Anasma 25 micrograms/250 micrograms/inhalation, suspension for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anasma 25 micrograms/250 micrograms/inhalation, suspension for pressurized inhalation

salmeterol/fluticasone propionate

Read all of 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, 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Anasma is and what it is used for
2. What you need to know before using Anasma
3. How to use Anasma
4. Possible side effects
5. How to store Anasma
6. Contents of the pack and other information

1. What Anasma is and what it is used for

Anasma contains two active substances, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier to breathe in and out. The effects last at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces inflammation and irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.

You should use Anasma every day as directed by your doctor. This will ensure that the medication works properly to control your asthma.

Anasma helps prevent breathlessness and wheezing. However, Anasma should not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, you must use your fast-acting "rescue" medication, such as salbutamol. You should always carry your fast-acting rescue medication with you.

2. What you need to know before using Anasma

Do not use Anasma

• if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients, norflurane (HFA 134a).

Warnings and precautions

Consult your doctor before starting to use Anasma if you have:

• Heart problems, including rapid or irregular heartbeat.
• Hyperactive thyroid gland.
• High blood pressure.
• Diabetes mellitus (Anasma may increase blood sugar levels).
• Low levels of potassium in the blood.
• Tuberculosis (TB) currently or in the past, or other lung infections.

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

Other medicines and Anasma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines for asthma or those obtained without a prescription. This is because, in some cases, Anasma should not be used together with certain other medicines.

Inform your doctor if you are taking any of the following medicines before starting to use Anasma:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mostly used to treat high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some medicines for HIV (such as ritonavir, cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of experiencing adverse effects with Anasma, including irregular heartbeats, or may worsen side effects. Therefore, your doctor may monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have recently taken these medicines, there may be an increased risk that this medicine could affect your adrenal gland.
• Diuretics, also known as "water pills", used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthines. These are often used to treat asthma.

Pregnancy and breastfeeding

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

Driving and using machines

Anasma is unlikely to affect your ability to drive or operate machinery.

3. How to use Anasma

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use Anasma every day, until your doctor tells you to stop. Do not take more than the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop taking Anasma or reduce your dose without first talking to your doctor.
• Anasma must be inhaled through the mouth into the lungs.

Adults and adolescents aged 12 years and older

• Anasma 25/50 micrograms: 2 actuations twice daily
• Anasma 25/125 micrograms: 2 actuations twice daily
• Anasma 25/250 micrograms: 2 actuations twice daily

Children aged 4 to 12 years

• Anasma 25/50 micrograms: 2 actuations twice daily

Anasma is not recommended for use in children under 4 years of age.

Your symptoms may become well controlled with Anasma taken twice daily. If so, your doctor may decide to reduce your dose to once daily. The dose may change to:

• once at night if you have nocturnal symptoms,
• once in the morning if you have diurnal symptoms.

It is very important that you follow your doctor's instructions regarding how many actuations and how often you should take them.

If you are using Anasma to treat asthma, your doctor will want to monitor your symptoms regularly. If your asthma worsens or you have increasing difficulty breathing, see your doctor immediately. You may notice more wheezing, a greater feeling of breathlessness, or find that you need to use your fast-acting rescue medication more frequently. If any of these occur, you must continue using Anasma, but do not increase the number of actuations. Your respiratory condition may worsen and you could become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should show you how to use your inhaler. They should periodically check your technique. Not using the Anasma inhaler correctly or as prescribed may result in your asthma not improving as it should.
• The medicine is contained in a pressurized cartridge inside a plastic casing with a mouthpiece.
• The inhaler has a counter on the back indicating how many actuations remain. Each time you activate the inhaler, one dose is released and the counter decreases by one unit.
• Be careful not to drop the inhaler, as this may cause the counter to decrease by one unit.

Checking the inhaler

1. If you are using your inhaler for the first time, check that it works properly. Remove the mouthpiece protector by gently pressing the sides with your thumb and index finger and pulling it off.

