Prospecto: information for the patient

Airflusal Forspiro 50 micrograms/500 micrograms/inhalation, powder for inhalation (single dose)

Salmeterol/fluticasone propionate

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Airflusal Forspiro

3.How to use Airflusal Forspiro

4.Adverse effects

5.Storage of Airflusal Forspiro

6.Contents of the package and additional information

Airflusal Forspiro is used to treat:

• asthma,
• Chronic Obstructive Pulmonary Disease (COPD).

This disease is characterized by causing continuous respiratory difficulties by narrowing the airways, often accompanied by cough and mucus. This medication reduces the number of exacerbations of COPD symptoms.

This medication contains two active ingredients:

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

Do not use Airflusal Forspiro:

• if you areallergicto salmeterol, fluticasona or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

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

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

Airflusal Forspiro prevents the onset of breathing difficulties and wheezing. Please note that it does not work when those breathing difficulties or wheezing have already started.

If you experience anasthma attack, you need to use a medicine that rapidly opens up the airways, such as salbutamol.

Inform your doctor immediately if your asthma or breathing difficulties worsen. You may feel:

• you are breathing more heavily,
• you have a tightness in the chest more often,
• you need to use your quick-relief inhaler more often.

Continue using Airflusal Forspiro even if you experience any of these situations, but do not increase the number of inhalations. Your respiratory condition may worsen and you may become seriously ill.

Consult your doctor as you may need additional treatment.

Children and adolescents

Asthma:

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

COPD:

Airflusal Forspiro should not be used in children and adolescents.

Using Airflusal Forspiro with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including medicines bought without a prescription.

The following medicines may influence or be influenced by Airflusal Forspiro:

• medicines to treat high blood pressure, heart disease or other diseases, with active ingredients that end in “olol” (beta-blockers), such as atenolol, propranolol and sotalol,
• medicines to treat viruses, including some medicines for HIV, such as ritonavir, or cobicistat. These medicines may increase the effects of salmeterol/fluticasona and your doctor may want to monitor you closely if you are taking these medicines,
• medicines to treat infections such as ketoconazol, itraconazol and erythromycin,
• oral or injected corticosteroids: medicines to treat inflammation or prevent rejection after an organ transplant,
• diuretics, also known as medicines to urinate, used to treat high blood pressure,
• other bronchodilators (such as salbutamol),
• medicines that contain xanthine. They are often used to treat asthma.

Pregnancy, breastfeeding and fertility

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

Your doctor will tell you if you can use this medicine during this time.

Driving and operating machines

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

Airflusal Forspiro contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Always follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.or pharmacist.

• Asthma

The recommended dose foradults and children over 12 years of ageis:

One inhalation twice a day.

Your doctor will want to monitor your symptoms regularly.

• Chronic Obstructive Pulmonary Disease

The recommended dosefor adultsis:

One inhalation twice a day.

If your symptoms are well controlled using Airflusal Forspiro twice a day, your doctor may decide to reduce your dose to once a day:

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

Form of use

Use Airflusal Forspiro every day as prescribed by your doctor, preferablyjust before mealsin 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 do not have symptoms.

Instructions for use

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

The inhaler contains 60 doses of medication in powder form on a rolled aluminum strip. It has a dose counter that indicates how many doses are left in decreasing order from 60 to 0. When the last 10 doses are reached, the numbers appear on a red background.

The inhaler is not rechargeable, you must replace it when it is empty and change it for a new one.

Before using the inhaler:

• Open the transparent lateral chamber of the inhaler.
• Cut the aluminum strip that protrudes from the lateral chamber by carefully pulling the strip against the "teeth" of the lateral chamber as shown below.Do not pull or tear it with force.

• Close the lateral chamber and discard the used strip.

Important: As the inhaler is used, the lateral chamber will gradually fill with the used aluminum strip. The aluminum strips withblack lines do not contain medication. Eventually, the numbered sections of the strip will appear in the lateral chamber.You should never have more than 2 sections of the aluminum stripin the lateral chamber, as this may cause the inhaler to jam. The remaining strip should be cut carefully and left in a safe place.

Using the inhaler:

Take the inhaler with your hands, as shown in the images.

1. Opening

• Opentheprotective cap downwardsso that the mouthpiece appears.
• Check the dose counter to see how many doses are left.

1. Preparation of the dose

• Push up the white lever. Make sure the lateral chamber is closed.

Remember: You should only manipulate the white lever when you are ready to inhale your medication dose. If you play with the white lever, you will waste doses.

• Opening:The white lever must be lifted completelyuntil it reaches its top anduntil it makes a "click" sound. This action moves a new dose to its position with its corresponding number above on the counter.

• Closing: Next,close the white leveruntil it makes "click" sound again in its original position. In this way, the inhaler is ready for immediate use.

