Patient Information Leaflet

Seffalair Spiromax 12.75micrograms/100micrograms 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, pharmacist or nurse.

-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, as it may harm them.

• Ifyou experience any side effects, consult yourdoctor, pharmacist or nurse,even if they are not listed in this leaflet. See section4.

1.What Seffalair Spiromax is and what it is used for

2.What you need to know before starting to use Seffalair Spiromax

3.How to use Seffalair Spiromax

4.Possible side effects

5.Storage of Seffalair Spiromax

6.Contents of the pack and additional information

Seffalair Spiromaxcontains 2active ingredients:salmeterol and fluticasone propionate:

• The salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways inside the lungs open. This facilitates the entry and exit of air. The effects of salmeterol last for a minimum of 12hours.
• The fluticasone propionate is a corticosteroid that reduces lung inflammation and irritation.

Seffalair Spiromax is used to treat asthma in adults and adolescents aged 12years or older.

Seffalair Spiromax helps prevent the onset of shortness of breath and wheezing.Do not use it to relieve an asthma attack. If you have an asthma attack, use a quick-relief inhaler (immediate relief), such as salbutamol,which you should always carry with you.

Do not use Seffalair Spiromax

-if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients in this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Seffalair Spiromax if you have:

• Cardiac disease, including rapid or irregular heartbeat
• Hyperactive thyroid gland
• Hypertension
• Diabetes (Seffalair Spiromax may increase blood sugar)
• Low potassium levels in the blood
• Tuberculosis (TB), current or past, or other lung infections

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

Children and adolescents

Do not administer this medication to children or adolescents under 12years of age, as it has not been studied in this age group.

Other medications and Seffalair Spiromax

Inform your doctor, nurse, or pharmacist if you are taking, have taken recently, or may need to use any other medication.It may not be suitable to use Seffalair Spiromax with other medications.

Inform your doctor if you are taking the following medications before starting to useSeffalairSpiromax:

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are primarily used to treat hypertension or cardiac problems such as angina pectoris.
• Medications to treat infections (such as ritonavir, ketoconazole, itraconazole, and erythromycin). Some of these medications may increase the amount of salmeterol or fluticasone propionate in the body. This may increase the adverse effects ofSeffalairSpiromax, including irregular heartbeat, or worsen its adverse effects.
• Corticosteroids (by mouth or injection). Recent use of these medications may increase the risk thatSeffalairSpiromax will affect the adrenal glands, reducing the amount of steroid hormones produced by them (adrenal suppression).

• Diuretics, medications that increase urine production and are used to treat hypertension.
• Other bronchodilators (such as salbutamol).

• Xanthine medications such as aminophylline and theophylline, often used to treat asthma.

Some medications may increase the effects of Seffalair Spiromax, so your doctor may want to keep you under close surveillance if you are taking these medications (including some HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

The safety of this medication for use during pregnancy is unknown. If you are breastfeeding, ask your doctor, nurse, or pharmacist before using this medication.

Driving and operating machinery

It is unlikely that Seffalair Spiromax will affect your ability to drive or operate machinery.

Seffalair Spiromax contains lactose

Each dose of this medication contains approximately 5.4milligrams of lactose.If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one inhalation twice a day.

• Seffalair Spiromax is for regular long-term use. Use it every day to keep asthma under control. Do not use more than the recommended dose. If in doubt, consult your doctor, nurse, or pharmacist again.

• Do not interrupt treatment with Seffalair Spiromax or reduce your dose without talking to your doctor or nurse first.

• Seffalair Spiromax must be inhaled through the mouth.

Your doctoror nursewill help you manage asthma. The doctoror nurse will change the medication you take to the inhaler if you need a different dose to control asthma properly.However, do not change the number of prescribed inhalations without talking to your doctor or nurse first.

If asthma worsens or you breathe worse, inform your doctor immediately.If you notice more wheezing, feel chest tightness more often, or need to use your quick-relief medication more, it is possible that asthma is worsening and you could become seriously ill. Continue usingSeffalairSpiromax, but do not increase the number of inhalations you take. Go to your doctor immediately, as you may need additional treatment.

Instructions for use

Training

Your doctor, nurse, or pharmacist must train you in the use of the inhaler, including how to inhale a dose effectively. This training is important to ensure you receive the dose you need. If you have not received this training, talk to your doctor, nurse, or pharmacist to teach you how to use the inhaler properly before using it for the first time.

