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The product code(s) for this leaflet is: PL 53266/0005.
Alvesco inhaler 80mcg and 160mcg
Alvesco®
Alvesco 80 and 160 mcg Inhaler
Ciclesonide
1. What Alvesco is and what it is used for
2. What you need to know before you use Alvesco
3. How to use Alvesco
4. Possible side effects
5. How to store Alvesco
6. Contents of the pack and other information
Alvesco is a clear and colorless aerosol spray for you to breathe in through your mouth and into your lungs. It is a Preventer medication (corticosteroid) that has to be taken every day and which becomes active only after it has been inhaled into your lungs.
Alvesco is used to treat persistent asthma in adult and adolescent patients (12 years old and more).
Alvesco helps you to breathe more easily by decreasing the symptoms of your asthma and by lessening the chances of an asthma attack. The effect builds up over a period of time, so this medicine needs to be taken every day, even when you are feeling well.
This medicine is not suitable for use in an acute attack of breathlessness. For quick relief from such an attack, use only your Reliever inhaler.
if you are allergic to ciclesonide or any of the other ingredients of this medicine. (listed in section 6).
Talk to your doctor or pharmacist before using Alvesco.
Check with your doctor if you are not sure. It is important to make sure that Alvesco is the right medicine for you.
During your treatment with Alvesco contact your doctor immediately if:
(You should use your Reliever inhaler which will normally lead quickly to an improvement.)
Your doctor will decide on your further treatment.
Contact your doctor if you experience blurred vision or other visual disturbances.
Patients with severe asthma are at risk of acute asthma attacks. For such patients the doctor will carry out regular thorough asthma control checks, including a lung function test.
Patients who are already taking corticosteroid tablets:
Alvesco can be used to replace your tablets, or to reduce the number of tablets you need to take. Please follow your doctor’s instructions carefully.
Patients with liver or kidney disorders
There is no need to adjust the dose of ciclesonide if you have liver or kidney problems. If you suffer from a severe liver condition, your doctor will check you more carefully for possible side effects resulting from disturbance of normal steroid production.
Children below 12 years of age:
This medicine is not recommended for children below the age of 12 because of a lack of information about its possible effects.
Please inform your doctor before using Alvesco, if you are currently being treated for any fungal or viral infections with medicine containing:
These may intensify the action of Alvesco so that the probability of side effects cannot be completely ruled out.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There is no interaction between Alvesco and food and drink.
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 taking this medicine.
Alvesco and its ingredients have no or negligible effects on the ability to drive or to use machinery.
This medicine contains 4.7 mg of alcohol (ethanol) in each dose. The amount in a dose of this medicine is equivalent to less than 1 ml beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will have spoken to you about how much of your medicine you need to take each day. This will depend on your individual need.
If necessary, your doctor may also prescribe corticosteroid tablets and/or, in the case of an infection, an antibiotic.
In most cases, either in the morning or in the evening – as one or two puffs once a day. Follow your doctor’s instructions very carefully. It is important that you take Alvesco regularly every day, even if you feel better.
If you find that you have to use your Reliever inhaler more than 2‑3 times a week, you should contact your doctor to have your medicine reviewed.
It is important that a doctor, nurse or pharmacist shows you first how to use your Alvesco inhaler properly. A good technique will make sure you are receiving the correct amount into your lungs. Please use the instructions in this leaflet as a reminder.
You may wish to practice in front of the mirror for the first couple of times until you are confident that you are using your Alvesco inhaler properly. Make sure that none of your medicine is escaping from the top or sides of your mouth.
If you have a new inhaler, or if you have not used your inhaler for a week or more, it must be tested before you use it. Remove the mouthpiece cover and press down three times on the canister inside the inhaler to release three puffs into the air - away from you.
You do not need to shake your Alvesco inhaler before using it. The medicine is already in a very fine solution, mixed to ensure you receive the correct dose with each puff.
During inhalation, you can either be sitting down or standing up.
1. Remove the mouthpiece cover and check the mouthpiece, both the inside and the outside, to make sure that it is both clean and dry.
2. Hold the inhaler upside down (base of the canister at the top) with your forefinger on the base of the canister and your thumb under the mouthpiece.
3. Breathe out as far as is comfortable.
Do not breathe out through the inhaler.
4. Place the mouthpiece in your mouth and close your lips firmly around it.
5. Just after starting to breathe in through your mouth, press down with your forefinger on the top of the inhaler to release a puff of the medicine while you are still breathing in slowly and deeply. Please take care that the puff of medicine does not escape through the top, bottom or sides of your mouth.
6. Hold your breath, take the inhaler from your mouth and remove your finger from the top of the inhaler. Continue holding your breath for about ten seconds or as long as is comfortable. Breathe out slowly through your mouth. Do not breathe out through the inhaler.
