Seffalair Spiromax

Patient Information Leaflet

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder

salmeterol/fluticasone propionate
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Seffalair Spiromax contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open. This makes it easier to breathe in and out. The effect of salmeterol lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Seffalair Spiromax is used for the treatment of asthma in adults and adolescents aged 12 years and older.
Seffalair Spiromax helps to prevent breathlessness and wheezing. It must not be used to relieve an
asthma attack. In such cases, you must use a fast-acting reliever inhaler (rescue inhaler), such as
salbutamol. You must always have your fast-acting reliever inhaler readily available.

2. What you need to know before using Seffalair Spiromax

Do not use Seffalair Spiromax

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Seffalair Spiromax if you have:

• a heart condition, including irregular or fast heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes (Seffalair Spiromax may increase blood sugar levels)
• low levels of potassium in the blood
• active or past tuberculosis (TB), or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
This medicine must not be given to children and adolescents under 12 years of age, as it has not been studied in this age group.
Other medicines and Seffalair Spiromax
Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. Seffalair Spiromax may not be suitable to use with certain other medicines.
Tell your doctor if you are taking the following medicines before using Seffalair Spiromax:

• beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mainly used for high blood pressure or heart conditions such as angina
• medicines used to treat infections (such as ritonavir, ketoconazole, itraconazole, and erythromycin). Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body. This may increase the risk of side effects from Seffalair Spiromax, including irregular heartbeat, or may worsen existing side effects
• corticosteroids (taken by mouth or by injection). Recent use of these medicines may increase the risk that Seffalair Spiromax will impair your adrenal glands, reducing the amount of steroid hormones produced by these glands (adrenal suppression)
• diuretics, medicines that increase urine production, used to treat high blood pressure
• other bronchodilators (such as salbutamol)
• xanthine medicines such as aminophylline and theophylline, which are often used to treat asthma.

Some medicines may increase the effects of Seffalair Spiromax, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
It is not known whether this medicine passes into breast milk. If you are breastfeeding, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Seffalair Spiromax will affect your ability to drive or operate machinery.
Seffalair Spiromax contains lactose
Each dose of this medicine contains approximately 5.4 milligrams of lactose. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use Seffalair Spiromax

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one inhalation twice daily.

• Seffalair Spiromax is for regular, long-term use. Use it every day to keep your asthma under control. Do not use more than the recommended dose. If you have any doubts, consult your doctor, nurse, or pharmacist.
• Do not stop treatment with Seffalair Spiromax or reduce the dose without first consulting your doctor or nurse.
• Seffalair Spiromax must be inhaled through the mouth.

Your doctor or nurse will help you manage your asthma. If you need a different dose to keep your asthma under control, your doctor or nurse may change your inhaled medicine. In any case, do not change the number of inhalations prescribed by your doctor or nurse without consulting them.
If your asthma or breathing worsens, inform your doctor immediately. If you experience increasing wheezing, more frequent chest tightness, or need to use your "reliever" medicine (fast-acting) more often, your asthma may be worsening and you could become seriously ill. Continue taking Seffalair Spiromax, but do not increase the number of inhalations. Contact your doctor immediately, as you may need additional treatment.

Instructions for use
Training
Your doctor, nurse, or pharmacist must instruct you on how to use the inhaler and how to correctly take your dose. This training is important so that you receive the dose you need.
If you have not received this training, ask your doctor, nurse, or pharmacist to show you how to correctly use the inhaler before using it for the first time.

Additionally, your doctor, nurse, or pharmacist should occasionally check that you are using the Spiromax device correctly and as prescribed. If you do not use Seffalair Spiromax correctly or do not inhale with sufficient force, you may not receive enough medicine into your lungs. This means the effect on your asthma will be inadequate.

How to prepare Seffalair Spiromax
Before using Seffalair Spiromax for the first time, prepare it as follows:

• Check that the dose indicator shows 60 inhalations available in the inhaler.
• Write the date you opened the aluminium foil pouch on the label of the inhaler.
• It is not necessary to shake the inhaler before use.