Your doctor, nurse, or pharmacist should also check from time to time that you are using the Spiromax device correctly and as prescribed. If you are not usingSeffalairSpiromax correctly or not inhaling it through sufficientlyforcedinspirations, you may not be receiving enough medication in the lungs. This means that the medication will not relieve asthma as much as it should.

Preparing Seffalair Spiromax

Before usingSeffalairSpiromaxfor the first time, you must prepare it for use as follows:

• Check the dose indicator to verify that the inhaler contains 60inhalations.
• Note the date when you opened the silver foil pouch on the label attached to the inhaler.
• You do not need to shake the inhaler before using it.

How to perform an inhalation

1. Hold the inhalerso that the semi-transparent and yellow-colored mouthpiece of the mouthpiece is in the lower position.

1. Open the mouthpiece cover by folding it down until you hear a loud click. This will meter out a dose of medication. The inhaler is now ready for use.

1. Exhale gently (as comfortably as possible). Do not exhale through the inhaler.

1. Insert the mouthpiece into your mouth and press your lips around it.Be careful not to block the airflow.

Breathe in through your mouth as deeply and forcefully as possible.

Remember that it is essential to perform aforcedinspiration.

1. Remove the inhaler from your mouth. You may notice a taste when performing the inhalation.

1. Hold your breath for 10seconds or as long as is comfortable.

1. Then, exhale gently(do not exhale through the inhaler).

1. Close the mouthpiece cover.

• After each dose, rinse your mouth with water and spit it out or brush your teeth before rinsing.
• Do not attempt to disassemble the inhaler or remove or twist the mouthpiece cover.
• The cover is attached to the inhaler and should not be removed.
• Do not use the Spiromax device if it has been damaged or if the mouthpiece has come loose from it.
• Do not open and close the mouthpiece cover unless you are about to use the inhaler.

Cleaning the Spiromax device

Keep the inhaler clean and dry.

If necessary, you can clean the mouthpiece of the inhaler with a dry cloth or paper towel after using it.

When to start using a new Seffalair Spiromax

• The dose indicator on the back of the device shows how many doses (inhalations) are left in the inhaler, starting at 60inhalations when full and ending at 0 (zero) when empty.

• The dose indicator shows the number of inhalations left only in the form of even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• When there are 20 or fewer, the numbers will appear in red on a white background. When the red numbers appear in the window, go to your doctor or nurse to get a new inhaler.

Nota:

• The mouthpiece emits a click even when the inhaler is empty.
• If you open and close the mouthpiece without taking an inhalation, the dose indicator will also include it in the count. This dose will be perfectly contained within the inhaler for the next inhalation. It is impossible to accidentally take more medication or a double dose in oneinhalation.

If you use more Seffalair Spiromax than you should

It is essential to take the dose prescribed by your doctor or nurse. Do not exceed the prescribed dose without consulting a doctor first. If you accidentally take more doses than recommended, talk to your nurse, doctor, or pharmacist. You may notice that your heart beats faster than normal and that you feel shaky. You may also notice dizziness, headache, muscle weakness, and joint pain.

If you have repeatedly used too many doses ofSeffalairSpiromax over a prolonged period, consult your doctor or pharmacist, as excessive use ofSeffalairSpiromax can reduce the amount of steroid hormones produced by the adrenal glands.

If you forgot to use Seffalair Spiromax

If you forgot to take a dose, take it as soon as you remember, butdo nottake a double dose to compensate for the missed doses. If it is almost time for the next dose,simply take the next dose at the usual time.

If you interrupt treatment with Seffalair Spiromax

It is very important to takeSeffalairSpiromax every day as indicated.Continue taking it until your doctor tells you to stop treatment. Do not interrupt treatment or abruptly reduce the dose of Seffalair Spiromax.This could make you breathe worse.

Additionally, if you abruptly interrupt treatment withSeffalairSpiromax or reduce your dose, you may experience (in rare cases) problems due to a decrease in the amount of steroid hormones produced by the adrenal glands (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Stomach pain
• Fatigue and loss of appetite, nausea
• Vomiting and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures (epileptic crises)

In situations of stress for your body, such as fever, accident or injury, infection, or surgery, adrenal insufficiency may worsen and you may also experience the previously mentioned adverse effects.

If you experience any type of adverse effect, consult your doctor or pharmacist. To avoid these symptoms, your doctor will prescribe more corticosteroids in the form of tablets (such as prednisolone).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.To reduce the likelihood of side effects, your doctor will prescribe the lowest dose of this combination of medications to control asthma.