It is important that you do not rush steps 3 to 6.
7. If you have been instructed to take another puff, wait about half a minute and repeat steps 3 to 6.
8. After use, always replace the mouthpiece cover to keep out dust. Replace firmly and snap into position.
9. For hygiene reasons
A correct technique will ensure the right amount of Alvesco is getting into your lungs every time you use your inhaler. Your doctor will check your inhalation technique regularly to ensure that your treatment can have the very best effect.
When the canister is completely empty you will not feel or hear any of the propellant being discharged.
If you find it difficult to use the inhaler, your doctor may recommend the use of a spacer. The spacer that fits the Alvesco inhaler is called AeroChamber PlusTM. If you use the AeroChamber PlusTM device, please follow the instructions provided with it. Your doctor or pharmacist will be able to advise you about the device.
It is important that you take your dose as advised by your doctor. You should not increase or decrease your dose without seeking medical advice.
There is no specific treatment necessary if you have used too much Alvesco but you should inform your doctor. If high doses are used over long periods, a certain degree of reduction in adrenal function cannot be ruled out and control of the adrenal function may be necessary.
If you have forgotten to use your Alvesco, just take your usual dose when it is next due. Do not take a double number of puffs to make up for the forgotten dose.
Even if you feel better, you should not stop using your Alvesco inhaler.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you do stop using this medicine, you must tell your doctor immediately.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop using this medicine and talk to your doctor straight away:
The other side effects seen with Alvesco are usually mild. In most cases you can continue with your treatment. The side effects you may experience are:
Uncommon side effects (may affect up to 1 in 100 patients treated):
Rare side effects (may affect up to 1 in 1,000 patients treated):
Frequency not known, but may also occur:
Alvesco may affect the normal production of corticosteroids in your body. This is usually seen in patients taking high doses over a long period of time. These effects may include:
Adolescents who are receiving treatment for a long period of time should have their height checked regularly by their doctor. If your growth rate is slowed, your doctor will adjust your treatment if possible to the lowest dose at which effective control of asthma is maintained.
Corticosteroid tablets can lead to more side effects than a corticosteroid inhaler such as Alvesco. If you have been taking steroid tablets before or during the use of Alvesco, the risk of side effects from the tablets may continue for a period of time. Regular check-ups with your doctor will ensure that you are taking the right dose of Alvesco for you. Regular check-ups will also identify any side effects early on and reduce the chances of them worsening.
Please remember:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use your inhaler after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
The container contains a pressurised liquid. Do not store above 50°C.
The container should not be punctured, broken or burned even if it seems empty. As with most inhaled medicines in pressurised containers, the healing effect of this medicinal product may become smaller when the container is cold. However, Alvesco delivers the same level of dose from minus 10°C to plus 40°C.
If your doctor decides to stop treatment or if the inhaler is empty, return it to your pharmacist for safe disposal. This is important as traces of medicine could remain in the container even if you have the impression that it might be empty.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Alvesco 80 Inhaler, 30 puffs - Each inhaler contains 4.32 g of HFA-134a, corresponding to 0.006 tonne CO2 equivalent (global warming potential GWP = 1430).
Alvesco 80 Inhaler, 60 puffs - Each inhaler contains 5.60 g of HFA-134a, corresponding to 0.008 tonne CO2 equivalent (global warming potential GWP = 1430).
Alvesco 80 Inhaler, 120 puffs - Each inhaler contains 8.82 g of HFA-134a, corresponding to 0.013 tonne CO2 equivalent (global warming potential GWP = 1430).
Alvesco 160 Inhaler, 30 puffs - Each inhaler contains 4.31 g of HFA-134a, corresponding to 0.006 tonne CO2 equivalent (global warming potential GWP = 1430).
Alvesco 160 Inhaler, 60 puffs - Each inhaler contains 5.59 g of HFA-134a, corresponding to 0.008 tonne CO2 equivalent (global warming potential GWP = 1430).
Alvesco 160 Inhaler, 120 puffs - Each inhaler contains 8.80 g of HFA-134a, corresponding to 0.013 tonne CO2 equivalent (global warming potential GWP = 1430).
Alvesco consists of a clear and colourless liquid in a pressurised aluminium container which delivers through a mouthpiece an accurately measured dose of ciclesonide in the form of a spray.
Pack sizes:
Inhaler with 30 accurately measured puffs.
Inhaler with 60 accurately measured puffs.
Inhaler with 120 accurately measured puffs.
Each strength of inhaler contains enough for 30, 60 or 120 puffs. Depending on the number of puffs per day your physician has recommended you to use:
Not all pack sizes may be marketed in all countries.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 11/2024.