How to inhale

1. Hold the inhaler with the yellow semi-transparent mouthpiece cap facing downwards.

2. Open the mouthpiece cap by folding it downwards until you hear a distinct click. This will advance the dose counter by one unit. The inhaler is now ready to use.

AIR INLET
Do not block
OPEN

3. Breathe out slowly (as deeply as possible). Do not breathe out through the inhaler.
4. Place the mouthpiece in your mouth and close your lips firmly around it. Be careful not to block the air inlets. Breathe in through your mouth as deeply and forcefully as possible. Remember that it is important to inhale forcefully.

BREATHE IN

5. Remove the inhaler from your mouth. During inhalation, you may notice a particular taste.
6. Hold your breath for 10 seconds, or as long as possible.
7. Now breathe out slowly (do not breathe out through the inhaler).
8. Close the mouthpiece cap.

CLOSE

• After each dose, rinse your mouth with water and spit it out, or brush your teeth before rinsing your mouth.
• Do not attempt to disassemble the inhaler or to remove or twist the mouthpiece cap.
• The cap is fixed to the inhaler and must not be detached.
• Do not use Spiromax if it is damaged or if the mouthpiece has become detached from Spiromax.
• Do not open and close the mouthpiece cap unless you are about to use the inhaler.

How to clean Spiromax
Keep the inhaler dry and clean.
If necessary, you may clean the inhaler mouthpiece after use with a dry cloth or tissue.

When to use a new Seffalair Spiromax

• The dose indicator on the back of the device shows the number of doses (inhalations) remaining in the inhaler, starting from 60 inhalations when full and decreasing to 0 (zero) when empty.

• The dose indicator displays the number of remaining inhalations in even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• When 20 or fewer inhalations remain, the numbers appear in red on a white background. When the red numbers appear in the window, contact your doctor or nurse to obtain a new inhaler.

Note

• The mouthpiece will still click even when the inhaler is empty.
• If you open and close the mouthpiece cap without inhaling, the dose indicator will continue to count down. This dose will remain inside the inhaler until the next inhalation. It is impossible to accidentally inhale too much medicine or receive a double dose with a single inhalation.

If you use more Seffalair Spiromax than you should
It is important that you take the dose prescribed by your doctor or pharmacist. Do not exceed the prescribed dose without consulting your doctor. If you accidentally take more doses than recommended, contact your nurse, doctor, or pharmacist. Your heart may beat faster than usual and you may feel weak. You may also experience dizziness, headache, muscle weakness, and joint pain.
If you have repeatedly used too many doses of Seffalair Spiromax over a long period, consult your doctor or pharmacist. This is because excessive use of Seffalair Spiromax may reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to use Seffalair Spiromax
If you forget to take a dose, take it as soon as you remember. However, do not take a double dose to make up for the missed dose. If it is almost time for your next dose, take the next dose at the usual time.

If you stop using Seffalair Spiromax
It is very important to take Seffalair Spiromax every day as recommended. Continue taking it
until your doctor tells you to stop. Do not stop treatment or suddenly reduce
the dose of Seffalair Spiromax. Otherwise, your breathing problems may worsen.

Additionally, if you suddenly stop treatment with Seffalair Spiromax or reduce the dose of Seffalair Spiromax, you may (very rarely) experience problems due to reduced production of steroid hormones by the adrenal glands (adrenal insufficiency), which may sometimes cause unwanted effects.

These unwanted effects may include any of the following:

• stomach pain
• tiredness and loss of appetite, nausea
• vomiting and diarrhoea
• weight loss
• headache or drowsiness
• low blood sugar levels
• low blood pressure and seizures (fits)

If your body is under stress, such as fever, accident or injury, infection, or surgery,
adrenal insufficiency may worsen and the above-mentioned unwanted effects may also occur.
If you experience any unwanted effect, contact your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (such as prednisolone).
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of this combination of medicines that keeps your asthma under control.
Allergic reactions: breathing may worsen immediately after using Seffalair Spiromax.
You may experience pronounced wheezing, coughing or shortness of breath. You may also develop itching, skin rash (urticaria) or swelling (usually of the face, lips, tongue or throat), or your heartbeat may suddenly become very fast, and you may feel dizzy or faint (possibly with collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Seffalair Spiromax, stop using Seffalair Spiromax immediately and contact your doctor without delay. Allergic reactions to Seffalair Spiromax are uncommon (may affect up to 1 in 100 people).
Other side effects are listed below.
Common (may affect up to 1 in 10 people)

