SEFFALAIR 14 MCG/113 MCG Inhalation powder

Зміст інструкції

1. Seffalair Spiromax 12.75 micrograms/100 micrograms powder for inhalation
   1. What is Seffalair Spiromax and what is it 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. Package contents and other information
2. Seffalair Spiromax 12.75 micrograms/200 micrograms powder for inhalation
   1. What is Seffalair Spiromax and what is it 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. Package contents and other information

Seffalair Spiromax 12.75 micrograms/100 micrograms 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. 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 could be harmful.
• If you get any side effects, even 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 is Seffalair Spiromax and what is it used for

Seffalair Spiromax contains 2 active ingredients: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to keep the airways in the lungs open. This makes it easier for air to enter and leave. The effect of salmeterol lasts 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 over.

Seffalair Spiromax helps to prevent breathlessness and wheezing. It should not be used to
relieve an asthma attack. In this case, you should use a reliever (emergency) inhaler with
fast action, such as salbutamol. You should always have your fast-acting emergency 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 suffer from:

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

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

Children and adolescents
This medicine should not be given to children and adolescents under 12 years of age, because
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 be used 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 used mainly 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 can increase the amount of salmeterol or fluticasone propionate in the body. This can increase the risk of unwanted effects from Seffalair Spiromax, including irregular heartbeat, or the unwanted effects may worsen
• corticosteroids (by mouth or by injection). Recent use of these medicines can increase the risk that Seffalair Spiromax will impair 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 can increase the effects of Seffalair Spiromax and your doctor may want 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, suspect you may be pregnant or are planning a pregnancy, 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 and operate machines.

Seffalair Spiromax contains lactose
Each dose of this medicine contains approximately 5.4 milligrams of lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Seffalair Spiromax

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts
consult your doctor or pharmacist.
The recommended dose is one inhalation twice a day.

• 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 doubts consult your doctor, nurse or pharmacist.
• Do not stop treatment with Seffalair Spiromax and do not reduce the dose without 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 inhaler 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 gets worse, tell your doctor immediately.If wheezing
increases, if you experience a feeling of tightness in the chest more often, or if you need to use your
“rescue” quick-acting medicine more frequently, your asthma may be getting worse and you may become
seriously ill. Continue to take Seffalair Spiromax, but do not increase the number of inhalations. Consult
your doctor immediately, as you may need other therapies.

Instructions for use
Training
Your doctor, nurse or pharmacist must instruct you on how to use the inhaler and how to take
the dose correctly. This training is important so 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.
Also, from time to time, your doctor, nurse or pharmacist must verify that you are using the
Spiromax device correctly and as prescribed. If you do not use Seffalair Spiromax correctly
or do not breathe with enoughforce, it is possible that not enough medicine will reach your lungs. This means that the effects on asthma will be insufficient.

How to prepare Seffalair Spiromax
Before using Seffalair Spiromax for the first time, you must prepare it as described below:

• check that the dose indicator shows the availability of 60 inhalations in the inhaler
• write the date of opening the aluminum pouch on the inhaler label
• you do not need to shake the inhaler before use.

How to inhale

• 1. Hold the inhalerwith the yellow semi-transparent mouthpiece cover facing downwards.

• 2. Open the mouthpiece cover by folding it down until you hear a loud click. This will increment the counter by one unit. Now the inhaler is ready for use.

AIR INTAKE
Do not block
OPEN

• 3. Exhale slowly (as deeply as possible). Do not exhale through the inhaler.
• 4. Position the mouthpiece in your mouth and close your lips tightly around it. Be careful not to block the air intakes. Inhale through your mouth as deeply and forcefully as possible. Remember that it is important to inhale strongly.

BREATHE

• 5. Remove the inhaler from your mouth. You may feel a particular taste during inhalation.
• 6. Hold your breath for 10 seconds or as long as possible.
• 7. Now exhale slowly(do not exhale through the inhaler).
• 8. Close the mouthpiece cover.

CLOSE

• After each dose, rinse your mouth with water and spit it out, or brush your teeth before rinsing your mouth.
• Do not try to disassemble the inhaler or remove or twist the mouthpiece cover.
• The cover 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 cover unless you are about to use the inhaler.

