Leaflet: information for the user

Alvesco 160 micrograms/inhalation, pressurized inhalation solution

Ciclesonide

Read the entire leaflet carefully before starting to use the medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

1. What isAlvescoand for what it is used

2. What you need to know before starting to useAlvesco

3. How to useAlvesco

4. Possible side effects

5. Storage ofAlvesco

6. Contents of the container and additional information

What is Alvesco?

Alvesco is a transparent and colorless aerosol to be inhaled through the mouth into the lungs. It is a preventive medication (corticosteroid) that must be taken daily and is only active when inhaled into the lungs.

The active substance in this medication is Ciclesonide (To consultother componentssee section 6).

What is Alvesco used for?

Alvesco is used to treat persistent asthma in adults and adolescents 12 years of age and older.

How does Alvesco work?

Alvesco helps you breathe better, reducing asthma symptoms and the likelihood of experiencing an asthma attack. The effect of the medication is enhanced over time, and for this reason, it must be taken daily, even when you feel well.

This medication is not suitable for asthma attacks. Use your rescue inhaler to quickly relieve these attacks.

No use Alvesco

if you are allergic to ciclesonide or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Alvesco.

Be especially careful with Alvesco

• Before starting treatment with this medication, inform your doctor if:you have received or are receiving treatment for pulmonary tuberculosis and fungal, viral, or bacterial infections.

Consult your doctor if you have any doubts. It is essential to ensure that Alvesco is the appropriate medication for you.

During treatment with Alvesco, visit your doctor immediately if:you experience:

• difficulty breathing and worsening of some symptoms: cough, asphyxia, wheezing, chest tightness, ronchi, or other symptoms of airway constriction. (You should use your rescue inhaler, which should provide a rapid improvement).
• if you wake up at night with symptoms.
• if you do not improve despite using the rescue inhaler.

Your doctor will decide on the continuation of treatment.

If you experience blurred vision or other visual problems, contact your doctor.

Special Patient Groups

Patients with severe asthmaare at risk of experiencing asthma attacks. For these patients, your doctor will regularly monitor your asthma and may perform a lung function test.

Patients taking oral corticosteroids:

Alvesco can be used to replace oral corticosteroids or to reduce the number of doses. Follow your doctor's instructions carefully.

• This situation can be achieved approximately 1 week after starting Alvesco inhalations.
• The number of tablets will be reduced gradually over a period of time.
• You may occasionally experience a general feeling of discomfort.
• It is essential to continue inhaling Alvesco and gradually reducing the number of tablets.
• If you experience severe symptoms such as nausea, vomiting, diarrhea, or fever, visit your doctor.
• This process may lead to minor allergic reactions such as rhinitis (nasal inflammation) or eczema (itching and skin redness).
• If you have changed your medication, you will be exposed to the risk of adrenal insufficiency for a period of time. This risk is related to the ingestion of oral corticosteroids. The symptoms of adrenal insufficiency (dizziness, fainting, nausea, loss of appetite, mood changes, hair loss, inability to cope with stress, weakness, headaches, memory problems, allergies, anxiety, and blood sugar disorders) may persist for a while.
• You may need to visit a specialist to determine the degree of reduction in adrenal function.
• Your doctor will also perform regular checks on your adrenal function.
• During periods of stress, such as surgical interventions or worsening of asthma attacks, you may need to take additional oral corticosteroids. If so, you should carry an identification card indicating this ingestion.

Patients with liver or kidney disorders

If you have liver or kidney disorders, no dose adjustment of ciclesonide is necessary.

If you have severe liver disorders, your doctor will examine you more closely to see if there are any secondary effects due to an alteration in the normal production of steroids.

Children under 12 years:

This medication is not recommended for children under 12 years due to a lack of information on its possible side effects.

Other medications and Alvesco

Inform your doctor before using Alvesco if you are receiving treatment for fungal or viral infections with medications containing:

• ketoconazole
• itraconazole
• ritonavir
• nelfinavir

These compounds may increase the effect of Alvesco, making it impossible to completely avoid the occurrence of side effects.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Use of Alvesco with food and drinks

Alvesco can be taken with or without food and drinks.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

• Your doctor will inform you of the risks and benefits of using Alvesco, as there is insufficient data on the effects of Alvesco on pregnant women.
• Alvesco can be used during pregnancy only when the potential benefits for the mother outweigh the possible risks for the fetus. If your doctor decides that you can continue using Alvesco, you should use the minimum dose of ciclesonide necessary to control your asthma.
• Children born to mothers treated during pregnancy with corticosteroids will be closely monitored for adrenal function.
• Consult your doctor if you want to use Alvesco during breastfeeding.
• The passage of ciclesonide through breast milk is unknown.
• The use of Alvesco in breastfeeding women will only be considered if the potential benefits for the mother outweigh the possible risks for the child.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No effects of Alvesco on driving and operating machinery are known.

