Alvesco 80

Package leaflet: Information for the user

Alvesco 80, 80 μg/inhalation; inhalation aerosol, solution
Alvesco 160, 160 μg/inhalation; inhalation aerosol, solution
Ciclesonide
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

1. What Alvesco is and what it is 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 pack and other information

1. What Alvesco is and what it is used for
What Alvesco is:
Alvesco is a clear, colourless inhalation aerosol intended for inhalation through the mouth into the lungs. It is a preventive medicine (a corticosteroid) that must be used daily and only exerts its effect after inhalation into the lungs.
What Alvesco is used for:
Alvesco is used for the treatment of chronic asthma in adult patients and adolescents (aged 12 years and older).
How Alvesco works:
Alvesco helps make breathing easier by reducing the severity of asthma symptoms and decreasing the likelihood of asthma attacks. Its effect builds gradually over time; therefore, the medicine should be taken daily, even when the patient feels well.
This medicine is not suitable for use during an acute asthma attack. To quickly relieve such an attack, only a reliever inhaler medicine should be used.

2. Important information before using Alvesco

When not to use Alvesco

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

Warnings and precautions
Before starting treatment with Alvesco, please discuss it with your doctor.
Before starting treatment with this medicine, inform your doctor if:

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

If in doubt, please contact your doctor. It is important to ensure that Alvesco is appropriate for the individual patient.
You must contact your doctor immediately if, while using Alvesco, the patient:

• experiences worsening breathing difficulties and increased symptoms such as cough, shortness of breath, wheezing, chest tightness, increased adventitious sounds (coarse crackles), or other signs of airway narrowing. (Use a reliever inhaler medicine, which usually leads to rapid improvement).
• wakes up at night due to asthma symptoms.
• does not improve after using a reliever inhaler medicine. The doctor will then determine further treatment.

If blurred vision or other visual disturbances occur, consult a doctor.
Special patient groups
In patients with severe asthma there is a risk of acute asthma attacks. In this patient group, the doctor will regularly perform thorough assessments of asthma control, including lung function tests.
Patients already taking oral corticosteroids:
Alvesco may be used instead of tablets or to reduce the number of required tablets. Follow your doctor's instructions exactly.

• The switch will begin approximately one week after starting inhaled Alvesco.
• The number of tablets taken will be carefully reduced over a period of time.
• During this time, the patient may occasionally feel generally unwell.
• Despite this, it is important to continue inhaled treatment with Alvesco and gradually reduce the number of tablets.
• If severe symptoms such as nausea, vomiting, diarrhoea, or high fever occur, contact your doctor.
• Switching from tablets to inhaled treatment may sometimes reveal mild allergic reactions, such as rhinitis or rash (itchy red skin).
• After switching from tablets to inhaled treatment, there may be a temporary risk of adrenal insufficiency related to previously taken oral corticosteroids. Symptoms of adrenal insufficiency (e.g. dizziness, fainting, nausea, loss of appetite, mood swings, hair loss, reduced stress tolerance, weakness, headache, memory disturbances, allergies, increased appetite, and changes in blood sugar levels) may also persist for some time.
• It may also be necessary to consult a specialist to determine the degree of adrenal insufficiency.
• Adrenal function will be monitored regularly by the doctor.
• In stressful situations, such as surgery or worsening asthma attacks, additional oral corticosteroid tablets may be required. For this reason, the patient should carry a steroid warning card indicating this.

