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BECLOMETASONE 100 MICROGRAM INHALER

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PATIENT INFORMATION LEAFLET
BECLOMETHASONE 50, 100, 250 microgram NEO-HALER
(beclometasone dipropionate)
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your 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 gets serious, or if you notice any side effects not listed in the leaflet,
please tell your doctor or pharmacist.
The full name of your medicine is Beclomethasone 50, 100 or 250 microgram Neo-haler, which will
be referred to as Beclomethasone Neo-haler throughout this leaflet.
Beclomethasone Neo-halers are available in three strengths. Your doctor will decide what strength
you need as part of your treatment.
In this leaflet
1. What a Beclomethasone Neo-haler is and what it is used for
2. Before you use your Beclomethasone Neo-haler
3. How to use your Beclomethasone Neo-haler
4. Possible side effects
5. How to store your Beclomethasone Neo-haler
6. Further Information

Your doctor should start you or your child on the lowest dose that is necessary to control your asthma
to reduce the chance of getting side effects.
Special care should also be taken and you should tell your doctor if you:
• are or have been taking steroid tablets and have just started to use Beclomethasone Neo-haler.
You should continue to carry a steroid warning card (if you have one) until your doctor tells you that
you no longer need to.
• have an accident or go into hospital. It is important to tell your doctor that you have been treated
for a long time with high doses of inhaled steroid. You may require extra steroids at this time.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. Remember to take this medicine with you if you have to
go into hospital.
Please read the special care note above if you are, or have been taking steroid tablets.
Pregnancy and breast-feeding
If you are pregnant, intending to become pregnant or are breast-feeding, you should use your
Beclomethasone Neo-haler only if your doctor tells you to.
Ask your doctor, asthma nurse or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Beclomethasone Neo-haler will have an affect on your ability to drive or use
machines, however, if affected you should not drive or operate machines.

3. HOW TO USE YOUR BECLOMETHASONE NEO-HALER
1. WHAT A BECLOMETHASONE NEO-HALER IS AND WHAT IT IS USED
FOR
Beclomethasone Neo-haler is a pressurized inhalation solution which contains the active substance
beclometasone dipropionate. Beclometasone dipropionate belongs to a group of medicines called
corticosteroids, which are often referred to as steroids.
Beclomethasone Neo-haler is used to help prevent the symptoms of asthma in patients who need
regular treatment. Steroids are used to treat asthma because they have an anti-inflammatory action.
This means that they reduce the swelling and irritation in the walls of the small air passages in the
lungs and so ease breathing problems.
Steroids also help to prevent attacks of asthma.

2. BEFORE YOU USE YOUR BECLOMETHASONE NEO-HALER
Do not use your Beclometasone Neo-haler if you are allergic (hypersensitive) to beclometasone
dipropionate, or any of the other ingredients in your Beclometasone Neo-haler (these are listed in
section 6, Further Information).

Please make sure that you know how, when, and how much of your Beclomethasone Neo-haler you
should use. Your doctor or asthma nurse should have discussed this with you and instructions should
be provided on the pharmacist’s label. If you are unsure ask your doctor, asthma nurse or pharmacist
for advice. It is very important that you follow your doctor’s instructions – do not use more
medicine than you were told to.
The usual starting dose is:
Adults:
Beclomethasone 50 microgram Neo-haler: The most you should take in 24 hours is 16 puffs.
Beclomethasone 100 microgram Neo-haler: The most you should take in 24 hours is 8 puffs.
Beclomethasone 250 microgram Neo-haler: The most you should take in 24 hours is 4 puffs.
Children:
Beclomethasone 50 microgram Neo-haler: The most you should take in 24 hours is 8 puffs.
Beclomethasone 100 microgram Neo-haler: The most you should take in 24 hours is 4 puffs.
How to use your Beclometasone Neo-haler
It is very important that you know how to use your Beclomethasone Neo-haler properly. This will
ensure that you inhale the spray produced by the Neo-haler into your lungs.

Tell your doctor if you are suffering, or have ever suffered from tuberculosis (TB).
Take special care with your Beclomethasone Neo-haler
It may take several days for your Beclomethasone Neo-haler to work. It is important that you use this
medicine regularly, even if you do not have any symptoms as it will also prevent further attacks of
asthma and wheezing. Do not stop treatment even if you feel better, unless you are told to do so by
your doctor.
• If your breathing or wheezing gets worse straight away, or after using your Beclomethasone Neohaler stop using it immediately and tell your doctor as soon as possible.
• If you have a sudden attack of breathlessness, you will need to take a different kind of medicine
– do not use your Beclomethasone Neo-haler as this will not help you. Please talk to your doctor
or pharmacist to make sure you have the right medicines available at all times.
• If you notice that your shortness of breath does not improve after 7 days of treatment, or it
becomes worse, you should tell your doctor as soon as possible.

Remove the cap from the Neo-haler mouthpiece. Make sure that the
mouthpiece is clean and clear of fluff and dirt.

Hold the Neo-haler upright, with your thumb on the base, below the
mouthpiece, as shown. Now shake the Neo-haler gently up and down a
few times.

