Asmanex

Package leaflet: Information for the user

Asmanex 200 micrograms inhalation powder

mometasone furoate
Please read this leaflet carefully before you use this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Asmanex is and what it is used for
2. What you need to know before using Asmanex
3. How to use Asmanex
4. Possible side effects
5. How to store Asmanex
6. Contents of the pack and other information

1. What Asmanex is and what it is used for

Asmanex contains the active substance mometasone furoate, which belongs to a group of medicines called corticosteroids, or steroids as they are more commonly known.
Corticosteroids should not be confused with the "anabolic" steroids that some athletes misuse. Corticosteroids are used to prevent asthma attacks due to their anti-inflammatory effect. They reduce swelling and irritation in the walls of the small airways in the lungs. This helps to relieve breathing difficulties.
Asmanex is used regularly to control asthma in adults and adolescents aged 12 years and older. It may be prescribed to you if you have never previously used steroids, or if your asthma is not controlled with other medicines. It may also be used if you are already taking other types of oral or inhaled steroids to control your asthma. When used regularly, Asmanex helps control asthma and prevent asthma attacks. This is a preventive medicine. Do not use this medicine to treat a sudden asthma attack. Always carry with you the bronchodilator (“reliever inhaler”) prescribed by your doctor, to use in case you have an asthma attack.

2. What you need to know before using Asmanex

Do not use Asmanex

• if you are allergic to mometasone furoate, to any other steroid, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Asmanex if:

• you have or have had tuberculosis (TB)
• you have an eye infection caused by the herpes simplex virus or any other type of infection
• you have developed oral thrush (white patches in the mouth or throat), which may require treatment. Your doctor may also advise you to stop treatment with Asmanex for a period of time or may decide to switch you to a different type of inhaler. After

inhaling the dose, rinse your mouth with water or mouthwash and spit it out without
swallowing. This will help prevent the development of oral thrush.
Contact your doctor if you experience blurred vision or any other visual disturbances.
Important information to remember when using Asmanex

• Seek immediate medical help if you experience shortness of breath or difficulty breathing shortly after taking Asmanex. These symptoms may indicate an “allergic” reaction to the medicine.
• Always carry a reliever bronchodilator inhaler (“reliever inhaler”) to quickly relieve asthma attack symptoms (such as coughing, shortness of breath, and chest tightness).
• If you have an asthma attack and your symptoms do not improve after using your “reliever” inhaler, or if your peak flow readings drop (your doctor will tell you what your personal peak flow numbers should be), seek immediate medical help. Inform your doctor about worsening asthma and the need to change your treatment.
• You may need to take steroid tablets or syrup during a severe asthma attack, other illnesses, or periods of stress. Your doctor may prescribe steroid tablets or syrup for you to carry with you and may provide you with a card containing instructions on when and how to use steroids.
• If you are using Asmanex and are reducing the dose of steroid tablets or syrup, you may start experiencing symptoms such as itching, watery eyes, or rash that were previously controlled. Your doctor will advise you on how to manage these symptoms. Inform your doctor if during this period you begin to notice joint or muscle pain, feelings of depression, fatigue, or lethargy.
• While being treated with inhaled corticosteroids, avoid contact with people who have measles or chickenpox. Inform your doctor if you come into contact with someone who has these infections. This is particularly important for children.
• Treatment with medicines like Asmanex may affect the normal levels of steroids in your body. One effect of this may be slowed growth in adolescents who are treated with this medicine over long periods. Your doctor will likely monitor your height from time to time.
• All steroids, especially when used long-term, may affect the function of the adrenal glands. Your doctor may perform appropriate tests to monitor this.
• Remember to bring this medicine, as well as any other medicines you are currently taking, with you if you go to the hospital.
• Your doctor may perform lung function tests during your treatment, especially if you are about to stop taking oral corticosteroid tablets.

Children and adolescents
There are no available data and it should not be used in children under 12 years of age.
Other medicines and Asmanex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This includes medicines used to treat fungal or viral infections, such as ketoconazole, itraconazole, ritonavir, nelfinavir, or cobicistat. These medicines may increase steroid levels in your blood.
Some medicines may increase the effects of Asmanex, and your doctor may wish to monitor you closely if you are taking any of these.
It is also important to inform your doctor before starting Asmanex if you are taking other steroids by injection, orally, or by inhalation. Your doctor will advise you on adjusting the dose of these other steroids.
Pregnancy and breastfeeding
If you are pregnant, planning a pregnancy, or breastfeeding, consult your doctor.
Driving and using machines
It is unlikely that Asmanex will affect your ability to drive or operate machinery.
Asmanex contains lactose
This medicine contains small amounts of lactose (4.64 mg/day is the maximum recommended daily dose). This amount is unlikely to cause problems in individuals with lactose intolerance.

