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Asmasal Clickhaler 95mcg/Inhalation

Asmasal* Clickhaler*

Inhalation Powder 95 micrograms/inhalation Salbutamol (as sulphate)



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Patient Information Leaflet


Please read this leaflet carefully before you start to take your medicine. If you require further information or have any questions or are not sure about anything ask your doctor/nurse or pharmacist. Do not throw this leaflet away until you have finished your medicine as you may want to read it again.

The information in this leaflet is arranged as follows:

1.    What Asmasal Clickhaler is 4. Possible side effects and what it is used for

2. Before you use your inhaler    5. How to store your inhaler

3. How to use your inhaler    6. Further information

1.    WHAT ASMASAL CLICKHALER IS AND WHAT IT IS USED FOR

What Asmasal Clickhaler is:

•    Asmasal Clickhaler is a dry powder inhaler for you to breathe in through your mouth and into your lungs

•    The medicine (salbutamol sulphate) belongs to a group of medicines called bronchodilators. These can help you breath more easily.

What Asmasal Clickhaler is used for:

•    This medicine is prescribed to relieve chest tightness and wheezing if you have asthma in adults and children 6 years and older. It can help to prevent attacks of wheezing (e.g. before exercise) and help you breath more easily.

2.    BEFORE YOU USE YOUR INHALER

Do not use the Asmasal Clickhaler if you are allergic to either lactose or salbutamol sulphate.

Tell your doctor or pharmacist before taking the medicine if the

answer is YES to any of the following questions:

1.    Have you ever had to stop taking another medicine for this condition because you were allergic to it or it caused problems?

2.    Are you pregnant, thinking of becoming pregnant or breastfeeding?

3.    Do you have raised blood pressure, any heart or circulation problems, a tumor near your kidney (phaeochromocytoma), or any problems with blood sugar levels including diabetes?

4.    Are you taking heart tablets such as digoxin?

5.    Do you have an overactive thyroid gland?

6.    Are you taking betablockers (e.g. propranolol) for blood pressure or migraine?

7.    Are you about to have a general anaesthetic?

8.    Do you have a history of heart disease, irregular heart rhythm or angina (chest pain)?

Injections of this type of medicine have resulted in very low levels of potassium in the blood. Special care is needed in acute severe asthma as this effect can be made worse by other medicines (e.g. theophylline, steroids or water tablets/injections) or by low oxygen levels. Blood levels of potassium should be measured in these conditions.

Tell your doctor if you are taking any other medicines.

Important information about some of the ingredients of Asmasal Clickhaler

If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking this medicine.

3. HOW TO USE YOUR INHALER

The instructions in Figure 1 show you how to use your inhaler. Supervise children using the Asmasal Clickhaler to ensure they use it correctly.

How do I know how many puffs to take and when?

Follow the instructions shown in Figure 1. If you have any problems tell your doctor, pharmacist or asthma nurse.

It is important that you inhale each dose as instructed by your doctor. The label will usually tell you what dose to take and how often. If it does not or you are not sure, ask your doctor or pharmacist.

Usually the most you would take in 24 hours is 2 puffs 4 times a day. The following is a guide:

Adult - for intermittent use:

1 or 2 puffs. If the response is inadequate, more puffs can be taken.

-    to prevent exercise induced asthma:

1 or 2 puffs 15 minutes before exercise.

-    to prevent wheezing before contact with a known trigger:

1 or 2 puffs can be taken beforehand

Children (6 to 12 years): For intermittent use, or to prevent exercise-induced asthma:

1 puff. If the response is inadequate, more puffs can be taken.


Figure 1. How to use your Asmasal Clickhaler

1. Remove mouthpiece cover from the inhaler.



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2. Shake the inhaler.


3.    Hold the inhaler upright with a finger on the push button.

Press the dosing button down firmly -once only until it clicks and release.

4.    Breathe out as far as is comfortable.

Do not blow into the device at any time.


5.    Place the mouthpiece in your mouth and close your lips firmly around it (do not bite it). Breathe in through your mouth steadily and deeply, to draw the medicine into your lungs.

6.    Hold your breath, take the inhaler from your mouth and continue holding your breath for about 5 seconds, or as long as is comfortable.

If more puffs are needed, keep the inhaler

upright and repeat Steps 2-6.

7.    Replace the mouthpiece cover to help keep the mouthpiece clean and the powder dry.


You must not inhale more doses or use your inhaler more often than your doctor advises. If your wheezing or breathing is very bad your doctor may tell you to take more as an emergency treatment only.

If you take too much

If you accidentally take more puffs than recommended you may notice that your heart is beating faster than usual and that you feel shaky. The effects usually wear off within a few hours but you should tell your doctor as soon as possible.

If you miss a dose

If you forget to inhale a dose do not worry, take the next dose when it is due or before if you become wheezy. Your doctor may have told you to use your inhaler regularly every day or only when you are wheezy or short of breath.

How is the Asmasal Clickhaler different to other inhalers?

