Alvesco

Package leaflet: Information for the user

Alvesco 80 and 160 mcg pressurised inhalation solution

Ciclesonide
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Alvesco is and what it is used for
2. What you need to know before using 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 an aerosol, clear and colourless, contained in a pressurised inhalation spray for inhalation through the mouth into the lungs. It is a preventive medicine (corticosteroid) that must be taken daily and becomes active only after being inhaled into the lungs.

What Alvesco is used for:
Alvesco is used to treat persistent asthma in adults and adolescents (12 years of age and older).

How Alvesco works:
Alvesco helps you breathe more easily by reducing both asthma symptoms and the risk of asthma attacks. The effect develops over time, so you must use this medicine every day, even when you feel well.

This medicine must not be used during acute attacks of breathlessness. For immediate relief during such attacks, use only your usual reliever inhaler therapy

2. What you need to know before using Alvesco

Do not use Alvesco
if you are allergic to ciclesonide or to any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Alvesco.

• Before starting treatment with this medicine, speak with your doctor if:

you have been treated, or are currently being treated, for pulmonary tuberculosis (TB), or fungal,
viral, or bacterial infections.
If you are unsure, check with your doctor. It is important to ensure that Alvesco is the right medicine
for you.
During treatment with Alvesco, contact your doctor immediately if:

• your breathing becomes more difficult and your symptoms—cough, shortness of breath, wheezing, chest tightness, increased lung sounds (rattles), or other symptoms of bronchial obstruction—worsen (you need to use your usual treatment for acute attacks, which normally brings rapid improvement).
• you wake up at night due to the above-mentioned symptoms.
• you do not get relief from using your usual inhaled therapy for acute attacks. Your doctor will decide on alternative treatment.

If you experience blurred vision or other vision problems, consult your doctor.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may
lead to a positive anti-doping test.

Specific patient groups
Patients with severe asthma are at risk of acute attacks. For these patients, the doctor will carry out thorough and regular monitoring of asthma status, including lung function testing.
Patients already taking oral corticosteroid tablets:
Alvesco may be used to replace tablets or to reduce the number of tablets you need. Follow your doctor's instructions carefully.

• This process will begin approximately one week after you start Alvesco inhalations.
• The number of tablets you take will be gradually reduced over a period of time.
• During this period, you may feel generally unwell.
• Despite this, it is important to continue both Alvesco inhalations and the gradual reduction of oral tablets.
• If you experience severe symptoms such as nausea, vomiting, diarrhea, or high temperature, contact your doctor.
• This process may sometimes reveal minor allergies such as rhinitis (inflammation inside the nose) or eczema (itching, red skin).
• If you have switched from tablets, you will remain at risk for some time of reduced adrenal function, which is related to the corticosteroid tablets you previously took. Symptoms of reduced adrenal function (e.g., dizziness, weakness, nausea, loss of appetite, mood changes, reduced body hair, inability to cope with stress, fatigue, headache, memory problems, allergies, strong food cravings, blood sugar abnormalities) may also persist for some time.
• You may also need to consult a specialist to determine the extent of adrenal insufficiency.
• Your doctor should also arrange regular monitoring of adrenal function.
• During periods of stress—for example, if you need surgery or experience worsening asthma attacks—you may require additional oral corticosteroid tablets. In such cases, you should carry a steroid identification card indicating the need for additional steroid administration.

Patients with liver or kidney problems
No dose adjustment of ciclesonide is necessary if you have liver or kidney problems.
If you have severe liver problems, your doctor will monitor you more closely for possible adverse effects resulting from altered normal steroid production.

Children under 12 years:
This medicine is not indicated for children under 12 years of age due to lack of information on possible effects.

Other medicines and Alvesco
Before using Alvesco, inform your doctor if you are being treated for fungal or viral infections with medicines containing:

• ketoconazole,
• itraconazole,
• ritonavir,
• cobicistat,
• nelfinavir. These may enhance the effect of Alvesco, so the possibility of adverse effects cannot be completely ruled out. Your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat). Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Alvesco with food and drink
There are no interactions between Alvesco and food or drink.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Since there is insufficient information on the effects of Alvesco in pregnant women, your doctor will discuss the risks and benefits of using Alvesco with you.
• Ciclesonide (the active ingredient in Alvesco) may be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to fetal development. If your doctor decides you may continue using Alvesco, the lowest effective dose of ciclesonide needed to maintain adequate asthma control will be used.
• Adrenal function should be closely monitored in infants born to mothers who received corticosteroid therapy during pregnancy.
• Talk to your doctor if you wish to use Alvesco while breastfeeding.
• It is not known whether inhaled ciclesonide passes into human breast milk.
• Prescribing Alvesco to breastfeeding women should only be considered if the expected benefit to the mother outweighs the potential risk to the infant.