3. How to use Asmanex

Make sure you know how to use the inhaler correctly. Be careful not to drop the inhaler, as this may cause it to malfunction. If in doubt, ask your doctor or pharmacist. Ensure you know when and how many doses of the medicine to inhale. Your doctor will advise you accordingly; instructions are also provided on the label. Always take this medicine exactly as directed by your doctor or pharmacist. Do not change the dose without consulting your doctor. If you have any doubts, consult your doctor or pharmacist.

For adults (including patients over 65 years of age) and adolescents aged 12 years and older with mild to moderate asthma, the recommended starting dose is 400 micrograms (1 dose or inhalation) once daily in the evening, using Asmanex 400 micrograms inhalation powder. However, for some patients, the starting dose may be 200 micrograms (1 dose or inhalation) twice daily, using Asmanex 200 micrograms inhalation powder. Once asthma is under control, your doctor may reduce the dose to 200 micrograms (1 dose or inhalation of Asmanex 200 micrograms inhalation powder) once daily in the evening. Depending on symptoms, your doctor may increase or decrease the daily dose to maintain asthma control.

For patients with severe asthma who are taking other steroid tablets or syrup, the usual starting dose of Asmanex is 400 micrograms twice daily; this is the maximum recommended dose. After approximately one week of treatment with Asmanex, your doctor may begin to gradually reduce the dose of the other corticosteroid, eventually stopping it completely. The dose of Asmanex may then be reduced if asthma remains well controlled.

Instructions for proper use of the inhaler

Remember that Asmanex delivers a very fine powder that must be inhaled into the lungs. You must be in an upright position when using the inhaler. Follow these instructions carefully to ensure you receive the correct dose.

Before removing the white cap, ensure that the dose indicator and the pointer on the cap are aligned. To open the inhaler, remove the white cap. Hold the inhaler upright with the pink base facing downwards. Hold the base and turn the cap counterclockwise to remove it. Once the cap is removed, the inhaler’s dose counter will begin counting down one number at a time.

Ensure that the dose indicator on the pink base and the pointer above it are aligned. After removing the cap, keep the inhaler upright before inhaling the dose.

To inhale the dose:

a) Remove the cap from the inhaler [Figure 1];
b) Bring the inhaler to your mouth, with the mouthpiece facing towards you;
c) Place the inhaler’s mouthpiece into your mouth, close your lips around it, and then inhale quickly and deeply [Figure 2];
d) Remove the inhaler from your mouth and hold your breath for about 10 seconds, or as long as possible. Do not exhale through the inhaler.
e) To close the inhaler, immediately replace the cap after each inhalation. The cap must be fully replaced and screwed on to load the next dose. To do this, screw the cap clockwise while gently pressing until you hear a click; the cap will then be fully closed [Figure 3]. The arrow on the cap must be exactly aligned with the dose window [Figure 4].

Figure 1 Figure 2 Figure 3 Figure 4
Removing the cap Inhalation Closing the inhaler Inhaler closed

After taking the dose, rinse your mouth with water or mouthwash and spit it out—do not swallow. This will help prevent the development of oral thrush.

Keep the inhaler clean and dry at all times. Clean the outside of the mouthpiece with a dry cloth. Do not wash the inhaler or allow it to come into contact with water.

At the base of the inhaler there is a viewing window containing a dose counter. This counter shows the number of doses remaining in the inhaler. Do not use Asmanex if the dose counter is not working properly. Consult your doctor or pharmacist.

When "01" appears in the viewing window, this means only one dose remains in the inhaler. After dose "01", the counter will show "00", the cap will close, and the inhaler will no longer be usable. Dispose of the inhaler at this point.

To ensure you always have sufficient medication available, ask your doctor for a new prescription before the inhaler runs out.

There is no fixed timeframe for how quickly the treatment will work. Some patients experience symptom relief within 24 hours of starting treatment, while others may not achieve maximum benefit for one to two weeks or longer. Your doctor will determine the duration of treatment with Asmanex.

