ALVESCO 160

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Alvesco 160 (Alvesco 160 Inhaler)
160 μg/inhalation; inhalation aerosol, solution
Ciclesonidum
Alvesco 160 and Alvesco 160 Inhaler are different trade names for the same medicinal product.
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Alvesco 160 is and what it is 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 pack and other information

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

What Alvesco 160 is
Alvesco 160 is a clear, colourless inhalation aerosol intended for inhalation through the mouth into the lungs. It is a preventive (corticosteroid) medicine which must be used daily and whose effect occurs only after inhalation into the lungs.
What Alvesco 160 is used for
Alvesco 160 is indicated for the treatment of persistent asthma in adults and adolescents (aged 12 years and older).
How Alvesco 160 works
Alvesco 160 helps you breathe more easily by reducing the severity of asthma symptoms and decreasing the likelihood of asthma attacks. The effect of the medicine builds up over time; therefore, it must be used daily, even if you feel 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 160

When not to use Alvesco 160

• 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 treatment with Alvesco 160, discuss this 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, contact your doctor. It is important to ensure that the medicine
Alvesco 160 is suitable for the individual patient.
You must contact your doctor immediately if, during treatment with
Alvesco 160, the patient:

• experiences worsening breathing difficulties and increased symptoms such as cough, shortness of breath, wheezing, chest tightness, increased coarse crackles on auscultation, or other signs of airway obstruction. (Use an inhaled medicine to relieve asthma attacks, which usually leads to rapid improvement.)
• asthma symptoms wake the patient from sleep.
• there is no improvement after using a reliever medicine for asthma attacks. 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 assessments of asthma control, including
lung function tests.
Patients who are already taking oral corticosteroids
Alvesco 160 may be used instead of tablets or to reduce the number of tablets required.
Follow your doctor's instructions exactly.

• The switch will begin approximately one week after starting inhaled Alvesco 160.
• The number of tablets taken will be gradually 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 160 and the gradual reduction in tablet dosage.
• If severe symptoms occur, such as nausea, vomiting, diarrhoea, or high fever, contact your doctor.
• Switching from tablet treatment to inhaled therapy may sometimes reveal mild allergic reactions, such as rhinitis or rash (itchy red skin).
• After switching from tablets to inhaled treatment, the patient may remain at risk of adrenal insufficiency for some time due to previously taken oral corticosteroids. Symptoms of adrenal insufficiency (e.g. dizziness, fainting, nausea, loss of appetite, mood changes, hair loss, reduced stress tolerance, fatigue, headaches, memory disturbances, allergies, increased appetite, and changes in blood sugar levels) may also persist for some time.
• It may be necessary to consult a specialist to determine the degree of adrenal insufficiency.
• Adrenal function will be regularly monitored by the doctor.
• During 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 due to impaired steroid production.
Children under 12 years of age
This medicine is not recommended for use in children under 12 years of age, due to lack of information on its effects in this age group.
Alvesco 160 and other medicines
Before taking Alvesco 160, 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 increase the effect of Alvesco 160, so the possibility of adverse reactions cannot be completely excluded.

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 160 with food and drink
No interactions have been observed between Alvesco 160 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 child, she should consult her doctor or pharmacist before using this medicine.

• Since there is insufficient information on the use of Alvesco 160 during pregnancy, the doctor will discuss the risks and benefits of using Alvesco 160 with the patient.
• Ciclesonide (the active substance in Alvesco 160) may be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the developing fetus. If the doctor decides that the patient may continue using Alvesco 160, 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 160 while breastfeeding, she should discuss this with her doctor.
• It is not known whether inhaled ciclesonide passes into human breast milk.
• Prescribing Alvesco 160 to breastfeeding women will be considered only if the expected benefit to the mother outweighs the potential risk to the infant.

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 anhydrous ethanol
This 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 cause noticeable effects.

3. How to use Alvesco 160

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

• If the patient has started using this medicine instead of or in addition to oral corticosteroids, see section 2, "Patients who are already taking oral corticosteroids."

What dose of Alvesco 160 should be used each day?
Your doctor will tell you what dose to take each day. The dose will depend on your individual needs.

• The recommended dose of Alvesco 160 is 160 micrograms once daily. This dose provides asthma control in most patients.
• In some patients, a reduced dose of 80 micrograms once daily may be sufficient to maintain adequate asthma control.
• In patients with severe asthma exacerbations, the dose of Alvesco 160 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 beyond 3 months of treatment with higher doses.

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

• Your doctor will adjust the dose to the lowest effective dose needed to control your asthma.
• Improvement in symptoms (wheezing, chest tightness, and cough) should be noticeable within 24 hours.

When should the Alvesco 160 inhaler be used?
In most cases, either in the morning or in the evening—one or two doses once daily. Follow your doctor's instructions precisely. It is important to use Alvesco 160 inhaler regularly every day, even if you feel better.
If you find that you need to use your reliever inhaler more than 2–3 times a week, you should contact your doctor for a reassessment of your treatment.