Alvesco contains ethanol

This medication contains 4.7 mg of alcohol (ethanol) per dose. The amount in a dose of this medication is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medication has no perceptible effect.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much Alvesco should I use daily?

Your doctor will have informed you of the amount of medication you need to use daily. This amount will be established according to your needs.

If necessary, your doctor may prescribe oral corticosteroids or, in the case of any infection, an antibiotic.

• Your doctor will adjust your dose to the minimum necessary to control asthma.
• You should start noticing an improvement in symptoms (whistling when breathing, chest tightness, and cough) within 24 hours.

When should I use my Alvesco inhaler?

In most cases, in the morning or afternoon, in one or two inhalations once a day. Follow your doctor's instructions closely. It is essential to use Alvesco regularly every day, even when you feel better.

If you notice that you need to use your rescue inhaler more than two or three times a week, you should visit your doctor to review your treatment.

How do I use the Alvesco inhaler?

It is essential that a doctor, nurse, or pharmacist teaches you how to use the inhaler correctly for the first time. Good technique will ensure that the right amount of Alvesco reaches your lungs. Follow the instructions in this leaflet to remember how to use it.

It is a good idea to practice in front of a mirror the first two times until you are sure you are using the Alvesco inhaler correctly.Youmust ensure that no amount of medication is lost through the top or sides of the mouth.

If you have a new inhaler, or if you have not used your inhaler for a week or more,youmust test it before use. Remove the mouthpiece cover and, with the inhaler away, pressthreetimes on the cartridge inside the inhaler to releasethreedischarges into the air.

Youdo not need to shake the Alvesco inhaler before use. The medication is in a suitable solution that ensures the correct dose is received with each inhalation.

During inhalation, you can sit or stand.

Follow these instructions carefully and use the images to guide you.

1. Remove the mouthpiece cover and check the mouthpiece, both inside and out, to ensure it is clean and dry.

1. Hold the inhaler upside down (the cartridge base upwards) with your index finger on the cartridge base and your thumb under the mouthpiece.

1. Exhaleas much as possible from your lungs. Do not exhale into the inhaler.

1. Place the mouthpiece in your mouth and close your lipsfirmlyaround it.

5.Immediately after starting to inhale through your mouth, press with your index finger on the top of the inhaler to release a dose while continuing to inhale slowly and deeply. Be careful not to let any medication escape through the top or sides of your mouth.

1. Hold your breath, remove the inhaler from your mouth and your index finger from the top of the inhaler. Continue holding your breath for approximately 10 seconds or until you start to feel uncomfortable holding your breath. Breathe out slowly through your mouth, but do not exhale into the inhaler.

It is a good idea not to rush through steps 3 to 6.

7.If you have been instructed to release another dose,waitapproximately half a minute andrepeatsteps 3 to 6.

8.After use, always place the mouthpiece cover to prevent dust from entering. When you close it properly, you will hear a click, indicating that it has closed correctly.

9.For hygiene reasons

• Clean the mouthpiece weekly with a dry tissue, both inside and out.
• Use a dry tissue folded and clean the front of the small hole through which the medication is released.
• Youmust not use water or other liquids.

Good technique will ensure that the right amount of medication reaches your lungs every time you use the inhaler. Your doctor will check that you are using an adequate inhalation technique to ensure that the treatment can have its maximum effect.

When the cartridge is completely empty, you will not hear or feel the propellant gas discharge.

If you start to have difficulty breathing or feel chest tightness after using the Alvesco inhaler:

• do not release any more doses.
• use your rescue inhaler to help you breathe.
• inform your doctor immediately.

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

If you use more Alvesco than you should

It is essential to take your dose according to your doctor's instructions. You must not increase or decrease your dose without consulting your doctor.

No specific treatment is required in the case of using more Alvesco than you should, although you should inform your doctor. If you use high doses for long periods, it cannot be ruled out that some degree of adrenal function reduction may occur, and it may be necessary to monitor adrenal function.

If you forget to use Alvesco

If you forget to use the Alvesco inhaler, use the usual dose at the next scheduled time.Youmust not make a double dose of the usual dose.

