Asmanex twisthaler

Package leaflet: Information for the patient

Asmanex Twisthaler, 400 micrograms/dose, inhalation powder
Mometasone furoate
Please read the entire 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Asmanex Twisthaler is and what it is 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 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 bronchial walls, thus making breathing easier.
Asmanex Twisthaler, when used regularly, prevents asthma symptoms in adults and adolescents aged 12 years and older. The medicine may be used in patients who have not previously been treated with steroids, in whom asthma is not controlled by other medications. It may also be given to patients who are already receiving other steroid treatments, either oral or inhaled, for asthma.
Regular use of Asmanex Twisthaler helps control asthma symptoms and prevents sudden asthma attacks. The medicine is used preventively. This medicine should not be used to relieve a sudden asthma attack. You should always have with you the rescue bronchodilator medicine (reliever inhaler) prescribed by your doctor, to be used in case of an asthma attack.

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 herpes simplex of the eye (viral infection) or any other type of infection,
• the patient has oral thrush (white patches in the mouth and throat), as appropriate treatment may be necessary. In such a case, the doctor may recommend temporarily stopping treatment with Asmanex Twisthaler or may prescribe an alternative inhaled medicine. After inhaling the medicine, rinse the mouth with water or a mouthwash and spit it out without swallowing. This may help prevent the development of 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 taking 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) ready for use, to quickly relieve bronchospasm or to stop asthma attacks (coughing, wheezing, and chest tightness).
• If an asthma attack does not improve despite using a bronchodilator inhaler (reliever inhaler), or if peak expiratory flow values decrease, call emergency services or go immediately to the nearest hospital emergency department. Inform the doctor managing the asthma treatment, as this may indicate worsening asthma and a change in therapy may be necessary.
• During a severe asthma attack, other illnesses, or periods of stress, it may be necessary to take a steroid in tablet or syrup form. The treating doctor may advise the patient to always carry a supply of oral steroid tablets or syrup and a patient information card containing dosing instructions and guidance on when to take oral steroids.
• If the patient is using Asmanex Twisthaler while reducing the dose of steroids taken as tablets or syrup, allergic symptoms previously not experienced may appear, such as itching, excessive tearing, or rash. In such cases, the doctor will recommend appropriate measures to manage these symptoms. If joint or muscle pain, feelings of depression, fatigue, or significant slowing 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 the doctor. This is particularly important for children.
• Medicines such as Asmanex Twisthaler may interfere with the body's normal steroid production. As a result, in adolescents receiving long-term treatment, growth may be slowed. The doctor will likely monitor growth periodically in adolescents taking this medicine.
• All steroids, especially when used long-term, may affect adrenal cortex function. Therefore, the 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 those used to treat fungal or viral infections, such as ketoconazole, itraconazole, ritonavir, nelfinavir, or cobicistat. These medicines may increase the blood concentration 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 about any corticosteroids the patient is taking, whether administered by injection, orally, or by inhalation, before starting Asmanex Twisthaler. The doctor may recommend adjusting the dose of these corticosteroids.

Pregnancy and breastfeeding
If the patient is pregnant or 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 the treating doctor clearly recommends such treatment.
There is no data on whether the medicine passes into breast milk. Breastfeeding should not be used during treatment with this medicine unless the treating doctor clearly recommends it.