Patients with liver or kidney disease
Dosage adjustment of ciclesonide is not necessary in patients with liver or kidney disease. If the patient has severe liver disease, the doctor will perform a more detailed assessment regarding possible adverse effects related to impaired steroid production.
Children under 12 years of age
This medicine is not recommended for use in children under 12 years of age, as there is insufficient information on its effects in this age group.
Alvesco and other medicines
Before taking Alvesco, inform your doctor if the patient is currently being treated for any fungal or viral infection with a medicine containing:

• ketoconazole,
• itraconazole,
• ritonavir,
• nelfinavir. These medicines may enhance the effect of Alvesco, so the possibility of adverse effects cannot be completely ruled out.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Alvesco with food and drink
No interactions have been observed between Alvesco and food or drink.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

• As there is insufficient information on the effects of Alvesco in pregnant women, the doctor will discuss the risks and benefits of using Alvesco with the patient.
• Ciclesonide (the active substance in Alvesco) may be used during pregnancy only if the potential benefit to the mother outweighs the possible risk to the developing fetus. If the doctor decides that the patient may continue using Alvesco, the lowest possible dose of ciclesonide that maintains asthma control will be used.
• Adrenal function will be carefully monitored in children whose mothers received corticosteroids during pregnancy.
• If the patient intends to use Alvesco while breastfeeding, she should discuss this with her doctor.
• It is not known whether inhaled ciclesonide passes into human breast milk.
• Prescribing Alvesco to breastfeeding women will only be considered if the expected benefit to the mother outweighs the possible risk to the infant.

Driving and operating machinery
Alvesco and its ingredients have no effect or have a negligible effect on the ability to drive or operate machinery.
Alvesco contains ethanol This medicine contains 4.7 mg of alcohol (ethanol) per dose. The amount of alcohol in each dose is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Alvesco

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the
doctor or pharmacist.

• If the patient has started using this medicine instead of oral corticosteroids or together with oral corticosteroids, see section 2 Patients who are already taking oral corticosteroids. What dose of Alvesco should be used each day? The doctor will tell the patient what dose to use each day. This will depend on the individual needs of the patient.
• The recommended dose of Alvesco is 160 micrograms once daily, which provides adequate asthma control in most patients.
• In some patients, a reduced dose of 80 micrograms once daily may be sufficient to maintain proper asthma control.
• In patients with a severe asthma exacerbation, the dose of Alvesco may need to be increased temporarily to 640 micrograms per day, administered as 320 micrograms twice daily. However, there are no data confirming additional therapeutic benefit after 3 months of higher-dose treatment.

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

• The doctor will adjust the dose to the lowest effective dose required to control the patient's asthma.
• Improvement in symptoms (wheezing, chest tightness, and cough) should be noticeable within 24 hours.

When to use the Alvesco inhaler?
In most cases, either in the morning or in the evening – one or two doses once daily. Follow the doctor's instructions precisely. It is important to use Alvesco regularly every day, even if the patient feels better.
If the patient finds that they need to use their reliever inhaler more than 2–3 times a week, they should contact their doctor, who will reassess the treatment.

How to use the Alvesco inhaler?
It is important that the doctor, nurse, or pharmacist shows the patient the correct way to use the Alvesco inhaler the first time. Proper technique ensures that the correct amount of medicine reaches the lungs. The instructions in this leaflet should be used as a reminder.
To ensure correct use of the Alvesco inhaler, it may be helpful to practice the first few inhalations in front of a mirror. Make sure the medicine does not escape through the patient's mouth.

A new inhaler or an inhaler that has not been used for one week or longer must be primed before use. Remove the mouthpiece cover and press the canister inside the inhaler three times to release three sprays into the air, directing the spray away from the face.

Shaking the Alvesco inhaler before use is not necessary. The medicine is a homogeneous solution, which ensures delivery of the correct dose with each inhalation.

The patient may sit or stand while inhaling.

Follow the instructions below carefully, using the accompanying illustrations.

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

2. Hold the inhaler upright with the base of the canister at the top. Place the index finger on top of the canister and the thumb under the mouthpiece.
3. Breathe out as fully as possible. Do not exhale into the inhaler.

4. Place the mouthpiece in the mouth and close lips firmly around it.
5. Just after starting to inhale through the mouth, press down on the top of the inhaler with the index finger to release a dose of medicine, while simultaneously taking a slow and deep breath in. Take care to ensure the medicine spray does not escape above, below, or beside the mouth.

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

It is important not to rush the steps described in points 3 to 6.

7. If a second dose is prescribed, wait about half a minute and repeat steps 3 to 6.
8. After use, always replace the mouthpiece cover to prevent dust from entering. Press the cover firmly and snap it into place.

Inhaler outlet

9. For hygiene reasons:
   • Clean the inner and outer surfaces of the mouthpiece weekly with a dry cloth.
   • Wipe the front part of the small opening through which the medicine is released, using a dry folded cloth.
   • Do not use water or other liquids.

Proper technique ensures that the correct dose of Alvesco reaches the lungs with each use of the inhaler. The doctor will regularly check the patient's inhalation technique to ensure optimal treatment effect.

When the canister is completely empty, the spray will no longer be audible or perceptible.

If the patient experiences wheezing or chest tightness after using the Alvesco inhaler:

• Do not use further doses.
• Use a reliever inhaler to ease breathing.
• Contact the doctor immediately.

If the patient has difficulty using the inhaler, the doctor may recommend using a spacer. A spacer compatible with the Alvesco inhaler is called AeroChamber Plus. When using the AeroChamber Plus device, follow the instructions provided with it. The doctor or pharmacist can provide advice on using this device.

Using more than the recommended dose of Alvesco
It is important that the dose used is in accordance with the doctor's instructions.
Do not increase or decrease the dose without consulting the doctor.
If an overdose of Alvesco is taken, specific treatment is not usually required, but the doctor should be informed. If large doses are used for prolonged periods, reduced adrenal function cannot be excluded, and adrenal function may need to be monitored.

Missing a dose of Alvesco
If the patient forgets to use Alvesco, they should take the next dose at the scheduled time. Do not use a double dose to make up for a missed dose.

Stopping use of Alvesco
Do not stop using the inhaled medicine Alvesco, even if the patient feels better. If there are any further doubts about using this medicine, consult the doctor or pharmacist.
If use of this medicine is stopped, inform the doctor immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop using the medicine and contact your doctor immediately if the patient experiences any of the following serious adverse reactions:

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

Other adverse reactions observed during treatment with Alvesco are usually mild.
In most cases, patients may continue treatment. The adverse reactions that may occur include:
Uncommon adverse reactions (may occur in 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
• dryness of the mucous membranes of the mouth or throat
• nausea or vomiting.

Rare adverse reactions (may occur in up to 1 in 1,000 treated patients):

• sensation of rapid or irregular heartbeat (palpitations)
• abdominal discomfort or pain
• high blood pressure.

Adverse reactions with unknown frequency, but which may also occur:

• sleep disorders, depression, feelings of worry, anxiety, restlessness, increased excitability, or irritability. These reactions are more likely to occur in children.
• blurred vision

Alvesco may adversely affect the body's normal production of corticosteroids. This usually affects patients taking high doses over a long period. Possible adverse reactions may include:

• slowed growth in adolescents
• thinning of the bones (osteoporosis)
• possible clouding of the eye lens (cataract), leading to blurred vision
• loss of vision caused by abnormally high pressure in the eye (glaucoma)
• moon-shaped face, increased upper body mass, and thinning of arms and legs (Cushingoid syndrome or Cushing's syndrome). The doctor will regularly monitor the growth of adolescents receiving long-term treatment. If growth has slowed, the doctor will adjust the dose, if possible, to the lowest effective dose that maintains adequate asthma control.

Oral corticosteroids may cause more adverse reactions than inhaled corticosteroids such as Alvesco. In patients who have taken steroid tablets before or during treatment with Alvesco, there may be a continued risk of tablet-related adverse reactions for some time. Regular medical check-ups will ensure that each patient receives the appropriate dose of Alvesco. Regular monitoring will also allow early detection of any adverse reactions and reduce the likelihood of their worsening.
Please remember:
If any of the adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Alvesco

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the cardboard box following the term: "EXP". The expiry date refers to the last day of the specified month.
The container holds a pressurized solution. Do not store above 50°C.
Do not pierce, damage, or burn the container, even if it appears to be empty.
As with most pressurized inhalation medicines, the effectiveness of this medicine may be reduced if the container is cold. However, Alvesco delivers consistent doses of medication from the device at temperatures ranging from minus 10°C to plus 40°C.
If your doctor decides to discontinue treatment or if the inhaler is empty, return it to a pharmacy for safe disposal. This is important because trace amounts of medicine may remain in the container, even if it appears to be empty.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Alvesco contains:

• The active substance is ciclesonide. Each dose (delivered via the inhaler mouthpiece) 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, equivalent to
0.008 tonnes of CO₂ equivalent (global warming potential GWP = 1430).
Alvesco 80 μg, 120 inhalation doses – Each inhaler contains 8.82 g of HFA-134a, equivalent to
0.013 tonnes of CO₂ equivalent (global warming potential GWP = 1430).
Alvesco 160 μg, 60 inhalation doses – Each inhaler contains 5.59 g of HFA-134a, equivalent to
0.008 tonnes of CO₂ equivalent (global warming potential GWP = 1430).
Alvesco 160 μg, 120 inhalation doses – Each inhaler contains 8.80 g of HFA-134a, equivalent to
0.013 tonnes of CO₂ equivalent (global warming potential GWP = 1430).

What Alvesco looks like and contents of the pack
Alvesco is a clear, colourless liquid contained in an aluminium pressurised container that delivers a precisely measured dose of ciclesonide as an aerosol via the mouthpiece.
The aluminium container is closed with a metering valve, fitted with a mouthpiece and a cap made of HDPE, and is contained in a cardboard box.

Pack sizes:
Inhaler containing 60 precisely metered inhalation doses.
Inhaler containing 120 precisely metered inhalation doses.

Inhalers of different strengths contain enough medicine for 60 or 120 inhalations. Depending on the number of daily doses, your doctor may recommend using:

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

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

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

This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria Alvesco 160, 80 micrograms – pressurised dosage inhaler
Bulgaria Alvesco 160, 80 micrograms pressurised inhalation, solution
Cyprus Alvesco 160, 80 micrograms, solution for pressurised inhalation
Croatia Alvesco 160, 80 micrograms, pressurised inhalation solution
Czech Republic Alvesco 160 micrograms/dose, solution for inhalation in pressurised container
Denmark Alvesco 160, 80 microgram/dosis, inhalation spray, solution
Finland Alvesco 160, 80 microgram/dose, inhalation solution
France Alvesco 160, 80 microgrammes/dose, solution for pressurised inhalation
Greece Alvesco 160, 80 micrograms, solution for pressurised inhalation
Spain Alvesco 160 micrograms/inhalation, solution for pressurised inhalation
Netherlands Alvesco 160, 80 Inhalator, aërosol, oplossing 160, 80 microgram/dosis
Ireland Alvesco 160, 80 micrograms pressurised inhalation solution
Latvia Alvesco 160, 80 micrograms, pressurised aerosol for inhalation, solution
Germany Alvesco 160, 80 micrograms, pressurised inhalation, solution
Norway Alvesco 160, 80 micrograms/dose inhalation aerosol
Poland Alvesco 160, 80 160, 80 μg/dose; inhalation aerosol, solution
Romania Alvesco 160, 80 Inhaler, 160, 80 micrograms/dose, pressurised inhalation solution
Slovakia Alvesco 160, 80 Inhaler, inhalation solution in pressurised container
Slovenia Alvesco 160, 80 micrograms/dose, pressurised inhalation solution
Sweden Alvesco 160, 80 microgram/dos inhalation spray, solution
Hungary Alvesco 160, 80 microgram pressurised inhalation solution
Northern Ireland Alvesco 160, 80 Inhaler
Italy Alvesco 160, 80 mcg pressurised solution for inhalation