Alvesco 160

Leaflet accompanying the packaging: information for the user

Alvesco 80, 80 μg/inhalation dose; inhalation aerosol, solution

Alvesco 160, 160 μg/inhalation dose; inhalation aerosol, solution

Ciclesonide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Alvesco and what is it used for
• 2. Important information before using Alvesco
• 3. How to use Alvesco
• 4. Possible side effects
• 5. How to store Alvesco
• 6. Contents of the packaging and other information

1. What is Alvesco and what is it used for

What is Alvesco:

Alvesco is a clear and colorless inhalation aerosol for inhalation through the mouth into the lungs. It is a preventive medicine (corticosteroid) that should be used daily and its effect occurs only after it has been inhaled into the lungs.

What is Alvesco used for:

Alvesco is used to treat chronic asthma in adult and adolescent patients (12 years and older).

How Alvesco works

Alvesco helps to make breathing easier by reducing the severity of asthma symptoms and reducing the likelihood of an asthma attack. The effect of the medicine increases over time, so the medicine should be taken daily, even if the patient feels better.
This medicine is not suitable for use during an acute asthma attack. To quickly relieve such an attack, only a bronchodilator inhaler should be used.

2. Important information before using Alvesco

When not to use Alvesco

• if the patient is allergic to ciclesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Alvesco, the patient should discuss it with their doctor.
Before startingtreatment with this medicine, the patient should inform their doctor if they have ever been treated for or are currently being treated for tuberculosis, fungal, viral, or bacterial infections.

• if the patient has ever been treated for or is currently being treated for tuberculosis, fungal, viral, or bacterial infections.

In case of doubt, the patient should contact their doctor. It is important to make sure that Alvesco is suitable for the patient.
The patient should immediatelycontact their doctor if, while using Alvesco, they experience:

• difficulty breathing and worsening symptoms, such as coughing, shortness of breath, wheezing, feeling of pressure in the chest, increased wheezing, or other symptoms of bronchospasm. (A bronchodilator inhaler should be used, which usually leads to rapid improvement).
• asthma symptoms that wake them up from sleep.
• no improvement after using a bronchodilator inhaler. The doctor will determine further treatment for the patient.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Special patient groups

In patients with severe asthmathere is a risk of acute asthma attacks. In this group of patients, the doctor will regularly perform thorough examinations to assess asthma control, including lung function tests.
Patients who are already taking corticosteroids in tablets:
Alvesco may be used instead of tablets or to reduce the number of tablets needed. The patient should follow the doctor's instructions exactly.

• The switch will start about a week after starting to use the Alvesco inhaler.
• The number of tablets taken will be gradually reduced over a period of time.
• During this time, the patient may sometimes feel unwell.
• Despite this, it is essential to continue the Alvesco inhaler treatment and gradually reduce the number of tablets taken.
• If severe symptoms occur, such as nausea, vomiting, diarrhea, or high fever, the patient should contact their doctor.
• Switching from tablets to inhalation may sometimes cause mild allergic reactions, such as nasal congestion or rash (itchy redness of the skin).
• After switching from tablets to inhalation, the patient may be at risk of reduced adrenal function for a while, related to the corticosteroids previously taken in tablet form. Symptoms of reduced adrenal function (such as dizziness, fainting, nausea, loss of appetite, mood changes, hair loss, reduced resistance to stress, weakness, headaches, memory disorders, allergies, increased appetite, and changes in blood sugar levels) may also persist for a while.
• It may also be necessary to consult a specialist to determine the degree of reduced adrenal function.
• Adrenal function will be regularly monitored by the doctor.
• In stressful situations, such as during surgery, worsening of asthma attacks, additional corticosteroid tablets may be needed. Therefore, the patient should carry a steroid warning cardwith this information.

Patient with liver or kidney disease
No dose adjustment of ciclesonide is necessary in patients with liver or kidney disease. If the patient has severe liver disease, the doctor will carefully assess the risk of side effects related to impaired steroid production.
Childrenunder 12 years of age
This medicine is not recommended for use in children under 12years of age, as there is no information on its effects in this age group.

