Asmanex TwisThaler 200 micrograms powder for inhalation

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Asmanex Twisthaler 200 micrograms inhalation powder

mometasone furoate

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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 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 simply referred to as steroids.

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

Asmanex Twisthaler is used regularly to control asthma in adults and adolescents aged 12 years and older. It may be prescribed either when you have not previously used a corticosteroid and your asthma is not controlled with other medications, or to control your asthma if you have previously been taking a different corticosteroid by oral or inhaled route. When used regularly, Asmanex Twisthaler helps you control your asthma and prevent asthma attacks. It is a "preventive medicine." Do not use it during an acute asthma attack. Always carry the bronchodilator ("reliever inhaler") prescribed by your doctor to use in case of 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, to any other corticosteroid, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• you have or have had tuberculosis.
• you have an eye infection caused by the herpes simplex virus or any other type of infection.
• you have fungal infections (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 time, or may decide to treat you with a different type of inhaler. Rinse your mouth with water or a mouthwash and spit it out without swallowing after taking your dose; this will help prevent fungal infections.

Contact 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 wheezing or have difficulty breathing shortly after using Asmanex. These symptoms may be an “allergic” reaction to this medicine.
• Always carry a bronchodilator inhaler (a “reliever” inhaler) with you to quickly relieve asthma attack symptoms (such as coughing, wheezing, and chest tightness).
• If you have an asthma attack and it does not improve after using your “reliever” inhaler, or if your peak flow measurement drops (your doctor will tell you what the correct values are for you), seek medical help immediately. Inform your doctor, as your asthma may be worsening and you may need a change in medication.
• You may also need to take an oral corticosteroid (in tablet or syrup form) during a severe asthma attack, during other illnesses, or during periods of stress. Your doctor may prescribe an oral corticosteroid for you to keep on hand and may also advise you to carry a corticosteroid warning card, which will guide you on when and how to use it.
• If you are taking Asmanex and reduce your dose of oral corticosteroid tablets or syrup, you may begin to experience symptoms such as itchy eyes, tearing, or skin rash that were previously under control. Your doctor will advise you on how to manage these symptoms. During this time, if you develop joint or muscle pain, depression, fatigue, or lethargy, inform your doctor.
• While using inhaled corticosteroids, avoid contact with anyone who has measles or chickenpox. If you come into contact with someone who has either of these diseases, inform your doctor. This is particularly important for children.
• Treatment with medicines like Asmanex Twisthaler may affect the normal levels of corticosteroids in your body. One effect of this may be that adolescents undergoing long-term treatment may grow more slowly. Your doctor will likely monitor your height periodically.
• All corticosteroids, especially when used long-term, may affect the function of the adrenal gland. Your doctor may perform a blood test to monitor this.
• Remember to bring this medicine and any other medicines you are taking with you if you go to the hospital.
• Your doctor may perform lung function tests during your treatment, especially if you are stopping oral corticosteroid tablets.

Children and adolescents

There is no available data, and therefore it should not be used in 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 need to take any other medicines, including those obtained without a prescription. This includes medicines used to treat 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 monitor you closely if you are taking these medicines.

It is also important to inform your doctor before starting Asmanex Twisthaler if you are taking other corticosteroids, whether by injection, orally, or by inhalation. Your doctor will advise you on how to adjust the dose of these other corticosteroids.

Pregnancy and breastfeeding

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

Driving and using machines

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

Asmanex Twisthaler contains lactose

It may cause allergic reactions in patients with allergy to cow's milk protein.

If your doctor has informed 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 at the maximum recommended daily dose). This amount is generally not problematic for people with lactose intolerance.

3. How to use Asmanex Twisthaler

Make sure you know how to properly use the inhaler. Avoid dropping the inhaler on the floor, as it may become damaged. If you have any problems, consult your doctor or pharmacist. Ensure you know when and how many doses you should inhale. Your doctor should have informed you, and instructions are provided in the package leaflet. Always follow exactly the dosing instructions for this medicine given by your doctor or pharmacist. Do not change the dose unless your doctor specifically tells you to do so. If in doubt, consult your doctor or pharmacist again.

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

For patients with severe asthma who may be taking other corticosteroids in tablet or syrup form, the usual starting dose of Asmanex Twisthaler is 400 micrograms twice daily, which is the highest recommended dose. Approximately one week after starting treatment with Asmanex Twisthaler, your doctor may begin to very gradually reduce the dose of the other corticosteroid and eventually discontinue it completely. Then, if your asthma remains well controlled, it may be possible to reduce the dose of Asmanex Twisthaler.

Instructions for proper use of the inhaler

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

Before removing the white cap, ensure that the dose counter and the arrow on the cap are aligned. To open the inhaler, remove the white cap. Hold the inhaler in an upright position with the pink base at the bottom. Hold it by the base and turn the cap counterclockwise to remove it. When the cap is removed, the dose counter on the inhaler will decrease by one unit.

Ensure that the counter on the pink base and the arrow above the counter are aligned with each other. Keep the inhaler upright after removing the cap and before inhaling your dose.

To inhale your dose:

• Remove the cap from the inhaler [Figure 1]

• Bring the inhaler to your mouth, with the mouthpiece facing you.

