POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL17901/0297, PL17901/0298.
Alvesco 40, 80 and 160 Inhaler
PACKAGE LEAFLET: INFORMATION FOR THE USER
Alvesco 40, 80 and 160 mcg Inhaler
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
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
1. WHAT ALVESCO IS AND WHAT IT IS USED FOR
What Alvesco is:
Alvesco is a clear and colourless 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.
The active ingredient in this medicine is ciclesonide. (For the other ingredients, see Section 6).
What Alvesco is used for:
This medicine is prescribed to control persistent asthma in adult and adolescent patients (12 years old and more).
It 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.
2. What you need to know before you use ALVESCO
Do not use Alvesco
if you are allergic (hypersensitive) to ciclesonide or any of the other ingredients of this medicine. (listed in section 6).
Take special care with 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.
Specific patient groups
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.
Other medicines and Alvesco
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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Using this medicine with food and drink
There is no interaction between Alvesco and food and drink.
Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant, want to become pregnant or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Alvesco and its ingredients have no or negligible effects on the ability to drive or to use machinery.
3. HOW TO USE ALVESCO
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much Alvesco should I take each day?
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.
When should I use my Alvesco inhaler?
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.
How do I use my Alvesco inhaler?
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 practise 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.
Follow these instructions carefully and use the pictures to guide you.
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 begin to feel wheezy or tightness in the chest after using your Alvesco inhaler:
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.
If you use more Alvesco than you should
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 forget to use Alvesco
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.
If you stop using Alvesco
Even if you feel better, you should not stop using your Alvesco inhaler.
If you do stop using this medicine, you must tell your doctor immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Alvesco 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.
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.
Reporting of side effects
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 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 ALVESCO
Keep 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 expose to temperatures 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.
6. Contents of the pack and other information
What Alvesco contains
What Alvesco looks like and contents of the pack
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.
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
This leaflet was last revised in 12/2016.
RSP 16 0094
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