Leaflet: information for the user

Asmanex Twisthaler 400 micrograms powder for inhalation

furoate of mometasone

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Asmanex Twisthaler

3. How to use Asmanex Twisthaler

4. Possible side effects

5. Storage of Asmanex Twisthaler

6. Contents of the pack and additional information

Asmanex Twisthaler contains the active ingredient furoate of mometasone, which belongs to a group of medications known as corticosteroids or simply steroids.

Corticosteroids should not be confused with the "anabolic steroids", which are used improperly by some athletes. Corticosteroids are used to prevent asthma attacks as they have an anti-inflammatory effect. They reduce inflammation and irritation of the walls of the small airways in the lungs. This helps to facilitate breathing.

Asmanex Twisthaler is used regularly to control asthma in adults and adolescents 12 years of age and older. It may be administered if a corticosteroid has not been used previously and asthma is not controlled with other medications. It may also be used to control asthma if a different corticosteroid has been taken orally or by inhalation. Used regularly, Asmanex Twisthaler will help control asthma and prevent asthma attacks. It is a "preventive medication". Do not use it in a sudden asthma attack. You should always carry the bronchodilator ("reliever inhaler") prescribed by your doctor, only for the case of having an asthma attack.

Do not use Asmanex Twisthaler

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Asmanex Twisthaler if:

• you have or have had tuberculosis.
• you have an eye infection caused by herpes simplex (virus) or any other type of infection.
• you have fungi (white patches in the mouth or throat) as you may need treatment. Your doctor may also advise you to stop using Asmanex Twisthaler for a while or may decide to treat you with a different type of inhaler. Rinse your mouth with water or a mouthwash and then spit it outwithout swallowing, after taking your dose; this will help prevent fungi.

Get in touch with your doctor if you experience blurred vision or other visual disturbances.

Important things to remember when using Asmanex Twisthaler

• Seek medical help immediately if you start to have sounds or have difficulty breathing shortly after using Asmanex. These symptoms may be an “allergic” reaction to this medicine.
• You must always carry a bronchodilator inhaler (a “reliever” inhaler) with you to quickly relieve the symptoms of an asthma attack (such as coughing, wheezing, and chest tightness).
• If you have an asthma attack and the attack does not improve after using the “reliever” inhaler or if your peak flow measurement falls (your doctor will tell you what the correct values are for you), you must seek medical help immediately. Tell your doctor, as your asthma may be getting worse and you may need to change your medicine.
• You may also need to take a corticosteroid tablet or syrup during a severe asthma attack, during other illnesses, or during periods of stress. Your doctor may prescribe a corticosteroid tablet or syrup for you to carry with you and will advise you on when and how to use it.
• If you are taking Asmanex and reduce the dose you take, of corticosteroid tablets or syrup, you may start to experience symptoms such as itchy eyes, tearing, or skin rash, which were previously controlled. Your doctor will tell you how to control these symptoms. During this time, if you start to notice joint or muscle pain, feeling depressed, tiredness, or lethargy, you must tell your doctor.
• While using inhaled corticosteroids, avoid contact with anyone who has measles or chickenpox. If you come into contact with anyone who has either of these diseases, tell your doctor. This is particularly important in children.
• The treatment with medicines like Asmanex Twisthaler may alter the normal levels of corticosteroids in your body. A result of this may be that adolescents who are being treated for a long time may grow more slowly. Your doctor will probably check your height from time to time.
• All corticosteroids, especially when used for a long time, may affect the functioning of the adrenal gland. Your doctor may do a blood test to check this.
• Remember to carry this medicine and any other you are taking with you if you have to go to the hospital.
• Your doctor may do tests on your lungs during your treatment, especially if you are stopping corticosteroid tablets.

Children and adolescents

There are no available data and, therefore, it should not be used by children under 12 years of age.

Other medicines and Asmanex Twisthaler

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those bought without a prescription. This includes medicines for treating fungal or viral infections, such as ketoconazole, itraconazole, ritonavir, nelfinavir, or cobicistat. These medicines may increase the amount of corticosteroid in your blood.

Some medicines may increase the effects of Asmanex Twisthaler, so your doctor will do thorough checks if you are taking these medicines.

It is also important to tell your doctor before starting to use Asmanex Twisthaler if you are taking other corticosteroids, by injection, orally, or inhaled. Your doctor will tell you how to adjust the dose of these other corticosteroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Asmanex Twisthaler does not affect your ability to drive or use machinery.

