Patient Information Leaflet

Asmanex Twisthaler, 200 micrograms/dose, inhalation powder
Mometasone furoate
Please read all of 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Asmanex Twisthaler is and what it is used for
Important information before using Asmanex Twisthaler
How to use Asmanex Twisthaler
Possible side effects
How to store Asmanex Twisthaler
Contents of the pack and other information

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

Asmanex Twisthaler contains the active substance mometasone furoate, which belongs to a group of medicines called corticosteroids or steroids.
Corticosteroids should not be confused with anabolic steroids, which are misused by some athletes. Due to their anti-inflammatory action, corticosteroids are used to prevent asthma attacks. They reduce swelling and irritation of the airway walls, thus making breathing easier.
Asmanex Twisthaler, when used regularly, helps prevent asthma symptoms in adults and adolescents aged 12 years and older. The medicine can be used in patients who have not previously been treated with steroids, when asthma is not controlled by other treatments. It may also be given to patients who are already using other steroids, either oral or inhaled, for asthma treatment.
Regular use of Asmanex Twisthaler helps control asthma symptoms and prevents sudden asthma attacks. This medicine is used preventively. Do not use this medicine to relieve a sudden asthma attack. You should always have your prescribed reliever medicine (a bronchodilator inhaler) available to treat an asthma attack if it occurs.

2. Important information before using Asmanex Twisthaler

When not to use Asmanex Twisthaler

if the patient is allergic to mometasone furoate, other steroids, or any of the excipients of this medicine – anhydrous lactose (listed in section 6).

Warnings and precautions
Before starting treatment with Asmanex Twisthaler, discuss with your doctor or pharmacist if:

the patient currently has or has ever had tuberculosis,
the patient has ocular herpes (a viral infection) or any other type of infection,
the patient has oral thrush (white patches in the mouth and throat), in which case appropriate treatment is required. Your doctor may recommend temporarily stopping Asmanex Twisthaler or switching to another inhaled medicine. After inhaling the medicine, rinse the mouth with water or a mouthwash and spit it out—do not swallow. This may help prevent oral thrush.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Important information to remember while using Asmanex Twisthaler

Call emergency services or go immediately to the nearest hospital emergency department if, shortly after inhaling Asmanex Twisthaler, sudden wheezing and breathing difficulties occur. These symptoms may indicate an allergic reaction to the medicine.
Always carry a reliever inhaler (a bronchodilator inhaler) for immediate use to quickly relieve bronchospasm or to stop asthma attacks (coughing, wheezing, and chest tightness).
If an asthma attack does not improve after using a reliever inhaler (bronchodilator inhaler) or if peak expiratory flow values drop, call emergency services or go immediately to the nearest hospital emergency department. Inform your asthma doctor, as this may indicate worsening asthma and a change in treatment may be necessary.
During a severe asthma attack, other illnesses, or periods of stress, it may be necessary to take an oral steroid (in tablet or syrup form). Your doctor may advise you to always keep a supply of oral steroids and a patient information card with instructions on dosing and when to take oral steroids.
If the patient is using Asmanex Twisthaler while reducing the dose of oral steroids (tablets or syrup), new allergic symptoms may appear, such as itching, excessive tearing, or rash. In such cases, the doctor will recommend appropriate treatment to manage these symptoms. If joint or muscle pain, depression, fatigue, or significant slowing down occur during this time, inform the doctor.
While using Asmanex Twisthaler, avoid contact with people who have measles or chickenpox. If exposed to either of these diseases, inform your doctor. This is especially important for children.
Medicines such as Asmanex Twisthaler may interfere with the body's normal steroid production. As a result, long-term treatment in adolescents may lead to slowed growth. Your doctor will likely monitor growth periodically in adolescents taking this medicine.
All steroids, especially when used long-term, may affect adrenal cortex function. Therefore, your doctor will regularly perform blood tests to monitor adrenal function.
If the patient is hospitalized, they should bring their Asmanex Twisthaler and all other medicines they are taking.
The treating doctor may perform lung function tests during treatment with Asmanex Twisthaler, especially if the patient is to stop taking oral corticosteroids.

