ANASMA ACCUHALER 50 micrograms/100 micrograms INHALATION, POWDER FOR INHALATION

2. What you need to know before starting to use Anasma

Do not use Anasma

• if you are allergic to salmeterol, fluticasone propionate, or the other component, lactose monohydrate.

Warnings and precautions

Consult your doctor before starting treatment if you have:

• Heart problems, including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Anasma may increase blood sugar levels).
• Low potassium levels 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.

Using Anasma with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those for asthma or those purchased without a prescription. The reason is that, in some cases, Anasma should not be administered with other medications.

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

• Beta blockers (such as atenolol, propranolol, and sotalol). Beta blockers are mainly used to treat high blood pressure or other heart conditions.
• Medications to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some medications for HIV (such as ritonavir, cobicistat). Some of these medications may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of experiencing side effects with Anasma, including irregular heartbeats, or may worsen side effects, so your doctor will monitor you closely if you are taking these medications.
• Corticosteroids (oral or injectable). If you have taken these medications recently, you may be at increased risk of this medication affecting your adrenal gland.
• Diuretics, also known as water pills, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications containing xanthine. They are often used to treat asthma.

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 medication.

Driving and using machines

Anasma is unlikely to affect your ability to drive or use machines.

Anasma Accuhaler contains lactose

Anasma Accuhaler contains up to 12.5 milligrams of lactose monohydrate per dose. The amount of lactose in this medication normally does not cause problems in people with lactose intolerance. However, it may cause allergic reactions in patients with cow's milk protein allergy. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medication.

3. How to use Anasma

Follow your doctor's or pharmacist's instructions for using this medication exactly. If you are unsure, 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 you are unsure, consult your doctor or pharmacist.
• Do not stop taking Anasma or reduce your dose without talking to your doctor first.
• Anasma should be inhaled through the mouth into the lungs.
• You may not be able to taste or feel the powder on your tongue, even if you have used the Accuhaler correctly.

For asthma

Adults and adolescents 12 years and older

• Anasma 50/100 Accuhaler One inhalation twice a day
• Anasma 50/250 Accuhaler One inhalation twice a day
• Anasma 50/500 Accuhaler One inhalation twice a day

Children 4 to 12 years old

• Anasma 50/100 Accuhaler One inhalation twice a day
• Anasma is not recommended for use in children under 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Anasma 50/500 Accuhaler One inhalation twice a day

Your symptoms may be well-controlled using Anasma twice a day. If this is the case, your doctor may decide to reduce your dose to once a day. The dose may change to:

• once at night if you have nocturnalsymptoms,
• once in the morning if you have diurnalsymptoms.

It is very important that you follow your doctor's instructions on how many applications and how often you should take your medication.

If you are using Anasma to treat asthma, your doctor will want to monitor your symptoms regularly.

If your asthma worsens or you have more difficulty breathing, see your doctor immediately.You may notice more wheezing or shortness of breath more often, or you may need to use your fast-acting rescue medication more frequently. If any of these things happen, you should continue using Anasma, but do not increase the number of applications. Your respiratory disease may worsen and become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should teach you how to use your inhaler. Periodically, they should check how you use it. Not using Anasma Accuhaler properly or as prescribed may result in your asthma or COPD not improving as it should.
• This Accuhaler contains blisters that contain Anasma powder.
• There is a dose counter on the top of the Accuhaler that indicates how many doses are left. It counts down to 0. The numbers from 5 to 0 will appear in red to warn you that there are few doses left. Once the counter reaches 0, your inhaler is empty.

Using your inhaler

1. To open the Accuhaler, hold the outer casing with one hand and place your thumb in the thumb grip with the other hand. Push your thumb away from you as far as it will go. You will hear a "click". This will open a small hole in the mouthpiece.

1. Hold the device with the mouthpiece towards you. You can hold it with your right or left hand. Slide the lever away from you. You will hear a "click". This will place the dose of medication in the mouthpiece.