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

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, which starts at 60 inhalations when full and goes down to 0 (zero) when empty.

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

Note

• The mouthpiece clicks even when the inhaler is empty.
• If you open and close the mouthpiece without inhaling, the dose indicator will continue to count. This dose will be retained inside the inhaler until the next inhalation. It is impossible to accidentally take an excessive amount of medicine or 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. Dizziness, headache, muscle weakness and joint pain may also occur.
If you have repeatedly used too many doses of Seffalair Spiromax for a long period of time, consult
your doctor or pharmacist. This is because excessive use of Seffalair Spiromax can 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 nottake a double dose to
make up for the missed dose. If it is almost time to take the next dose, take the dose at the usual time.

If you stop taking Seffalair Spiromax
It is very important to take Seffalair Spiromax every day as recommended. Continue to take it
until your doctor tells you to stop. Do not stop treatment and do not suddenly reduce
the dose of Seffalair Spiromax. Otherwise, your breathing problems may
worsen.
Also, if you suddenly stop treatment with Seffalair Spiromax or reduce the dose of Seffalair
Spiromax, problems due to reduced production of steroid hormones by the adrenal glands (adrenal insufficiency) may occur (very rarely) which sometimes cause adverse
effects.
These 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

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

If you have any questions about using this medicine, contact 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 controls your asthma.

Allergic reactions: breathing may worsen immediately after using Seffalair Spiromax.
Wheezing, coughing or shortness of breath may occur. Itching, rash (hives) and swelling (usually of the face, lips, tongue or throat) may also appear, or your heartbeat may suddenly become very fast and you may feel faint and dizzy (possibly with collapse or loss of consciousness). If any of these effects occur or appear suddenly after using Seffalair Spiromax, stop using Seffalair Spiromax and tell your doctor immediately. 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, creamy-yellow patches in the mouth and throat, and also irritation of the tongue, hoarseness and irritation of the throat. It may help to rinse your mouth with water and spit it out immediately or brush your teeth after each inhalation. Your doctor may prescribe an anti-fungal medicine to treat thrush
• Muscle pain
• Back pain
• Flu
• 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
• Sore throat
• 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, you may need more frequent blood sugar checks and possibly adjustment of your diabetes treatment
• Cataract (clouding of the lens in the eye)
• Very fast heartbeat (tachycardia)
• Feeling of unwellness (tremor) and fast heartbeat (palpitations) - these effects are usually harmless and decrease with continued treatment
• Feeling worried or anxious
• Changes in behaviour, such as unusual activity and irritability (although these effects are more likely to occur in children)
• Sleep disorders
• Hay fever
• Nasal congestion (blocked nose)
• Irregular heartbeat (atrial fibrillation)
• Chest infection
• Pain in the limbs (arms or legs)
• Stomach pain
• Indigestion
• Skin damage and tearing
• Skin inflammation
• Inflammation of the throat, usually characterised by a sore throat (pharyngitis).

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

• Difficulty breathing or worsening wheezing immediately after using SeffalairSpiromax.If this happens, stop using the Seffalair Spiromax inhaler. Use your ‘reliever’ (‘rescue’) inhaler to help your breathing and tell your doctor immediately.
• Seffalair Spiromax can alter the normal production of steroid hormones in the body, particularly if you have taken high doses for prolonged periods. The effects include:
• slowed growth in children and adolescents
• glaucoma (damage to the nerve of the eye)
• rounded face (moon face) (Cushing’s syndrome).

Your doctor will check regularly for any of these side effects and
make sure you receive the lowest dose of this combination of medicines that controls your asthma.

• Irregular or unsteady heartbeat or extra beats (arrhythmias). Tell your doctor, but do not stop treatment with Seffalair Spiromax unless your doctor tells you to.
• Fungal infection in the esophagus (the tube down which food passes), which can cause difficulty swallowing.