How to use the Alvesco 160 inhaler?
It is important that your doctor, nurse, or pharmacist shows you the correct way to use the Alvesco 160 inhaler the first time. Proper technique ensures that the correct amount of medicine reaches your lungs. The instructions in this leaflet should be used as a reminder.
To ensure you are using the Alvesco 160 inhaler correctly, it may be helpful to perform the first few inhalations in front of a mirror. Make sure the medicine does not escape through your mouth.

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

Do not shake the Alvesco 160 inhaler before use. The medicine is a uniform solution, which ensures delivery of the correct dose with each inhalation.

You may sit or stand while inhaling.

Follow the instructions below carefully, using the accompanying illustrations.

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

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

4. Place the mouthpiece in your mouth and close your lips firmly around it.
5. Just as you start to breathe in through your mouth, press down with your index finger on the top of the inhaler to release a dose, while simultaneously taking a slow, deep breath in. Be careful not to let the medicine escape through the top, bottom, or sides of your mouth.

6. Hold your breath, remove the inhaler 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 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 then repeat steps 3 to 6.
8. After use, always replace the mouthpiece cap to prevent dust from entering. Press the cap 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 tissue.

• Do not use water or any other liquids.

Proper technique ensures that the correct dose of Alvesco 160 reaches your lungs with each inhalation. Your doctor will regularly check your inhalation technique to ensure optimal treatment effectiveness.

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

If you experience wheezing or chest tightness after using the Alvesco 160 inhaler:

• Do not take further doses.
• Use your reliever inhaler to help ease breathing.
• Contact your doctor immediately.

If you have difficulty using the inhaler, your doctor may recommend a spacer device. The spacer compatible with the Alvesco 160 inhaler is called AeroChamber Plus™. When using the AeroChamber Plus™ device, follow the instructions provided with it. Your doctor or pharmacist can advise you on its use.

Using more Alvesco 160 than prescribed
It is important to use the dose prescribed by your doctor.
Do not increase or decrease the dose without consulting your doctor.
If you accidentally take too much Alvesco 160, specific treatment is not usually required, but you should inform your doctor. If high doses are used for a prolonged period, adrenal function suppression cannot be ruled out, and monitoring of adrenal function may be necessary.

Missing a dose of Alvesco 160
If you forget to use Alvesco 160, take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Alvesco 160 inhaler
Do not stop using Alvesco 160 inhaler, even if you feel better.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
If you stop using this medicine, inform your doctor immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment must be discontinued and immediate contact made with the attending physician if the
patient experiences any of the following serious adverse effects:

• severe allergic reactions, such as swelling of the lips, tongue, and throat (may occur in no more than 1 in 1,000 treated patients),
• allergic reactions: skin rash, redness, itching, or skin eruptions in the form of hives, urticaria (may occur in no more than 1 in 100 treated patients),
• cough or wheezing worsening after inhalation (may occur in no more than 1 in 100 treated patients).

Other adverse effects observed during treatment with Alvesco 160 are usually mild.
In most cases, patients may continue treatment. Adverse effects that may occur include:
Uncommon adverse effects (may occur in no more than 1 in 100 treated patients):

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

Rare adverse effects (may occur in no more than 1 in 1,000 treated patients):

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

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

• sleep disturbances, depression, or feelings of worry, anxiety, restlessness, increased excitability, or irritability. These effects are more likely to occur in children.

Alvesco 160 may adversely affect the normal production of corticosteroids in the patient's body.
This usually affects patients taking high doses over a prolonged period.
Adverse effects that may occur include:

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

Oral corticosteroid tablets may cause more adverse effects than inhaled corticosteroids such as Alvesco 160.
In patients who have taken steroid tablets before or during treatment with Alvesco 160, there may be a residual risk of tablet-related adverse effects for some time. Regular medical check-ups will ensure that each patient receives the appropriate dose of Alvesco 160. Regular monitoring will also allow early detection of any adverse effects and reduce the likelihood of their worsening.
Please note that:
If any of the adverse symptoms worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist immediately.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps gather further information on the safety of the medicine.

5. How to store Alvesco 160

Keep this medicine out of sight and reach of children.
No special storage conditions apply.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
The container contains a pressurised 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 pressurised inhalation medicines, the effectiveness of this medicine may be reduced if the container is cold. However, Alvesco 160 delivers the same dose of medicine 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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Alvesco 160 contains:

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

What Alvesco 160 looks like and contents of the pack
Alvesco 160 is a clear, colourless liquid contained in an aluminium pressurised canister, which delivers a precisely measured dose of ciclesonide as an aerosol through the inhaler mouthpiece.
The aluminium canister is fitted with a metering valve and is packaged in a cardboard box.
Pack sizes
Inhaler containing 60 precisely measured inhalation doses.
The inhaler contains enough medicine for 60 inhalations.
An inhaler with 60 doses contains enough medicine for one to two months.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082MA Amsterdam, The 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, The Netherlands
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Romania, country of export: 9031/2016/01
Parallel import authorisation number: 60/22
This medicinal product is authorised for sale in the European Economic Area countries 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 Alvesco 160 microgramos/inhalación solución para inhalación en envase a presión
The 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 mikrogram/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