• A fungal infection (thrush) causing raised yellow-cream coloured patches in the mouth and throat, as well as tongue irritation, hoarseness and throat irritation. It may help to rinse your mouth with water and spit it out immediately, or to brush your teeth after each inhalation. Your doctor may prescribe an antifungal medicine to treat the thrush
• Muscle pain
• Back pain
• Influenza
• Low levels of potassium in the blood (hypokalaemia)
• Inflammation of the nose (rhinitis)
• Inflammation of the sinuses (sinusitis)
• Inflammation of the nose and throat (nasopharyngitis)
• Headache
• Cough
• Throat irritation
• Pain or inflammation in the back of the throat
• Hoarseness or loss of voice
• Dizziness.

Uncommon (may affect up to 1 in 100 people)

• Increased sugar (glucose) in the blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring may be needed and your diabetes treatment may need to be adjusted
• Cataract (clouding of the lens in the eye)
• Very fast heartbeat (tachycardia)
• Feeling of shakiness (tremor) and awareness of a fast heartbeat (palpitations) – these effects are usually harmless and tend to decrease with continued treatment
• Feeling worried or anxious
• Behavioural changes, such as unusual activity and irritability (although these effects occur mainly in children)
• Sleep disorders
• Hay fever
• Nasal congestion (blocked nose)
• Irregular heartbeat (atrial fibrillation)
• Chest infection
• Pain in the limbs (arms or legs)
• Stomach ache
• Indigestion
• Skin damage and skin laceration
• Skin inflammation
• Inflammation of the throat, usually characterised by sore throat (pharyngitis).

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

• Difficulty breathing or worsening of wheezing immediately after using Seffalair Spiromax. If this occurs, stop using the Seffalair Spiromax inhaler. Use your "reliever" (rescue) fast-acting inhaler to help you breathe better and contact your doctor immediately.
• Seffalair Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for prolonged periods. Effects include:
  • growth retardation in children and adolescents
  • glaucoma (damage to the optic nerve in the eye)
  • rounded face (moon face) (Cushing's syndrome).

Your doctor will regularly monitor for any of these side effects and ensure that you receive the lowest dose of this combination of medicines that keeps your asthma under control.

• Irregular, erratic or extra heartbeats (arrhythmias). Inform your doctor, but do not stop treatment with Seffalair Spiromax unless your doctor tells you to.
• Fungal infection of the oesophagus (the tube through which food passes), which may cause difficulty swallowing.

Frequency not known, but may also occur:

• Blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seffalair Spiromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box and on the inhaler label after "Exp". The expiry date refers to the last day of that month.
Do not store above 25 °C. Keep the mouthpiece cover closed after removing the wrapper.
Use within 2 months of removing the wrapper. Write the date of opening of the aluminium pouch on the label of the inhaler.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Seffalair Spiromax contains

• The active substances are salmeterol and fluticasone propionate. Each pre-dispensed dose contains 14 micrograms of salmeterol (as salmeterol xinafoate) and 113 micrograms of fluticasone propionate. Each delivered dose (the dose exiting the mouthpiece) contains 12.75 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (see section 2, “Seffalair Spiromax contains lactose”).

Description of the appearance of Seffalair Spiromax and contents of the pack
Each Seffalair Spiromax inhaler contains powder for inhalation for 60 inhalations and has a white body with a yellow semi-transparent mouthpiece cap.
Seffalair Spiromax is available in packs containing 1 inhaler and in multipacks containing 3 boxes, each box containing 1 inhaler. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands

Manufacturer
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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S TEVA HELLAS Α.Ε.
Tlf.: +45 44985511 il-Greċja
Tel: +30 2118805000

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 915359180 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Package leaflet: information for the patient

Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder

salmeterol/fluticasone propionate
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Seffalair Spiromax contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier to breathe in and out. The effect of salmeterol lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Seffalair Spiromax is used for the treatment of asthma in adults and adolescents aged 12 years and older.
Seffalair Spiromax helps prevent breathlessness and wheezing. It must not be used to relieve an asthma attack. In such cases, you must use a fast-acting reliever inhaler (rescue inhaler), such as salbutamol. You must always have your fast-acting reliever inhaler readily available.

