200 micrograms and 400 micrograms inhaled powder 
mometasone furoate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Asmanex Twisthaler is and what it is used for 
2. What you need to know before using Asmanex Twisthaler 
3. How to use Asmanex Twisthaler 
4. Possible side effects 
5. How to store Asmanex Twisthaler 
6. Contents of the packaging 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 only.

Corticosteroids should not be confused with anabolic steroids that are abused by some athletes. Corticosteroids are used to prevent asthma attacks because they have anti-inflammatory effects. They reduce swelling and irritation in the walls of the smaller trachea, which alleviates breathing problems.

Asmanex Twisthaler is used regularly for the maintenance treatment of asthma in adults and adolescents, 12 years and older. You can use it if you have not used a steroid before and your asthma is not controlled with other drugs. You can also use it if you have taken another steroid either orally or as an inhalation for the maintenance treatment of your asthma. When used regularly, Asmanex Twisthaler helps control asthma and prevent asthma attacks. You should use it for preventive purposes. Do not use this medicine in case of a sudden asthma attack. You should always carry your bronchodilator medicine (if needed) as prescribed by your doctor, should you have an asthma attack.

2. What you need to know before using Asmanex Twisthaler

Do not use Asmanex Twisthaler

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

Warnings and cautions

Talk to your doctor or pharmacist before using Asmanex Twisthaler if:

  • you have or have ever had tuberculosis ( TB ).
  • you have herpes simplex ( virus ) infection in your eyes or any other type of infection.
  • you get a fungal infection (white spots in the mouth or throat, so-called cod) because it may require treatment. Your doctor may also tell you to stop using Asmanex Twisthaler for a while or decide to treat you with another type of inhaler. Rinsing your mouth with water or mouthwash after taking your dose and then spitting out will help prevent fungal infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Important to remember when using Asmanex Twisthaler

  • Seek medical attention immediately if you start wheezing or have difficulty breathing shortly after using Asmanex. These symptoms may be an “allergic” reaction to the medicine.
  • You should always have a tracheal dilator (if needed) with you to quickly relieve the symptoms of an asthma attack (such as coughing, wheezing, and tightness in the chest).
  • If you have an asthma attack and the attack is not alleviated after using your bronchodilator or if the PEF value drops (your doctor should tell you which PEF value is right for you), you should seek medical attention immediately. Tell your doctor about this as your asthma may be getting worse and you may need to change your medication.
  • You may also need to take steroid tablets in case of severe asthma attacks, during other illness or periods of stress. Your doctor may give you steroid tablets, which you should take with you along with dosing instructions that will advise you on when and how to use them.
  • If you take Asmanex and reduce the dose of one of the steroid tablets that you are already taking, you may experience symptoms such as itching, watery eyes, or rash, which were previously under control. Your doctor will tell you how to control these symptoms. If you begin to feel joint or muscle pain, depression, fatigue, or feeling sleepy during this time, tell your doctor.
  • Avoid contact with people who have measles or chickenpox when using inhaled steroids. If you come in contact with someone who has any of these infections, tell your doctor. This is especially important when it comes to children.
  • Treatment with drugs like Asmanex Twisthaler can change your normal steroid levels in the body. One effect of this may be that young people who are treated for a long time can grow more slowly. Your doctor will probably check your height from time to time.
  • All steroids, especially when used for a long time, can affect the function of the adrenal glands. Your doctor can check this through a blood test.
  • Remember to bring this medicine and other medicines with you if you need to go to a hospital.
  • Your doctor may check your lungs during treatment, especially if you are about to stop taking corticosteroid tablets.

Children and young people

No data are available and should not be used for children under 12 years of age.

Other medicines and Asmanex Twisthaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This also applies to medicines used to treat fungal or viral infections such as ketoconazole, itraconazole, ritonavir, nelfinavir, or cobicistat. These drugs can increase steroid levels in the blood.

Some medicines may increase the effects of Asmanex Twisthaler and your doctor may want to monitor you closely if you are taking these medicines.

It is also important that you tell your doctor before using Asmanex Twisthaler if you are taking other steroids, either by injection , by mouth, or by inhalation. Your doctor will tell you how to adjust the dose of one of these steroids.

Pregnancy and breastfeeding

Ask your doctor if you are pregnant, planning to become pregnant, or breast-feeding.

Driving and using machines

Asmanex Twisthaler is unlikely to affect your ability to drive or use machines.

Asmanex Twisthaler contains lactose

This medicine contains a small amount of lactose (4.64 mg per day when taking the highest recommended daily dose ). This amount does not normally cause problems for lactose-intolerant people.

