Airflusal Forspiro 50 micrograms/250 micrograms/inhalation powder for inhalation (single dose)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Airflusal Forspiro 50 micrograms/250 micrograms/inhalation, inhalation powder (unit dose)

Salmeterol/fluticasone propionate

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, consult 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Airflusal Forspiro is and what it is used for

Airflusal Forspiro is used to treat:

• asthma.

This medicine contains two active substances:

• salmeterol: a long-acting active substance that opens the airways,
• fluticasone: a corticosteroid that reduces irritation and inflammation in the lungs.

2. What you need to know before using Airflusal Forspiro

Do not use Airflusal Forspiro:

• if you are allergic to salmeterol, fluticasone, or to any other component of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Airflusal Forspiro if you have:

• heart problems, including rapid or irregular heartbeat,
• overactive thyroid,
• high blood pressure,
• diabetes mellitus (Airflusal Forspiro may increase blood sugar levels),
• low levels of potassium in the blood,
• tuberculosis (TB) currently or in the past, or other lung infections.

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

Airflusal Forspiro prevents breathing difficulties and wheezing from starting. Please note that it does not work once breathing difficulties or wheezing have already begun.

If you have such a breathless attack, you need to use a medicine that quickly opens the airways, such as salbutamol.

Tell your doctor immediately if your asthma or breathing difficulties get worse. You may notice that:

• you wheeze more,
• you feel chest tightness more often,
• you need to use your fast-acting "rescue" inhaler more frequently.

Continue using Airflusal Forspiro even if any of these situations occur, but do not increase the number of inhalations. Your chest condition could worsen and you could become seriously ill. Consult your doctor, as you may need additional treatment.

Children and adolescents

Airflusal Forspiro must not be used in children under 12 years of age.

Using Airflusal Forspiro with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.

The following medicines may interact with or be affected by Airflusal Forspiro:

• medicines to treat high blood pressure, heart diseases, or other conditions, containing active substances ending in “olol” (beta-blockers), such as atenolol, propranolol, and sotalol,
• medicines to treat viral infections, including some HIV medicines, such as ritonavir or cobicistat. These medicines may increase the effects of salmeterol/fluticasone, and your doctor may want to monitor you carefully if you are taking them,
• medicines to treat infections, such as ketoconazole, itraconazole, and erythromycin,
• corticosteroids taken orally or by injection: medicines used to treat inflammation or prevent organ transplant rejection,
• 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, breastfeeding, and fertility

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.

Your doctor will advise you whether you can use this medicine during this time.

Driving and using machines

It is unlikely that Airflusal Forspiro will affect your ability to drive or operate machinery.

Airflusal Forspiro contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

The amount of lactose contained in this medicine usually does not cause problems in people with lactose intolerance.

3. How to use Airflusal Forspiro

Always follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Asthma

The recommended dose for adults and children over 12 years of age is:

One inhalation twice daily.

Your doctor will want to monitor your symptoms regularly.

If your symptoms become well controlled using Airflusal Forspiro twice daily, your doctor may decide to reduce your dose to once daily:

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

Method of use

Use Airflusal Forspiro every day as prescribed by your doctor, preferably just before meals in the morning or at night.

After use, rinse your mouth with water.

If you do not use Airflusal Forspiro correctly or as prescribed, your breathing difficulties may worsen. For optimal treatment, you must use Airflusal Forspiro daily, even if you have no symptoms.

Instructions for use

Your doctor, nurse, or pharmacist should teach you how to use your inhaler and should periodically check your technique.

The inhaler contains 60 doses of powdered medicine in a coiled aluminum strip. It has a dose counter that shows you how many doses remain, counting down from 60 to 0. When the last 10 doses remain, the numbers appear on a red background.

The inhaler is not refillable; you must replace it when empty with a new one.

Before using the inhaler:

• Open the transparent side chamber of the inhaler.
• Cut the aluminum strip protruding from the side chamber by carefully pulling the strip against the "teeth" of the side chamber, as shown below. Do not pull or yank forcefully.

• Close the side chamber and discard the used strip.

Important: As the inhaler is used, the side chamber gradually fills with the used aluminum strip. Aluminum strips with black lines do not contain medicine. Eventually, numbered sections of the strip will appear in the side chamber. There should never be more than 2 sections of the aluminum strip in the side chamber, as this may cause the inhaler to jam. The excess strip should be carefully cut and stored safely.

Using the inhaler:

Hold the inhaler in your hands as shown in the images.

1. Opening

• Open the protective cap downwards so that the mouthpiece appears.
• Check the dose counter to see how many doses remain.

1. Preparing the dose

• Lift upwards the edge of the white lever. Ensure the side chamber is closed.

Remember: Only handle the white lever when you are ready to inhale your dose. If you play with the white lever, you will waste doses.

• Opening: The white lever must be lifted completely to its full extent until it clicks. This action advances a new dose into position, displaying its corresponding number on the counter.

• Closing: Then, close the white lever until it clicks back into its original position. The inhaler is now ready for immediate use.

1. Inhaling the dose

• With the inhaler's mouthpiece away from your mouth, exhale as much as you can or until you feel comfortable. Never exhale directly into the inhaler, as this may affect the dose.
• Hold the inhaler with the protective cap facing downwards.
• Close your lips firmly around the mouthpiece.
• Inhale deeply and continuously through the inhaler, not through your nose.

• Remove the inhaler from your mouth and hold your breath for 5 to 10 seconds, or as long as possible without discomfort.
• Then, begin breathing slowly, but not through the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water and spit it out. This may help prevent fungal infections in the mouth and reduce hoarseness.