Driving and using machines
Alvesco and its ingredients have no effects or negligible effects on the ability to drive or operate machinery.

Alvesco contains ethanol
This medicine contains 4.7 mg of alcohol (ethanol) per dose. The amount in one dose of this
medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this
medicine will not produce significant effects.

3. How to use Alvesco

Always use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.

• If you have just started using this medicine instead of oral corticosteroid tablets, or in addition to them, see section 2, Patients who are already taking oral corticosteroid tablets.

How much Alvesco should I take each day?
Your doctor will have told you how much of this medicine you need to take each day. This depends on your individual needs.

• The recommended dose of Alvesco is 160 micrograms once daily, which provides asthma control in most patients.
• In some patients, a reduced dose of 80 micrograms once daily may be sufficient to maintain effective asthma control.
• A temporary increase in the dose of Alvesco may be necessary in patients experiencing a severe worsening of their asthma symptoms. This may increase up to 640 micrograms per day, administered as 320 micrograms twice daily; however, there are no data confirming additional therapeutic benefit beyond 3 months of treatment with these higher doses. If needed, your doctor may also prescribe oral corticosteroid tablets and/or, in case of infection, an antibiotic.
  • Your doctor will adjust the dose to the lowest level necessary to control your asthma.
  • You should start noticing an improvement in your symptoms (shortness of breath, chest tightness, and cough) within 24 hours.

When should I use my Alvesco inhaler?
In most cases, in the morning or evening – one or two sprays once daily. Follow your doctor’s instructions exactly. It is important that you take Alvesco regularly every day, even if you feel better.
If you find that you need your usual reliever inhaler more than 2–3 times a week, consult your doctor to review your treatment.

How should I use my Alvesco inhaler?
It is important that a doctor, nurse, or pharmacist initially shows you how to correctly use the Alvesco inhaler. Proper technique ensures that the right amount of medicine reaches your lungs. Use the instructions in this leaflet as a reminder.
For the first few times, you may practice in front of a mirror until you are confident you can use the Alvesco inhaler correctly. Make sure the medicine does not escape from the top or sides of your mouth.
If the inhaler is new or has not been used for one week or longer, check that it works before use. Remove the mouthpiece cap and press down three times on the canister inside the inhaler to release three test sprays into the air, away from yourself.

Do not shake the Alvesco inhaler before use. The medicine is already in a fine solution, properly mixed so that you receive the correct dose with each spray.

You may sit or stand while inhaling.

Follow these instructions carefully and use the illustrations as a guide.

1. Remove the mouthpiece cap and check inside and outside to ensure the mouthpiece is clean and dry.

2. Hold the inhaler upright (with the base of the canister at the top), with your index finger on top of the canister and your thumb on the base, below the mouthpiece.
3. Breathe out as much air as possible. Do not breathe out into the inhaler.

4. Place the mouthpiece in your mouth and close your lips tightly around it.
5. Immediately after starting to inhale through your mouth, press down on the top of the inhaler to release one spray of the medicine, continuing to inhale steadily and deeply. Make sure the spray does not escape from the top, bottom, or sides of your mouth.

6. Hold your breath, remove the inhaler mouthpiece from your mouth, and remove your index finger from the top of the inhaler. Continue holding your breath for about ten seconds, or as long as possible. Then breathe out slowly through your mouth. Avoid breathing out into the inhaler.

It is important not to rush steps 3 to 6.

7. If you have been instructed to take a second spray, wait about half a minute and then repeat steps 3 to 6.
8. After use, always replace the mouthpiece cap to protect it from dust. Press until you hear a click.

9. For hygiene reasons:
   • Clean the mouthpiece weekly with a dry cloth, both inside and outside.
   • Using a folded dry cloth, wipe the area around the small hole from which the medicine is released.
   • Do not use water or other liquids.