Alvesco and other medicines

Before using Alvesco, the patient should inform their doctor if they are currently being treated for any fungal or viral infections with a medicine containing:

• ketokonazole,
• itraconazole,
• ritonavir,
• nelfinavir. These medicines may enhance the effect of Alvesco, so it is not possible to completely rule out the possibility of side effects.

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and any medicines they plan to take.

Alvesco with food and drink

No interactions have been found between the use of Alvesco and food or drink .

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.

• Because there is not enough information on the use of Alvesco in pregnant women, the doctor will discuss the risks and benefits of using Alvesco with the patient.
• Ciclesonide (the active substance of Alvesco) may be used during pregnancy only if the potential benefits to the mother outweigh the potential risk to the fetus. If the doctor decides that the patient can continue to use Alvesco, the smallest possible dose of ciclesonide will be used to maintain control of asthma.
• Adrenal function will be carefully monitored in children whose mothers received corticosteroids during pregnancy.
• If the patient plans to use Alvesco while breastfeeding, they should discuss this with their doctor.
• It is not known whether inhaled ciclesonide passes into breast milk.
• Prescribing Alvesco to breastfeeding women will only be considered if the expected benefits to the mother outweigh the potential risk to the baby. .

Driving and using machines

Alvesco and its ingredients do not affect or have a negligible effect on the ability to drive or operate machinery.
Alvesco contains ethanolThis medicine contains 4.7 mg of alcohol (ethanol) per dose . The amount of alcohol in each 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 have noticeable effects.

3. How to use Alvesco

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

• If the patient has started using this medicine instead of corticosteroids in tablets or together with corticosteroids in tablets, see section 2 Patients who are already taking corticosteroids in tablets.

What dose of Alvesco should be used each day?

The doctor will tell the patient what dose of Alvesco to use each day. This will depend on the individual needs of the patient.

• The recommended dose of Alvesco is 160 micrograms once a day and this is the dose that controls asthma symptoms in most patients.
• In some patients, a reduced dose of 80 micrograms once a day may be an effective maintenance dose to control asthma.
• In patients with severe worsening of asthma symptoms, it may be necessary to increase the dose of Alvesco for a period to 640 micrograms per day taken in doses of 320 micrograms twice a day, however, there are no data to support additional therapeutic effect after 3 months of using higher doses.

If necessary, the doctor may also prescribe corticosteroids in tablets and/or antibiotics in case of infection.

• The doctor will adjust the dose to the minimum dose necessary to control the patient's asthma.
• Improvement in symptoms (wheezing, feeling of pressure in the chest, and coughing) should be noticeable within 24 hours.

When to use the Alvesco inhaler?

In most cases, eitherin the morning orin the evening – one or two doses once a day. The patient should follow the doctor's instructions exactly. It is essential to use Alvesco regularly every day, even if the patient feels better.
If the patient finds that they need to use a bronchodilator inhaler more often than 2-3 times a week, they should contact their doctor, who will reassess the treatment.

How to use the Alvesco inhaler?

It is essential that the doctor, nurse, or pharmacist shows the patient how to use the Alvesco inhaler correctly for the first time. Good technique will ensure that the correct dose of medicine is delivered to the lungs. The instructions in this leaflet should be used as a reminder.
To ensure that the patient uses the Alvesco inhaler correctly, it may be necessary to perform a few initial applications in front of a mirror. The patient should make sure that the medicine does not come out of the mouth.

• 4. Insert the mouthpiece into the mouth and close the lips, tightlysurrounding the mouthpiece.
• 5. Just after starting to inhale through the mouth, press the top of the inhaler with the index finger to release a dose of medicine, while performing a slow and deep inhalation. The patient should be careful not to let the dose of medicine escape through the top, bottom, or sides of the mouth.

• 6. Hold the breath, remove the inhaler from the mouth, and release the index finger from the top of the inhaler. Continue to hold the breath for about ten seconds or as long as possible. Perform a slow exhalation through the mouth. The patient should avoid blowing into the inhaler.

It is essential not to rush when performing the actions described in points 3 to 6.