3. How to use Asmanex Twisthaler

Make sure you know how to use your Twisthaler properly. Handle the inhaler carefully so that you do not drop it as it may not work properly. If you are not sure, talk to your doctor or pharmacist. Make sure you know when and how many doses you should inhale. Your doctor should have told you this and the instructions should be on the pharmacy label. Always use this medicine exactly as your doctor or pharmacist has told you. Never change your dose unless your doctor tells you to. Ask your doctor or pharmacist if you are unsure.

For adults (including patients over 65 years of age) and adolescents 12 years of age and older, with mild to moderate asthma, the recommended starting dose is 400 micrograms (1 dose or inhalation ) once daily in the evening, requiring Asmanex Twisthaler 400 micrograms inhalation powder. For some patients, the starting dose may be 200 micrograms (1 dose or inhalation ) twice daily, which requires Asmanex Twisthaler 200 micrograms of inhalation powder. If your asthma is under control, your doctor may reduce the dose by one to 200 micrograms (1 dose or inhalation)by Asmanex Twisthaler 200 micrograms inhalation powder ) once a day in the evening. 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 steroid tablets, the usual starting dose for Asmanex Twisthaler is 400 micrograms twice daily, which is the highest recommended dose. After about a week of treatment with Asmanex Twisthaler, your doctor may start to reduce the dose of one of the other corticosteroids very slowly until you can stop taking it completely. It may then be possible to reduce the dose of one of the Asmanex Twisthaler if your asthma is well controlled.

Instructions on how to use your inhaler correctly

Remember that Asmanex Twisthaler emits a very fine powder that you must inhale into your lungs. You should have an upright position when using your Twisthaler. Follow these instructions carefully to obtain the correct dose.

Before removing the white protective sleeve, make sure that the counter and the arrow on the protective sleeve are facing each other. Open the inhaler by removing the white protective sleeve. Hold the inhaler upright with the pink base facing down (Asmanex Twisthaler 200 micrograms inhalation powder ) or the reddish-brown base facing down (Asmanex Twisthaler 400 micrograms inhaling powder ). Grasp the base and turn the sleeve counterclockwise to remove it. When you remove the sleeve, the inhaler dose counter will reduce the number by one. Make sure the counter on the pink or maroon base and the cursor above the counter are facing each other. Hold the inhaler upright after removing the sleeve and before taking your dose.

To take your dose

a) remove the protective sleeve from the inhaler (Fig. 1).

b) bring the inhaler to your mouth with the mouthpiece facing you.

c) insert the mouthpiece of the inhaler into your mouth, close your lips around the mouthpiece and take a quick, deep breath (Figure 2).

d) take the inhaler out of your mouth and hold your breath for about 10 seconds or as long as it feels good. Do not exhale through the inhaler.

e) replace the protective sleeve immediately after each inhalation to close the inhaler. The sleeve must be replaced properly and rotated to load dose one for the next inhalation. To do this, turn the sleeve clockwise while gently pushing the sleeve down until a clicking sound is heard and the sleeve is completely closed (Fig. 3). The marker on the sleeve must be directed towards the counter window (Fig. 4).





Picture 1Open Picture 2Inhale Picture 3Close Picture 4Closed inhaler

Rinse your mouth with water or mouthwash as soon as you have taken your dose and then spit it out. This helps prevent the emergence of cod.

Always keep the inhaler clean and dry. Clean the outside of the nozzle with a dry cloth or soft paper. Do not wash the inhaler, avoid contact with water.

At the base of the inhaler, there is a window with a counter. This shows the number of doses left in the inhaler. Do not use Asmanex Twisthaler if the calculator does not work properly.

Take it to a doctor or pharmacist.

When the counter shows “01”, it means that only one dose remains in the inhaler. When dose a 01 is taken, the counter will show “00”, the sleeve will lock and the inhaler cannot be used, which must then be discarded. To be sure you always have enough medicine, be sure to get a new prescription from your doctor before the inhaler is empty.

There is no set time for how fast the treatment works. Some patients may receive some relief within 24 hours of starting treatment; others experience the greatest benefit only after one to two weeks or later. Your doctor will tell you how long to use Asmanex Twisthaler.

If you use more Asmanex Twisthaler than you should 

It is important that you take a dose as stated on the package label or as your doctor has informed you. Do not increase or decrease the dose without consulting a doctor.

If you forget to use Asmanex Twisthaler

If you forget to take a dose then take the next dose when it is time for it. Do not take a double dose to make up for a forgotten dose.

If you stop using Asmanex Twisthaler

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

Your symptoms may return if you stop using this medicine earlier than your doctor has told you to. If you think your asthma does not get better or seems to get worse, after you start using Asmanex Twisthaler, see your doctor again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

  • Symptoms of a severe allergic reaction include swelling of the eyes, face, lips, mouth, tongue, or throat which may make it difficult to swallow or breathe, itchy rash, fainting, and dizziness which may cause you to collapse.