Children and adolescents
Due to 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 the patient is currently taking or has recently taken, including those obtained without a prescription, and any medicines the patient plans to take, including antifungal or antiviral medicines such as ketoconazole, itraconazole, ritonavir, nelfinavir, or cobicistat. These medicines may increase the blood levels of mometasone furoate.
Some medicines may enhance the effect of Asmanex Twisthaler, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
It is especially important to inform the doctor before starting Asmanex Twisthaler about any corticosteroids the patient is taking, whether administered by injection, orally, or by inhalation. The doctor may recommend adjusting the dose of these corticosteroids.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Do not use Asmanex Twisthaler during pregnancy unless clearly recommended by the treating doctor.
There is no information available on whether the medicine passes into breast milk. Do not breastfeed while using this medicine unless clearly recommended by the treating doctor.

Driving and operating machinery
Asmanex Twisthaler has no or negligible effect on the ability to drive and operate machinery.

Asmanex Twisthaler contains lactose
This medicine contains a small amount 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

The patient must be certain they are able to use the Twisthaler inhaler correctly. In case of
doubt, please contact a doctor or pharmacist. Before using the medicine, the patient
must be certain of when and how many doses of the medicine to use. The doctor should inform the patient
how to use Asmanex Twisthaler. The instructions for using the inhaler should be read carefully.
This medicine should always be used exactly as prescribed by the doctor or pharmacist. In case of
doubt, consult the doctor or pharmacist.
Do not change the dose of this medicine without explicit instruction from the doctor.
For adults (including those aged 65 years and older) and adolescents aged 12 years and older with
mild or moderate asthma symptoms, the recommended starting dose is
400 micrograms (2 inhalations) once daily in the evening.
For some patients, the starting dose may be 200 micrograms (1 inhalation) twice
daily. If symptoms improve, the doctor may reduce the dose to 200 micrograms (1 inhalation)
once daily in the evening. Depending on symptoms, the doctor may increase or decrease the daily dose
to maintain control of asthma symptoms.
For patients with severe asthma symptoms, who may also be using other corticosteroids in tablet or syrup form,
the usual starting dose of Asmanex Twisthaler is typically 400 micrograms
twice daily. This is the maximum recommended dose. After approximately one week of treatment with
Asmanex Twisthaler, the doctor may recommend gradually reducing the dose of another
corticosteroid being used, until it is completely discontinued. If asthma symptoms are well
controlled, it may also be possible to reduce the dose of Asmanex Twisthaler.
Instructions for correct use of the inhaler
It should be remembered that the fine powder released from the Twisthaler inhaler must be inhaled into
the lungs. The patient should stand upright while using the Twisthaler inhaler. The following instructions
must be followed exactly to ensure correct dosing of the medicine.
Before removing the white cap, ensure that the counter and indicator on the cap are aligned in a straight line.
To open the inhaler, remove the white cap. Hold the inhaler vertically with the pink base pointing downward.
Grasp the base and unscrew the cap by turning it counter-clockwise. After removing the cap, the dose counter in the inhaler will register a reduction of one remaining dose.
Ensure that the counter on the pink base and the indicator on the upper counter are
aligned in a straight line. When the cap is removed and before administering the appropriate dose, the inhaler must be held vertically.
To inhale a dose of medicine, follow these steps:
a) Remove the cap from the inhaler (Fig. 1).
b) Bring the inhaler close to the mouth, with the mouthpiece facing the patient.
c) Place the mouthpiece in the mouth, seal lips tightly around it, and take a quick, deep breath in (Fig. 2).
d) Remove the inhaler from the mouth and hold breath for about 10 seconds, or as long as possible. Do not exhale through the inhaler.
e) To close the inhaler, replace the cap immediately after completing each inhalation.
To load a new dose, place the cap back on and turn it clockwise, gently pressing down until a "click"
is heard, indicating the cap is fully closed (Fig. 3). The arrow on the cap must be fully aligned with the counter window (Fig. 4).

Diagram of the medication instructions showing hands holding an inhaler, a person placing the device in their mouth, and a close-up of the mechanism of action

