FLUSAMIX 50 µg/500 µg Powder for Inhalation

Leaflet: information for the user

Flusamix Easyhaler 50 micrograms/500 micrograms/inhalation, powder for inhalation

Salmeterol/fluticasone propionate

Read this leaflet carefully before you start using this medicine, as 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 isFlusamix Easyhalerand what it is used for

2. What you need to know before you start usingFlusamix Easyhaler

3. How to useFlusamix Easyhaler

4. Possible side effects

5. Storage ofFlusamix Easyhaler

6. Contents of the pack and additional information

Flusamix Easyhaler contains two active ingredients, salmeterol and fluticasone propionate:

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

Your doctor has prescribed this medication to help prevent respiratory problems such as:

• Asthma.
• Chronic Obstructive Pulmonary Disease (COPD). Flusamix Easyhaler, in a dose of 50/500 micrograms, reduces the number of exacerbations of COPD symptoms.

You must use Flusamix Easyhaler every day as recommended by your doctor. This will ensure the medication works correctly in controlling your asthma or COPD.

Flusamix Easyhaler helps prevent shortness of breath and wheezing. However, Flusamix Easyhaler should not be used to relieve a sudden attack of shortness of breath or wheezing. In such a case, you must use your quick-relief medication, such as salbutamol. You should always carry your quick-relief medication with you.

Do not take Flusamix Easyhaler:

• If you are allergic to salmeterol, fluticasone propionate or to any of the other ingredients, lactose monohydrate (which contains small amounts of milk proteins).

Warnings and precautions

Consult your doctor before starting to use Flusamix Easyhaler if you haveany

• Cardiac abnormalities including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Flusamix Easyhaler may increase blood sugar levels).
• Low levels of potassium in the blood.
• Tuberculosis (TB) today or in the past, or other lung infections.

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

Use of Flusamix Easyhaler with other medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication..This includes medications for asthma or any medication obtained without a prescription. The reason is that in some cases, Flusamix Easyhaler should not be administered with other medications.

Inform your doctor if you take any of the following medications, before starting to use Flusamix Easyhaler:

• β-blockers (such as atenolol, propranolol and sotalol). β-blockers are used mainly to treat hypertension or other cardiac conditions.
• Medications to treat infections (such as ketoconazole, itraconazole and erythromycin and some HIV medications: ritonavir and cobicistat). Some of these medications mayincrease the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of experiencing adverse effects with Flusamix Easyhaler, including irregular heartbeat, or may worsen the adverse effects. Your doctor may want to monitor you closely if you take these medications.
• Corticosteroids (oral or injectable). If you have taken these medications recently, you may increase the risk of this medication affecting your adrenal gland.
• Diuretics, also known as medications to urinate, 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

It is unlikely that Flusamix Easyhaler will affect your ability to drive or operate machinery.

Flusamix Easyhaler contains lactose

Flusamix Easyhaler contains up to 16.8 milligrams of lactose in each dose. 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 them before using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be used exactly as directed by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure.

• Use Flusamix Easyhaler every day until your doctor tells you to stop. Do not take more than the recommended dose.
• Do not stop taking Flusamix Easyhaler or reduce your dose without talking to your doctor first.
• Flusamix Easyhaler should be inhaled through the mouth into the lungs.

For asthma

Adults and adolescents 12 years and older

• One inhalation of Flusamix Easyhaler 50/500 twice a day

Children under 12 years of age

• Flusamix Easyhaler is not recommended for use in children under 12 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• One inhalation of Flusamix Easyhaler 50/500 twice a day

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

Your doctor will help you control your asthma and adjust your medication dose to the minimum that controls your asthma. If your doctor thinks you need a lower dose than what is available with Flusamix Easyhaler, they will prescribe an inhaler with the same active ingredients as Flusamix Easyhaler but with a lower dose of corticosteroids.

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

How to use Flusamix Easyhaler

The instructions on how to use the inhaler are found at the end of the leaflet.To get the complete information, read the instructions “How to use your Easyhaler inhaler” included after section 6 of this leaflet.

If your asthma worsens or you have greater difficulty breathing, see your doctor immediately.You may notice more wheezing or a feeling of choking more often or that you need to use your rescue medication more frequently. If any of these things happen to you, continue using Flusamix Easyhaler, but do not increase the number of applications. Your respiratory disease may worsen and seriously harm you. See your doctor, as you may need additional treatment.

If you use more Flusamix Easyhaler than you should

It is very important to use the inhaler exactly as you have been told. If you have accidentally taken a higher dose than recommended, consult your doctor or pharmacist. You may notice that your heart beats faster than normal and feel tremors. You may also have dizziness, headache, muscle weakness, and joint pain.

If you have used high doses for a long time, ask your doctor or pharmacist for advice. This is because high concentrations of Flusamix Easyhaler can reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose or accidental ingestion, 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 Flusamix Easyhaler

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

If you interrupt treatment with Flusamix Easyhaler

It is very important to use Flusamix Easyhaler every day exactly as directed.Continue taking it until your doctor tells you to stop. Do not stop or abruptly reduce your treatment with Flusamix Easyhaler.This could make your breathing worse.