Frequency not known, but may occur:

• blurred vision

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and on the inhaler label
after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Keep the mouthpiece cover closed after
removal of the foil wrapper.
Use within 2 months of removing the foil wrapper.Write the date of opening the aluminium pouch
on the inhaler label.
Do not dispose of any medicine in 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 ingredients are salmeterol and fluticasone propionate. Each metered dose contains 14 micrograms of salmeterol (as salmeterol xinafoate) and 113 micrograms of fluticasone propionate. Each delivered dose (the dose that comes out of 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 and a
semi-transparent yellow mouthpiece cover.
Seffalair Spiromax is available in packs containing 1 inhaler and in multi-packs of 3 boxes,
each containing 1 inhaler. Not all pack sizes may be marketed in your country.

Marketing authorisation holder
Teva B.V.
Swensweg 5,
2031 GA Haarlem,
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 medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 3 820 73 73

Lietuva
UAB Teva Baltics
Tel: +370 5 266 02 03

България
Тева Фарма ЕАД
Teл: +359 2 489 95 85

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 3 820 73 73

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Magyarország
Teva Gyógyszergyár Zrt
Tel.: +36 1 288 64 00

Danmark
Teva Denmark A/S
Tlf: +45 44 98 55 11

Malta
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 207 540 7117

Deutschland
Teva GmbH
Tel: +49 731 402 08

Nederland
Teva Nederland B.V.
Tel: +31 800 0228 400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 661 0801

Norge
Teva Norway AS
Tlf: +47 6677 55 90

Ελλάδα
Specifar A.B.E.E.
Greece
Τηλ: +30 211 880 5000

Österreich
ratiopharm Arzneimittel Vertriebs GmbH
Tel: +43 1 97007 0

España
Teva Pharma S.L.U.
Tél: +34 91 387 32 80

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 22 345 93 00

France
Teva Santé
Tél: +33 1 55 91 7800

Portugal
Teva Pharma - Produtos Farmacêuticos Lda
Tel: +351 21 476 75 50

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

România
Teva Pharmaceuticals S.R.L
Tel: +4021 230 6524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Teva Pharma Iceland ehf
Simi: +354 550 3300

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 207 540 7117

Slovenská republika
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 5726 7911

Italia
Teva Italia S.r.l.
Tel: +39 028 917 981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 20 180 5900

Κύπρος
Specifar A.B.E.E.
Greece
Τηλ: +30 211 880 5000

Sverige
Teva Sweden AB
Tel: +46 42 12 11 00

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: + 44 207 540 7117

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

Latvija
Teva Baltics filiāle Latvijā
Tel: +371 673 23 666

Seffalair Spiromax 12.75 micrograms/200 micrograms powder for inhalation

salmeterol/fluticasone propionate

Read this leaflet carefully before you start to use 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 could be harmful.
• If you get any side effects, even 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 is Seffalair Spiromax and what is it used for

Seffalair Spiromax contains 2 active ingredients: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to keep the airways in the lungs open. This makes it easier for air to enter and leave. 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 over.

Seffalair Spiromax helps to prevent shortness of breath and wheezing. It should not be used to
relieve an asthma attack. In this case, you should use a reliever (emergency) inhaler with
fast action, such as salbutamol. You should always have your fast-acting emergency 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 suffer from:

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

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

Children and adolescents
Seffalair Spiromax should not be given to children and adolescents under 12 years of age, because
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 be used 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 used mainly 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 can increase the amount of salmeterol or fluticasone propionate in the body. This can increase the risk of unwanted effects from Seffalair Spiromax, including irregular heartbeat, or the unwanted effects may worsen
• corticosteroids (by mouth or injection). Recent use of these medicines can increase the risk that Seffalair Spiromax will impair 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 can increase the effects of Seffalair Spiromax and your doctor may want 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, suspect 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 and use machines.

Seffalair Spiromax contains lactose
Each dose of this medicine contains approximately 5.4 milligrams of lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Seffalair Spiromax

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one inhalation twice a day.

