Patient leaflet - Respocort 100 mcg/actuation pressurised inhalation solution Autohaler
1. What Respocort Autohaler is and what it is used for
Respocort Autohaler contains beclometasone dipropionate which is one of a group of medicines known as corticocosteroids .
Respocort Autohaler is used to prevent the symptoms of mild, moderate, or severe asthma in patients children aged 5 and over, adolescents and adults who require regular treatment.
How your medicine works
- Beclometasone dipropionate pressurised inhalation solution works deep in your lungs to make breathing easier by reducing the inflammation, swelling and irritation in the airways. This type of medicine is known as a ‘preventer’. It needs to be taken regularly every day, even if you have no symptoms.
- This inhaler will not give immediate relief of wheezing or breathlessness during a sudden asthma attack. You will need to use a ‘reliever’ inhaler which contains a different medicine. You should still continue to use this inhaler.
2. What you need to know before you use Respocort Autohaler
Do not use Respocort Autohaler:
- if you are allergic to beclometasone dipropionate or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before using Respocort Autohaler:
- if you are suffering from tuberculosis (TB) now or have you suffered from it in the past
- if you are allergic to other similar inhalers
if you are suffering from a sudden attack of breathlessness. It will not help. Use a quick-acting
‘reliever’ inhaler for this purpose and carry it with you at all times.
- if your asthma seems to be getting worse. Perhaps you are more wheezy and short of breath than usual, your ‘reliever’ inhaler seems to be less effective, you require more puffs from your ‘reliever’ inhaler than usual, or you do not seem to be getting better. Your doctor may need to increase the dose of your steroid inhaler or give you a course of steroid tablets, or change your treatment altogether. If you have had an infection in your chest your doctor may prescribe a course of antibiotics.
- when transferring from steroid tablets to an inhaler you find that, even if your chest is getting better, you feel generally unwell, you develop a rash, eczema or a runny nose and sneezing (rhinitis). Do not stop treatment with your inhaler unless your doctor tells you to.
Important points to remember while you are using this medicine:
- Your doctor may prescribe this inhaler to replace steroid tablets, which may mean for a short time you have to take both medicines. It is important to follow your doctor’s advice. Whilst you are reducing the number of steroid tablets that you take you may feel generally unwell even though you can breathe as well as normal or better. If you have other allergies you may find that stopping your steroid tablets makes them worse. If this happens keep using your inhaler and tell your doctor.
- If you have been treated for a long time with high doses of inhaled steroid, you may require a course of steroid tablets or possibly a steroid injection in times of stress. For example, during admission to hospital after a serious accident, before an operation, during an acute attack of asthma or if you have a chest infection or other serious illness. Your doctor will decide if you need any extra steroid treatment and will also advise you as to how long you need to take the course of steroid tablets and how you should reduce these as you get better.
- There may be times when you need to take steroid tablets as well as using your inhaler, for example if you have worsening asthma attacks, you get a chest infection or you need an operation. Your doctor may give you a small supply of steroid tablets to be taken in these situations; if he/she does you will be given full instructions on how and when to take them. Contact your doctor immediately if you think that you need to take steroid tablets, even if you have your own supply.
- You should have been given a steroid card with this inhaler, if you have not, please ask your pharmacist for one. Make sure you carry your steroid card with you at all times until your doctor decides that it is no longer necessary.
- Visit your doctor regularly for a review of your condition.
- Contact your doctor if you experience blurred vision or other visual disturbances.
- If you have to go into hospital, remember to take all your inhalers and other medicines including those bought without a prescription with you.
Children and adolescents
Children or adolescents who are using the inhaler for a prolonged period may grow more slowly. Your doctor may therefore wish to monitor the height of a child receiving prolonged treatment with Respocort Autohaler.
Other medicines and Respocort Autohaler
Tell your doctor or pharmacist if you are taking/using or have recently taken/used or might take/use any other medicines obtained with or without prescription and/or inhalers either prescribed by a doctor or bought from a pharmacy.
In particular tell your doctor if you are taking:
- Disulfiram
- Metronidazole
o
- Some medicines may increase the effects of Respocort Autohaler and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Pregnancy and breast-feeding
- 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.