1. To ensure it works, shake the inhaler well, point the mouthpiece away from you, and press down on the cartridge to release one actuation into the air. Repeat these steps—shaking the inhaler before releasing each actuation—until the dose counter reads 120. If you have not used your inhaler for a week or longer, release two actuations of the medicine into the air.

Using the inhaler

It is important to begin inhaling as slowly as possible just before using your inhaler.

1. It is advisable to stand or sit upright while using the inhaler.
2. Remove the mouthpiece protector (as shown in the figure). Check inside and outside that the mouthpiece is clean and free of foreign particles.
3. Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and that the contents of the inhaler are properly mixed.

1. Hold the inhaler vertically, with your thumb on the base of the inhaler, below the mouthpiece. Breathe out as much air as possible.

1. Place the mouthpiece in your mouth, between your teeth. Close your lips around the mouthpiece. Do not bite it.

1. Breathe in slowly and deeply through your mouth. Immediately after starting to inhale, press firmly on the top of the inhaler to release the medication. Do this while continuing to inhale deeply and steadily.

1. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Continue holding your breath for several seconds, as long as you can.

1. Wait approximately half a minute between each actuation, then repeat steps 3 to 7.

2. Afterwards, rinse your mouth with water and spit it out and/or brush your teeth. This will help prevent mouth ulcers and hoarseness.

3. After use, always immediately replace the mouthpiece protector to protect it from dust. When the mouthpiece protector is correctly placed, it will make a "click" sound. If it does not click, rotate the mouthpiece protector, turn it over, and try again. Do not use excessive force.

Take your time with steps 4, 5, 6, and 7. It is important that just before using the inhaler, you exhale as slowly as possible. The first few times you use the inhaler, you should do so in front of a mirror. If you see "mist" escaping from the top of the inhaler or from the sides of your mouth, start again from step 3.

As with all inhalers, caregivers must ensure that children using Anasma Inhaler use the correct inhalation technique described above.

If you or your child finds it difficult to use the inhaler, your doctor, nurse, or other healthcare professional may recommend using the inhaler with the Volumatic spacer device. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the spacer with your inhaler, how to maintain your spacer, and answer any questions you may have. If you are using the spacer with your inhaler, it is important not to stop using it without first consulting your doctor or nurse. It is also important not to change the type of spacer you are using without consulting your doctor. If you stop using the spacer or change the type of spacer, your doctor may need to adjust the dose of medication required to control your asthma. Always consult your doctor before making any changes to your asthma treatment.

Some children or individuals with weak hand strength may find it easier to hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs on the base, below the mouthpiece.

You should obtain a replacement inhaler when the counter reads 020. Stop using the inhaler when the counter reads 000, as the remaining actuations in the cartridge may not be sufficient to complete a full dose. Never attempt to alter the counter numbering or remove the counter from the metal cartridge.

Cleaning the inhaler

To prevent blockage of your inhaler, it is important to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece protector.
• Never remove the metal cartridge from the plastic casing.
• Clean the inside and outside of the mouthpiece and plastic casing with a dry tissue.
• Replace the mouthpiece protector. It will make a "click" when correctly in place. If it does not click, rotate the mouthpiece protector, turn it over, and try again. Do not use excessive force.

Do not immerse the metal cartridge in water.

If you use more Anasma than you should

It is very important to use the inhaler as directed. If you accidentally take a higher dose than recommended, consult your doctor or pharmacist. You may notice your heart beating faster than normal and feel tremors. You may also experience headache, dizziness, muscle weakness, and joint pain.

If you have used high doses over long periods, you should seek advice from your doctor or pharmacist. This is because high concentrations of Anasma may reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount taken.

If you forget to use Anasma

Do not take a double dose to make up for missed doses. Take the next dose at your usual time.

If you stop treatment with Anasma

It is very important that you use Anasma every day as directed. Continue taking it until your doctor tells you to stop. Do not stop treatment with Anasma abruptly. This could cause your breathing to worsen.

Additionally, if you stop taking Anasma suddenly or reduce your dose, you could (very rarely) develop problems with your adrenal gland (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Stomach pain.
• Tiredness and loss of appetite, feeling unwell.
• Malaise and diarrhea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Hypotension and seizures (fits).

