Patient Information Leaflet

Please read this leaflet carefully before you start to take your 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 onto others. It may harm them, even if their symptoms are the same as yours.

The information in this leaflet is arranged as follows:

1.    What Asmabec Clickhaler is and    4. Possible side effects

what it is used for    5. How to store your inhaler

2.    Before you use your inhaler    6. Further information

3.    How to use your inhaler

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

What Asmabec Clickhaler is:

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

•    The medicine (beclometasone dipropionate) belongs to a group of medicines called steroids. These can help to control asthma.

What Asmabec Clickhaler is used for:

•    This medicine is prescribed to control asthma in adults and children 6 years and older.

•    The medicine works by reducing the inflammation in your lungs.

Do not use this medicine to treat a sudden attack of breathlessness - it will not help you.

You will probably need a different kind of medicine in a different colour pack which your doctor may already have given you. If you have more than one medicine be careful not to confuse them.

2.    BEFORE YOU USE YOUR INHALER

Do not use the Asmabec Clickhaler if you are allergic to either lactose or beclometasone dipropionate.

Tell your doctor or pharmacist before taking the medicine if the

answer is YES to any of the following questions:

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

2.    Do you have or had you had tuberculosis (TB)?

3.    Do you have any infection in your eye, mouth or chest?

4.    Are you taking any of the following anti-fungal or anti-viral drugs for infections: ketoconazole, itrazonazole, nelfinavir or ritonavir?

Tell your doctor if you are taking any other medicines.

If you have an intolerance to any sugars tell your doctor before taking this medicine.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist before using Asmabec.

3. HOW TO USE YOUR INHALER

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

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

The pharmacist's label on the box should tell you how many puffs to take and how often.

Asmabec Clickhaler is usually taken 2 or 4 times a day (e.g. 2 puffs in the morning and evening). The dose varies depending how severe the asthma is. The lowest dose that keeps your asthma under control should be used.

The following is a guide:

Adult starting dose:

200 to 400 micrograms/day up to a maximum of 2000 micrograms per day

Adult maintenance dose:

400 to 800 micrograms per day up to a maximum of 2000 micrograms per day

Children (6 to 12 years): 200 to 400 micrograms per day Not suitable for children under 6 years

You must not inhale more doses or use your inhaler more often than your doctor advises.

Figure 1. How to use your Asmabec Clickhaler

1. Remove mouthpiece cover from the inhaler.

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. Keep the inhaler upright.

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.

Your dose may be reduced when your asthma is under control. Your doctor or nurse may want to regularly review your treatment to make sure you are on the right dose.

How do I use the counter on my Asmabec Clickhaler?

Figure 2. Your Asmabec 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:

5    6 M 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:

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

^ ACTUATIONS TAKEN Means 10 puffs have been taken

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 Means there is 1 puff left

•    You can now breathe in your last dose

•    The inhaler is now empty.

ACTUATIONS TAKEN Your 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 Asmabec Clickhaler

1. Remove 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.

4. POSSIBLE SIDE EFFECTS

Very rare side effects:

•    Allergic reactions including skin rashes or redness or swelling of the face or throat causing difficulty breathing.

If you experience an allergic reaction, stop taking this medicine and go to the nearest hospital accident and emergency department as soon as possible.

•    Wheezing

Stop taking this medicine and tell your doctor as soon as possible

if you notice that your shortness of breath and/or wheeze is becoming worse.

Very occasional side effects:

•    Throat or tongue becomes sore.

•    Fungal infection of mouth or throat.

•    Voice becomes a little hoarse.

Rinsing your mouth with water after inhaling each dose may help prevent these side-effects.

Side-effects if you use high doses for a long period:

•    Stop your body producing its own steroid causing low blood pressure, dizziness, increased heart rate, fatigue, lethargy.

•    Bone thinning.

•    Pain in the eye and blurred vision.

•    Slow down growth in children and adolescents.

•    Easy bruising of the skin.

•    Cataracts (the lens of the eye becomes cloudy).

•    Cushing's syndrome (a condition of the adrenal glands causing weight gain, rounded (moon shaped) face and high blood pressure)

Other side-effects include:

•    Weight loss. • Stomach pains. • Convulsions (fits).

•    Feeling sick or being sick. • Unable to concentrate.

•    Headache. • Weakness, confusion, sweating. • Tiredness.

•    Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to occur in children.

These may be made worse by trauma, surgery, infections or suddenly reducing or stopping treatment.

If any side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 to protect from moisture and light.

•    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 which is stated on the carton label and on the base of the inhaler after EXP. The expiry date refers to the last day of that month.

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

6. FURTHER INFORMATION

What Asmabec Clickhaler contains:

The active ingredient in this medicine is beclometasone dipropionate. The colour of the button indicates the strength and number of puffs in the inhaler:

Can I stop using my inhaler?

•    Do not stop treatment even if you feel better unless told to do so by your doctor.

•    It takes a few days for this medicine to work and it is very important that you use it regularly.

If you take too much

If you accidentally take more puffs than recommended tell your doctor. It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice.

If you miss a dose

If you forget to inhale a dose do not worry, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for the next dose.

How is the Asmabec 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 you 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.

The only other ingredient in this medicine is lactose monohydrate (which contains milk protein).

What Asmabec Clickhaler looks like:

The medicine is an inhalation powder in a white inhaler with a coloured button at the top. See Figure 4 below:

Figure 4. Your Asmabec Clickhaler

The marketing authorisation holder is:

RPH Pharmaceuticals AB, Lagervagen 7, 136 50 Jordbro, Sweden. The manufacturer is:

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

Date of preparation of the leaflet: May 2011    P1016J