Budesonide / Formoterol: package leaflet

metered. Your inhaler is now ready for use.

mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

7. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

If you are to take a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water after every dose, and spit it out.
Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler.

Cleaning your Spiromax
Keep your Spiromax dry and clean.
If necessary, you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.

When to start using a new Spiromax
- The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.

• The dose indicator, on the rear of the device, shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations..
• For inhalations remaining from 20 downwards to ‘8’, 6’,’4’,’2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.

Note:
- The mouthpiece will still ‘click’ even when your Spiromax is empty. If you open and close the mouthpiece without taking an inhalation the dose indicator will still register it as a count.
- This dose will be securely held inside the inhaler for when the next inhalation is due. It is impossible to accidentally take extra medicine or a double dose in one inhalation.
- Keep the mouthpiece closed all the time unless you are about to use your inhaler.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using BiResp Spiromax, you should continue to use BiResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:
- Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
- Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of BiResp Spiromax.

If you use more BiResp Spiromax than you should
It is important that you take your dose as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.

If you use more BiResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
The most common symptoms that may occur after when you use more BiResp Spiromax than you should are trembling, headache or a rapid heartbeat.

If you forget to use BiResp 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 a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time.

If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler’, then seek medical advice.

If you stop using BiResp Spiromax
Do not stop using your inhaler without telling your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen to you, stop using BiResp Spiromax and talk to your doctor immediately:

Rare side effects: may affect up to 1 in 1,000 people

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction, which may also include rash and itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately (see below).

Very rare side effects: may affect up to 1 in 10,000 people

• Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm’). If either of these symptoms occur, stop using BiResp Spiromax straightaway and use your ‘reliever inhaler’ if you have one. Contact your doctor immediately as you may need to have your treatment changed.

Other possible side effects:

Common: may affect up to 1 in 10 people
- Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use BiResp Spiromax.
- Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with water after using your medicine.
- Mild sore throat, coughing and a hoarse voice.
- Headache.
- Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking BiResp Spiromax they could be symptoms of a lung infection:
- Fever or chills
- Increased mucus production, change in mucus colour
- Increased cough or increased breathing difficulties.

Uncommon: may affect up to 1 in 100 people
- Feeling restless, nervous, agitated, anxious or angry
- Disturbed sleep
- Feeling dizzy
- Nausea (feeling sick)
- Fast heartbeat
- Bruising of the skin
- Muscle cramps
- Blurred vision.

Rare:
- Low levels of potassium in your blood
- Uneven heartbeat.

Very rare:
- Depression
- Changes in behaviour, especially in children
- Chest pain or tightness in the chest (angina pectoris)
- Disturbance of the heart’s electrical system which does not cause symptoms (prolongation of the QTc- interval)
- An increase in the amount of sugar (glucose) in your blood, when you have a blood test
- Taste changes, such as an unpleasant taste in the mouth
- Changes in your blood pressure.
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
- Changes in bone mineral density (thinning of the bones)
- Cataract (clouding of the lens in the eye)
- Glaucoma (increased pressure in the eye)
- A slowing of the rate of growth of children and adolescents
- An effect on the adrenal gland (a small gland next to the kidney). Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.

These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store BiResp 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 carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
• Do not store above 25 oC. Keep the mouthpiece cover closed after removal of the foil wrapping.
• Use within 6 months of removing from the foil wrapping. Use the label on the inhaler to write down the date you open the foil pouch.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What BiResp Spiromax contains
- The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
- The other ingredient is lactose monohydrate, which contains milk proteins (see section 2 under ‘BiResp Spiromax contains lactose’).

What BiResp Spiromax looks like and contents of the pack

BiResp Spiromax is an inhalation powder.
Each BiResp Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.

Packs of 1, 2, and 3 inhalers. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva Pharma B.V.,
Swensweg 5, 2031GA Haarlem, The Netherlands.

Manufacturer

Norton (Waterford) Limited
Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

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

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Laboratorios BIAL, S.A.
Tel.: +34 915624196

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300

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

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Alvogen ehf.
Sími: +354 5222900
Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

This leaflet was last revised in month YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

metered. Your inhaler is now ready for use.

mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

7. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

If you are to take a second inhalation, repeat steps 1 to 7.
Rinse your mouth with water after every dose and spit it out.
Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler.
Cleaning your Spiromax
Keep your Spiromax dry and clean.
If necessary, you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.