2. What you need to know before using Seffalair Spiromax

Do not use Seffalair Spiromax

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Seffalair Spiromax if you have:

• a heart condition, including irregular or fast heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes (Seffalair Spiromax may increase blood sugar levels)
• low levels of potassium in the blood
• active or past tuberculosis (TB), or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Seffalair Spiromax must not be given to children and adolescents under 12 years of age, as it has not been studied in this age group.
Other medicines and Seffalair Spiromax
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. Seffalair Spiromax may not be suitable to use with certain other medicines.
Tell your doctor if you are taking the following medicines before using Seffalair Spiromax:

• beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mainly used for high blood pressure or heart conditions such as angina
• medicines used to treat infections (such as ritonavir, ketoconazole, itraconazole, and erythromycin). Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body. This may increase the risk of side effects from Seffalair Spiromax, including irregular heartbeat, or may worsen existing side effects
• corticosteroids (taken by mouth or by injection). Recent use of these medicines may increase the risk that Seffalair Spiromax suppresses the adrenal glands, reducing the amount of steroid hormones produced by the glands (adrenal suppression)
• diuretics, medicines that increase urine production used to treat high blood pressure
• other bronchodilators (such as salbutamol)
• xanthine medicines such as aminophylline and theophylline, which are often used to treat asthma.

Some medicines may increase the effects of Seffalair Spiromax, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
It is not known whether this medicine passes into breast milk. If you are breastfeeding, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Seffalair Spiromax will affect your ability to drive or use machinery.
Seffalair Spiromax contains lactose
Each dose of this medicine contains approximately 5.4 milligrams of lactose. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use Seffalair Spiromax

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one inhalation twice daily.

• Seffalair Spiromax is for regular, long-term use. Use it every day to keep your asthma under control. Do not use a higher dose than recommended. If you have any doubts, consult your doctor, nurse, or pharmacist.
• Do not stop treatment with Seffalair Spiromax or reduce the dose without first consulting your doctor or nurse.
• Seffalair Spiromax must be inhaled through the mouth.

Your doctor or nurse will help you manage your asthma. If you need a different dose to keep your asthma under control, your doctor or nurse may adjust your inhaled medicine. However, do not change the number of inhalations prescribed by your doctor or nurse without consulting them first.
If your asthma or breathing worsens, inform your doctor immediately. If you experience increasing wheezing, more frequent chest tightness, or need to use your rapid-acting "reliever" medicine more often, your asthma may be worsening and you could become seriously ill. Continue taking Seffalair Spiromax, but do not increase the number of inhalations. Contact your doctor immediately, as you may need additional treatment.

Instructions for Use
Training
Your doctor, nurse, or pharmacist must instruct you on how to use the inhaler and how to correctly take your dose. This training is important to ensure you receive the dose you need.
If you have not received this training, ask your doctor, nurse, or pharmacist to show you how to use the inhaler correctly before using it for the first time.

Additionally, your doctor, nurse, or pharmacist should periodically check that you are using the Spiromax device correctly and as prescribed. If you do not use Seffalair Spiromax correctly or do not inhale with sufficient force, you may not receive an adequate amount of medicine into your lungs. This means the medicine may not work effectively against your asthma.

How to prepare Seffalair Spiromax
Before using Seffalair Spiromax for the first time, prepare it as follows:

• Check that the dose indicator shows 60 inhalations available in the inhaler.
• Write the date you opened the aluminium pouch on the label of the inhaler.
• It is not necessary to shake the inhaler before use.

How to inhale

1. Hold the inhaler with the yellow semi-transparent mouthpiece cap facing downwards.

2. Open the mouthpiece cap by folding it downwards until you hear a distinct click. This will advance the dose counter by one unit. The inhaler is now ready for use.

