Alvesco 160

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Alvesco 160 (Alvesco 160 Inhaler)

160 μg/inhalation dose; inhalation aerosol, solution

Ciclesonide
Alvesco 160 and Alvesco 160 Inhaler are different trade names for the same medicine.

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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Alvesco 160 and what is it used for
• 2. Important information before using Alvesco 160
• 3. How to use Alvesco 160
• 4. Possible side effects
• 5. How to store Alvesco 160
• 6. Contents of the packaging and other information

1. What is Alvesco 160 and what is it used for

What is Alvesco 160

Alvesco 160 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 inhalation into the lungs.

What is Alvesco 160 used for

Alvesco 160 is used to treat chronic asthma in adult and adolescent patients (12 years and older).

How does Alvesco 160 work

Alvesco 160 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 well.
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 160

When not to use Alvesco 160

Warnings and precautions

Before starting treatment with Alvesco 160, 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 or are currently being treated for tuberculosis, fungal, viral, or bacterial infections.

In case of doubts, the patient should contact their doctor. It is essential to ensure that Alvesco 160 is suitable for the patient.
The patient should immediatelycontact their doctor if, while using Alvesco 160, 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.

Special patient groups

In patients with severe asthma, there 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 160 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 treatment with Alvesco 160 inhaler.
• 160.
• The number of tablets taken will be carefully reduced over a period of time.
• During this time, the patient may sometimes feel unwell.
• However, it is essential to continue treatment with Alvesco 160 inhaler 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 treatment may sometimes cause mild allergic reactions, such as nasal congestion or rash (itchy redness of the skin).
• After switching from tablets to inhalation treatment, the patient may be at risk of reduced adrenal function for some time, related to the corticosteroids previously taken in tablet form. Symptoms of reduced adrenal function (e.g., 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 some time.
• It may also be necessary to consult a specialist to determine the degree of reduced adrenal function.
• The doctor will regularly monitor the patient's adrenal function.
• In stressful situations, such as during surgery, asthma attacks, additional corticosteroid tablets may be necessary. Therefore, the patient should carry a steroid warning cardindicating this.

Patients 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 12 years of age, as there is no information on its effects in this age group.

Alvesco 160 and other medicines

Before taking Alvesco 160, 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 160, so it is not possible to rule out the possibility of side effects.

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Alvesco 160 with food and drink

No interactions have been found between the use of Alvesco 160 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 effects of Alvesco 160 in pregnant women, the doctor will discuss the risks and benefits of using Alvesco 160 with the patient.
• Ciclesonide (the active substance of Alvesco 160) may be used during pregnancy only if the potential benefits to the mother outweigh the potential risks to the fetus. If the doctor decides that the patient can continue using Alvesco 160, 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 160 while breastfeeding, they should discuss it with their doctor.
• It is not known whether inhaled ciclesonide passes into breast milk.
• Prescribing Alvesco 160 to breastfeeding women will only be considered if the expected benefits to the mother outweigh the potential risks to the baby.

Driving and using machines

Alvesco 160 and its ingredients do not affect or have a negligible effect on the ability to drive or operate machinery.

Alvesco 160 contains ethanol

This medicine contains 4.7 mg of alcohol (ethanol) in each 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 160

This medicine should always be used as directed by the doctor. If you have any doubts, you should consult your doctor or pharmacist.

• If the patient 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 160 should be used every day?

The doctor will tell the patient what dose of the medicine to use every day. This will depend on the patient's individual needs.

• The recommended dose of Alvesco 160 is 160 micrograms once a day and 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 appropriate maintenance dose to control asthma.
• In patients with severe asthma exacerbation, it may be necessary to increase the dose of Alvesco 160 for a period of time to 640 micrograms per day, taken in doses of 320 micrograms twice a day, but there are no data to support additional therapeutic effects after 3 months of using higher doses.

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

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

When to use the Alvesco 160 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 160 regularly every day, even if the patient feels better.
If the patient finds that they need to use a bronchodilator inhaler more frequently than 2-3 times a week, they should contact their doctor, who will reassess the treatment.

How to use the Alvesco 160 inhaler?

It is essential that the doctor, nurse, or pharmacist shows the patient how to use the Alvesco 160 inhaler correctly for the first time. Good technique will ensure that the correct amount 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 160 inhaler correctly, it may be necessary to perform a few initial doses in front of a mirror. The patient should make sure that the medicine is not coming out of the mouth.

• 1. Remove the mouthpiece cover and check the mouthpiece inside and outside to make sure it is clean and dry.

• 2. Hold the inhaler with the canister pointing upwards (the base of the canister at the top), placing the index finger on the bottom of the canister and the thumb under the mouthpiece.
• 3. Exhale slowly and deeply. Do not breathe out into the inhaler.

• 4. Put the mouthpiece into the mouth and close the lips, firmlyholding the mouthpiece.
• 5. Just after starting to inhale through the mouth, press the canister with the index finger to release a dose of the medicine, taking a slow and deep breath at the same time. The patient should be careful not to let the dose of medicine come out 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 canister. Continue holding the breath for about 10 seconds or as long as possible. Breathe out slowly 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, waitfor about half a minute and repeatsteps 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.
• 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

Spray nozzle
inhaler
dry, folded tissue.

• do notuse water or other liquids.

Proper technique will ensure that the patient receives the correct dose of Alvesco 160 with each use of the inhaler. The doctor will regularly check the patient's inhalation technique to ensure the best treatment effect.
After the canister is completely empty, the release of the medicine will stop being heard and felt.

If, after using the Alvesco 160 inhaler, the patient experiences wheezing or a feeling of pressure in the chest:

• do nottake additional doses.
• use a bronchodilator inhaler to relieve 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 160 inhaler is called AeroChamber PlusTM. When using the AeroChamber PlusTM 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 160 than recommended

It is essential to take the dose of the medicine as recommended 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 160

If the patient misses a dose of Alvesco 160, they should take the next dose at the scheduled time. Do nottake a double dose to make up for the missed dose.

Stopping treatment with Alvesco 160

The patient should not stop using Alvesco 160 inhaler, even if they feel better.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

If the patient stops using this medicine, they should inform their doctor immediately.

4. Possible side effects

Like all medicines, Alvesco 160 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 severe 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),
• coughing or wheezing worsening after inhalation (may occur in less than 1 in 100 patients).

Other side effects that may occur when using Alvesco 160 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 (rapid heartbeat)
• discomfort or abdominal pain
• high blood pressure.

Side effects with unknown frequency, but may also occur:

• sleep disturbances, depression, or feelings of anxiety, restlessness, nervousness, increased excitability, or irritability. The occurrence of these effects is more likely in children.

Alvesco 160 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:

• slowed growth in adolescents
• thinning of bones
• possible cataracts (clouding of the lens of the eye), causing blurred vision
• vision loss due to high pressure in the eye (glaucoma)
• moon face, weight gain 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 asthma control, if possible.

Corticosteroids in tablets may cause more side effects than inhaled corticosteroids, such as Alvesco 160. In patients who have taken steroid tablets before or during treatment with Alvesco 160, the risk of side effects related to tablet use may persist for some time. Regular medical check-ups will ensure that the patient is taking the correct dose of Alvesco 160. 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:

Reporting side effects

If side effects occur, including any side effects not mentioned in the leaflet, the patient 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 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Alvesco 160

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

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

The patient should not pierce, damage, or burn the container, even if it seems empty.
Like most inhalers in pressurized containers, the effectiveness of this medicine may be lower if the container is cold. However, the same doses of Alvesco 160 are released from the container at temperatures between -10°C and 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 the medicine in the container, even if it seems empty.
Medicines should not be disposed of in 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 160 contains:

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

What Alvesco 160 looks like and what the packaging contains

Alvesco 160 is a clear and colorless liquid in a pressurized aluminum canister, which delivers a precise dose of ciclesonide in the form of an aerosol.
The aluminum canister is equipped with a dosing valve in a cardboard box.

Pack sizes

An inhaler containing 60precisely measured inhalation doses.
The inhaler contains enough medicine for 60 inhalations.
The inhaler with 60 doses contains enough medicine for one to two months.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

AstraZeneca AB
Global External Sourcing (GES), Astraallén
Gärtunaporten (B 674 :5), 151 85, Södertälje, Sweden
Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam, Netherlands

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Marketing authorization number in Romania, the country of export:9031/2016/01

Parallel import authorization number: 60/22

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

Austria Alvesco 160 Mikrogramm –Dosieraerosol
Bulgaria Alvesco 160 micrograms pressurised inhalation, solution
Cyprus Alvesco 160 μικρογραμμάρια, διάλυμα για εισπνοή υπό πίεση
Croatia Alvesco 160 mikrograma stlačeni inhalat otopina
Czech Republic Alvesco Inhaler 160 mikrogramů/dávka roztok k inhalaci v tlakovém obalu
Denmark Alvesco 160 mikrogram/dosis, inhalationsspray, opløsning
Finland Alvesco 160 mikrog/ annos inhalaatiosumute, liuos
France Alvesco 160 microgrammes/dose, solution pour inhalation en flacon pressurisé
Greece Alvesco 160 μικρογραμμάρια, διάλυμα για εισπνοή υπό πίεση
Spain Alvesco160 microgramos/ inhalación solución para inhalación en envase a presión
Netherlands Alvesco 160 Inhalator, aërosol, oplossing 160 microgram/dosis
Ireland Alvesco 160 micrograms pressurised inhalation solution
Latvia Alvesco 160 mikrogrami aerosols inhalācijām, zem spiediena, šķīdums
Germany Alvesco 160 Mikrogramm, Druckgasinhalation, Lösung
Norway Alvesco 160 mikrogrammicrograms/dose inhalasjonsaerosol,
Poland Alvesco 160 160 μg/dawkę inhalacyjną; aerozol inhalacyjny, roztwór
Romania Alvesco 160 Inhaler, 160 micrograme/doză a, solutie de inhalat presurizată
a 160 micrograme / doza
Slovakia Alvesco 160 Inhalátor inhalačný roztok v tlakovom obale
Slovenia Alvesco 160 mikrogramov/odmerek inhalacijska raztopina pod tlakom
Sweden Alvesco 160 microgram/dos inhalationsspray, lösning
Hungary Alvesco 160 mikrogramm túlnyomásos inhalációs oldat
Northern Ireland Alvesco 160 Inhaler
Italy Alvesco 160 mcg soluzione pressurizzata per inalazione
Date of leaflet approval: 31.01.2022
[Information about the trademark]