After taking the medicine, rinse the mouth with water or a mouthwash solution and then spit it out—do not swallow. This procedure may help prevent the development of oral thrush.
The inhaler should remain dry and kept clean at all times. Wipe the mouthpiece surface with a dry cloth or tissue. Do not wash the inhaler and avoid contact with water.
Inside the base of the inhaler there is a counter window displaying the number of doses remaining in the inhaler. Do not use Asmanex Twisthaler if the counter display is incorrect. In such a case, consult a doctor or pharmacist.
If "01" appears in the counter window, this indicates that one dose remains in the inhaler. After the "01" dose, the counter will show "00", the cap will close, and no further doses can be administered from this inhaler. The inhaler should then be discarded.
Before the current package is fully used, obtain a new prescription from the doctor to ensure continuous availability of the medicine.
The time required to achieve improvement varies. In some patients, improvement occurs within 24 hours of starting treatment, while in others, satisfactory improvement may not be observed until 1 or 2 weeks, or even longer. The duration of treatment with Asmanex Twisthaler will be determined by the doctor.
Use of a higher than recommended dose of Asmanex Twisthaler
It is very important that the patient uses the medicine exactly as prescribed by the doctor. Do not increase or
decrease the dose without medical advice. Consult the doctor if a higher than recommended dose has been
accidentally used.
Missing a dose of Asmanex Twisthaler
If a dose is missed, take the next dose at the usual time. Do not inhale a double dose to make up for a missed dose.
Stopping treatment with Asmanex Twisthaler
Do not suddenly stop using Asmanex Twisthaler, even if symptoms improve.
First consult the treating doctor.
Symptoms may return if treatment is stopped without consulting the doctor.
If the patient notices no improvement or worsening of asthma symptoms after starting
treatment with Asmanex Twisthaler, they should contact the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Treatment with Asmanex Twisthaler must be discontinued and immediate contact made with a doctor
if the patient develops any of the following symptoms:
severe allergic reaction symptoms, including swelling of the eyes, face, lips, tongue or throat, which may
cause difficulty swallowing or breathing, itchy rash, dizziness
and fainting, which may lead to collapse.
If the patient experiences worsening of symptoms immediately after inhalation, such as: cough,
wheezing, breathing difficulties or shortness of breath, a reliever bronchodilator inhaler should be used
and immediate contact made with a doctor. Asmanex Twisthaler must not be used again until after
consultation with a doctor.
An allergic reaction (hypersensitivity) to inhaled steroids may occur. Symptoms include rash,
itching, and redness and swelling of the eyes, face, lips or throat. If any of these symptoms occur,
immediate contact with a doctor is required. Asmanex Twisthaler must not be used again until after
consultation with a doctor.
The most commonly occurring adverse effects include fungal infections (thrush) of the mouth or throat
(appearance of white patches) (very common, i.e. occurring in 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. occurring in no more than 1 in 10 people using the medicine,
in the group of patients receiving 400 micrograms of mometasone furoate twice daily).
Contact a doctor as soon as possible if any of the above adverse effects occur.
Other adverse effects occurring less frequently (no more than 1 in 100 people using the medicine)
include dryness of the mouth and throat, dyspepsia, weight gain, and rapid or strong heartbeat
(palpitations). Contact a doctor if any of these symptoms occur.
In patients using inhaled steroids, including Asmanex Twisthaler, increased intraocular pressure (including
glaucoma) or cataract may rarely occur (no more than 1 in 1000 people using the medicine).
Frequency not known (cannot be estimated from available data): blurred vision.
Contact a doctor if blurred vision or eye pain occurs.
Other adverse effects that may occur during steroid use include:
slowed or altered growth rate in adolescents and decreased bone mineral density.
Sleep disturbances, depression, feeling anxious, anxiety, nervousness, excessive excitement or irritability
(frequency not known) may also occur during treatment with inhaled corticosteroids.
These adverse effects are more likely to occur in children.
Steroids may also impair adrenal function, causing weakness, fatigue, dizziness and fainting upon
prolonged standing or changing position from sitting to standing.
The occurrence of these adverse effects is significantly less likely with inhaled corticosteroids than
with oral corticosteroids.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions
at the 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Asmanex Twisthaler

Keep this 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 following: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C. Do not store in a refrigerator or freeze.
Keep in the original packaging to protect from moisture. The medicine remains stable for 2 months after first opening. After this period, the medicine should be disposed of in accordance with local regulations.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Asmanex Twisthaler contains

The active substance is micronized mometasone furoate. One dose of Asmanex Twisthaler contains 200 micrograms of micronized mometasone furoate.
The other ingredient is: anhydrous lactose.

What Asmanex Twisthaler looks like and contents of the pack
The inhaler has a white mouthpiece and a pink base containing a dose counter window indicating the number of doses (inhalations) remaining in the inhaler.
The inhaler contains 30 or 60 doses. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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