As this is a dry powder inhaler and not an aerosol spray:

It may taste or feel different from other inhalers you may have used. You cannot see any spray when the button is pressed. This does not mean your inhaler isn't working.

How can your check your inhaler is working?

If you are concerned that your inhaler is not working, you can reassure yourself by pressing the button and then gently tapping the mouthpiece on your hand. You will then see a tiny amount of powder on your hand.


Figure 2. Your Asmasal Clickhaler counter How does the counter work?

•    On the back of your inhaler is a counter to tell you how many puffs you have taken.

•    Every time you use your Asmabec Clickhaler the counter moves on by 1, for example:


ACTUATIONS TAKEN Means 56 puffs have been taken

How do

you know when there are only 10 puffs left?

When there are only ten puffs left, red warning lines appear to remind you that your inhaler is nearly empty and you must make sure you have a replacement inhaler ready.

The first time you see these red warning lines it means there are 10 puffs left in your inhaler:

^ ACTUATIONS TAKEN Means there are 10 puffs left

The counter then counts up the final ten doses for example:


5 6




^ ACTUATIONS TAKEN Means there is 1 puff left

How do you know when your Asmabec Clickhaler is empty?

After you have pushed the button down for the last puff in the inhaler, the push button will lock in a pressed down position and the counter will again show red warning lines and '0':



^ ACTUATIONS TAKEN Your inhaler is now empty

•    You can now breathe in your last dose

•    The inhaler is now empty.


Cleaning your inhaler

For hygiene reasons, it is important to clean the mouthpiece cover and mouthpiece regularly. Figure 3 shows you how to clean your inhaler.


Figure 3. How to clean your Asmasal Clickhaler

1. Remove the mouthpiece cover from the inhaler.



2. Remove the mouthpiece. Press downwards on the end of the mouthpiece.


3. Wipe the body of the inhaler with a dry cloth or tissue.

Do not use water.


4. Wipe the mouthpiece with a dry cloth or tissue.

Do not use water.


5. Re-attach the mouthpiece to the body of the inhaler and then replace the mouthpiece cover.



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Should you suffer from deep, rapid breathing, cold and blue coloured fingers and toes, are unable to concentrate or generally feel unwell go to the nearest hospital.

Tell your doctor as soon as possible if you notice a sudden worsening of your shortness of breath and/or wheeze shortly after using your inhaler.

If the relief of wheezing or chest tightness is not as good as usual or does not last as long as usual or you are using your inhaler more often than usual, tell your doctor as soon as possible. It may be that your chest condition is getting worse and perhaps you may need an extra medicine.

Very rare side effects:

Allergic reactions including skin rashes or redness or swelling of the face, lips or throat, wheezing, low blood pressure or collapse.

If you experience an allergic reaction, stop taking this medicine and contact your doctor IMMEDIATELY Children using this inhaler may become restless or excitable Very occasional side effects:

•    Shaky • Headache • Heart beating faster • Feel tense • Feel sick

•    Feel dizzy • Feel nervous • Muscle cramps Other side effects include:

•    Palpitations • Irritation of the mouth and throat • Wheezing

If you feel unwell or notice anything unusual or which you do not understand, tell your doctor as soon as possible. Some of the effects mentioned above may be more common when you start to take your medicine or when drinking alcohol and could affect your driving or ability to use machines. If you are affected do not drive or operate machinery.

Although it is not known exactly how this happens, some people may occasionally experience chest pains (due to heart problems such as angina). Tell your doctor if you develop these symptoms whilst receiving treatment with salbutamol, but do not stop taking this medicine unless told to do so.

5. HOW TO STORE YOUR INHALER

How should I store my inhaler?

It is important that the inhaler is kept dry. Store in the original package in order to protect from moisture.

Replace the inhaler if it becomes immersed in water or exposed to very damp conditions.

Keep the mouthpiece cover on your inhaler when you are not using it. This will keep the mouthpiece clean and help to keep the powder dry.

Keep your inhaler in a safe place out of the reach and sight of children.

Do not store above 30°C.

How long can I use the inhaler for?

Do not use the inhaler after the expiry date shown on the base of the inhaler.

Once the inhaler is removed from its foil pouch do not use it for longer than 6 months.

6. FURTHER INFORMATION

What Asmasal Clickhaler contains:

•    The active ingredient in this medicine is salbutamol sulphate. Each measured dose contains 95 micrograms of salbutamol.

•    The only other ingredient in this medicine is lactose (milk sugar). What Asmasal Clickhaler looks like:

The medicine is contained in a white inhaler with a blue button at the top. See Figure 4 below:

Figure 4 Your Asmasal Clickhaler

1.    Button

2.    Mouthpiece Cover

3.    Mouthpiece

4.    Dose Counter

The product licence is held by:

RCH PharmaceuticolsAB, Lagervagen7, 136 50 Jordbro,Sweden.

The product is manufactured by:

Recipharm Ltd, Ashton-under-Lyne, OL7 9RR, UK.

Date of preparation of the leaflet: September 2009