If you use more Asmanex than you should:

It is important that you take the dose as indicated on the pharmacist’s label or as advised by your doctor. Do not increase or decrease the dose without consulting your doctor. Inform your doctor if you accidentally take a higher dose than prescribed.

If you forget to take Asmanex:

If you miss a dose of Asmanex, take the next dose as scheduled. Do not take a double dose to make up for the missed dose.

If you stop using Asmanex:

Do not stop treatment with Asmanex abruptly, even if your asthma seems to have improved. Discuss this with your doctor first.

If you stop treatment earlier than prescribed by your doctor, symptoms may return. If you feel that your asthma is not improving or is worsening after starting Asmanex, consult your doctor.

If you have any questions about using this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Asmanex and contact your doctor immediately if you experience any of the following
symptoms:
Symptoms of a severe allergic reaction include swelling of the eyes, face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing, itchy rash, feeling faint or dizzy, which may lead to collapse.
If you notice an increase in coughing, breathlessness, difficulty breathing or shortness of breath immediately after inhaling the medicine, use your "reliever" inhaler and contact your doctor immediately. Do not use Asmanex again until you have consulted your doctor.
You may have an allergic reaction (hypersensitivity) to inhaled steroids. In this case, you may notice the appearance of a rash, itching, redness and swelling of the eyes, face, lips or throat. Contact your doctor immediately if you experience any of these symptoms. Do not use Asmanex until you have consulted your doctor.
The most commonly reported side effects include candida infection (thrush) in the mouth or throat (which appears as white patches), hoarseness, sore throat or headache. Contact your doctor immediately if you develop any of these side effects.
Other uncommon side effects (may affect up to 1 in 100 people) include dryness of the mouth and throat, indigestion, weight gain, and fast or pounding heartbeat (palpitations). Consult your doctor if you notice any of these symptoms.
Rarely (may affect up to 1 in 1,000 people), patients using inhaled steroids, including Asmanex, may develop increased eye pressure (including glaucoma) or cataracts. Not known (frequency cannot be estimated from the available data): blurred vision.
Consult your doctor if your vision becomes blurred or if you experience eye pain.
Other possible side effects of steroids include slowed or impaired growth in adolescents and thinning of the bones. Inhaled corticosteroids may also cause sleep disturbances, depression or feelings of anxiety, restlessness, nervousness, excitability or irritability. These effects are more likely to occur in children. Steroids may also affect the adrenal gland, causing weakness, fatigue or dizziness and fainting when standing for long periods or when standing up. These effects are much less likely to occur with inhaled corticosteroids than with oral steroids.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Asmanex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, aluminium pouch, and label after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
Store each inhaler in the original packaging to protect the medicine from moisture until the time of use, and use within 3 months of first opening. Open only one inhaler at a time.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Asmanex contains

• The active substance is mometasone furoate. Each inhalation contains 200 micrograms.
• The only other ingredient is anhydrous lactose (which contains traces of milk proteins).

Description of the appearance of Asmanex and contents of the pack
The inhaler mouthpiece is white, with a pink base featuring a viewing window that displays the number of inhalations remaining in the inhaler. The inhalers contain either 30 or 60 inhalations (doses), and each pack contains either one inhaler enclosed in a bag (for both 30- and 60-dose inhalers) or three individually packaged inhalers enclosed together in a bag (only for 60-dose inhalers). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Italy

Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Asmanex Twisthaler
Belgium: Asmanex Twisthaler 200 microgrammes Poudre pour inhalation
Denmark: Asmanex Twisthaler 200 mikrogram inhalationspulver
Finland: Asmanex Twisthaler
France: Asmanex Twisthaler 200 microgrammes/dose, poudre pour inhalation
Germany: Asmanex Twisthaler 200 Mikrogramm Pulver zur Inhalation
Greece: Asmanex Twisthaler
Iceland: Asmanex Twisthaler, 200 míkróg. Innöndunarduft
Ireland: Asmanex Twisthaler 200 micrograms Inhalation Powder
Italy: Asmanex 200 microgrammi polvere per inalazione
Norway: Asmanex Twisthaler
Portugal: Asmanex Twisthaler
Spain: Asmanex Twisthaler 200 microgramos polvo para inhalación
Sweden: Asmanex Twisthaler
United Kingdom: Asmanex Twisthaler 200 micrograms Inhalation Powder