If you experience an increase in coughing, wheezing, difficulty breathing, or shortness of breath immediately after inhaling the medicine, use your “on-demand medicine” and contact your doctor immediately. You should not use Asmanex Twisthaler again until you have seen your doctor.

Inhaled steroids can cause allergic reactions (hypersensitivity). It can manifest itself as skin rash, itching and redness, and swelling of the eyes, face, lips, and throat. If you get any of these symptoms, contact your doctor immediately. You should not use Asmanex Twisthaler again until you have seen your doctor.

The most commonly reported side effects include fungal infection (cod) in the mouth or throat (it turns out to be white spots), hoarseness, sore throat, or headache. Tell your doctor as soon as possible if you get any of these side effects.

Other less common (may affect up to 1 in 100 people) side effects include dry mouth and dry throat, indigestion, weight gain, and rapid or rapid heartbeat (palpitations). Contact your doctor if you experience any of these symptoms.

It is rare (may affect up to 1 in 1,000 people) that patients using inhaled steroids, including Asmanex Twisthaler, experience increased pressure in the eyes (including glaucoma ) or cataracts.

No known frequency (cannot be calculated from the available data): blurred vision.

Other possible side effects of steroids include inhibited or altered growth patterns in adolescents and decreased bone density.

Sleep problems, depression, anxiety, restlessness, anxiety, feeling very hurried and/or irritable may also occur during treatment with inhaled steroids. These side effects are more likely to occur in children.

Steroids can also affect the adrenal glands and cause weakness, fatigue or dizziness, and fainting when you stand up for a long time or get up from a sitting position.

The likelihood of these effects occurring is less than when corticosteroids are given as an inhalation compared to whether they are given by mouth or swallowed.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Asmanex Twisthaler

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

Do not store above 30 ° C. Store in a cold place. Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton as “EXP” and on the label and foil pouch as “EXP”. The expiration date is the last day of the specified month.

Store the Twisthaler wire in its original packaging to protect it from moisture until it is to be used. Use the opened package within 3 months of first opening it. Only open one Twisthaler at a time.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is mometasone furoate. Each inhalation contains 200 micrograms or 400 micrograms.
  • The other ingredient is lactose, anhydrous (which contains traces of milk proteins).

What the medicine looks like and the contents of the pack

Asmanex Twisthaler 200 micrograms inhalation powder

The mouthpiece of the inhaler is white, with a pink base, provided with a window where the number of remaining inhalations is displayed. There are inhalers with 30 or 60 inhalations ( doses ), each pack contains one bag with one inhaler (for inhaler with 30 or 60 doses ) or three separate packs, each containing one inhaler (for inhaler with 60 doses ) ). Not all pack sizes may be marketed.

Asmanex Twisthaler 400 micrograms inhalation powder

The mouthpiece of the inhaler is white, with a reddish-brown base, provided with a window where the number of remaining inhalations is displayed. There are inhalers with 14, 30, or 60 inhalations ( doses ), each pack contains a bag with one inhaler (for inhalers with 14, 30, or 60 doses ) or three separate packs, each containing one inhaler (for inhaler with 60 doses is). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Manufacturer:

Schering-Plow Labo NV

Industrial park. 30

B-2220 Heist-op-den-Berg

Belgium

Information provided by:

This medicinal product is authorized under the European Economic Area under the names:

Belgium Asmanex Twisthaler 200 micrograms Powder for inhalation
Asmanex Twisthaler 400 micrograms Powder for inhalation
Denmark: Asmanex Twisthaler 200 micrograms inhalation powder
Asmanex Twisthaler 400 micrograms inhalation powder
Finland: Asmanex Twisthaler
France: Asmanex Twisthaler 200 micrograms/dose, powder for inhalation
Asmanex Twisthaler 400 micrograms / dose, powder for inhalation
Greece: Asmanex Twisthaler
Ireland: Asmanex Twisthaler 200 micrograms Inhalation Powder
Asmanex Twisthaler 400 micrograms Inhalation Powder
Iceland: Asmanex Twisthaler, 200 micrograms. Inhalation powder
Asmanex Twisthaler, 400 micrograms. Inhalation powder
Italy: Asmanex 200 micrograms powder for inhalation
Asmanex 400 micrograms powder for inhalation
Norway: Asmanex Twisthaler
Portugal Asmanex Twisthaler
Spain: Asmanex Twisthaler 200 micrograms powder for inhalation
Asmanex Twisthaler 400 micrograms powder for inhalation
Sweden: Asmanex Twisthaler
UK: Asmanex Twisthaler 200 micrograms Inhalation Powder
  Asmanex Twisthaler 400 micrograms Inhalation Powder
Germany: Asmanex Twisthaler 200 micrograms powder for inhalation
  Asmanex Twisthaler 400 micrograms powder for inhalation
Austria: Asmanex Twisthaler

Muhammad Nadeem

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