• Place the inhaler’s mouthpiece into your mouth, close your lips around it, and inhale quickly and deeply. [Figure 2]

• Remove the inhaler from your mouth and hold your breath for about 10 seconds, or as long as comfortable. Never exhale through the inhaler.

• To close the inhaler, immediately replace the cap after each inhalation. The cap must be fully replaced and turned to load the dose for the next inhalation. Turn it clockwise while gently pressing down until you hear a “click,” indicating that the cap is completely closed [Figure 3]. The arrow on the cap should be fully aligned with the counter window [Figure 4].

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

Remove the cap Inhalation Close the inhaler Inhaler closed

After completing your dose, rinse your mouth with water or an oral wash solution and spit it out—do not swallow. This will help prevent the development of fungal infection.

Keep your inhaler clean and dry at all times. Wipe the external surface of the mouthpiece with a dry cloth or tissue. Do not wash the inhaler; avoid contact with water.

On the base of the inhaler there is a window with a counter that shows the number of doses remaining. Do not use Asmanex Twisthaler if you notice that the counter is not working properly. Take it to your doctor or pharmacist.

When “01” appears in the counter window, this means only one dose remains in the inhaler. After inhaling the “01” dose, the counter will show “00,” the cap will become locked, and no further doses can be obtained from the inhaler. At this point, discard the inhaler.

To ensure you always have sufficient medication available, have your doctor prescribe a new inhaler before the current one runs out.

The time to symptom relief varies among individuals. Although some patients experience improvement within 24 hours of starting treatment, others may not achieve maximum benefit until one to two weeks or more have passed. Your doctor will advise you on how long you should continue using Asmanex Twisthaler.

If you use more Asmanex Twisthaler than you should

It is important to take your dose exactly as indicated on the label or advised by your doctor.

Do not increase or decrease your dose without medical supervision.

If you accidentally take more than the prescribed dose, inform your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, stating the medication and amount taken. Telephone (91) 562 04 20.

If you forget to use Asmanex Twisthaler

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

If you stop using Asmanex Twisthaler

Do not suddenly stop using Asmanex Twisthaler, even if your asthma seems to improve. Speak with your doctor first.

Your symptoms may return if you stop using this medicine before your doctor advises you to do so. If you think your asthma is not improving or appears to worsen after starting Asmanex Twisthaler, see your doctor again.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Symptoms of a severe allergic reaction, including swelling of the eyes, face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing, skin rash with itching, feeling faint and dizziness, which may lead to fainting.

If you experience increased coughing, wheezing, difficulty breathing or shortness of breath immediately after inhaling the medicine, use your "reliever" inhaler and contact your doctor immediately. You must 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, inform your doctor immediately. You must not use Asmanex Twisthaler again until you have seen your doctor.

The most commonly reported adverse effects include candida infection (fungal infection) in the mouth or throat (white patches), hoarseness, sore throat or headache. Consult your doctor as soon as possible if you develop any of these adverse effects.

Other less common adverse effects (affecting less than 1 in 100 patients) may include dryness of the mouth and throat, indigestion, weight gain, and rapid or strong heartbeat (palpitations). Contact your doctor if you notice any of these symptoms.

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

Frequency not known (cannot be estimated from available data): blurred vision.

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

Other possible adverse effects of corticosteroids include slowed or altered growth rate in adolescents and decreased bone mineral density. Sleep disturbances, depression, feelings of anxiety, restlessness, nervousness, excitability or irritability may also occur with the use of inhaled corticosteroids. These effects are more likely to occur in children. Corticosteroids may also affect the function of your adrenal glands, causing weakness, fatigue or dizziness, as well as lightheadedness when standing for long periods or upon standing up from a sitting position. These effects are much less likely with inhaled corticosteroids than with oral corticosteroids.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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, the aluminum bag, and the label, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Do not refrigerate or freeze.

Store each inhaler in its original packaging to protect it from moisture until needed, and use it within 3 months of opening. Open only one inhaler at a time.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused containers or medicines, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Asmanex Twisthaler

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

Nature of the product and contents of the pack

The mouthpiece of the inhaler is white, with a pink base containing a window that displays the number of inhalations remaining in the inhaler. There are inhalers containing either 30 or 60 inhalations (doses); each package contains one bag with one inhaler (for either 30 or 60 inhaled doses) or three individual bags each containing one inhaler (only for 60 inhaled doses).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Germany: Asmanex Twisthaler 200 Mikrogramm Pulver zur Inhalation

Austria: Asmanex Twisthaler

Belgium: Asmanex Twisthaler 200 microgrammes Poudre pour inhalation

Denmark: Asmanex Twisthaler 200 mikrogram inhalationspulver

Spain: Asmanex Twisthaler 200 microgramos polvo para inhalación

Finland: Asmanex Twisthaler

France: Asmanex Twisthaler 200 microgrammes/dose, poudre pour inhalation

Greece: Asmanex Twisthaler

Ireland: Asmanex Twisthaler 200 micrograms Inhalation Powder

Iceland: Asmanex Twisthaler, 200 míkróg. Innöndunarduft

Italy: Asmanex 200 microgrammi polvere per inalazione

Norway: Asmanex Twisthaler

Portugal: Asmanex Twisthaler

United Kingdom: Asmanex Twisthaler 200 micrograms Inhalation Powder

Sweden: Asmanex Twisthaler

Date of the most recent review of this summary: 11/2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/