• 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 and do not reduce the dose without 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 inhaler 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 gets worse, tell your doctor immediately.If wheezing
increases, if you experience a feeling of tightness in the chest more often, or if you need to use your
“rescue” quick-relief medicine more frequently, your asthma may be getting worse and you may become
seriously ill. Continue to take Seffalair Spiromax, but do not increase the number of inhalations. Consult
your doctor immediately, as you may need other therapies.

Instructions for use
Training
Your doctor, nurse or pharmacist must instruct you on how to use the inhaler and how to take
the dose correctly. 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 use the inhaler correctly before using it for the first time.
Also, from time to time, your doctor, nurse or pharmacist must check that you are using the
Spiromax device correctly and as prescribed. If you do not use Seffalair Spiromax correctly
or do not breathe with enoughforce, it is possible that not enough medicine will reach your lungs. This means that the effects on asthma will be insufficient.

How to prepare Seffalair Spiromax
Before using Seffalair Spiromax for the first time, you must prepare it as described below:

• check that the dose indicator shows the availability of 60 inhalations in the inhaler
• write the date of opening the aluminum pouch on the inhaler label
• you do not need to shake the inhaler before use.

How to inhale

• 1. Hold the inhalerwith the yellow semi-transparent mouthpiece cover facing downwards.

• 2. Open the mouthpiece cover by folding it down until you hear a loud click. This will increment the counter by one unit. The inhaler is now ready for use.

AIR INTAKE
Do not block
OPEN

• 3. Exhale slowly (as deeply as possible). Do not exhale through the inhaler.
• 4. Place the mouthpiece in your mouth and close your lips tightly around it. Be careful not to block the air intakes. Inhale 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. You may feel a particular taste during inhalation.
• 6. Hold your breath for 10 seconds or as long as possible.
• 7. Now exhale slowly(do not exhale through the inhaler).
• 8. Close the mouthpiece cover.

CLOSE

• After each dose, rinse your mouth with water and spit it out, or brush your teeth before rinsing your mouth.
• Do not try to disassemble the inhaler or remove or twist the mouthpiece cover.
• The cover is fixed to the inhaler and should 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 cover unless you are about to use the inhaler.

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

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 reaching 0 (zero) when empty.

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

Note

• The mouthpiece clicks even when the inhaler is empty.
• If you open and close the mouthpiece without inhaling, the dose indicator will continue to count. This dose will be retained inside the inhaler until the next inhalation. It is impossible to accidentally take an excessive amount of medicine or 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. Dizziness, headache, muscle weakness and joint pain may also occur.
If you have repeatedly used too many doses of Seffalair Spiromax for a long period of time, consult
your doctor or pharmacist. This is because excessive use of Seffalair Spiromax can 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 nottake a double dose to
make up for the missed dose. If it is almost time to take the next dose, take the dose
at the usual time.

If you stop taking Seffalair Spiromax
It is very important to take Seffalair Spiromax every day as recommended. Continue to take it
until your doctor tells you to stop. Do not stop treatment and do not suddenly reduce
the dose of Seffalair Spiromax. Otherwise, your breathing problems may
worsen.
In addition, if you suddenly stop taking Seffalair Spiromax or reduce the dose of Seffalair
Spiromax, problems due to reduced production of steroid hormones by the adrenal glands (adrenal insufficiency) may occur (very rarely), sometimes causing adverse
effects.
These 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

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

If you have any doubts about using this medicine, contact your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of this combination of medicines that controls your asthma.

Allergic reactions: Immediately after using Seffalair Spiromax, your breathing may worsen.
Wheezing, coughing or shortness of breath may occur. Itching, rash (hives) and swelling (usually of the face, lips, tongue or throat) may also appear, or your heartbeat may suddenly become very fast and you may feel faint and dizzy (possibly with collapse or loss of consciousness). If any of these effects occur or occur suddenly after using Seffalair Spiromax, stop using
Seffalair Spiromax and tell your doctor immediately. 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) that causes raised, creamy-yellow patches in the mouth and throat, and also irritation of the tongue, hoarseness and irritation of the throat. It may be helpful to rinse your mouth with water and spit it out immediately or brush your teeth after each inhalation. Your doctor may prescribe an antifungal medicine to treat thrush.
• Muscle pain
• Back pain
• Flu
• 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
• Sore throat
• 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, you may need more frequent blood sugar checks and possibly an adjustment to your diabetes treatment.
• Cataract (clouding of the lens in the eye)
• Very fast heartbeat (tachycardia)
• Feeling of discomfort (tremor) and a fast heartbeat (palpitations) - these effects are usually harmless and decrease as treatment continues
• Feeling worried or anxious
• Changes in behaviour, such as unusual activity and irritability (although these effects are more likely to occur in children)
• Sleep disturbances
• Hay fever
• Nasal congestion (stuffy nose)
• Irregular heartbeat (atrial fibrillation)
• Chest infection
• Pain in the limbs (arms or legs)
• Stomach pain
• Indigestion
• Skin damage and tearing
• Skin inflammation
• Inflammation of the throat, usually characterised by a sore throat (pharyngitis).

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

• Difficulty breathing or worsening wheezing immediately after using SeffalairSpiromax.If this happens, stop using the Seffalair Spiromax inhaler. Use your “reliever” (“rescue”) inhaler to help your breathing and tell your doctor immediately.
• Seffalair Spiromax can alter the normal production of steroid hormones in the body, particularly if you have taken high doses for prolonged periods. The 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 check for any of these side effects and
ensure that you receive the lowest dose of this combination of medicines that controls your
asthma.

• Irregular or erratic heartbeat or extra beats (arrhythmias). Tell your doctor, but do not stop treatment with Seffalair Spiromax unless your doctor tells you to.
• Fungal infection in the oesophagus (the tube down which food passes), which can cause difficulty swallowing.

Frequency not known, but may occur:

• blurred vision

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 which is stated on the package and on the inhaler label
after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Keep the mouthpiece cover closed after
removal of the blister pack.
Use within 2 months of removing the blister pack.Write the date of opening the aluminium pouch
on the inhaler label.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Seffalair Spiromax contains

• The active ingredients 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 that comes out of the mouthpiece) contains 12.75 micrograms of salmeterol (as salmeterol xinafoate) and 202 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (see section 2 under “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
semi-transparent yellow mouthpiece cover.
Seffalair Spiromax is available in packs containing 1 inhaler and in multiple packs consisting of
3 boxes, each containing 1 inhaler. Not all pack sizes may be marketed in
your country.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5,
2031 GA Haarlem,
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 medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 3 820 73 73

Lietuva
UAB Teva Baltics
Tel: +370 5 266 02 03

България
Тева Фарма ЕАД
Teл: +359 2 489 95 85

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 3 820 73 73

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Magyarország
Teva Gyógyszergyár Zrt
Tel.: +36 1 288 64 00

Danmark
Teva Denmark A/S
Tlf: +45 44 98 55 11

Malta
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 207 540 7117

Deutschland
Teva GmbH
Tel: +49 731 402 08

Nederland
Teva Nederland B.V.
Tel: +31 800 0228 400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 661 0801

Norge
Teva Norway AS
Tlf: +47 6677 55 90

Ελλάδα
Specifar A.B.E.E.
Greece
Τηλ: +30 211 880 5000

Österreich
ratiopharm Arzneimittel Vertriebs GmbH
Tel: +43 1 97007 0

España
Teva Pharma S.L.U.
Tél: +34 91 387 32 80

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 22 345 93 00

France
Teva Santé
Tél: +33 1 55 91 7800

Portugal
Teva Pharma - Produtos Farmacêuticos Lda
Tel: +351 21 476 75 50

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

România
Teva Pharmaceuticals S.R.L
Tel: +4021 230 6524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 207 540 7117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Teva Pharma Iceland ehf
Simi: +354 550 3300

Slovenská republika
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 5726 7911

Italia
Teva Italia S.r.l.
Tel: +39 028 917 981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 20 180 5900

Κύπρος
Specifar A.B.E.E.
Greece
+30 211 880 5000

Sverige
Teva Sweden AB
Tel: +46 42 12 11 00

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 207 540 7117

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

Latvija
Teva Baltics filiāle Latvijā
Tel: +371 673 23 666