When to start using a new Spiromax
- The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.

• The dose indicator, on the rear of the device, shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• For inhalations remaining from 20 downwards to ‘8’, ‘6’, ‘4’, ‘2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.

Note:
- The mouthpiece will still ‘click’ even when your Spiromax is empty.
- If you open and close the mouthpiece without taking an inhalation, the dose indicator will still register it as a count. This dose will be securely held inside the inhaler for when the next inhalation is due. It is impossible to accidentally take extra medicine or a double dose in one inhalation.
- Keep the mouthpiece closed all the time unless you are about to use your inhaler.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using BiResp Spiromax, you should continue to use BiResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:
- Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
- Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of BiResp Spiromax.

If you use more BiResp Spiromax than you should
It is important that you take your dose as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.

If you use more BiResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
The most common symptoms that may occur after when you use more BiResp Spiromax than you should are trembling, headache or a rapid heartbeat.

If you forget to use BiResp 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 a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time.

If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler’, then seek medical advice.

If you stop using BiResp Spiromax
Do not stop using your inhaler without telling your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen to you, stop using BiResp Spiromax and talk to your doctor immediately:

Rare side effects: may affect up to 1 in 1,000 people

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction, which may also include rash and itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately (see below).

Very rare side effects: may affect up to 1 in 10,000 people

• Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm’. If either of these symptoms occur, stop using BiResp Spiromax straightaway and use your ’reliever inhaler’ if you have one. Contact your doctor immediately as you may need to have your treatment changed.

Other possible side effects:

Common: may affect up to 1 in 10 people
- Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use BiResp Spiromax
- Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with water after using your medicine
- Mild sore throat, coughing and a hoarse voice
- Headache
- Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking BiResp Spiromax they could be symptoms of a lung infection:
- Fever or chills
- Increased mucus production, change in mucus colour
- Increased cough or increased breathing difficulties.

Uncommon: may affect up to 1 in 100 people
- Feeling restless, nervous, agitated, anxious or angry
- Disturbed sleep
- Feeling dizzy
- Nausea (feeling sick)
- Fast heartbeat
- Bruising of the skin
- Muscle cramps
- Blurred vision.

Rare:
- Low levels of potassium in your blood
- Uneven heartbeat.

Very rare:
- Depression
- Changes in behaviour, especially in children
- Chest pain or tightness in the chest (angina pectoris)
- Disturbance of the heart’s electrical system which does not cause symptoms (prolongation of the QTc- interval)
- An increase in the amount of sugar (glucose) in your blood, when you have a blood test
- Taste changes, such as an unpleasant taste in the mouth
- Changes in your blood pressure
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
- Changes in bone mineral density (thinning of the bones)
- Cataract (clouding of the lens in the eye)
- Glaucoma (increased pressure in the eye)
- A slowing of the rate of growth of children and adolescents
- An effect on the adrenal gland (a small gland next to the kidney). Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.

These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store BiResp 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 carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
• Do not store above 25oC. Keep the mouthpiece cover closed after removal of the foil wrapping.
• Use within 6 months of removing from the foil wrapping. Use the label on the inhaler to write down the date you open the foil pouch.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What BiResp Spiromax contains
- The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.

• The other ingredient is lactose monohydrate, which contains milk proteins (see section 2 under ‘BiResp Spiromax contains lactose’).

What BiResp Spiromax looks like and contents of the pack

BiResp Spiromax is an inhalation powder.
Each BiResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.

Packs of 1, 2, and 3 inhalers. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva Pharma B.V.,
Swensweg 5, 2031GA Haarlem, The Netherlands.

Manufacturer

Norton (Waterford) Limited
Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.E.
Τηλ: +30 2118805000

Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Laboratorios BIAL, S.A.
Polska
Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +34 915624196

Tel.: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Alvogen ehf.
Sími: +354 5222900

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

This leaflet was last revised in month YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

metered. Your inhaler is now ready for use.

mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

7. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

If you are to take a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water after every dose, and spit it out.
Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler.

