ASMANEX 400 mcg/dose Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Asmanex Twisthaler, 400 micrograms/dose, inhalation powder
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Asmanex Twisthaler and what is it used for
4. Important information before using Asmanex Twisthaler
   1. When not to use Asmanex Twisthaler
   2. Warnings and precautions
   3. Important information to remember while using Asmanex Twisthaler
   4. Children and adolescents
   5. Asmanex Twisthaler and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Asmanex Twisthaler contains lactose
5. How to use Asmanex Twisthaler
   1. Do not change the dose of the medicine without your doctor's clear recommendation.
   2. Instructions for proper use of the inhaler
   3. Using a higher dose of Asmanex Twisthaler than recommended
   4. Missing a dose of Asmanex Twisthaler
   5. Stopping treatment with Asmanex Twisthaler
   6. Do not stop using Asmanex Twisthaler suddenly, even if you feel better.
   7. Contact your doctor first.
6. Possible side effects
   1. Stop using Asmanex Twisthaler and contact your doctor immediately if you experience any of the following symptoms:
   2. Reporting side effects
7. How to store Asmanex Twisthaler
8. Contents of the pack and other information
   1. What Asmanex Twisthaler contains
   2. What Asmanex Twisthaler looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the package leaflet: 11/2022

Package Leaflet: Information for the Patient

Asmanex Twisthaler, 400 micrograms/dose, inhalation powder

Mometasone furoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of Contents of the Package Leaflet

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

1. What is Asmanex Twisthaler and what is it used for

Asmanex Twisthaler contains the active substance mometasone furoate, which belongs to a group of medicines called corticosteroids or steroids.
Do not confuse corticosteroids with anabolic steroids, which are misused by some athletes. Corticosteroids have anti-inflammatory properties and are used to prevent asthma attacks. They reduce swelling and irritation of the airways, making it easier to breathe.
Regular use of Asmanex Twisthaler helps control asthma symptoms in adults and adolescents aged 12 and over. The medicine can be used in patients who have not previously been treated with steroids, or in those whose asthma is not controlled with other medicines. It can also be given to patients who are already taking other steroids, either orally or by inhalation, for the treatment of asthma.
Regular use of Asmanex Twisthaler helps control asthma symptoms and prevents sudden asthma attacks. The medicine is used preventively. Do not use this medicine to stop a sudden asthma attack. You should always carry a prescribed bronchodilator (inhaler that makes breathing easier) with you in case of an asthma attack.

2. Important information before using Asmanex Twisthaler

When not to use Asmanex Twisthaler

Warnings and precautions

Before starting treatment with Asmanex Twisthaler, discuss with your doctor or pharmacist if you:

• currently have or have had tuberculosis in the past,
• have an eye infection (viral infection) or any other type of infection,
• have thrush (white patches in the mouth and throat), as you may need appropriate treatment. Your doctor may recommend stopping Asmanex Twisthaler for a while or using another inhaler. After using the medicine, rinse your mouth with water or mouthwash and spit it out, do not swallow. This can help prevent thrush.
• If you experience blurred vision or other vision disturbances, contact your doctor.

Important information to remember while using Asmanex Twisthaler

• If you experience sudden wheezing and difficulty breathing shortly after using Asmanex Twisthaler, call emergency services or go to the emergency department of the nearest hospital. These symptoms may indicate an allergic reaction to the medicine.
• Always carry a prescribed bronchodilator (inhaler that makes breathing easier) with you to quickly relieve bronchospasm or asthma attacks (coughing, wheezing, and chest tightness).
• If you experience an asthma attack that does not improve with the use of a bronchodilator (inhaler that makes breathing easier) or if your peak expiratory flow rate decreases, call emergency services or go to the emergency department of the nearest hospital. Inform your doctor, as this may indicate worsening asthma and a change in treatment may be necessary.
• In case of a severe asthma attack, other illnesses, or stress, you may need to take a steroid in the form of tablets or syrup. Your doctor may recommend that you always carry a certain amount of steroid tablets or syrup with you, along with an information card containing dosage instructions and guidelines on when to use the oral steroid.
• If you are using Asmanex Twisthaler and reducing the dose of steroids you are taking in the form of tablets or syrup, you may experience allergic reactions that have not occurred before, such as itching, excessive tearing, or rash. In this case, your doctor will recommend appropriate action to control these symptoms. If you experience joint or muscle pain, depression, fatigue, or significant slowing down during this period, inform your doctor.
• While using Asmanex Twisthaler, avoid contact with people who have chickenpox or shingles. If you come into contact with someone who has one of these illnesses, inform your doctor. This is especially important for children.
• The use of medicines like Asmanex Twisthaler may disrupt the normal production of steroids in the body. As a result, long-term treatment in adolescents may lead to growth retardation. In adolescents taking the medicine, the doctor will likely periodically monitor growth.
• All steroids, especially when used for a long time, can disrupt the function of the adrenal gland. Therefore, your doctor will regularly perform blood tests to monitor adrenal function.
• If you are going to be hospitalized, take Asmanex Twisthaler and any other medicines you are taking with you.
• Your doctor may perform lung function tests while you are using Asmanex Twisthaler, especially if you are stopping the use of oral corticosteroids.