• 7. If a second dose is prescribed, the patient should waitfor about half a minute and repeatsteps 3 to 6.
• 8. After use, the patient should always replace the mouthpiece cover to prevent dust from entering. The cover should be pushed firmly and clicked into place.
• 9. For hygiene reasons
• the inner and outer surfaces of the mouthpiece should be cleaned weeklywith a drytissue.
• the front of the small hole through which the medicine is released should be wiped with a dryfolded tissue.
• do notuse water or other liquids.

Proper technique will ensure that the correct dose of Alvesco is delivered to the lungs during each use of the inhaler. The doctor will regularly check the patient's inhalation technique to ensure the best treatment effect.
After the container is completely empty, the release of the medicine will stop being heard and felt.

If, after using the Alvesco inhaler, the patient experiences wheezing or a feeling of pressure in the chest:

• do nottake additional doses.

Nozzle
of the inhaler

• use a bronchodilator inhaler to facilitate breathing.
• contact the doctor immediately.

If using the inhaler is difficult for the patient, the doctor may recommend using a spacer. The spacer that fits the Alvesco inhaler is called the AeroChamber Plus . When using the AeroChamber Plus device, the patient should follow the instructions provided with it. The doctor or pharmacist will advise on the use of this device.

Using a higher dose of Alvesco than recommended

It is essential to take the dose of Alvesco as prescribed by the doctor.
The patient should not increase or decrease the dose of the medicine without consulting their doctor.
In case of overdose, there is no need for special treatment, but the patient should inform their doctor. When using high doses for an extended period, it is not possible to rule out the risk of reduced adrenal function, and it may be necessary to monitor adrenal function.

Missing a dose of Alvesco

If the patient forgets to use Alvesco, they should take the next dose at the scheduled time. Do nottake a double dose to make up for the missed dose.

Stopping the use of Alvesco

The patient should not stop using the Alvesco inhaler, even if they feel better. If they have any further questions about the use of this medicine, they should ask their doctor or pharmacist.

In case of stopping the use of this medicine, the patient should immediately inform their doctor.

4. Possible side effects

Like all medicines, Alvesco can cause side effects, although not everybody gets them.
The patient should stop using the medicine and contact their doctor immediately if they experience any of the following serious side effects:

• severe allergic reactions, such as swelling of the mouth, tongue, and throat (may occur in less than 1 in 1,000 patients),
• allergic reactions: skin rash, redness, itching, or hives (may occur in less than 1 in 100 patients),
• cough or wheezing worsening after inhalation (may occur in less than 1 in 100 patients).

Other side effects that may occur when using Alvesco are usually mild.
In most cases, the patient can continue treatment. Side effects that may occur include:

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

Rare side effects (may occur in less than 1 in 1,000 patients):

• heart palpitations (palpitations)
• discomfort or abdominal pain
• high blood pressure.

Side effects with unknown frequency, but which may also occur:

• sleep disturbances, depression, or feelings of anxiety, nervousness, agitation, or irritability. The occurrence of these effects is more likely in children.
• Blurred vision

Alvesco may have a negative effect on the body's production of corticosteroids. This usually applies to patients taking high doses for a long time.
Side effects that may occur include:

• slowing down of growth in adolescents
• thinning of bones
• possible cataract (causing blurred vision)
• vision loss due to high pressure in the eye (glaucoma)
• moon-shaped face, increased weight in the upper body, and thinning of the arms and legs (Cushing's syndrome). The doctor will regularly monitor the growth of adolescents receiving long-term treatment. If growth slows down, the doctor will adjust the dose to the smallest dose that maintains effective control of asthma, if possible.

Corticosteroids in tablets may cause more side effects than inhaled corticosteroids, such as Alvesco. In patients who have taken steroid tablets before or during the use of Alvesco, the risk of side effects related to the use of tablets may persist for a while. Regular medical check-ups will ensure that the patient is taking the correct dose of Alvesco. Regular check-ups will also allow for early detection of any side effects and reduce the likelihood of their severity.
The patient should remember that:

If any of the side effects get worse, or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Alvesco

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after “EXP”. The expiry date refers to the last day of the month stated.

The container contains a pressurized solution. Do not store above 50°C.