Cleaning your Spiromax
Keep your Spiromax dry and clean.
If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.

When to start using a new Spiromax
- The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.

• The dose indicator, on the rear of the device, shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• For inhalations remaining from 20 downwards to ‘8’, 6’,’4’,’2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.

Note:
- The mouthpiece will still ‘click’ even when your Spiromax is empty. If you open and close the mouthpiece without taking an inhalation the dose indicator will still register it as a count.
- This dose will be securely held inside the inhaler for when the next inhalation is due. It is impossible to accidentally take extra medicine or a double dose in one inhalation.
- Keep the mouthpiece closed all the time unless you are about to use your inhaler.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using DuoResp Spiromax, you should continue to use DuoResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:
- Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
- Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of DuoResp Spiromax.

If you use more DuoResp Spiromax than you should
It is important that you take your dose as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.

If you use more DuoResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
The most common symptoms that may occur after when you use more DuoResp Spiromax than you should are trembling, headache or a rapid heartbeat.

If you forget to use DuoResp 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 a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time.

If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler’, then seek medical advice.

If you stop using DuoResp Spiromax
Do not stop using your inhaler without telling your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen to you, stop using DuoResp Spiromax and talk to your doctor immediately:

Rare side effects: may affect up to 1 in 1,000 people

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction, which may also include rash and itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately (see below).

Very rare side effects: may affect up to 1 in 10,000 people

• Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm’). If either of these symptoms occur, stop using DuoResp Spiromax straightaway and use your ‘reliever inhaler’ if you have one. Contact your doctor immediately as you may need to have your treatment changed.

Other possible side effects:

Common: may affect up to 1 in 10 people
- Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use DuoResp Spiromax.
- Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with water after using your medicine.
- Mild sore throat, coughing and a hoarse voice
- Headache
- Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking DuoResp Spiromax they could be symptoms of a lung infection:
- Fever or chills
- Increased mucus production, change in mucus colour
- Increased cough or increased breathing difficulties.

Uncommon: may affect up to 1 in 100 people
- Feeling restless, nervous, agitated, anxious or angry
- Disturbed sleep
- Feeling dizzy
- Nausea (feeling sick)
- Fast heartbeat
- Bruising of the skin
- Muscle cramps
- Blurred vision.

Rare:
- Low levels of potassium in your blood

• Uneven heartbeat.

Very rare:
- Depression
- Changes in behaviour, especially in children
- Chest pain or tightness in the chest (angina pectoris)
- Disturbance of the heart’s electrical system which does not cause symptoms (prolongation of the QTc- interval)
- An increase in the amount of sugar (glucose) in your blood, when you have a blood test.
- Taste changes, such as an unpleasant taste in the mouth
- Changes in your blood pressure.
- Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
- Changes in bone mineral density (thinning of the bones)
- Cataract (clouding of the lens in the eye)
- Glaucoma (increased pressure in the eye)
- A slowing of the rate of growth of children and adolescents
- An effect on the adrenal gland (a small gland next to the kidney). Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.

These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store DuoResp 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 carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
• Do not store above 25 oC. Keep the mouthpiece cover closed after removal of the foil wrapping.
• Use within 6 months of removing from the foil wrapping. Use the label on the inhaler to write down the date you open the foil pouch.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What DuoResp Spiromax contains
- The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
- The other ingredient is lactose monohydrate, which contains milk proteins (see section 2 under ‘DuoResp Spiromax contains lactose’)

What DuoResp Spiromax looks like and contents of the pack

DuoResp Spiromax is an inhalation powder.
Each DuoResp Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.

Packs of 1, 2, and 3 inhalers. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva Pharma B.V.,
Swensweg 5, 2031GA Haarlem, The Netherlands.

Manufacturer

Norton (Waterford) Limited
Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Operations Poland Sp. z o.o. Mogilska 80 Str. 31-546 Kraków Poland

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.E.
Τηλ: +30 2118805000

Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280
Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Alvogen ehf.
Sími: +354 5222900

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

This leaflet was last revised in month YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

metered. Your inhaler is now ready for use.

mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

7. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

If you are to take a second inhalation, repeat steps 1 to 7.
Rinse your mouth with water after every dose and spit it out.

Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler.
Cleaning your Spiromax
Keep your Spiromax dry and clean.
If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.

When to start using a new Spiromax
- The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.

• The dose indicator, on the rear of the device, shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• For inhalations remaining from 20 downwards to ‘8’, ‘6’, ‘4’, ‘2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.

Note:
- The mouthpiece will still ‘click’ even when your Spiromax is empty.
- If you open and close the mouthpiece without taking an inhalation, the dose indicator will still register it as a count. This dose will be securely held inside the inhaler for when the next inhalation is due. It is impossible to accidentally take extra medicine or a double dose in one inhalation.
- Keep the mouthpiece closed all the time unless you are about to use your inhaler.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using DuoResp Spiromax, you should continue to use DuoResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:
- Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
- Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of DuoResp Spiromax.

If you use more DuoResp Spiromax than you should

It is important that you take your dose as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.

If you use more DuoResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
The most common symptoms that may occur after when you use more DuoResp Spiromax than you should are trembling, headache or a rapid heartbeat.

If you forget to use DuoResp 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 a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time.

If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler’, then seek medical advice.

If you stop using DuoResp Spiromax
Do not stop using your inhaler without telling your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen to you, stop using DuoResp Spiromax and talk to your doctor immediately:

Rare side effects: may affect up to 1 in 1,000 people

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction, which may also include rash and itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately (see below).

Very rare side effects: may affect up to 1 in 10,000 people

• Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm’. If either of these symptoms occur, stop using DuoResp Spiromax straightaway and use your ’reliever inhaler’ if you have one. Contact your doctor immediately as you may need to have your treatment changed.

Other possible side effects:

Common: may affect up to 1 in 10 people
- Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use DuoResp Spiromax.
- Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with water after using your medicine.
- Mild sore throat, coughing and a hoarse voice
- Headache
- Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking DuoResp Spiromax they could be symptoms of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus colour
• Increased cough or increased breathing difficulties.

Uncommon: may affect up to 1 in 100 people
- Feeling restless, nervous, agitated, anxious or angry
- Disturbed sleep
- Feeling dizzy
- Nausea (feeling sick)
- Fast heartbeat
- Bruising of the skin
- Muscle cramps
- Blurred vision.

Rare:
- Low levels of potassium in your blood
- Uneven heartbeat.

Very rare:
- Depression
- Changes in behaviour, especially in children
- Chest pain or tightness in the chest (angina pectoris)
- Disturbance of the heart’s electrical system which does not cause symptoms (prolongation of the QTc- interval)
- An increase in the amount of sugar (glucose) in your blood, when you have a blood test
- Taste changes, such as an unpleasant taste in the mouth
- Changes in your blood pressure.
- Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
- Changes in bone mineral density (thinning of the bones)
- Cataract (clouding of the lens in the eye)
- Glaucoma (increased pressure in the eye)
- A slowing of the rate of growth of children and adolescents
- An effect on the adrenal gland (a small gland next to the kidney). Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.

These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store DuoResp 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 carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
• Do not store above 25oC. Keep the mouthpiece cover closed after removal of the foil wrapping.

• Use within 6 months of removing from the foil wrapping. Use the label on the inhaler to write down the date you open the foil pouch.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What DuoResp Spiromax contains
- The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
- The other ingredient is lactose monohydrate, which contains milk proteins (see section 2 under ‘DuoResp Spiromax contains lactose’).

What DuoResp Spiromax looks like and contents of the pack

DuoResp Spiromax is an inhalation powder.
Each DuoResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.

Packs of 1, 2, and 3 inhalers. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva Pharma B.V.,
Swensweg 5, 2031GA Haarlem, The Netherlands.

Manufacturer:

Norton (Waterford) Limited
Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Operations Poland Sp. z o.o. Mogilska 80 Str. 31-546 Kraków Poland

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.E.
Τηλ: +30 2118805000

Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Alvogen ehf.
Sími: +354 5222900

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

This leaflet was last revised in month YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.