Additionally, if you stop taking Flusamix Easyhaler suddenly or reduce your dose, you may (very rarely) experience problems with the adrenal gland (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Abdominal pain
• Fatigue and loss of appetite, feeling unwell
• Discomfort and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Hypotension and convulsions (seizures)

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

If you have any adverse 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 the use of this medication, ask your doctor, nurse, or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.To reduce the occurrence of side effects, your doctor will prescribe the lowest dose of Flusamix Easyhaler that controls your asthma or Chronic Obstructive Pulmonary Disease (COPD).

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

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

Inform your doctorif you have any of the following effects while using Flusamix Easyhaler, they may be symptoms of a lung infection:

• Fever or cold
• Increased mucous production, change in mucous color
• Increased coughing or difficulty breathing

The following are other side effects:

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

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

Frequent (may affect less than 1 in 10 people)

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

• Osteoporosis and fractures.
• Salivary gland inflammation (sensation of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain).
• Reduction of potassium levels in the blood (may feel irregular heartbeats, muscle weakness, cramps).

Rare (may affect less than 1 in 100 people)

• Increased blood sugar levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed.
• Cataracts (opacity of the lens of the eye)
• Very fast heart rate (tachycardia)
• Feel tremors and a very fast or irregular heart rate (palpitations). These side effects are usually harmless and decrease as treatment continues
• Chest pain
• Sense of concern (occurs mainly in children)
• Sleep disturbances
• Allergic skin eruption.

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

• Difficulty breathing (or wheezing) that worsens immediately after using Flusamix Easyhaler.If this happens,stop using Flusamix Easyhaler. Use your quick-relief inhaler to improve your breathing andinform your doctor immediately.
• Flusamix Easyhaler may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods of time. The effects include:

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

Your doctor will regularly monitor any of these side effects and ensure that you are taking the lowest dose of Flusamix Easyhaler 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 Flusamix Easyhaler unless your doctor tells you to.
• Fungal infection of the esophagus (throat), which can cause difficulty swallowing.

Unknown frequency (cannot be estimated from available data), but may also appear:

• Depression or aggression. It is more likely that these effects will appear in children.
• Blurred vision.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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 bag, and inhaler label after CAD. The expiration date is the last day of the month indicated.

Replace your Flusamix Easyhaler 2 months after opening the aluminum bag. Write the date it was opened, to help you remember.

After opening the aluminum bag, do not store at a temperature above 25°C and protect it from moisture. It is recommended to keep the Easyhaler inhaler inside the protective cover.

If your Flusamix Easyhaler inhaler becomes wet, you must replace it with a new one.

Medicines should not be thrown away through drains or in the trash. Dispose of the containers and medications you do not need at the SIGREdisposal point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Flusamix Easyhaler

• Each dose contains xinafoate of salmeterol equivalent to 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the product and contents of the package

Flusamix Easyhaler is an inhaler that contains your medication. The inhalation powder is white in color. Each inhaler contains 60 doses and consists of a white body and a violet top.

Flusamix Easyhaler is available in packages of 1, 2, or 3 inhalers.

Only some package sizes may be marketed.

Your package may contain a protective cover. If you need a protective cover, please contact the Marketing Authorization Holder (see details below).

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Responsible for Manufacturing

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Orion Pharma S.L.

Avda. Alberto Alcocer 46B, 28016 Madrid, Tel.: 91 599 86 01

Last review date of this prospectus:August 2022

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

You can access detailed and updated information on how to administer this medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet addresshttps://cima.aemps.es/info/83644.

QR Code

How to use the Easyhaler inhaler

About your Easyhaler inhaler

Flusamix Easyhaler may be different from other inhalers you have used before. Therefore, it is very important that you use it correctly, otherwise, you may not receive the correct amount of medication. This could make you feel unwell or could be the cause of your asthma or COPD not being treated properly.

Your doctor, nurse, or pharmacist will teach you how to use your inhaler correctly. Make sure you understand how to use it correctly. If you are unsure, contact your doctor, nurse, or pharmacist again. As with all inhalers, caregivers must ensure that children prescribed Flusamix Easyhaler use the correct inhalation technique, as described below. You can also use the instructional video available athttps://cima.aemps.es/info/83644.

First use of the Easyhaler

CÓMO UTILIZAR CORRECTAMENTE

After using the inhaler

• Replace the cap on the mouthpiece. This will prevent the inhaler from accidentally activating.
• After inhaling, rinse your mouth with water and then spit it out and/or brush your teeth. This will help prevent the development of thrush and hoarseness.

Limpieza del inhalador Easyhaler

Keep your inhaler dry and clean. If necessary, you can clean the mouthpiece with a dry cloth. Do not use water: the powder inside the Easyhaler inhaler is sensitive to moisture.

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