Patient Information Leaflet: Information for the User

Asmanex 400 microgram powder for inhalation

mometasone furoate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Asmanex is and what it is used for
2. What you need to know before using Asmanex
3. How to use Asmanex
4. Possible side effects
5. How to store Asmanex
6. Contents of the pack and other information

1. What Asmanex is and what it is used for

Asmanex contains the active substance mometasone furoate, which belongs to a group of medicines called corticosteroids, more commonly known as steroids.
Corticosteroids must not be confused with "anabolic" steroids, which some athletes misuse. Corticosteroids are used to prevent asthma attacks due to their anti-inflammatory effect. They reduce swelling and irritation in the walls of the small airways in the lungs. This helps to relieve breathing problems.
Asmanex is used regularly to control asthma in adults and adolescents aged 12 years and older. It may be prescribed for you if you have never previously used steroids, and if your asthma is not controlled by other medicines. It may also be used if you are already taking other types of oral or inhaled steroids to control your asthma. When used regularly, Asmanex helps control asthma and prevent asthma attacks. It is a preventive medicine. Do not use this medicine to treat sudden asthma attacks. Always carry with you the bronchodilator ("reliever inhaler") prescribed by your doctor, to use in case you have an asthma attack.

2. What you need to know before using Asmanex

Do not use Asmanex

• if you are allergic to mometasone furoate, to any other steroid, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Asmanex if:

• you suffer from or have previously suffered from tuberculosis (TB)
• you have an infection with herpes simplex (virus) of the eye or any other type of infection
• you have developed oral thrush (white patches in the mouth or throat) which may require treatment. Your doctor may also advise you to stop treatment with Asmanex for a period of time, or may decide to switch you to a different type of inhaler. After

inhaling the dose, rinse your mouth with water or a mouthwash and spit it out without
swallowing. This will help prevent the development of oral thrush.
Contact your doctor if you experience blurred vision or other visual disturbances.
Important information to remember when using Asmanex

• Seek immediate medical help if you experience breathlessness or difficulty breathing shortly after taking Asmanex. These symptoms may indicate an "allergic" reaction to the medicine.
• Always carry with you a bronchodilator inhaler (a "reliever inhaler") to quickly relieve symptoms of an asthma attack (such as coughing, breathlessness, and tightness in the chest).
• If you have an asthma attack and your symptoms do not improve after using your "reliever" inhaler, or if your peak flow readings drop (your doctor will tell you your personal best peak flow number), seek immediate medical help. Inform your doctor about worsening asthma and the need to change your treatment.
• You may need to take steroid tablets or syrup during a severe asthma attack, other illnesses, or periods of stress. Your doctor may prescribe steroid tablets or syrup for you to keep on hand and may provide you with a card containing instructions on when and how to use the steroids.
• If you are taking Asmanex and are reducing the dose of steroid tablets or syrup, you may start to experience symptoms such as itching, watery eyes, or rash, which were previously under control. Your doctor will advise you on how to manage these symptoms. Inform your doctor if during this time you begin to notice joint or muscle pain, feelings of depression, tiredness, or lethargy.
• While being treated with inhaled corticosteroids, avoid contact with people who have measles or chickenpox. Inform your doctor if you come into contact with someone who has one of these infections. This is particularly important for children.
• Treatment with medicines such as Asmanex may affect the normal levels of steroids in your body. One effect of this may be slowed growth in adolescents who are treated with this medicine for long periods. Your doctor will likely monitor your height from time to time.
• All steroids, especially if used for long periods, may affect the function of the adrenal gland. Your doctor may carry out appropriate tests to check this.
• Remember to bring this medicine, as well as any other medicines you are currently taking, with you if you go to hospital.
• Your doctor may perform a lung examination during your treatment, especially if you are about to stop taking oral corticosteroid tablets.

Children and adolescents
There are no available data, and Asmanex must not be used in children under 12 years of age.
Other medicines and Asmanex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This includes medicines used to treat fungal or viral infections, such as ketoconazole, itraconazole, ritonavir, nelfinavir, or cobicistat. These medicines may increase the level of steroids in your blood.
Some medicines may increase the effects of Asmanex, and your doctor may wish to monitor you closely if you are taking these medicines.
Before starting to use Asmanex, it is also important to inform your doctor if you are taking other steroids by injection, orally, or by inhalation. Your doctor will advise you on how to adjust the dose of these other steroids.
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor.
Driving and using machines
It is unlikely that Asmanex will affect your ability to drive or operate machinery.
Asmanex contains lactose
This medicine contains small amounts of lactose (4.64 mg/day is the maximum recommended daily dose). This amount is unlikely to cause problems in individuals with lactose intolerance.