Driving and operating machinery
Asmanex Twisthaler has no effect or has 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, the patient should contact their doctor or pharmacist. Before using the medicine, the patient
must be sure of when and how many doses of the medicine to use. The doctor should inform the patient
how to use Asmanex Twisthaler. The patient should read the instructions for using the
inhaler. 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 the medicine without explicit instruction from the doctor.
For adults (including those over 65 years of age) and adolescents aged 12 years and older with mild or
moderate asthma symptoms, the recommended starting dose is 400 micrograms (1 inhalation) once daily,
in the evening.
In some patients, the starting dose may be 200 micrograms (1 inhalation of Asmanex Twisthaler in the lower dose –
200 micrograms/dose, powder for inhalation) twice daily.
If improvement occurs, the doctor may reduce the dose to 200 micrograms (1 inhalation of Asmanex Twisthaler
200 micrograms/dose, powder for inhalation) once daily in the evening.
Depending on symptoms, the doctor may increase or decrease the daily dose so that asthma symptoms
are kept under control.
For patients with severe asthma symptoms who may also be using other steroids in tablet or syrup form,
the usual starting dose of Asmanex Twisthaler is 400 micrograms twice daily. This is the maximum
recommended dose. After approximately one week of using Asmanex Twisthaler, the doctor may recommend
gradually reducing the dose of the other 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 is important to remember that the fine powder released from the Twisthaler inhaler must be inhaled into the lungs.
The patient should stand upright when using the Twisthaler inhaler. Follow the instructions below carefully to ensure
correct delivery of the medicine dose.
Before removing the white cap, ensure that the counter and the indicator on the cap are aligned in a straight line.
To open the inhaler, remove the white cap. Hold the inhaler vertically with the brown base pointing downwards.
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 dose.
Ensure that the counter on the brown base and the indicator on the upper part 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 the medicine:
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, close lips tightly around it, and inhale quickly and deeply (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, immediately replace the cap after 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).

Fig. 1. Fig. 2. Fig. 3. Fig. 4.
After taking the medicine, rinse the mouth with water or a mouthwash and then spit it out—do not swallow. This procedure may help prevent the development of oral thrush.
The inhaler should remain dry and clean at all times. Clean the mouthpiece surface with a dry cloth or tissue. Do not wash the inhaler and avoid contact with water.
The base of the inhaler contains a counter window showing the number of doses remaining in the inhaler. Do not use Asmanex Twisthaler if the counter display is not functioning correctly. In such a case, consult the doctor or pharmacist.
If "01" appears in the counter window, this means 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 delivered from this inhaler. The inhaler should then be discarded.
Before the current package is completely 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 it may take 1 or 2 weeks, or even longer, before satisfactory improvement is observed. The duration of treatment with Asmanex Twisthaler will be determined by the doctor.
Using more than the 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 an accidental overdose has occurred.
Missing a dose of Asmanex Twisthaler
If a dose is missed, take the next dose at the usual time. Do not take 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 medical advice.
If the patient notices no improvement or worsening of asthma symptoms after starting Asmanex Twisthaler, they should contact their doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Treatment with Asmanex Twisthaler must be discontinued and medical advice sought immediately
if the patient experiences any of the following symptoms:
Signs of a severe allergic reaction, including swelling of the eyes, face, lips, tongue or throat, which may
cause difficulty in 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, difficulty breathing or breathlessness, a fast-acting inhaled bronchodilator should be used
and medical advice sought immediately. 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 and throat. If any of these symptoms occur,
medical advice must be sought immediately. Asmanex Twisthaler must not be used again until after
consultation with a doctor.
The most commonly reported side 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).
Medical advice should be sought as soon as possible if any of the above side effects occur.
Other side effects occurring not very commonly (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). Medical advice should be sought if any of these symptoms occur.
In patients using inhaled steroids, including Asmanex Twisthaler, there have been rare reports (no more
than 1 in 1000 people using the medicine) of increased intraocular pressure (including glaucoma) or
cataract.
Frequency not known (cannot be estimated from the available data): blurred vision.
Medical advice should be sought if blurred vision or eye pain occurs.
Other side 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 side effects
are more likely to occur in children.
Steroids may also impair adrenal function, causing weakness, fatigue, dizziness and fainting upon
prolonged standing or when changing position from sitting to standing.
The occurrence of these side effects is considerably less likely with inhaled corticosteroids than with
oral corticosteroids.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or
pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions
of 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.
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of the 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 following: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C. Do not store in the 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 400 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 burgundy-colored base containing a dose counter window showing 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 Warszawa
Tel.: + 48 22 105 50 01
[email protected]

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