Proper technique ensures that the correct amount of Alvesco reaches your lungs each time you use the inhaler. Your doctor will regularly check your inhalation technique to ensure the treatment is as effective as possible. When the canister is completely empty, you will no longer feel or hear the propellant being released.

If you develop wheezing or chest tightness after using Alvesco:

• Do not take additional sprays.
• Use your usual reliever inhaler to improve breathing.
• Contact your doctor immediately.

If you have difficulty using the inhaler, your doctor may recommend using a spacer device. The spacer suitable for Alvesco is called AeroChamber Plus. If you use the AeroChamber Plus device, follow the instructions provided with it. Your doctor or pharmacist can advise you about this device.

If you use more Alvesco than you should
It is important that you take your dose exactly as prescribed by your doctor. Do not increase or reduce the dose without medical advice. If you have used too much Alvesco, no specific treatment is usually required, but you should inform your doctor. If high doses are used for prolonged periods, some degree of adrenal suppression cannot be ruled out, and monitoring of adrenal function may be necessary.

If you forget to use Alvesco
If you forget to use your Alvesco inhaler, simply take your next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

If you stop using Alvesco
Even if you feel better, do not stop treatment with the Alvesco inhaler. If you have any questions about using this medicine, consult your doctor or pharmacist.

If you stop treatment with this medicine, contact your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, stop using this medicine and contact your doctor immediately:

• severe allergic reactions such as swelling of the lips, tongue and throat (may affect up to 1 in 1,000 treated patients)
• allergic reactions: skin rash, redness, itching or skin inflammation such as eczema and urticaria (may affect up to 1 in 100 treated patients)
• cough or wheezing, worsening immediately after inhalation (may affect up to 1 in 100 treated patients)

Other side effects reported with Alvesco are generally mild. In most cases, treatment can be continued. The possible side effects are:

Uncommon side effects (may affect up to 1 in 100 treated patients):

• hoarseness
• burning, inflammation or irritation of the mouth or throat
• oral thrush (fungal infection of the mouth)
• headache
• unpleasant taste sensation
• dryness of the mouth or throat
• nausea or vomiting

Rare side effects (may affect up to 1 in 1,000 treated patients):

• awareness of heartbeat (palpitations)
• malaise or abdominal pain
• high blood pressure

Side effects with unknown frequency (could also occur):

• sleep problems, depression, feeling unwell, restlessness, nervousness, hyperexcitability or irritability. These effects may occur more easily in children
• blurred vision

Alvesco may interfere with the normal production of corticosteroids in the body. This effect usually occurs in patients taking high doses for long periods of time.
These effects may include:

• growth retardation in adolescents
• thinning of the bones
• possible clouding of the eye's lens (cataract), leading to blurred vision
• loss of vision caused by abnormally high pressure inside the eye (glaucoma)
• moon-shaped face, weight gain in the upper body with thinning of arms and legs (Cushingoid features or Cushing's syndrome)

Adolescents receiving long-term treatment should be regularly monitored by their doctor for height. If growth is slowed, the doctor will adjust the treatment, reducing the dose to the lowest level that still provides adequate asthma control, if possible. Oral corticosteroid tablets may cause more side effects than inhaled corticosteroids such as Alvesco. If you have taken steroid tablets before or concurrently with Alvesco, the risk of side effects from the tablets may persist for some time. Regular visits to your doctor will ensure that your Alvesco dose is appropriate. Regular check-ups also allow early detection of any side effects and reduce the likelihood of their worsening.

Remember:
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alvesco

Keep this medicine out of the sight and reach of children.
Do not use the inhaler after the expiry date stated on the label and the carton after EXP.
The expiry date refers to the last day of the stated month.
The dispenser contains a pressurized solution. Do not expose to temperatures above 50°C.
The container must not be punctured, broken, or burned, even if it appears to be empty.
As with most medicines in pressurized containers, the therapeutic effect of this medicine may decrease when the container is cold. However, Alvesco delivers the same dose from minus 10°C to plus 40°C.
If your doctor decides to discontinue your treatment or if the inhaler is empty, return it to the pharmacist for safe disposal. This is important because traces of medicine may remain in the container even if it appears to be empty.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Alvesco contains

• The active substance is ciclesonide. Each time the inhaler is pressed, a spray is generated (dose delivered through the mouthpiece) containing 80 or 160 micrograms of ciclesonide.
• The excipients are anhydrous ethanol and propellant (HFA-134a, norflurane).
• This medicinal product contains fluorinated greenhouse gases.