3. How to use Asmanex

Make sure you know how to use the inhaler correctly. Be careful not to drop the inhaler, as this may cause it to malfunction. If in doubt, ask your doctor or pharmacist. Ensure you know when and how many doses of the medicine to inhale. Your doctor will advise you accordingly; instructions are also provided on the label. Always take this medicine exactly as instructed by your doctor or pharmacist. Do not change the dose without consulting your doctor. If you have any doubts, consult your doctor or pharmacist.

For adults (including patients over 65 years of age) and adolescents aged 12 years and older with mild to moderate asthma, the recommended starting dose is 400 micrograms (1 dose or inhalation) once daily in the evening, using Asmanex 400 micrograms inhalation powder. However, for some patients, the starting dose may be 200 micrograms (1 dose or inhalation) twice daily, using Asmanex 200 micrograms inhalation powder. Once asthma is under control, your doctor may reduce the dose to 200 micrograms (1 dose or inhalation of Asmanex 200 micrograms inhalation powder) once daily in the evening. Depending on symptoms, your doctor may adjust the daily dose up or down to maintain asthma control.

For patients with severe asthma who are taking other steroid tablets or syrup, the usual starting dose of Asmanex is 400 micrograms twice daily; this is the maximum recommended dose. After approximately one week of treatment with Asmanex, your doctor may begin to very gradually reduce the dose of the other corticosteroid, eventually stopping it completely. The dose of Asmanex may then be reduced if asthma remains well controlled.

Instructions for proper use of the inhaler

Remember that Asmanex delivers a very fine powder that must be inhaled into the lungs. You must be in an upright position when using the inhaler. Follow these instructions carefully to ensure you receive the correct dose.

Before removing the white cap, ensure that the dose indicator and pointer on the cap are aligned. To open the inhaler, remove the white cap. Hold the inhaler upright with the brownish-red base facing downwards. Hold the base and turn the cap counterclockwise to remove it. Once the cap is removed, the inhaler’s dose counter will begin counting down by one.

Ensure that the dose indicator on the brown base and the pointer above it are aligned. After removing the cap, keep the inhaler upright before inhaling the dose.

To inhale the dose:

a) Remove the cap from the inhaler [Figure 1];
b) Bring the inhaler to your mouth, with the mouthpiece facing towards you;
c) Place the inhaler’s mouthpiece into your mouth, close your lips around it, then inhale quickly and deeply [Figure 2];
d) Remove the inhaler from your mouth and hold your breath for about 10 seconds, or as long as possible. Do not exhale through the inhaler.
e) To close the inhaler, immediately replace the cap after each inhalation. The cap must be fully replaced and screwed on to prepare the next dose. To do this, screw the cap clockwise while gently pressing until you hear a click; the cap will then be fully closed [Figure 3]. The arrow on the cap must be exactly aligned with the dose window [Figure 4].

Figure 1 Figure 2 Figure 3 Figure 4
Removing the cap Inhalation Closing the inhaler Inhaler closed

After taking the dose, rinse your mouth with water or mouthwash and spit it out—do not swallow. This will help prevent the development of oral thrush.

Keep the inhaler clean and dry at all times. Clean the outside of the mouthpiece with a dry cloth. Do not wash the inhaler and avoid contact with water.

At the base of the inhaler there is a viewing window containing a dose counter. This counter shows the number of doses remaining in the inhaler. Do not use Asmanex if the dose counter is not working properly. Take it to your doctor or pharmacist.

When "01" appears in the viewing window, this means only one dose remains in the inhaler. After the "01" dose, the counter will show "00", the cap will close, and the inhaler can no longer be used. Discard the inhaler at this point.

To ensure you always have sufficient medicine available, ask your doctor for a new prescription before the inhaler runs out.

There is no fixed timeframe for how quickly the treatment will work. Some patients experience symptom relief within 24 hours of starting treatment, while others may not achieve maximum benefit for one to two weeks or longer. Your doctor will determine the duration of treatment with Asmanex.

