.

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Document: leaflet MAH BRAND_PLPI 16369-1567 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Bricanyl® Turbohaler® 0.5mg/dose inhalation powder

(terbutaline sulphate)

The name of your medicine is Bricanyl® Turbohaler® 0.5mg/dose inhalation powder but will be referred to as Bricanyl Turbohaler throughout the remainder of this leaflet.

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.

What is in this leaflet

1.    What Bricanyl Turbohaler is and what it is used for

2.    What you need to know before you use Bricanyl Turbohaler

3.    How to use Bricanyl Turbohaler

4.    Possible side effects

5.    How to store Bricanyl Turbohaler

6.    Contents of the pack and other information


Turbohaler is a multidose inhaler from which very small amounts of powder are administered (Figure 1). When you breathe in through Turbohaler the powder is delivered to your lungs. It is therefore important that you inhale forcefully and deeply through the mouthpiece.



How to prepare a new Turbohaler for use

Before using Turbohaler for the first time you need to prepare the inhaler for use.


1. What Bricanyl Turbohaler is and what it is used for


Unscrew and lift off the white cover.

Hold the Turbohaler upright with the blue grip downwards (Figure 2). Do not hold the mouthpiece when you turn the blue grip. Turn the blue grip as far as it will go in one direction, and then back again in the opposite direction as far as it will go. It does not matter which way you turn first. During this procedure you will hear a click. Perform the procedure twice.

The turbohaler is now prepared for use, and you should not repeat the above procedure again. To take a dose, please continue according to the instructions below.


Figure 2


Bricanyl Turbohaler is an inhaler. It contains 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 Turbohaler is used for asthma and other breathing problems where you have a tight chest and difficulty breathing.


2. What you need to know before you _use Bricanyl Turbohaler_


Do not use Bricanyl Turbohaler:

• If you are allergic to terbutaline.


Warnings and precautions

Talk to your doctor or pharmacist before using Bricanyl T urbohaler if:

•    You have diabetes. If so, you may need some extra blood sugar tests when you start using Bricanyl Turbohaler.

•    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 Turbohaler.

Other medicines and Bricanyl Turbohaler

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 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).


How to take an inhalation

Every time you need to take an inhalation, follow the instructions

below.

1.    Unscrew the white cover and lift it off.

2.    Hold your Turbohaler upright with the blue grip at the bottom.

3.    Do not hold the mouthpiece when you load your Turbohaler. To load your Turbohaler with a dose, turn the blue grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound. Your T urbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.

4.    Hold your Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Turbohaler.

5.    Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.

6.    Remove your Turbohaler from your mouth. Then breathe out gently. The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.




If you are to undergo surgery with general anaesthetics it is important that you inform your doctor about all medicines 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 T urbohaler, talk to your doctor straight away.


Driving and using machines

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


3. How to use Bricanyl Turbohaler


Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. If Bricanyl Turbohaler is to be used by a child, make sure that they use it correctly.

How much to take

•    The recommended dose is one inhalation as required.

•    Do not take more than four inhalations in any 24 hour period.

•    One inhalation from your Bricanyl Turbohaler should last for up to six hours.

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.

Please read the complete instructions carefully before you start to take your medication


7.    If you are to take a second inhalation, repeat steps 2 to 6.

8.    Replace the cover by screwing it back on tightly.

With each inhalation some medication may stick to the inside of your mouth and throat. T o reduce the risk of side effects it is advised that you, when possible, rinse your mouth with water after using Bricanyl Turbohaler.

Do not try to remove or twist the mouthpiece. It is fixed to your T urbohaler and must not be taken off. Do not use your T urbohaler if it has been damaged or if the mouthpiece has come apart from your Turbohaler.

Cleaning your Turbohaler

Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

When to start using a new Turbohaler

•    When a red mark first appears in the indicator window under the mouthpiece, there are about 20 doses left. You will need to see your doctor for another prescription.

•    When the red mark reaches the bottom of the indicator window, your Turbohaler is empty and you must start using your new Turbohaler.



Note:

•    The grip will still twist and 'click' even when your Turbohaler is empty.

•    The sound that you hear as you shake your T urbohaler is produced by a drying agent and not the medicine. Therefore the sound does not tell you how much medicine is left in your Turbohaler.

•    If you load your T urbohaler more than once by mistake before taking your dose, you will still only receive one dose.