ALVESCO 80 MCG Pressurized solution for inhalation

Зміст інструкції

1. What is Alvesco and what is it used for
2. What you need to know before using Alvesco
3. How to use Alvesco
4. Possible side effects
5. How to store Alvesco
6. Package Contents and Other Information

Alvesco80 and 160 mcg pressurised inhalation solution
Ciclesonide
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Alvesco is and what it is used for
• 2. What you need to know before you use 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 is Alvesco and what is it used for

What is Alvesco:
Alvesco is a clear and colorless aerosol, in a spray pack to be inhaled through the mouth and into the
lungs. It is a preventive medicine (corticosteroid) that must be taken every day and becomes active only after being inhaled into the lungs.
The active substanceof this medicine is ciclesonide. (For the other ingredients, see section

6)

What is Alvesco used for:
This medicine is prescribed to control persistent asthma in adults and adolescents (12
years and older).
It helps you breathe more easily by reducing both asthma symptoms and the risk of an asthma attack.
The effect develops over time, so you need to use this medicine every day, even when
you feel well.

This medicine should not be used during acute attacks of breathlessness. In
these attacks for quick relief, use only your usual inhaler therapy for acute attacks

2. What you need to know before using Alvesco

Do not use Alvesco
if you are allergic (hypersensitive) to ciclesonide or toany of the other ingredients of this
medicine (listed in section 6)

Take special care with Alvesco

• Before startingtreatment with this medicine, talk to your doctor if:

you have been treated for, or are currently being treated for, pulmonary tuberculosis (TB), fungal,
viral or bacterial infections.
If you are not sure, check with your doctor. It is important to make sure that Alvesco is the right
medicine for you.
During treatment with Alvesco, contact your doctor immediatelyif:

• your breathing becomes difficult and your symptoms, cough, shortness of breath, wheezing, chest tightness, increased noises (ronchi) or other symptoms of bronchial obstruction worsen (you should use your usual therapy for acute attacks which normally leads to rapid improvement).
• you wake up at night due to the aforementioned symptoms.
• you do not get relief from using your usual reliever inhaler for acute attacks. The doctor will decide on another treatment. For those who play sports: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test. Specific patient groupsPatients with severe asthmaare at risk of acute attacks. For these patients, the doctor will perform a thorough and regular check of the asthmatic status, including a lung function test. Patients who are already taking corticosteroid tablets: Alvesco can be used to replace the tablets, or to reduce the number of tablets you need. Carefully follow your doctor's instructions.
• This will start about a week after you have started inhaling Alvesco.
• The number of tablets you take will be reduced cautiously over a period of time.
• During this period of time you may feel a sense of general malaise.
• Despite this, it is important to continue both with Alvesco inhalations and slowly reducing the number of tablets to take.
• If you experience severe symptoms such as nausea, vomiting, diarrhea, or high fever, contact your doctor.
• This process can sometimes reveal minor allergies such as rhinitis (inflammation inside the nose) or eczema (itching, reddened skin).
• If you have switched from tablets, you will continue to be at risk of reduced adrenal function for some time, which is related to the corticosteroid tablets you have taken. Symptoms of reduced adrenal function (e.g. dizziness, weakness, nausea, loss of appetite, mood swings, decreased hair, inability to cope with stress, fatigue, headache, memory problems, allergies, strong food cravings, blood sugar abnormalities) may also continue for some time.
• You may also need to consult a specialist to determine the extent of the reduction in adrenal function.
• The doctor must also arrange a regular check of adrenal function.
• During periods of stress, for example, if you are to undergo surgery, worsening asthma attacks, you may need additional corticosteroid tablets. Inthis case, you must carry an identification cardfor steroid usersspecifying the need for additional administration.

Patients with liver or kidney problems
No dose adjustment of ciclesonide is necessary if you have liver or kidney problems.
If you suffer from severe liver problems, the doctor will monitor you more carefully for possible
side effects resulting from the alteration of normal steroid production.

Childrenunder 12 years of age:
This medicine is not indicated for children under 12years of age due to lack of
information about possible effects.