Asmanex Twisthaler contains lactose

It may cause allergic reactions in patients with a milk protein allergy.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before using this medicine.

This medicine contains a small amount of lactose (4.64 mg/day in the maximum recommended daily dose). This amount normally does not cause problems in people with lactose intolerance.

Make sure you know how to use the inhaler properly. Avoid letting the inhaler fall to the ground, as it may be damaged. If you have any problems, consult your doctor or pharmacist. Make sure you know when and how many doses to inhale. Your doctor should have told you and the instructions are in the leaflet. Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist.Do not change the dose, unless your doctor tells you to do so.In case of doubt, consult your doctor or pharmacist again.

For adults (including those over 65 years old) and adolescents over 12 years old, with mild to moderate asthma, the recommended initial dose is 400 micrograms (1 dose or inhalation) once a day at night, needing Asmanex Twisthaler 400 micrograms powder for inhalation. However, for some patients, the initial dose may be 200 micrograms (1 dose or inhalation) twice a day, needing Asmanex Twisthaler 200 micrograms powder for inhalation. If your asthma is controlled, your doctor may reduce the dose to 200 micrograms (1 dose or inhalation of Asmanex Twisthaler 200 micrograms powder for inhalation) once a day at night. Depending on your symptoms, your doctor may increase or decrease your daily dose to keep your asthma under control.

For patients with severe asthma who may be taking other corticosteroids, in tablets or syrup, the usual initial dose of Asmanex Twisthaler is 400 micrograms twice a day, which is the highest recommended dose. After approximately one week of treatment with Asmanex Twisthaler, your doctor may start to gradually reduce the dose of the other corticosteroid and eventually stop it altogether. Then, if your asthma is well controlled, it may be possible to reduce the dose of Asmanex Twisthaler.

Instructions for proper use of the inhaler

Remember that Asmanex Twisthaler produces a very fine powder, which must be inhaled into your lungs. You should be standing when using your inhaler. To receive the correct dose, follow these instructions carefully.

Before removing the white cap, make sure the counter and the arrow on the cap are aligned. To open the inhaler, remove the white cap. Hold the inhaler in a vertical position, with the purple base down. Hold by the base and turn the cap counterclockwise to remove it. When removing the cap, the dose counter on the inhaler will decrease by one unit.

Make sure the counter on the purple base and the arrow over the counter are aligned one with the other. Hold the inhaler upwards once the cap is removed and before inhaling your dose.

To inhale your dose:

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 of the inhaler in your mouth, close your lips around the mouthpiece and inhale quickly and deeply. [Figure 2]

d) Remove the inhaler from your mouth and hold your breath for about 10 seconds or for as long as is comfortable for you. Never exhale through the inhaler.

e) To close the inhaler, replace the cap immediately after each inhalation. The cap must be fully placed and turned to load the dose for the next inhalation. To do this, turn it clockwise while pressing lightly downwards until you hear a "click" indicating that the cap is completely closed. [Figure 3]. The arrow on the cap must be fully aligned with the window on the counter. [Figure 4].

Fig. 1 Fig. 2 Fig. 3 Fig. 4

Remove the cap Inhalation Close the inhaler Inhaler closed

Once you have finished taking your dose, rinse your mouth with water or a mouthwash solution and then spit it outwithout swallowing. This will prevent the development of fungi.

Keep your inhaler clean and dry at all times. Clean the outer face of the mouthpiece with a cloth or paper towel. Do not wash the inhaler; avoid contact with water.

On the base of the inhaler, there is a window with a counter, which shows the number of doses remaining in the inhaler. Do not use Asmanex Twisthaler if you observe that the counter does not work correctly. Take it to your doctor or pharmacist.

When "01" appears in the window with the counter, it means that there is only one dose left in the inhaler. After inhaling the dose 01, the counter will show "00", the cap will be blocked, and no new doses can be obtained from the inhaler. In this situation, discard the inhaler.

To ensure that you always have sufficient medication, ask your doctor to prescribe it again before the inhaler you are using runs out.

The time until you experience relief from symptoms varies between individuals. Although some patients experience improvement within 24 hours of starting treatment; others may not experience the maximum benefit until one to two weeks or more have passed. Your doctor will tell you for how long you should continue using Asmanex Twisthaler.