AIR INLET
Do not block
OPEN

3. Breathe out slowly (as deeply as possible). Do not exhale through the inhaler.
4. Place the mouthpiece in your mouth and close your lips firmly around it. Be careful not to block the air inlets. Breathe in through your mouth as deeply and forcefully as possible. Remember, it is important to inhale forcefully.

BREATHE IN

5. Remove the inhaler from your mouth. During inhalation, you may notice a particular taste.
6. Hold your breath for 10 seconds, or as long as possible.
7. Now breathe out slowly (do not exhale through the inhaler).
8. Close the mouthpiece cap.

CLOSE

• After each dose, rinse your mouth with water and spit it out, or brush your teeth before rinsing your mouth.
• Do not attempt to disassemble the inhaler or remove or twist the mouthpiece cap.
• The cap is fixed to the inhaler and must not be detached.
• Do not use Spiromax if it is damaged or if the mouthpiece has detached from Spiromax.
• Do not open and close the mouthpiece cap unless you are about to use the inhaler.

How to clean Spiromax
Keep the inhaler dry and clean.
If necessary, you may clean the mouthpiece after use with a dry cloth or tissue.

When to use a new Seffalair Spiromax

• The dose indicator on the back of the device shows the number of doses (inhalations) remaining in the inhaler, starting from 60 when full and decreasing to 0 (zero) when empty.

• The dose indicator displays the number of inhalations remaining in even numbers. The spaces between the even numbers represent the odd number of inhalations remaining.
• When 20 or fewer inhalations remain, the numbers appear in red on a white background. When the numbers in the window turn red, contact your doctor or nurse to obtain a new inhaler.

Note

• The mouthpiece will still click even when the inhaler is empty.
• If you open and close the mouthpiece cap without inhaling, the dose counter will still advance. This dose will remain inside the inhaler until the next inhalation. It is impossible to accidentally inhale too much medicine or receive a double dose with a single inhalation.

If you use more Seffalair Spiromax than you should
It is important to take only the dose prescribed by your doctor or pharmacist. Do not exceed the prescribed dose without consulting your doctor. If you accidentally take more doses than recommended, contact your nurse, doctor, or pharmacist. Your heart may beat faster than usual and you may feel weak. You may also experience dizziness, headache, muscle weakness, and joint pain.
If you have repeatedly used too many doses of Seffalair Spiromax over a long period, consult your doctor or pharmacist. This is because excessive use of Seffalair Spiromax may reduce the amount of steroid hormones produced by the adrenal glands.

If you forget to use Seffalair Spiromax
If you forget to take a dose, take it as soon as you remember. However, do not take a double dose to make up for the missed dose. If it is almost time for your next dose, take the next dose at your usual time.

If you stop using Seffalair Spiromax
It is very important to take Seffalair Spiromax every day as recommended. Continue taking it until your doctor tells you to stop. Do not stop treatment or suddenly reduce the dose of Seffalair Spiromax. Otherwise, your breathing problems may worsen.

Additionally, if you suddenly stop treatment with Seffalair Spiromax or reduce the dose, you may (very rarely) develop problems due to reduced production of steroid hormones by the adrenal glands (adrenal insufficiency), which may sometimes cause unwanted effects.

These unwanted effects may include any of the following:

• stomach pain
• fatigue and loss of appetite, nausea
• vomiting and diarrhoea
• weight loss
• headache or drowsiness
• low blood sugar levels
• low blood pressure and seizures (fits)

If your body is under stress, such as fever, accident or injury, infection, or surgery, adrenal insufficiency may worsen and the above-mentioned unwanted effects may also occur.
If you experience any unwanted effects, contact your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (such as prednisolone).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of this combination of medicines that keeps your asthma under control.
Allergic reactions: after using Seffalair Spiromax, your breathing may get worse.
You may experience pronounced wheezing, cough or shortness of breath. You may also develop itching, skin rash (urticaria), or swelling (usually of the face, lips, tongue or throat), or your heartbeat may suddenly become very rapid, and you may feel faint or dizzy (possibly with collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Seffalair Spiromax, stop using Seffalair Spiromax immediately and contact your doctor without delay.
Allergic reactions to Seffalair Spiromax are uncommon (may affect up to 1 in 100 people).

Other side effects are listed below.

Common (may affect up to 1 in 10 people)

• A fungal infection (thrush) causing raised yellow-cream coloured patches in the mouth and throat, as well as irritation of the tongue, hoarseness and throat irritation. It may help to rinse your mouth with water and spit it out immediately, or to brush your teeth after each inhalation. Your doctor may prescribe an antifungal medicine to treat thrush.
• Muscle pain
• Back pain
• Influenza
• Low levels of potassium in the blood (hypokalaemia)
• Inflammation of the nose (rhinitis)
• Inflammation of the sinuses (sinusitis)
• Inflammation of the nose and throat (rhinopharyngitis)
• Headache
• Cough
• Throat irritation
• Pain or inflammation in the back of the throat
• Hoarseness or loss of voice
• Dizziness

Uncommon (may affect up to 1 in 100 people)

• Increased sugar (glucose) in the blood (hyperglycaemia). If you have diabetes, more frequent blood sugar checks may be needed and your anti-diabetic treatment may need to be adjusted
• Cataract (clouding of the lens in the eye)
• Very rapid heartbeat (tachycardia)
• Feeling shaky and having a rapid heartbeat (palpitations) – these effects are usually harmless and tend to decrease with continued treatment
• Feeling anxious or worried
• Behavioural changes, such as unusual activity and irritability (although these effects occur mainly in children)
• Sleep disorders
• Hay fever
• Nasal congestion (blocked nose)
• Irregular heartbeat (atrial fibrillation)
• Chest infection
• Pain in the limbs (arms or legs)
• Stomach ache
• Indigestion
• Skin damage and tearing
• Skin inflammation
• Inflammation of the throat, usually associated with sore throat (pharyngitis)

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

• Difficulty breathing or worsening of wheezing immediately after using Seffalair Spiromax. In this case, stop using the Seffalair Spiromax inhaler. Use your fast-acting “reliever” (rescue) inhaler to help you breathe better and contact your doctor immediately.
• Seffalair Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for prolonged periods. Effects include:
  • delayed growth in children and adolescents
  • glaucoma (damage to the optic nerve in the eye)
  • rounded face (moon face) (Cushing's syndrome)

Your doctor will regularly monitor you for any of these possible side effects and ensure that you receive the lowest dose of this combination of medicines that keeps your asthma under control.

• Irregular or extra heartbeats (arrhythmias). Inform your doctor, but do not stop treatment with Seffalair Spiromax unless instructed by your doctor.
• Fungal infection of the oesophagus (the tube through which food passes), which may cause difficulty swallowing.

Frequency not known, but may also occur:

• Blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seffalair Spiromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the label of the inhaler
after Exp. The expiry date refers to the last day of that month.
Do not store above 25 °C. Keep the mouthpiece cover closed after
removal of the wrapping.
Use within 2 months of removal from the foil pouch. Write the date of opening of the aluminium foil pouch
on the label of the inhaler.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Seffalair Spiromax contains

• The active substances are salmeterol and fluticasone propionate. Each metered dose contains 14 micrograms of salmeterol (as salmeterol xinafoate) and 232 micrograms of fluticasone propionate. Each delivered dose (the dose exiting the mouthpiece) contains 12.75 micrograms of salmeterol (as salmeterol xinafoate) and 202 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate (see section 2, "Seffalair Spiromax contains lactose").

Description of the appearance of Seffalair Spiromax and contents of the pack
Each Seffalair Spiromax inhaler contains powder for inhalation for 60 inhalations and has a white body and a yellow semi-transparent mouthpiece cap.
Seffalair Spiromax is available in packs containing 1 inhaler and in multipacks consisting of 3 boxes, each containing 1 inhaler. Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Teva B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands

Manufacturer
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

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S TEVA HELLAS Α.Ε.
Tlf.: +45 44985511 il-Greċja
Tel: +30 2118805000

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 915359180 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.