Other medicines and Alvesco
Before using Alvesco, tell your doctor if you are being treated for any fungal or
viral infection with other medicines containing:

• ketoconazole,
• itraconazole,
• ritonavir,
• nelfinavir. These can intensify the action of Alvesco so that the probability of side effects cannot be completely excluded. Tell your doctor or pharmacist if you are takingor have recently taken any othermedicine, including those available without a prescription.Use of this medicine with food and drinkThere are no interactions between Alvesco and food and drinks. Pregnancy, breastfeeding and fertilityTell your doctor if you are pregnant, want to become pregnant or are breastfeeding.
• Because there is insufficient information about the effects of Alvesco on pregnant women, the doctor will discuss the risks and benefits of using Alvesco with you.
• Ciclesonide (the active ingredient of Alvesco) can only be taken during pregnancy when the possible benefits for the mother justify the possible risk to the development of the fetus. If the doctor decides that you can continue to use Alvesco, the smallest possible dose of ciclesonide effective for maintaining adequate asthma control will be used.
• Adrenal function should be carefully monitored in children born to mothers treated with corticosteroids during pregnancy.
• Talk to your doctor if you want to use Alvesco while breastfeeding.
• It is not known whether ciclesonide administered by inhalation passes into human breast milk.
• The prescription of Alvesco to breastfeeding women should only be considered if the expected benefit for the mother is greater than the possible risk to the child. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machinesAlvesco and its components have no effects or negligible effects on the ability to drive or operate machinery.

3. How to use Alvesco

Always use this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.

• If you have just started using this medicine instead of or together with corticosteroid tablets, see section 2, Patients who are already taking corticosteroid tablets How much Alvesco should I take each day?Your doctor will have told you how much of this medicine you need to take each day. This depends on your individual needs.
• The recommended dose of Alvesco is 160 micrograms once a day, which leads to asthma control in the majority of patients.
• In some patients a reduction of the dose to 80 micrograms, once a day, may be an adequate dose to maintain effective asthma control.
• An increase in the dose of Alvesco may be necessary for a short period of time in patients who suffer from a severe worsening of their asthma symptoms. This can reach 640 micrograms per day, taken as 320 micrograms twice a day but there is no data to confirm an additional therapeutic effect after 3 months with these high doses. If necessary, your doctor may also prescribe corticosteroid tablets and/or, in case of infection, an antibiotic.
• Your doctor will adjust the dose to the minimum necessary to control your asthma.
• You will start to notice an improvement in your symptoms (shortness of breath, chest tightness and cough) within 24 hours.

When should I use my Alvesco inhaler?
In most cases, in the morning or evening - one or two puffs once a day. Follow
exactly your doctor's instructions. It is important that you take Alvesco regularly every day,
even if you feel better.
If you find you need your usual reliever inhaler for acute attacks more than 2-3 times a
week, consult your doctor to review your treatment.

How should I use my Alvesco inhaler?
It is important that a doctor, nurse or pharmacist initially shows you how to
use the Alvesco inhaler correctly. Good technique ensures that the right amount of medicine reaches your lungs. Use the instructions in this leaflet as a reminder.
For the first few times you can practice in front of a mirror, until you are sure you know how to use
the Alvesco inhaler exactly. Make sure the medicine does not escape from the top or sides of your mouth.
If the inhaler is new or has not been used for a week or more, checkits operation
before use. Remove the cap from the mouthpiece and press down on the container
inside the inhaler threetimes to release threetest sprays, away from your face.

Do notshake the Alvesco inhaler before use. The medicine is already in a very fine solution,
mixed so that you receive the correct dose with each puff.
During inhalation you can be either sitting or standing.

Follow these instructions carefully and use the illustrations as a guide.

• 1. Remove the cap from the mouthpiece and check the inside and outside to make sure the mouthpiece is

clean and dry.

• 2. Hold the inhaler upright (bottom of the container at the top), with your index finger on the top of the

container and your thumb on the base, under the mouthpiece.