When your body is under stress, such as fever, trauma (e.g., traffic accident), infection, or surgery, adrenal insufficiency may worsen, and you may experience any of the adverse effects listed above.

If you experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of oral corticosteroids during that time (such as prednisolone).

If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. To reduce the occurrence of adverse effects, your doctor will prescribe the lowest dose of Anasma that controls your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Anasma. You may experience wheezing, coughing, or shortness of breath. You may also notice itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel your heart beating very fast, feel dizzy, or feel like you are going to faint (which could lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Anasma, stop using Anasma and contact your doctor immediately. Allergic reactions to Anasma are uncommon (affecting fewer than 1 in 100 people).

Other adverse effects listed below:

Very common (may affect more than 1 in 10 people)

• Headache, which usually improves with continued treatment.
• Increased incidence of colds has been reported in patients with COPD.

Common (may affect fewer than 1 in 10 people)

• Candidiasis (itching, appearance of cream-yellowish ulcers) in the mouth and throat. Also, pain in the tongue, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medication may help. For treatment of candidiasis, your doctor may prescribe antifungal medication (to treat fungal infections).
• Joint pain, inflammation, and muscle pain.
• Muscle cramps.

The following adverse effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased cough, or increased difficulty breathing.
• Bruising and fractures.
• Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Reduction in blood potassium levels (you may feel irregular heartbeats, muscle weakness, or cramps).

Uncommon (may affect fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, your blood sugar levels will need to be monitored more frequently, and your usual diabetes treatment may need to be adjusted if necessary.
• Cataracts (clouding of the eye's lens).
• Very fast heart rate (tachycardia).
• Tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling anxious (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin rash.

Rare (may affect fewer than 1 in 1,000 people)

• Breathing difficulties or wheezing that worsen immediately after using Anasma. If this happens, stop using Anasma. Use your fast-acting "rescue" inhaler to improve your breathing and contact your doctor immediately.

• Anasma may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods of time. Effects include:

• Growth retardation in children and adolescents.

• Decreased bone mineral density.

• Glaucoma.

• Weight gain.

• Rounded face (moon face) (Cushing's syndrome).

Your doctor will regularly monitor for any of these adverse effects and ensure you are taking the lowest effective dose of Anasma to control your asthma.

• Changes in behaviour, such as hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeats or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Anasma unless your doctor tells you to.
• Fungal infection of the oesophagus (throat), which may cause difficulty swallowing.

Frequency not known, but may also occur:

• Depression or aggression. These effects are more likely to occur in children.
• Blurred vision.

Reporting of adverse effects

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

5. Storage of Anasma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store at temperatures above 25 °C. Do not refrigerate or freeze.

As with most pressurized inhalers, the therapeutic effect of this medicine may be reduced when the cartridge is cold.

The cartridge contains a pressurized liquid. Do not expose to temperatures above 50 °C. Protect from direct sunlight. Do not pierce, break, or burn the cartridge, even if it appears to be empty.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anasma

• Each metered dose contains: 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
• The other component is a propellant: norflurane (HFA 134a).

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0172 tonnes of CO2 (global warming potential GWP = 1,430).

Appearance of the product and contents of the pack

• Anasma Inhaler is presented as a pressurized container with a dose counter, which delivers the medicine as a suspension for inhalation through the mouth into the lungs.

• The cartridge contains a white to off-white inhalation suspension.

• The cartridges are contained within a plastic device incorporating a mouthpiece and a cap for the mouthpiece.

The devices are packaged in packs of 1 inhaler.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome, S.A.

Avenida de Extremadura, 3 - 09400 Aranda de Duero (Burgos), Spain

or

Glaxo Wellcome Production

Zone Industrielle No.2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France

Tel: +33 2 3223 5500; Fax: +33 2 3223 5558

or

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36, D-23843 Bad Oldesloe, Germany.

Date of the most recent revision of this leaflet: 01/2025

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