Cleaning

• If necessary, the outer part of the mouthpiece may be cleaned with a dry tissue.
• Never disassemble the inhaler parts for cleaning or any other purpose!
• The inhaler parts must not be cleaned with water or wet cloths, as moisture may affect the dose!
• Never insert paper clips or any other sharp objects into the mouthpiece or any other part, as this may damage your inhaler!

If you use more Airflusal Forspiro than you should

Contact your doctor or pharmacist.

Symptoms of overdose include:

• dizziness,
• headache,
• rapid heartbeat,
• muscle weakness,
• joint pain,
• tremors.

If you have used high doses for prolonged periods, seek advice from your doctor or pharmacist. This is because high concentrations of salmeterol/fluticasone may reduce the amount of steroid hormones produced by the adrenal gland.

It is important that you take your dose exactly as instructed by your pharmacist or prescribed by your doctor. Do not increase or decrease your dose without your doctor's consent.

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 Airflusal Forspiro

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

If you stop using Airflusal Forspiro

Do not stop or reduce your dose of Airflusal Forspiro suddenly without your doctor's consent, as this may worsen your breathing problems and, very rarely, cause adverse effects. These may include:

• stomach pain,
• fatigue and loss of appetite, feeling unwell,
• malaise and diarrhea,
• weight loss,
• headache or drowsiness,
• low blood sugar,
• low blood pressure and seizures (fits).

Very rarely, if you have an infection or experience extreme stress (e.g., fever, trauma, infection, after a serious accident, or if you have undergone surgery), you may experience similar adverse effects. To prevent these symptoms, your doctor may prescribe additional corticosteroids (such as prednisolone).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Allergic reactions: You may notice that your breathing suddenly worsens immediately after using Airflusal Forspiro. You may experience wheezing, coughing, or shortness of breath. You may also notice itching, rash (urticaria), or swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel dizzy, or feel like you are losing consciousness (which could lead to collapse or loss of awareness). If you experience any of these effects, or if they occur suddenly after using Airflusal Forspiro, inform your doctor immediately. Allergic reactions to Airflusal Forspiro are uncommon (may affect up to 1 in 100 people).

Other adverse effects that may occur with the following frequencies are:

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

• Headache. This usually improves with continued treatment,
• Increased number of colds in patients with COPD.

Common (may affect up to 1 in 10 people)

• Mouth or throat ulcers (itching, appearance of creamy-yellow ulcers) in the mouth and throat. Also, tongue pain, 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 mouth ulcers, your doctor may prescribe antifungal medication,

• Joint pain and inflammation, and muscle pain,
• Muscle cramps.

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

• Pneumonia (lung infection).

Inform your doctor if you notice any of the following symptoms while inhaling Airflusal Forspiro, as they could be signs of a lung infection:

• Increased sputum production,
• Increased mucus production,
• Change in sputum color,
• Fever,
• Chills,
• Increased cough,
• Increased difficulty breathing.
• Bruising and body-wide fractures,
• Sinus inflammation,
• Low blood potassium levels (you may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon (may affect up to 1 in 100 people)

• Very fast heart rate (tachycardia),
• Feeling of tremors and a fast or irregular heartbeat (palpitations).

These adverse effects are usually harmless and tend to decrease with continued treatment,

• Feeling of anxiety. This effect is more likely to occur in children,
• Increased blood sugar levels.

If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetic treatment if necessary,

• Sleep disturbances,
• Chest pain,
• Clouding of the eye's lens (cataracts),
• Allergic-type skin rash.

Rare (may affect up to 1 in 1,000 people)

• Worsening breathing difficulties or wheezing immediately after using Airflusal Forspiro. If this happens, stop using Airflusal Forspiro and use your fast-acting "rescue" inhaler to help you breathe. Contact your doctor immediately,
• Abnormal production of certain hormones, particularly when this medicine is used at high doses over a long period of time.

Symptoms include:

• Slowed growth in children and adolescents,
• Decreased bone mineral density,
• Increased eye pressure (glaucoma),
• Weight gain,
• Rounded, moon-shaped face (Cushing's syndrome).

Your doctor will regularly monitor for any of these adverse effects and ensure you are taking the lowest possible dose.

• Changes in behavior, such as hyperactivity and irritability.

These adverse effects occur mainly in children.

• Irregular heartbeat or extra heartbeats.

Consult your doctor, but do not stop taking Airflusal Forspiro unless your doctor tells you to do so,

• Fungal infections in the esophagus (throat), which may cause difficulty swallowing.

Frequency not known, but which 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Airflusal Forspiro

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

Store below 25°C.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Airflusal Forspiro

For the 50 micrograms/250 micrograms/inhalation dose, inhalation powder (single dose):

• The active substances are salmeterol and fluticasone. Each measured dose of Airflusal Forspiro delivers 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This corresponds to a delivered dose of: 45 micrograms of salmeterol (as salmeterol xinafoate) and 233 micrograms of fluticasone propionate.
• The other component is lactose monohydrate.

Appearance of Airflusal Forspiro and contents of the pack

• The purple plastic dry powder inhaler contains 60 doses of powder in an aluminum blister.
• Each dose is a single dose.

This medicine is available in packs containing 1, 2, 3, 4, 5, 6 or 10 inhalers with 60 doses.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Aeropharm

François-Mitterrand-Allee 1

07407 Rudolstadt

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden: Mesaflu Forspiro

Date of the most recent revision of this leaflet: February 2018.

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

You can access detailed and up-to-date information on how to administer this medicine by scanning the QR code included in the package leaflet, packaging, and labelling with your mobile phone (smartphone). You can also access the same information at the following internet address: https://cima.aemps.es/info/80248