• 3. Exhaleas much air as possible. Do not exhale into the inhaler

• 4. Put the mouthpiece in your mouth and close your lips tightly around the mouthpiece.
• 5. Immediately after starting to inhale through your mouth, press down on the top of the inhaler to release a puff of medicine, continuing to inhale steadily and deeply. Make sure the puff does not escape from the top, bottom or sides of your mouth.
• 6. Hold your breath, remove the mouthpiece of the inhaler from your mouth and remove your index finger from the top of the

inhaler. Continue to hold your breath for about ten seconds or as long as
possible. Exhale slowly through your mouth. Avoid exhaling into the inhaler.

It is important not to rush steps 3 to 6

• 7. If you have been instructed to take another puff, waitabout half a minute and

repeatsteps 3 to 6.

• 8. After use, always put the cap back on the mouthpiece to protect it from dust. Press until you hear a click.
• 9. For hygiene reasons

• clean the mouthpiece weekly with a drycloth, both inside and outside
• using a dry, folded cloth, wipe the area of the small hole from which the medicine comes
• do notuse water or other liquids A correct technique will ensure that the right amount of Alvesco reaches your lungs every time you use the inhaler. Your doctor will regularly check your inhalation technique to ensure that the treatment can have the best effect. When the container is completely empty, you will not feel or hear the propellant escaping.

If your breathing becomes wheezy or you feel chest tightness after using Alvesco:

• do not take any further puffs.
• use your usual reliever inhaler to improve your breathing.
• contact your doctor immediately.If you have difficulty using the inhaler, your doctor may advise you to use a spacer. The spacer suitable for Alvesco is called AeroChamber Plus. If you use the

AeroChamber Plus device, follow the instructions provided with it. Your doctor or pharmacist will be able
to advise you on this device.

If you use more Alvesco than you should
It is important that you take your dose as it has been established by your doctor.
You should not increase or decrease the dose without medical advice.
If you have used too much Alvesco, no specific treatment is necessary, but you should inform your
doctor. If high doses are used for long periods, some degree of adrenal suppression cannot be ruled out and adrenal function may need to be checked.

If you forget to use Alvesco
If you have forgotten to use the Alvesco inhaler, simply take the next dose at the
scheduled time. Do nottake a double dose to make up for a missed dose.

If you stop using Alvesco
Even if you feel better, you should not stop treatment with the Alvesco inhaler

If you stop treatment with this medicine, contact your doctor immediately.

4. Possible side effects

Like all medicines, Alvesco can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop using this
medicine and contact your doctor immediately:
serious allergic reactions such as swelling of the lips, tongue and throat (may affect up to 1 in 1000 patients treated)
allergic reactions: skin rash, redness, itching or inflammation such as eczema and hives
(may affect up to 1 in 100 patients treated)
coughing or wheezing that gets worse immediately after inhalation (may affect up to 1
in 100 patients treated)
Other side effects reported with Alvesco are generally mild. In most
cases you will be able to continue treatment. The side effects that may occur are:
Uncommon side effects (may affect up to 1 in 100 patients treated):

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

Rare side effects (may affect up to 1 in 1000 patients treated):

• feeling of a racing heartbeat (palpitations)
• feeling unwell or abdominal pain
• high blood pressure

With unknown frequency, but may also occur:

• sleep problems, depression or feeling unwell, restlessness, nervousness, overexcitement or irritability. These effects may more easily occur in children

Alvesco may interfere with the normal production of corticosteroids in the body. This effect
usually occurs in patients who take high doses for long periods of time.
These effects may include:

• delayed growth in adolescents
• thinning of the bones
• possible clouding of the lens of the eye (cataract) with blurred vision
• loss of vision caused by abnormally high pressure inside the eye (glaucoma)
• moon-shaped face, weight gain in the upper part of the body and thinning of arms and legs (cushingoid features or Cushing's syndrome). Adolescents receiving treatment for long periods should be regularly checked by the doctor regarding height. If growth is slowed, the doctor will adjust the treatment if possible to the lowest dose that ensures adequate asthma control. Corticosteroid tablets may give more side effects than inhaled corticosteroids such as Alvesco. If you have taken steroid tablets before or at the same time as Alvesco, the risk of side effects from the tablets may persist for a certain period of time. Regular visits to the doctor will ensure that the dose of Alvesco you are taking is correct. Regular visits also allow for early identification of any side effects and reduce the possibility that they become more severe.