Respocort Autohaler contains ethanol
This medicine contains 4.74 mg of alcohol (ethanol) in each puff (actuation). The amount in each puff of this medicine is equivalent to less than 0.1 ml beer or 0.04 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
3. How to use Respocort Autohaler
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. .
This inhaler has a softer feel and a different taste than other inhalers you may have used before. This inhaler is an extra fine aerosol which results in more of each dose being delivered to your lungs. Your doctor may, therefore, prescribe a lower dose of this inhaler than your previously used inhaler.
Even when your doctor has prescribed a lower dose, you may find that the number of puffs you are asked to take from this inhaler is the same as from your previous inhaler; this is because this inhaler may be a lower strength product (which means that each puff of this inhaler contains less beclometasone dipropionate than your old inhaler).
Do not take more puffs than your doctor has told you to. In some circumstances, your doctor may prescribe more than the usual number of puffs. You should check with your doctor or pharmacist if you are not sure. The usual number of puffs to take is:
Adults, elderly and adolescentsover 12 years
Mild asthma
Respocort 100 Autohaler is not suitable for the starting dose. It is suitable for an increased dose of one puff twice a day.
Moderate asthma
The starting dose is one puff twice a day. This may be increased to two puffs twice a day. Severe asthmaThe starting dose is two puffs twice a day. This may be increased to four puffs twice a day.
The maximum dose is a total of eight puffs per day.
Children aged 5 years and over
Respocort 100 Autohaler is not suitable for the starting dose. It is suitable for an increased dose of one puff twice a day.
The starting dose is one puff from a similar inhaler delivering 50 micrograms beclometasone dipropionate/puff twice a day.
Children with well-controlled asthma on doses of up to 400 micrograms per day of other beclometasone dipropionate inhalers or equivalent may be titrated to a dose of 50-100 micrograms twice daily.
Respocort 100 Autohaler would not normally be recommended in this age group. However, during periods of deterioration in asthma control, the dose may be increased to 200 micrograms per day in two divided doses. The dose should be reduced to the minimum needed to maintain effective control of asthma.
What to do if you think your treatment is not working
If you think your usual treatment is not working, for example your symptoms are not getting better, or are getting worse, or you need to use more puffs from your reliever inhaler, or if your reliever inhaler does not seem to be working as well as usual, or your peak flow falls, please tell your doctor. Your asthma may be getting worse.
If you use more Respocort Autohaler than you should
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 accidentally take more puffs than recommended, please tell your doctor.
If you forget to use your inhaler
If you forget to use this inhaler at your usual time, take your recommended number of puffs as soon as you remember unless it is nearly time to use your inhaler again. DO NOT take a double dose to make up for a forgotten dose. Then continue to use your inhaler regularly at the correct time, as prescribed by your doctor.
If you think your usual treatment is not working, for example your symptoms are not getting better, or are getting worse, or you need to use more puffs from your reliever inhaler, or if your reliever inhaler does not seem to be working as well as usual, or your peak flow falls, please tell your doctor. Your asthma may be getting worse.
If you use more medicine than you should
If you accidentally take more puffs than recommended, please tell your doctor.
Ask your doctor for a prescription for a replacement inhaler before this one is empty.
Before use:
If this is a new device or if you have not used it for 2 weeks or more, it must be tested before use by releasing 2 puffs into the air in the following way:
- 1. Take the cover off from the mouthpiece, by pulling down on the lip at the back (fig. 1).
- 2. Point the mouthpiece away from you so that the puffs of medicine will go into the air. Push the lever up so that it stays up (fig. 2).
- 3. Then, to release a puff, push the dose release slide on the bottom of the device in the direction indicated by the arrow on it (fig. 3).
- 4. To release the second puff you need to return the lever to its down position (fig. 4) and follow steps 2 and 3 again.
After releasing the second puff, return the lever to its down position, to be ready to take a puff of your medicine.
How to use your Respocort Autohaler™ device
- 1. Take the cover off from the mouthpiece, by pulling down on the lip at the back.
- 2. Hold your Autohaler device upright as shown. Push the lever up so that it stays up. Continue to hold your device upright, making sure that your hand is not blocking the air vent (marked by X in fig. 2) at the bottom of the device.
- 3. Breathe out as far as is comfortable and then immediately place the mouthpiece in your mouth and close your lips around it.