If you use more Asmanex than you should:
It is important that you take the dose as indicated on the pharmacist’s label or as advised by your doctor. Do not increase or decrease the dose without consulting your doctor. Inform your doctor if you have accidentally taken a higher dose than prescribed.

If you forget to take Asmanex:
If you miss a dose of Asmanex, take the next dose as scheduled. Do not take a double dose to make up for the missed one.

If you stop using Asmanex:
Do not stop treatment with Asmanex suddenly, even if your asthma seems to have improved. Discuss this with your doctor first.
If you stop treatment earlier than prescribed by your doctor, your symptoms may return. If you feel that your asthma is not improving or is getting worse after starting treatment with Asmanex, consult your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Asmanex and contact your doctor immediately if you experience any of the
following symptoms:
Symptoms of a severe allergic reaction include swelling of the eyes, face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing, itchy rash, feeling faint or dizzy, which may lead to collapse.
If you notice an increase in coughing, breathlessness, difficulty breathing or shortness of breath immediately after inhaling the medicine, use your "reliever" inhaler and contact your doctor immediately. Do not use Asmanex again until you have consulted your doctor.
You may have an allergic reaction (hypersensitivity) to inhaled steroids. In this case, you may notice a rash, itching, redness or swelling of the eyes, face, lips or throat. Contact your doctor immediately if you experience any of these symptoms. Do not use Asmanex until you have consulted your doctor.
The most commonly reported side effects include candida infection (thrush) in the mouth or throat (which appears as white patches), hoarseness, sore throat or headache. Contact your doctor immediately if you develop any of these side effects.
Other uncommon side effects (may affect up to 1 in 100 people) include dryness of the mouth and throat, indigestion, weight gain and fast or pounding heartbeat (palpitations). Consult your doctor if you notice any of these symptoms.
Rarely (may affect up to 1 in 1,000 people), patients using inhaled steroids, including Asmanex, may develop increased eye pressure (including glaucoma) or cataracts.
Not known (frequency cannot be estimated from the available data): blurred vision.
Consult your doctor if you experience blurred vision or eye pain.
Other possible side effects of steroids include slowed or impaired growth in adolescents and thinning of the bones. Inhaled corticosteroids may also cause sleep problems, depression or feelings of anxiety, restlessness, nervousness, excitability or irritability. These effects are more likely to occur in children. Steroids may also affect the adrenal gland, causing weakness, fatigue or dizziness and fainting when standing for long periods or when standing up. These effects are much less likely to occur with inhaled corticosteroids than with oral steroids.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Asmanex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, aluminium pouch, and label after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
Store each inhaler in its original packaging to protect the medicine from moisture until the time of use, and then use within 3 months of first opening. Open only one inhaler at a time.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Asmanex contains

• The active substance is mometasone furoate. Each inhalation contains 400 micrograms.
• The only other ingredient is anhydrous lactose (which contains traces of milk proteins).

Description of the appearance of Asmanex and contents of the pack
The mouthpiece of the inhaler is white, with a reddish-brown base equipped with a viewing window
that displays the number of inhalations remaining in the inhaler. The inhalers contain 14, 30, or
60 inhalations (doses). Each package contains either one inhaler enclosed in a bag (for each of the
14-, 30-, or 60-dose inhalers) or three individually packaged inhalers enclosed together in a
bag (only for the 60-dose inhalers). Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Austria: Asmanex Twisthaler
Belgium: Asmanex Twisthaler 400 microgrammes Poudre pour inhalation
Denmark: Asmanex Twisthaler 400 mikrogram inhalationspulver
Finland: Asmanex Twisthaler
France: Asmanex Twisthaler 400 microgrammes/dose, poudre pour inhalation
Germany: Asmanex Twisthaler 400 Mikrogramm Pulver zur Inhalation
Greece: Asmanex Twisthaler
Iceland: Asmanex Twisthaler, 400 míkróg. Innöndunarduft
Ireland: Asmanex Twisthaler 400 micrograms Inhalation Powder
Italy: Asmanex 400 micrograms inhalation powder
Norway: Asmanex Twisthaler
Portugal: Asmanex Twisthaler
Spain: Asmanex Twisthaler 400 microgramos polvo para inhalación
Sweden: Asmanex Twisthaler
United Kingdom: Asmanex Twisthaler 400 micrograms Inhalation Powder