Alvesco 80 mcg, 30 doses – Each inhaler contains 4.32 g of HFA-134a, corresponding to
0.006 tonnes of CO₂ equivalent (global warming potential = 1430).
Alvesco 80 mcg, 60 doses – Each inhaler contains 5.60 g of HFA-134a, corresponding to
0.008 tonnes of CO₂ equivalent (global warming potential = 1430).
Alvesco 80 mcg, 120 doses – Each inhaler contains 8.82 g of HFA-134a, corresponding to
0.013 tonnes of CO₂ equivalent (global warming potential = 1430).
Alvesco 160 mcg, 30 doses – Each inhaler contains 4.31 g of HFA-134a, corresponding to
0.006 tonnes of CO₂ equivalent (global warming potential = 1430).
Alvesco 160 mcg, 60 doses – Each inhaler contains 5.59 g of HFA-134a, corresponding to
0.008 tonnes of CO₂ equivalent (global warming potential = 1430).
Alvesco 160 mcg, 120 doses – Each inhaler contains 8.80 g of HFA-134a, corresponding to
0.013 tonnes of CO₂ equivalent (global warming potential = 1430).

Description of the appearance of Alvesco and contents of the pack

Alvesco consists of a clear, colourless liquid in an aluminium pressurised container that delivers an accurately measured dose of ciclesonide as a spray through a mouthpiece.

Pack sizes:

Inhaler with 30 metered doses
Inhaler with 60 metered doses
Inhaler with 120 metered doses

For each dosage strength, the inhaler contains sufficient medicine for 30, 60 or 120 doses.
Depending on the number of sprays per day recommended by your doctor:

• The inhaler with 30 doses contains enough medicine for two to four weeks
• The inhaler with 60 doses contains enough medicine for one to two months
• The inhaler with 120 doses contains enough medicine for two to four months

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam
The Netherlands

Manufacturer
Covis Pharma Europe BV
Gustav Mahlerplein 2
1082 MA Amsterdam
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria Alvesco 160<80> Mikrogramm –Dosieraerosol
Bulgaria Alvesco 160<80> micrograms pressurised inhalation, solution
Cyprus Alvesco 160<80> μικρογραμμάρια, διάλυμα για εισπνοή υπό πίεση
Croatia Alvesco 160<80> mikrograma stlačeni inhalat otopina
Czech Republic Alvesco 160 mikrogramů/dávka roztok k inhalaci v tlakovém obalu
Denmark Alvesco 160<80> mikrogram, inhalationsspray, opløsning
Finland Alvesco 160<80> mikrog/annos inhalaatiosumute, liuos
France Alvesco 160<80> microgrammes/dose solution pour inhalation en flacon pressurisé
Germany Alvesco 160<80> Mikrogramm, Druckgasinhalation, Lösung
Greece Alvesco 80 και 160 μικρογραμμάρια, διάλυμα για εισπνοή υπό πίεση
Hungary Alvesco 160<80> mikrogramm túlnyomásos inhalációs oldat
Ireland Alvesco 160<80> micrograms pressurised inhalation solution
Italy Alvesco 160<80> mcg soluzione pressurizzata per inalazione
Latvia Alvesco 160<80> mikrogrami aerosols inhalācijām, zem spiediena, šķīdums
The Netherlands Alvesco 160<80> Inhalator, aërosol, oplossing 160, 80 microgram/dosis
Norway Alvesco 160<80> micrograms/dose inhalasjonsaerosol, oppløsning
Poland Alvesco 160<80> μg/dawkę inhalacyjną; aerozol inhalacyjny, roztwór
Romania Alvesco 160<80> Inhaler, solutie de inhalat presurizata 160 micrograme / doza
Slovakia Alvesco 160<80> Inhalátor inhalačný roztok v tlakovom obale
Slovenia Alvesco 160<80> mikrogramov/odmerek inhalacijska raztopina pod tlakom
Spain Alvesco160 microgramos/ inhalación solución para inhalación en envase a presión
Sweden Alvesco 160<80> microgram/dos inhalationsspray, lösning
United Kingdom (Northern Ireland) Alvesco 160<80> Inhaler

This leaflet was last updated on