If you interrupt treatment with Alvesco

Although you may feel better, you must not stop using your Alvesco inhaler.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Inform your doctor immediately if you stop using Alvesco.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

• Severe allergic reactions such as: swelling of the lips, tongue, and throat (may affect 1 in every 1,000 patients treated)
• Allergic reactions: skin rash, redness, itching, or hives (may affect up to 1 in 1,000 patients treated 1 in 100 patients)
• Coughing or hissing sound may worsen after inhalation (may affect 1 in every 100 patients treated)

The rest of the side effects observed with Alvesco are normally mild. In most cases, treatment can continue. The side effects you may experience are:

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

• hoarseness,
• burning, inflammation, irritation of the mouth or throat
• mouth ulcers (fungal infections in the oral cavity)
• headache
• bad taste in the mouth
• dryness of the mouth or throat
• nausea or vomiting

Rare side effects (may affect up to 1 in 10,000 patients treated):

• palpitations (sensation of heartbeats)
• abdominal discomfort or pain
• high blood pressure

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

• sleep disorders, depression, or feeling anxious, restless, nervous, over-excited, or irritable. These effects are more likely to occur in children
• blurred vision

Alvesco may affect the normal production of corticosteroids in your body. This is usually detected in patients taking high doses for a long period of time. Among these less common side effects are:

• delayed growth in adolescents
• bone density loss
• possible opacity of the crystalline lens (cataracts) causing blurred vision
• vision loss caused by excessively high intraocular pressure (glaucoma)
• moon face, weight gain in the trunk, and thinning of arms and legs (Cushing's syndrome).

Your doctor should regularly check the height of adolescents treated for a long period of time. If growth rate slows down, your doctor will adjust the treatment, if possible to the lowest dose capable of maintaining effective asthma control.

Inhaled corticosteroids like Alvesco may cause fewer side effects than oral corticosteroids. If you have taken oral corticosteroids before or during treatment with Alvesco, the risk of experiencing side effects related to taking this type of medication may persist for a while. If you have regular check-ups, your doctor should check if you are taking the right dose of Alvesco. During these consultations, side effects in an early stage can be identified and thus reduce the likelihood of them worsening.

Remember that:

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after EXP. The expiration date is the last day of the month indicated.

The container contains a pressurized liquid. Do not store at a temperature above 50°C.

Do not pierce, break, or burn the container, even if it appears to be empty.

Like all medications for inhalation in pressurized containers, the therapeutic effect of this medication may decrease if the container is cold. However, Alvesco delivers a constant dose in a temperature range from 10 °C below zero to 40 °C.

If your doctor decides to discontinue treatment or if the inhaler is empty, return it to the pharmacist for safe disposal. This is important because there may be residual medication in the container, even if it appears to be completely empty. Do not pierce, break, or burn the container, even if it appears to be empty.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Alvesco

• Theactive ingredientis ciclesonide. Each inhalation (dose released by the inhaler) contains 160 micrograms of ciclesonide.
• Theother components (excipients) areanhydrous ethanol and a propellant gas (HFA-134a, Norflurano).
• This medicine contains fluorinated greenhouse gases.

Alvesco160 micrograms 30 inhalations -Each inhaler contains 4.31 g of HFA-134a, which corresponds to 0.006 tonnes of CO2equivalent to (global warming potential GWP = 1430).

Alvesco160 micrograms 60 inhalations -Each inhaler contains 5.59 g of HFA-134a, which corresponds to 0.008 tonnes of CO2equivalent to (global warming potential GWP = 1430).

Alvesco160 micrograms 120 inhalations -Each inhaler contains 8.80 g of HFA-134a, which corresponds to 0.013 tonnes of CO2equivalent to (global warming potential GWP = 1430).

Appearance of Alvesco and contents of the package

Alvesco consists of a transparent and colourless liquid in an aluminium pressure container that releases a precise dose of ciclesonide in the form of an aerosol through the mouthpiece.

Package sizes:

Inhaler with30 inhalationsmeasured with precision

Inhaler with60 inhalationsmeasured with precision

Inhaler with120 inhalationsmeasured with precision

Each inhaler contains a sufficient dose for 30, 60 or 120 inhalations. Depending on the number of daily inhalations recommended by the doctor:

• The inhaler with 30 inhalations contains sufficient medication for four weeks.
• The inhaler with 60 inhalations contains sufficient medication for one or two months.
• The inhaler with 120 inhalations contains sufficient medication for two or four months.

Only some package sizes may be commercially available.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder

Covis Pharma Europe B.V.

Gustav Mahlerplein 2

1082 MA Amsterdam

Netherlands

Manufacturer:

Covis Pharma Europe B.V.

Gustav Mahlerplein 2

1082 MA Amsterdam

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

Paseo Club Deportivo 1, Edificio 4, Pozuelo de Alarcón 28223, Madrid

Spain

This medicine is authorised in other EU countries under the following names:

Austria	Alvesco 160, 80 Mikrogramm – Dosieraerosol
Bulgaria	Alvesco 160, 80 micrograms, pressurised inhalation, solution
Cyprus	Alvesco160, 80?mikrogramm?ria, ????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????< Країна реєстрації Spain Активна речовина Ciclesonida Потрібен рецепт Так Виробник Covis Pharma Europe B.V. 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