Children and adolescents

Due to the lack of available data, Asmanex Twisthaler should not be used in children under 12 years of age.

Asmanex Twisthaler and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription, as well as medicines used to treat fungal or viral infections, such as ketoconazole, itraconazole, ritonavir, nelfinavir, or cobicistat. These medicines may increase the levels of mometasone furoate in your blood.
Some medicines may enhance the effect of Asmanex Twisthaler, and your doctor may want to monitor your condition closely while you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
It is especially important to inform your doctor before starting treatment with Asmanex Twisthaler if you are taking corticosteroids, either by injection, orally, or by inhalation. Your doctor will adjust the dose of these corticosteroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Do not use Asmanex Twisthaler in pregnant women unless your doctor has clearly recommended it.
There is no data on the passage of the medicine into breast milk. Do not breastfeed while using this medicine unless your doctor has clearly recommended it.

Driving and using machines

Asmanex Twisthaler has no or negligible influence on the ability to drive and use machines.

Asmanex Twisthaler contains lactose

The medicine contains small amounts of lactose (the maximum recommended daily dose contains 4.64 mg of lactose). This amount of lactose usually does not cause problems in patients with lactose intolerance.

3. How to use Asmanex Twisthaler

You must be sure that you can use the Twisthaler inhaler correctly. If you are unsure, contact your doctor or pharmacist. Before using the medicine, make sure you know when and how many doses to use. Your doctor should inform you how to use Asmanex Twisthaler. Read the instructions for using the inhaler. Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

Do not change the dose of the medicine without your doctor's clear recommendation.

In adults (including those over 65 years of age) and adolescents aged 12 and over with mild or moderate asthma, the recommended initial dose is 400 micrograms (1 inhalation) once daily, in the evening.
In some patients, the initial dose may be 200 micrograms (1 inhalation of Asmanex Twisthaler 200 micrograms/dose, inhalation powder) twice daily.
If there is an improvement, your doctor may reduce the dose to 200 micrograms (1 inhalation of Asmanex Twisthaler 200 micrograms/dose, inhalation powder) once daily, in the evening.
Depending on the symptoms, your doctor may increase or decrease the daily dose to keep asthma symptoms under control.
In patients with severe asthma who may also be taking other steroids in the form of tablets or syrup, the usual initial dose of Asmanex Twisthaler is 400 micrograms twice daily. This is the maximum recommended dose. After about one week of using Asmanex Twisthaler, your doctor may recommend gradually reducing the dose of the other corticosteroid, until it is completely stopped. If asthma symptoms are well-controlled, it may also be possible to reduce the dose of Asmanex Twisthaler.

Instructions for proper use of the inhaler

Remember that the fine powder released from the Twisthaler inhaler must be inhaled into the lungs. Stand upright while using the Twisthaler inhaler. Follow the instructions below carefully to use the inhaler correctly.
Before removing the white cap, make sure the counter and the arrow on the cap are in line.
To open the inhaler, remove the white cap. Hold the inhaler upright with the brown base down. Grip the base and twist the cap counterclockwise. After removing the cap, the dose counter on the inhaler will count down by one.
Make sure the counter on the brown base and the arrow on the upper counter are in line. When the cap is removed and before administering the dose, hold the inhaler upright.
To inhale the dose, follow these steps:
a)
Remove the cap from the inhaler (Figure 1.).
b)
Bring the inhaler to your mouth, with the mouthpiece facing you.
c)
Place the mouthpiece in your mouth, close your lips around it, and take a quick, deep breath (Figure 2.).
d)
Remove the inhaler from your mouth and hold your breath for about 10 seconds or as long as you can. Do not breathe out through the inhaler.
e)
To close the inhaler, replace the cap immediately after each inhalation.
To load a new dose, put the cap back on and twist it clockwise while gently pressing down until you hear a "click", which means the cap is fully closed (Figure 3.). The arrow on the cap must be fully in line with the counter window (Figure 4.).