1. Inhalation of the dose

• With the mouthpiece of the inhaler away from your mouth, exhale as much as you can or until you feel comfortable.You should never exhale directly onto the inhaleras this may affect the dose.
• Hold the inhaler with theprotective cap facing downwards.
• Close your lips firmly around the mouthpiece.
• Breathe deeply and uninterruptedly through the inhaler, not through your nose.

• Remove the inhaler from your mouth andhold your breath for 5 to 10 secondsor as long as possible without discomfort.
• Then, start breathing slowly,but outside the inhaler.
• Close the protective cap of the mouthpiece.
• Rinse your mouth with water and spit it out afterwards. This may help prevent fungal infections in your mouth and prevent hoarseness.

Cleaning

• If necessary, the exterior of the mouthpiece can be cleaned with a dry handkerchief.
• You should never separate the parts of the inhaler to clean them or for any other purpose!
• You should never clean the parts of the inhaler with water or with damp cloths, as moisture may affect the dose!
• You should never insert paper clips or any other sharp objects into the mouthpiece, or in any other part, as this may damage your inhaler!

If you use more Airflusal Forspiro than you should

Contact your doctor or pharmacist.

The symptoms of overdose are:

• dizziness,
• headache,
• rapid heartbeats,
• muscle weakness,
• joint pain,
• shaking.

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

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

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 forgot to use Airflusal Forspiro

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

If you interrupt treatment with Airflusal Forspiro

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

• stomach pain,
• fatigue and loss of appetite, feeling sick,
• discomfort and diarrhea,
• weight loss,
• headache or drowsiness,
• low blood sugar levels,
• low blood pressure and convulsions (seizures).

Very rarely, if you have an infection or if you experience extreme stress (such as fever, trauma, or 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 other questions about the use of this medication, ask your doctor or pharmacist.

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

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Airflusal Forspiro.You may have coughs and wheezing or shortness of breath. You may also notice itching, hives (urticaria), and swelling (usually on the face, lips, tongue, or throat). You may also feel, suddenly, that your heart is beating very fast, feel like you're 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 Airflusal Forspiro, inform your doctor immediately.Allergic reactions to Airflusal Forspiro are rare (they can affect up to 1 in 100 people).

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

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

• headache. It usually improves as you continue treatment,
• increase in the number of colds in COPD patients.

Frequent(may affect up to 1 in 10 people)

• mouth ulcers (itching, appearance of yellowish cream-colored ulcers) in the mouth and throat. Also, tongue pain, hoarse voice, 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 you.

Your doctor may prescribe antifungal medication for the treatment of mouth ulcers,

• joint pain and inflammation, and muscle pain,
• muscle cramps.

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

• bronchitis (lung infection),

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

increased sputum production,

• increased mucus production,
• change in sputum color,
• fever,
• chills,
• increased cough,
• increased difficulty breathing.
• cardenales and fractures throughout the body,
• inflammation of the nasal sinuses,
• low potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, or cramps).

Frequent(may affect up to 1 in 100 people)

• very fast heart rate (tachycardia),
• feel tremors and a fast or irregular heart rate (palpitations).

These side effects are usually harmless and decrease as you continue treatment,

• feeling of concern. It is more likely to appear in children,
• increase in blood sugar levels.

If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed,

• sleep disorders,
• chest pain,
• opacity in the crystalline lens of the eye (cataracts),
• allergic skin rash

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

• difficulty breathing or wheezing that worsensjust after using Airflusal Forspiro. If this happens to youstop using Airflusal Forspiroand use your rescue inhaler to help you breathe.Consult your doctor immediately,
• abnormal production of certain hormones, particularly when this medicine is used at high doses for a long period of time.

The symptoms are:

• delayed growth in children and adolescents,
• decreased bone mineral density,
• increased intraocular pressure (glaucoma),
• weight gain,
• moon-shaped face (Cushing's syndrome).

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

• changes in behavior, such as hyperactivity and irritability.

These side effects occur mainly in children.

• irregular heartbeats or extra heartbeats.

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

• fungus infections in the esophagus (throat), which can cause difficulty swallowing.

Unknown frequency, 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 about the safety of this medicine.

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

Store below 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Airflusal Forspiro

For the 50 micrograms/500 micrograms/inhalation dose, inhalation powder (single dose):

• The active principles are salmeterol and fluticasone. Each dose of Airflusal Forspiro provides 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate. This corresponds to a released dose of: 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.
• The other component is lactose monohydrate.

Appearance of Airflusal Forspiro and contents of the packaging

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

This medicine is available in packaging that contains 1, 2, 3, 4, 5, 6 or 10 inhalers with 60 doses.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Aeropharm

François-Mitterrand-Allee 1

07407 Rudolstadt

Germany

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

Sweden:Mesaflu Forspiro

Last review date of this leaflet:February 2018.

Detailed and updated information on this medicine 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 medicine by scanning the QR code included in the leaflet, packaging, and labeling with your mobile phone (smartphone). You can also access the same information at the following internet address: https://cima.aemps.es/info/80249