- 4. Breathe in slowly and deeply through the mouthpiece. Do not stop breathing in when you hear the slight click and feel the puff in your mouth as it is important that you carry on breathing in after the puff is released.
- 5. Hold your breath for 10 seconds and then breathe out slowly.
- 6. The lever must be lowered to the down position after each puff. If your doctor has prescribed more than one puff, repeat steps 2 - 6. After use, replace the cover on the mouthpiece.
How to tell when your Respocort Autohaler device is empty
When the device is completely empty you will not feel or hear any propellant being discharged.
Cleaning instructions
For normal hygiene, the mouthpiece of your Autohaler device should be cleaned weekly with a clean, dry tissue or cloth. You should also rinse your mouth with water after using your inhaler. Caution
- Do not wash or put any part of your inhaler in water
- Do not push a drying cloth or anything else into any part of the Autohaler since it may cause damage to its operating parts.
- Do not take the Autohaler apart.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If immediately after taking a puff of this inhaler you feel wheezy or tight chested do not take any more puffs. Use your reliever inhaler to help your breathing and contact your doctor immediately.
Stop using your inhaler and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
- an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Treatment with Respocort Autohaler may affect the normal production of corticosteroids in the body, your doctor may take a blood sample from time to time to check on this.
Keep using your inhaler but see your doctor as soon as possible if you become unwell, particularly with any of the following:
- abdominal pain
- weakness
- vomiting
This is especially important if you have been exposed to other stress such as other illness, surgery or infection.
The following side effects may also occur in patients taking beclometasone dipropionate. If you experience any of these effects, keep using your inhaler but see your doctor if they last for a while or they are worrying you:
Common: may affect up to 1 in 10 people
- hoarseness
- difficulty in swallowing accompanied by earache and swollen glands, sore throat (pharyngitis)
- a sore mouth or thrush (white spots in your mouth and throat). These are less likely if you rinse your mouth out with water after using your inhaler. If you get thrush, your doctor may recommend a medicine to treat you
- change in taste
Uncommon: may affect up to 1 in 100 people
- feeling sick
- headache
- tremor (shaking)
- feeling dizzy or faint
- difficulty in breathing, increase in wheezing, shortness of breath and cough (bronchospasm)
- blurred vision
Very rare: may affect up to 1 in 10,000 people
- bone thinning
- clouding of the lens of the eye (cataract) resulting in blurred vision
- loss of vision due to abnormally high pressure in the eye may occur
The following may also occur, although the frequency is not known (cannot be estimated from the available data):
- sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to occur in children
Additional side effects in children and adolescents
Growth retardation, especially when using the inhaler in high doses for a prolonged period (see section 2).
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Respocort Autohaler
Keep this medicine out of sight and reach of children.
Do not store your inhaler above 25°C. Avoid storage in direct sunlight or heat. Protect from frost. You can use your inhaler at temperatures as low as -10°C.
The canister is pressurised and should not be punctured or burnt even if it seems empty. Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Respocort Autohaler contains:
- The active ingredient is beclometasone dipropionate.
The Respocort 100 Autohaler device delivers 100 micrograms of beclometasone dipropionate per puff
(actuation).
- The other ingredients are propellant HFA-134a and ethanol.
- The name of your medicine is Respocort 100 micrograms/actuation pressurised inhalation solution Autohaler This is its brand name, its common name is beclometasone dipropionate pressurised inhalation solution.
What Respocort Autohaler looks like and contents of the packs
- The Respocort Autohaler is a breath-actuated device with a pressurised canister fitted with a metering valve.
- Your inhaler contains 100 or 200 puffs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Kindeva Drug Delivery Limited
Loughborough LE11 5SF
United Kingdom
Manufacturer
Respocort Autohaler devices are made by the product licence holder; Kindeva Drug Delivery Limited, Loughborough, Leicestershire, LE11 5SF, United Kingdom.
This leaflet was last revised in November 2020.
For further information about asthma, contact the National Asthma Campaign, the independent UK charity working to conquer asthma:
National Asthma Campaign, Providence House, Providence Place, London N1 0NT. Asthma Helpline: 0345 010203 (Open Monday to Friday, 9am to 7pm. All calls charged at local rates.). Or visit the National Asthma Campaign’s web site - http://www.asthma.org.uk