Allergic reactions: you may notice that you suddenly breathe worse immediately after using Seffalair Spiromax.You may have many wheezes and coughs or feel short of breath. You may also present with hives, a skin rash (hives) and swelling (usually of the face, lips, tongue or throat) or notice that your heart suddenly beats very fast or a sensation of dizziness or fainting (which can lead to syncope or loss of consciousness).If you experience any of these effects or they appear suddenly after usingSeffalairSpiromax, interrupt treatment withSeffalairSpiromax and inform your doctor immediately.Allergic reactions toSeffalairSpiromax are rare (can affect up to 1 in 100people).

Below are other side effects:

Common(can affect up to 1 in 10people)

• A fungal infection (candidiasis) that causespainful, elevated patchesin the mouth and throat, as well astongue pain and hoarseness and throat irritation.You may find relief by rinsing your mouth with water and spitting it out immediately or brushing your teeth after each inhalation. Your doctor may prescribe an antifungal medication to treat the candidiasis.
• Muscle pain.
• Back pain.
• Flu.
• Low levels of potassium in the blood (hypokalemia).
• Runny nose (rhinitis).
• Paranasal sinus inflammation (sinusitis).
• Nasal and throat inflammation (nasopharyngitis).
• Headache.
• Cough.
• Throat irritation.
• Pain or inflammation in the back of the throat.
• Hoarseness or aphonia.
• Dizziness.

Uncommon(can affect up to 1 in 100persons)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, you may need to monitor blood sugar levels more frequently and, possibly, adjust your usual diabetes treatment.

• Cataracts (lens clouding in the eye).
• Very fast heart rate (tachycardia).
• Sensation of trembling and that the heart beats rapidly (palpitations): they are usually harmless and decrease as treatment continues.

• Feelings of concern or anxiety.
• Changes in behavior, such as unusual activity and irritability (although these effects occur mainly in children).
• Sleep disturbances.
• Allergic rhinitis.
• Blocked nose (nasal congestion).
• Irregular heartbeat (atrial fibrillation).
• Chest infection.
• Pain in the limbs (arms or legs).
• Stomach pain.
• Indigestion.
• Skin damage and shedding.
• Skin inflammation.
• General throat inflammation, usually characterized by sore throat (pharyngitis).

Rare(can affect up to 1 in 10000people)

• Difficulty breathing or wheezing that worsens immediately after using Seffalair Spiromax.If this occurs,interrupt treatment with the inhalerSeffalairSpiromax. Use your "rescue" inhaler ("immediate relief") with rapid action to help you breathe andinform your doctor immediately.
• Seffalair Spiromax may affect normal steroid hormone production in the body, especially if you have taken high doses for prolonged periods.Among the effects are:

• Slowed growth in children and adolescents
• Glaucoma (eye nerve damage)
• Rounded face (moon-shaped) (Cushing's syndrome)

Your doctor will check you periodically for these side effects and ensure that you are taking the lowest dose of this combination of medications to control asthma.

• Irregular or rapid heartbeat or additional heartbeats (arrhythmias). Inform your doctor, but do not interrupt treatment withSeffalairSpiromax, unless your doctor tells you to.
• A fungal infection of the esophagus, which can cause difficulty swallowing.

Unknown frequency, but it may also appear:

• Blurred vision.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughthe national notification system included in theAppendix V.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 and on the inhaler label after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25orC.Keep the mouthpiece cover closed after removing the aluminum foil wrapper.

Use within 2months after removal from the aluminum foil wrapper.Use the label attached to the inhaler to note the date when you opened the paper pouch.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment..

Composition of Seffalair Spiromax

• The active principles are salmeterol and fluticasone propionate. Each measured dose contains 14 micrograms of salmeterol (in the form of salmeterol xinafoate) and 113 micrograms of fluticasone propionate.Cheapedosesupplied(thedosethatcomesfromtheapplicatory)and113microgramsoffluticasonepropionate.
• The other component is lactose monohydrate (see section 2, subsection “Seffalair Spiromax contains lactose”).

Appearance of the product and contents of the package

Each inhaler Seffalair Spiromax contains powder for inhalation for 60 inhalations and has a white body with a semi-transparent and yellow-colored mouthpiece.

Seffalair Spiromax is presented in packages containing 1 inhaler and in multiple packages containing 3 boxes, each containing 1 inhaler inside. It may only be commercially available in some sizes in your country.

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Responsible for manufacturing

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Unit 14/15, 27/35 & 301, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str. 31-546 Kraków, Poland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu