AIRFLUSAL FORSPIRO 50 micrograms/250 micrograms inhalation powder (single dose)

Introduction

Package Leaflet: Information for the Patient

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

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Airflusal Forspiro is used to treat:

• asthma.

This medicine contains two active substances:

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

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

Do not use Airflusal Forspiro:

• if you are allergicto salmeterol, fluticasone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start using Airflusal Forspiro if you have:

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

Talk to 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 once these breathing difficulties or wheezing have started.

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

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

• you are wheezing more,
• you have tightness in the chest more often,
• you need to use your quick-acting "rescue" inhaler more often.

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

Children and adolescents

Airflusal Forspiro should 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 take any other medicines, including those obtained without a prescription.

The following medicines may affect or be affected by Airflusal Forspiro:

• medicines to treat high blood pressure, heart disease or other diseases, with active substances ending 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/fluticasone and your doctor may want to monitor you closely if you are taking these medicines,
• medicines to treat infections, such as ketoconazole, itraconazole and erythromycin,
• corticosteroids that are taken orally or injected: medicines 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 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and using machines

Airflusal Forspiro is unlikely to affect your ability to drive or use machines.

Airflusal Forspiro contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

The amount of lactose in this medicine normally does not cause problems in people who are lactose intolerant.

3. How to use Airflusal Forspiro

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

• Asthma

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

One inhalation twice a day.

Your doctor will want to regularly check your symptoms.

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 nighttime symptoms,
• once in the morning if you have daytime symptoms.

Method of use

Use Airflusal Forspiro every day, as your doctor has prescribed, preferably just before mealsin the morning or evening.

After use, rinse your mouth with water.

If you do not use Airflusal Forspiro correctly or as prescribed, your breathing difficulties may get worse. For optimal treatment, you should use Airflusal Forspiro daily, even if you do not have symptoms.

Instructions for use

Your doctor, nurse or pharmacist should show you how to use your inhaler and check how you use it from time to time.

The inhaler contains 60 doses of medicine in a powder form in an aluminum strip. It has a dose counter that shows 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 refillable, you should replace it when it is empty and replace it with 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 forcefully.

• 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 with black lines do not contain medicine. Eventually, the numbered sections of the strip will appear in the lateral chamber. There should never be more than 2 sections of the aluminum stripin the lateral chamber, as this can cause the inhaler to jam. The excess strip should be carefully cut and left in a safe place.

Using the inhaler:

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

1. Opening

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

1. Dose preparation

• Lift the white lever upwards. Check that the lateral chamber is closed.

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

• Opening: The white lever should be lifted completelyuntil it clicks. This action moves a new dose to its position with its corresponding number above on the dose counter.

• Closing: Then, close the white leveruntil it clicks again in its original position. This way, the inhaler is ready for immediate use.

1. Inhaling the dose

• With the inhaler mouthpiece away from your mouth, exhale as much as you can or until you feel comfortable. Never exhale directly over the inhaleras this can 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 secondsor as long as you can 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. This can help prevent fungal infections in the mouth and hoarseness.

Cleaning

• If necessary, the outside of the mouthpiece can be cleaned with a dry cloth.
• Never separate the parts of the inhaler to clean them or for any other purpose!
• The parts of the inhaler cannot be cleaned with water or wet cloths, as moisture can affect the dose!
• Never insert pins or any other sharp object into the mouthpiece or any other part, as this can damage your inhaler!

If you use more Airflusal Forspiro than you should

Talk to your doctor or pharmacist.

The symptoms of overdose are:

• dizziness,
• headache,
• rapid heartbeat,
• muscle weakness,
• joint pain,
• feeling shaky.

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

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

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

If you forget to use Airflusal Forspiro

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

If you stop using Airflusal Forspiro

Do not stop using Airflusal Forspiro suddenly or reduce your dose without your doctor's consent, as this can cause your breathing difficulties to get worse and very rarely can cause side effects. These 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 convulsions (seizures).

Very rarely, if you have an infection or if you experience extreme stress (such as fever, trauma and infection, after a serious accident or if you have undergone surgery), you may experience similar side effects. To prevent these symptoms from occurring, your doctor may prescribe you extra 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 all people suffer from them.

Allergic Reactions: you may notice that your breathing suddenly worsens immediately after using Airflusal Forspiro.You may have wheezing and 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 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 Airflusal Forspiro, inform your doctor immediately.Allergic reactions to Airflusal Forspiro are rare (they can 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. It usually improves when continuing treatment,
• increase in the number of colds in patients with COPD.

Common(may affect up to 1 in 10 people)

• thrush (itching, appearance of yellowish-white ulcers) in the mouth and throat. Also, pain in the tongue, 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.

For the treatment of thrush, your doctor may prescribe antifungal medication,

• pain, inflammation in the joints, 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, they could be symptoms of a lung infection:

increased production of sputum,

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

Uncommon(may affect up to 1 in 100 people)

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

These adverse effects are usually harmless and decrease when continuing treatment,

• feeling of concern. This effect is more likely to appear in children,
• increased blood sugar levels.

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

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

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

• difficulty breathing or wheezing that worsensright after using Airflusal Forspiro. If this happens to you, stop using Airflusal Forspiroand use your rapid-acting "rescue" inhaler to help you breathe. Consult your doctor immediately,
• abnormal production of certain hormones, particularly when this medication is used at high doses for a long period.

The symptoms are:

• delayed growth in children and adolescents,
• decrease in bone mineral density,
• increased eye pressure (glaucoma),
• weight gain,
• round face in the shape of a full moon (Cushing's syndrome).

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

• changes in behavior, such as hyperactivity and irritability.

These adverse 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,

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

Frequency not known, but which may also appear:

• depression or aggression.

It is more likely that these effects will appear in children.

• Blurred vision

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Airflusal Forspiro

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Airflusal Forspiro

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

• The active ingredients are salmeterol and fluticasone. Each measured dose of Airflusal Forspiro provides 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This corresponds to a released 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 Package Contents

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

This medication is available in packages that contain 1, 2, 3, 4, 5, 6, or 10 inhalers with 60 doses.

Only some package 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 medication is authorized in the Member States of the European Economic Area under the following names:

Sweden: Mesaflu Forspiro

Date of the last revision of this prospectus:February 2018.

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/

You can access detailed and updated information on how to administer this medication by scanning the QR code included in the prospectus, 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/80248