Breathe out fully to empty the lungs and then place the mouthpiece firmly
between your lips.

• thrush (fungal infection) in the mouth and throat

Now breathe in slowly and deeply. At the same time press the aerosol can
with your first finger to fire the aerosol and release the medicine.

It is important that you do not rush steps 3 and 4.
Breathing Technique - It is important that you start to breathe in as slowly as possible just before
using your Neo-haler – try practicing in the mirror for the first few times. If you see a mist or spray
coming from the top of the Neo-haler or the sides of your mouth you should start again from step 2.

Remove the Neo-haler from your mouth and hold your breath for 10
seconds, or as long as possible. Breathe out slowly.

6. If more than one puff is required, wait at least one minute and repeat the procedure from step 2.
Replace the cap
Young children may need help and adult guidance to breathe in at the same time as the Neo-haler is
fired.
Older children, or people with weak hands - if you have difficulty in working the Neo-haler with one
hand as shown in the diagrams, use both hands. With all aerosols it is wise to test fire the Neo-haler
before using it for the first time and also if it has not been used for a while.
If you use more Belcomethasone Neo-haler than you should
If you have accidentally taken more than the recommended or prescribed dose, contact your nearest
hospital casualty department or tell your doctor or pharmacist immediately.
It is dangerous to exceed the recommended dose.
If you forget to use Belcomethasone Neo-haler
If you miss a dose do not worry, just take the next dose when it is due. Do not take a double dose to
make up for a forgotten dose.
If you stop using Belcomethasone Neo-haler
Do not stop using your Neo-haler even if you feel better. Speak to your doctor first. He/she will
advise you when to stop using your Neo-haler.

Common (between 1 in 10 and 1 in 100 people)
• sore throat or tongue
• hoarseness of voice
Brushing your teeth, or rinsing your mouth or gargling with water and spitting it out immediately after
each dose may help to prevent these side effects. Using a spacer device may also be helpful. If you
do experience these side effects, tell your doctor but do not stop treatment unless you are told to.
Uncommon (between 1 in 100 and 1 in 1,000 people)
• allergic reactions, including skin rashes or redness, itching or wheal like nettle rash or hives
Very rare (in less than 1 in 10,000 people):
• anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (mainly in
children).
• inhaled beclometasone dipropionate may affect the normal production of steroids in the body. This
is more likely to happen if high doses are being used over a long period of time. You may need to
take other steroids during periods of stress, illness and surgery.
• children and adolescents may grow more slowly than others especially if they are receiving
treatment over a long period of time. They will have their height checked regularly by their doctor.
• large amounts of steroid in the body (known as Cushing’s syndrome symptoms may include weight
gain around the body and face, excess sweating and thinning of the skin).
• thinning of the bones
• certain eye disorders (known as cataract and glaucoma).
Your doctor will help prevent these happening by prescribing the lowest dose of steroids at which
your asthma is well controlled.
If any of these 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 BECLOMETHASONE NEO-HALER
Keep out of the reach and sight of children.
o
Do not store above 30 C. Keep away from direct sunlight or heat. Protect from frost.
Do not puncture or burn the canister, even if it seems empty. Do not allow the canister to become
cold as this reduces the effect of the medicine.
Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the last day of
that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

Cleaning your Neo-haler
1. Clean your Neo-haler at least once a week as it can become blocked, which would stop it working
properly.
2. Remove the metal canister from the plastic body and then remove the plastic cap from the
mouthpiece.
3. Rinse the plastic body and mouthpiece cap in warm water. Avoid excessive heat and DO NOT put
the metal canister into water.
4. Dry thoroughly then replace the canister and mouthpiece cap.

6. FURTHER INFORMATION

If you have any further questions about this product ask your doctor or pharmacist.

Each Beclometasone Neo-haler contains at least 200 puffs of medicine.

4. POSSIBLE SIDE EFFECTS

Your medicine is available as 50, 100 and 250 micrograms.

Like all medicines, Beclomethasone Neo-haler can cause side effects, although not everybody gets
them. If you get any of the following symptoms after using your Neo-haler you should stop taking
this medicine and contact your doctor or pharmacist immediately:

Marketing Authorisation Holder and Manufacturer:
Fannin (UK) Limited, 42-46 Booth Drive, Park farm South, Wellingborough, Northamptonshire, NN8
6GT, UK
Manufacturer responsible for batch release:
Fannin (UK) Limited, 57 High Street, Odiham, Hants, RG29 1LF.

• severe allergic reactions, which can be sudden, including swelling of the face or throat, or
shortness of breath, difficulty in breathing, wheezing and skin rashes or redness.

What your Belcomethasone Neo-haler contains:
The active ingredient is beclometasone dipropionate. The other ingredients are oleic acid,
dichlorodifluoromethane and trichloroflucromethane.
What your Belcomethasone Neo-haler looks like and the contents of the pack:
Beclomethasone Neo-halers consist of an aluminium canister sealed with a metered valve, and held
in a plastic actuator fitted with a removable mouthpiece cover.

• swelling around the eyes, face, lips and throat.
Other side effects have also been reported:
Very common (seen in more than 1 in 10 people)

This leaflet was last approved in 08/2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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