Figure 1.
Figure 2.
Figure 3.
Figure 4.
After using the medicine, rinse your mouth with water or mouthwash and spit it out, do not swallow. This can help prevent thrush.
The inhaler should always be kept dry and clean. Clean the mouthpiece with a dry cloth or tissue. Do not wash the inhaler, and avoid contact with water.
The inhaler has a counter window that shows the number of doses left. Do not use Asmanex Twisthaler if the counter readings are not correct. In this case, contact your doctor or pharmacist.
If the counter window shows "01", it means there is one dose left in the inhaler. After the "01" dose, the counter will show "00", the cap will be locked, and it will not be possible to administer further doses from this inhaler. Dispose of it.
Before using a new pack, get a new prescription from your doctor so that you can always use the medicine.
The time it takes to see an improvement varies. In some patients, an improvement occurs within 24 hours of starting treatment, while in others it may take 1 or 2 weeks, or even longer, before a satisfactory improvement is seen. The duration of treatment with Asmanex Twisthaler will be decided by your doctor.

Using a higher dose of Asmanex Twisthaler than recommended

It is very important that you use the medicine as recommended by your doctor. Do not increase or decrease the dose of the medicine without your doctor's recommendation. Contact your doctor if you have accidentally used a higher dose of the medicine than recommended.

Missing a dose of Asmanex Twisthaler

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Asmanex Twisthaler

Do not stop using Asmanex Twisthaler suddenly, even if you feel better.

Contact your doctor first.

A relapse of symptoms may occur if you stop treatment without consulting your doctor.
If you find that your asthma symptoms do not improve or worsen after starting treatment with Asmanex Twisthaler, contact your doctor.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Asmanex Twisthaler can cause side effects, although not everybody gets them.

Stop using Asmanex Twisthaler and contact your doctor immediately if you experience any of the following symptoms:

Symptoms of a severe allergic reaction, including swelling of the eyes, face, lips, tongue, or throat, which may cause difficulty swallowing or breathing, itching rash, dizziness, and fainting, which may cause collapse.
If you experience worsening symptoms, such as coughing, wheezing, or difficulty breathing, after inhaling the medicine, use a bronchodilator and contact your doctor immediately. Do not use Asmanex Twisthaler again until you have consulted your doctor.
An allergic reaction (hypersensitivity) to inhaled steroids may occur. Symptoms include rash, itching, and redness and swelling of the eyes, face, lips, and throat. If you experience any of these symptoms, contact your doctor immediately. Do not use Asmanex Twisthaler again until you have consulted your doctor.
The most common side effects include fungal infections (thrush) of the mouth or throat (white patches appear) (very common, i.e., more than 1 in 10 people using the medicine, in the group of patients receiving 400 micrograms of mometasone furoate twice daily), hoarseness, sore throat, or headache (common, i.e., up to 1 in 10 people using the medicine, in the group of patients receiving 400 micrograms of mometasone furoate twice daily). Contact your doctor as soon as possible if you experience any of these side effects.
Other side effects that occur not very commonly (up to 1 in 100 people using the medicine) include dryness of the mouth and throat, indigestion, weight gain, and rapid or strong heartbeat (palpitations). Contact your doctor if you experience any of these symptoms.
In patients using inhaled steroids, including Asmanex Twisthaler, rare (up to 1 in 1,000 people using the medicine) cases of increased eye pressure (including glaucoma) or cataracts have occurred.
Unknown frequency (cannot be estimated from available data): blurred vision. Contact your doctor if you experience blurred vision or eye pain.
Other side effects that may occur when using steroids include growth retardation or changes in growth rate in adolescents, and decreased bone mineral density.
When using inhaled corticosteroids, sleep disturbances, depression, feeling anxious, fear, nervousness, overexcitement, or irritability (unknown frequency) may also occur. The occurrence of these side effects is more likely in children.
Steroids may also disrupt adrenal gland function, causing weakness, fatigue, dizziness, and fainting when standing for a long time or changing position from sitting to standing. The occurrence of these side effects is much less likely when using inhaled corticosteroids than when using oral corticosteroids.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Asmanex Twisthaler

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, foil pouch, and label after EXP. The expiry date refers to the last day of the month.
Store below 30°C. Do not store in the refrigerator or freeze.
Store in the original package to protect from moisture. The medicine remains stable for 2 months after opening. After this time, the medicine should be disposed of in accordance with local regulations.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Asmanex Twisthaler contains

• The active substance of the medicine is mometasone furoate. One dose of Asmanex Twisthaler contains 400 micrograms of mometasone furoate.
• The other ingredient is lactose anhydrous.

What Asmanex Twisthaler looks like and contents of the pack

The inhaler has a white mouthpiece and a brown base containing a counter window that shows the number of doses (inhalations) left in the inhaler.
The inhaler contains 30 or 60 doses. Not all pack sizes may be available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]

Manufacturer

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

Date of last revision of the package leaflet: 11/2022