Remember:
If any of the side effects gets worse, or if you notice any side effect

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at the address:

www.agenziafarmaco.gov.it/it/responsabili.By reporting side effects you can help
provide more information on the safety of this medicine

5. How to store Alvesco

Keep Alvesco out of the sight and reach of children.
Do not use the inhaler after the expiry date which is stated on the label and the package after
EXP. The expiry date refers to the last day of the month.

The device contains a pressurized solution. Do not expose to temperatures above
50°C.
The container must not be punctured, broken or burned even if it appears empty.
As with most medicines in pressurized containers, the therapeutic effect of this
medicine may decrease when the container is cold. However Alvesco delivers the same dose from
minus 10°C to plus 40°C.
If your doctor decides to stop your treatment or if the inhaler is empty, return it to the pharmacist
for safe disposal. This is important because traces of
medicine may remain in the container even if you think it is empty.

6. Package Contents and Other Information

What Alvesco contains

• The active substanceis ciclesonide. Each time the inhaler is pressed, a spray (dose released through the mouthpiece) containing 80 or 160 micrograms of ciclesonide is generated
• The excipientsare anhydrous ethanol and propellant (HFA-134a, Norflurane).

Description of the appearance of Alvesco and package contents
Alvesco consists of a clear and colorless liquid in a pressurized aluminum container that
releases a precisely measured dose of ciclesonide in the form of a spray through a mouthpiece.

Pack sizes:
Inhaler with 30 doses
Inhaler with 60 doses
Inhaler with 120 doses
For each dosage, the inhaler contains enough for 30, 60 or 120 doses.
Depending on the number of sprays per day recommended by your doctor:

• the inhaler with 30 doses contains enough medicine for two to four weeks
• the inhaler with 60 doses contains enough medicine for one to two months
• the inhaler with 120 doses contains enough medicine for two to four months

Not all pack sizes may be marketed.

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

Manufacturer
Takeda GmbH
Byk-Gulden-Strasse 2
78467 Konstanz, Germany
AstraZeneca AB
Global External Sourcing (GES)
Astraallén, Gärtunaporten
SE-15185 Södertälje
Sweden

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Austria Alvesco 160<80>Mikrogramm –Dosieraerosol
Bulgaria Alvesco 160<80>micrograms pressurised inhalation, solution
Cyprus Alvesco 160<80>micrograms, pressurised inhalation solution
Croatia Alvesco 160<80>mikrograma stlačeni inhalat otopina
Czech Republic Alvesco 160 Inhaler
Denmark Alvesco 160<80>mikrogram, inhalationsspray, opløsning
Finland Alvesco 160<80>mikrog/ annos inhalaatiosumute, liuos
France Alvesco 160<80>microgrammes/dose solution pour inhalation en flacon
pressurisé
Germany Alvesco 160<80>Mikrogramm, Druckgasinhalation, Lösung
Greece Alvesco 80 and 160 micrograms, solution for inhalation under pressure
Hungary Alvesco 160<80>mikrogramm túlnyomásos inhalációs oldat
Ireland Alvesco 160<80>micrograms pressurised inhalation solution
Italy Alvesco 160<80>mcg pressurised inhalation solution
Latvia Alvesco 160<80>aerosols inhalācijām, zem spiediena, šķīdums
Netherlands Alvesco 160<80>Inhalator
Norway Alvesco 160<80>micrograms/dose inhalasjonsaerosol, oppløsning
Poland Alvesco 160<80>
Romania Alvesco 160<80>Inhaler, solutie de inhalat presurizata 160 micrograme /
doza
Slovakia Alvesco 160<80>Inhalátor
Slovenia Alvesco 160<80>mikrogramov inhalacijska raztopina pod tlakom
Spain Alvesco160 microgramos/ inhalación solución para inhalación en envase a
presión
Sweden Alvesco 160<80>microgram/dos inhalationsspray, lösning
United Kingdom Alvesco 160<80>Inhaler

This leaflet was last updated on