Do not pierce, damage, or burn the container, even if it seems empty.
Like most pressurized inhalers, the effectiveness of this medicine may be lower if the container is cold. However, the Alvesco inhaler releases the same doses of medicine at temperatures from -10°C to 40°C.
If the doctor decides to stop treatment or if the inhaler is empty, the patient should return it to the pharmacy for safe disposal. This is important because there may be residual amounts of medicine in the container, even if it seems empty.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Alvesco contains:

• The active substance of Alvesco is ciclesonide. Each dose (delivered through the mouthpiece of the inhaler) contains 80 or 160 micrograms of ciclesonide.
• The other ingredients are: anhydrous ethanol and propellant gas (HFA-134a, norflurane).
• This medicine contains fluorinated greenhouse gases.

Alvesco 80 μg, 60 inhalation doses - Each inhaler contains 5.60 g of HFA-134a, which corresponds to

• 0.008 tons of CO2 equivalent (global warming potential GWP = 1430). Alvesco 80 μg, 120 inhalation doses - Each inhaler contains 8.82 g of HFA-134a, which corresponds to
• 0.013 tons of CO2 equivalent (global warming potential GWP = 1430).

Alvesco 160 μg, 60 inhalation doses - Each inhaler contains 5.59 g of HFA-134a, which corresponds to

• 0.008 tons of CO2 equivalent (global warming potential GWP = 1430). Alvesco 160 μg, 120 inhalation doses - Each inhaler contains 8.80 g of HFA-134a, which corresponds to
• 0.013 tons of CO2 equivalent (global warming potential GWP = 1430).

What Alvesco looks like and contents of the pack

Alvesco is a clear and colorless liquid in a pressurized aluminum container that delivers a precise dose of ciclesonide in the form of an aerosol.
The aluminum container with a metering valve, equipped with a mouthpiece and a HDPE cap, is in a carton box.

Pack sizes:

An inhaler containing 60precisely measured inhalation doses.
An inhaler containing 120precisely measured inhalation doses.
Inhalers of different strengths contain enough medicine for 60 or 120 inhalations. Depending on the number of doses per day, the doctor may recommend using:

• an inhaler with 60 doses, which contains enough medicine for one to two months
• an inhaler with 120 doses, which contains enough medicine for two to four months.

Marketing authorization holder and manufacturer

Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082MA Amsterdam
Netherlands

Manufacturer

Marketing authorization holder

Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082MA Amsterdam
Netherlands

This medicinal product is authorized 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/dosis, inhalationsspray, opløsning
Finland
Alvesco 160, 80 mikrog/annos inhalaatiosumute, liuos
France
Alvesco 160, 80 microgrammes/dose, solution pour inhalation en flacon pressurisé
Greece
Alvesco 160, 80 μιρογραμμάρια, διάλυμα για εισπνοή υπό πίεση
Spain
Alvesco 160 microgramos/inhalación solución para inhalación en envase a presión
Netherlands
Alvesco 160, 80 Inhalator, aërosol, oplossing 160, 80 microgram/dosis
Ireland
Alvesco 160, 80 micrograms pressurised inhalation solution
Latvia
Alvesco 160, 80 mikrogrami aerosols inhalācijām, zem spiediena, šķīdums
Germany
Alvesco 160, 80 Mikrogramm, Druckgasinhalation, Lösung
Norway
Alvesco 160, 80 mikrogram/mikrogram inhalasjonsaerosol,
Poland
Alvesco 160, 80 160, 80 μg/dawkę inhalacyjną; aerozol inhalacyjny, roztwór
Romania
Alvesco 160, 80 Inhaler, 160, 80 micrograme/doză a, solutie de inhalat presurizată a 160 micrograme / doza
Slovakia
Alvesco 160, 80 Inhalátor inhalačný roztok v tlakovom obale
Slovenia
Alvesco 160, 80 mikrogramov/odmerek inhalacijska raztopina pod tlakom
Sweden
Alvesco 160, 80 microgram/dos inhalationsspray, lösning
Hungary
Alvesco 160, 80 mikrogramm túlnyomásos inhalációs oldat
Northern Ireland Alvesco 160, 80 Inhaler
Italy
Alvesco 160, 80 mcg soluzione pressurizzata per inalazione

Date of last revision of the leaflet: 12/2024