Each time the lever is pulled back, a blister is opened, and the powder is prepared for inhalation. Do not play with the lever, as the blisters will open, and medication will be wasted.

1. Hold the Accuhaler away from your mouth. Breathe out as much as you reasonably can. Do not breathe into the Accuhaler.

1. Place the mouthpiece in your lips; take a slow, steady breath in through the Accuhaler, not through your nose.

Remove the Accuhaler from your mouth.

Hold your breath for 10 seconds or as long as you can.

Breathe out slowly.

1. Afterward, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent mouth ulcers and hoarseness.

1. To close the Accuhaler, slide the lever back towards you as far as it will go. You will hear a "click".

The lever will automatically return to its original position.

The Accuhaler is now ready to be used again.

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

Cleaning your inhaler

To clean it, wipe the mouthpiece of the Accuhaler with a dry cloth.

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 that your heart beats faster than normal, and you may feel tremors. You may also feel dizzy, have a headache, weakness, and joint pain.

If you have used large doses for long periods, you should ask your doctor or pharmacist for advice. This is because high concentrations of Anasma can reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Anasma

Do not take a double dose to make up for missed doses. Take the next dose at the 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 may (very rarely) experience problems with your adrenal gland (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include:

• Stomach pain.
• Fatigue and loss of appetite, feeling unwell.
• Discomfort and diarrhea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Low blood pressure and seizures (attacks).

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

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. To reduce the occurrence of side effects, your doctor will prescribe the lowest dose of Anasma that controls your asthma or Chronic Obstructive Pulmonary Disease (COPD).

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Anasma. You may experience wheezing and coughing or shortness of breath. You may also notice itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). You may also feel your heart beating very fast, feel like you are going to pass out, and feel dizzy (which can lead to collapse or loss of consciousness). If you experience any of these effects or if they appear suddenly after using Anasma, stop taking Anasma and consult your doctor immediately. Allergic reactions to Anasma are rare (affect less than 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (frequent side effect)

Tell your doctorif you experience any of the following symptoms while inhaling Anasma, as they may be symptoms of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased coughing or difficulty breathing

The following side effects are also listed:

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

• Headache, which usually improves with continued treatment.
• An increase in the number of colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD).

Common (may affect less than 1 in 10 people)

• Candidiasis (itching, appearance of yellowish-white 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 the treatment of candidiasis, your doctor may prescribe antifungal medication (for the treatment of fungal infections).
• Pain, inflammation in the joints, and muscle pain.
• Muscle cramps.

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

• Bruises and fractures.
• Sinusitis (feeling of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain).
• Decreased potassium levels in the blood (may cause irregular heartbeats, muscle weakness, cramps).

Uncommon (may affect less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more closely and adjust your usual diabetes treatment as needed.
• Cataracts (clouding of the eye lens).
• Very fast heart rate (tachycardia).
• Feeling tremors and a fast or irregular heartbeat (palpitations). These side effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling anxious (occurs mainly in children).
• Sleep disorders.
• Rash.
• Allergic skin rash.

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

• Difficulty breathing (or wheezing) that worsens immediately after using Anasma. If this happens, stop using Anasma. Use your fast-acting "rescue" inhaler to improve your breathing and consult your doctor immediately.
• Anasma may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods. The effects include:

• Delayed growth in children and adolescents.
• Decreased bone mineral density.
• Glaucoma.
• Weight gain.
• Round face (moon face) (Cushing's syndrome).

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

• Changes in behavior, 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 in the esophagus (throat), which can 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 side effects

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

5. Storage of Anasma

Keep this medication out of sight and reach of children.

Do not use Anasma after the expiration date that appears on the label and on the carton after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Anasma

• Each pre-dispensed dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the Product and Package Contents

Anasma Accuhaler contains a strip of blisters. The blisters protect the inhalation powder from atmospheric effects.

Each dose is pre-dispensed.

The devices are available in packages of 1 accuhaler x 60 inhalations.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 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, 23843 Bad Oldesloe, Germany

This leaflet was revised in July 2020.

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