If you use more Asmanex Twisthaler than you should

It is essential that you take your dose as indicated on the label or as advised by your doctor.

Do not increase or decrease your dose without medical supervision.

If you accidentally take a higher dose than prescribed, inform your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service indicating the medication and the amount ingested. Phone (91) 562 04 20.

If you forget to use Asmanex Twisthaler

If you forget a dose, simply take the next dose when due. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Asmanex Twisthaler

Do not stop using Asmanex Twisthaler suddenly, even if your asthma seems to be improving. Talk to your doctor first.

Your symptoms may return if you stop using this medication before your doctor tells you to. If you think your asthma is not improving or seems to be worsening after starting to use Asmanex Twisthaler, go back to see your doctor.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Severe allergic reaction symptoms, including swelling of the eyes, face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, skin rash with itching, feeling of dizziness and dizziness that may cause a fainting spell.

If you notice an increase in cough, wheezing, difficulty breathing, or lack of air immediately after inhaling the medicine, use your "reliever" inhaler and contact your doctor immediately. Do not use Asmanex Twisthaler again until you have seen your doctor.

Allergic reactions (hypersensitivity) to inhaled corticosteroids may occur. If this happens, you may notice skin rash, itching, and redness and swelling of the eyes, face, lips, and throat. If you experience any of these symptoms, tell your doctor immediately. Do not use Asmanex Twisthaler again until you have seen your doctor.

The most frequently reported side effects include oral or throat candidiasis (fungal infection) (white spots), hoarseness, sore throat, or headache. Consult your doctor as soon as possible if you develop any of these side effects.

Other side effects that are infrequently reported (affect less than 1 in 100 patients) may include dry mouth and throat, indigestion, weight gain, and rapid or strong heartbeats (palpitations). Contact your doctor if you notice any of these symptoms.

In rare cases (affect less than 1 in 1,000 patients), patients treated with inhaled corticosteroids, including Asmanex Twisthaler, have experienced increased intraocular pressure (including glaucoma) or cataracts.

Unknown frequency (cannot be estimated from available data): blurred vision.

Contact your doctor if you experience blurred vision or have eye pain.

Other possible side effects of corticosteroids include delayed or altered growth rate in adolescents and decreased bone mineral density. They may also cause sleep problems, depression, or feelings of concern, anxiety, nervousness, excitability, or irritability with the use of inhaled corticosteroids. There is a greater likelihood of these effects occurring in children. Corticosteroids can also affect the function of your adrenal glands, causing weakness, fatigue, or dizziness, as well as lightheadedness when standing for a long time or getting up from a seated position. It is much less likely that these effects will occur with the use of inhaled corticosteroids compared to the use of oral corticosteroids.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, aluminum foil pouch, and label, after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C). Do not refrigerate or freeze.

Store each inhaler in the original packaging to protect it from moisture until you need it, and then use it within 3 months of opening. Only open one inhaler at a time.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Asmanex Twisthaler

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

Appearance of the product and contents of the package

The mouthpiece of the inhaler is white, with a garnet base that contains a window showing the number of inhalations remaining in the inhaler. There are inhalers of 14, 30 or 60 inhalations (doses), each package contains a bag with an inhaler (for each 14, 30 or 60 doses inhaled) or three individual bags each with an inhaler (only for 60 doses inhaled).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible for manufacturing

Organon Heist bv

Industriepark30

2220Heist-op-den-Berg

Belgium

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Asmanex Twisthaler 400 Mikrogramm Powder for Inhalation

Austria: Asmanex Twisthaler

Belgium: Asmanex Twisthaler 400 microgrammes Powder for Inhalation

Denmark: Asmanex Twisthaler400mikrogram inhalation powder

Spain: Asmanex Twisthaler400microgramos powder for inhalation

Finland: Asmanex Twisthaler

France: Asmanex Twisthaler 400 microgrammes/dose, powder for inhalation

Greece: Asmanex Twisthaler

Ireland: Asmanex Twisthaler 400 micrograms Inhalation Powder

Iceland: Asmanex Twisthaler,400míkróg. Inhalation powder

Italy: Asmanex 400 microgrammi powder for inhalation

Norway: Asmanex Twisthaler

Portugal: Asmanex Twisthaler

United Kingdom: Asmanex Twisthaler 400 micrograms Inhalation Powder

Sweden: Asmanex Twisthaler

Last review date of this leaflet: 11/2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/