B. PACKAGE LEAFLET

Package leaflet: Information for the patient

BiResp Spiromax 160 microgram­s/4.5 microgram­s, inhalation powder budesonide/for­moterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What BiResp Spiromax is and what it is used for

• 2. What you need to know before you use BiResp Spiromax

• 3. How to use BiResp Spiromax

• 4. Possible side effects

• 5. How to store BiResp Spiromax

• 6. Contents of the pack and other information

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

BiResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting P2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily.

BiResp Spiromax is indicated for use in adults and adolescents 12 years of age and older only.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

BiResp Spiromax can be prescribed for asthma in two different ways.

• a) You may be prescribed two asthma inhalers: BiResp Spiromax together with a separate ‘reliever inhaler’ such as salbutamol.

• Use BiResp Spiromax every day. This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
• Use the ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

• b) You may be prescribed BiResp Spiromax as your only asthma inhaler.

• Use BiResp Spiromax every day. This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
• Use BiResp Spiromax when you need to take extra inhalations or puffs for relief of asthma symptoms, to make it easier to breathe again and if agreed with the doctor also to prevent asthma symptoms from happening (for example, when exercising or on exposure to allergens). They do not need a separate inhaler for this.

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. BiResp Spiromax can also be used to treat the symptoms of severe COPD in adults only.

2. What you need to know before you use BiResp Spiromax

Do not use BiResp Spiromax if

You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor,pharmacist or nurse before taking BiResp Spiromax if

• you are diabetic.
• you have a lung infection.
• you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
• you have problems with your thyroid or adrenal glands.
• you have low levels of potassium in your blood.
• you have severe liver problems.
• you regularly drink alcohol

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use BiResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests. When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use BiResp Spiromax.

Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.

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

Children

Do not give this medicine to children under the age of 12 years.

Other medicines and BiResp Spiromax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• P blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including

eyedrops (such as timolol for glaucoma).

• Oxytocin which is given to pregnant women to induce labour.
• Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procainamide and terfenadine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
• Steroid tablets that you take by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidone and the chemotherapy medicine procarbazine).
• Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called ‘HIV protease inhibitors’ (such as ritonavir) to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

Some medicines may increase the effects of BiResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using BiResp Spiromax.

Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work to help lower any risk of interaction with the anesthetic you receive.

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking BiResp Spiromax do NOT use this medicine unless your doctor tells you to.
• If you get pregnant while using BiResp Spiromax, do NOT stop using BiResp Spiromax but talk to your doctor immediately.

Driving and using machines

BiResp Spiromax is not likely to affect your ability to drive or to use tools or machines.

BiResp Spiromax contains lactose

Lactose is a type of sugar found in milk. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.

3. How to use BiResp Spiromax

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.

• It is important to use BiResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
• If you are using BiResp Spiromax for asthma, your doctor will want to regularly check your symptoms.

Asthma

BiResp Spiromax can be prescribed for asthma in two different ways. The amount of BiResp Spiromax to use and when to use it depends on how it has been prescribed for you.

• If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A) Using BiResp Spiromax and a separate ‘reliever inhaler’.
• If you have been prescribed BiResp Spiromax as your only inhaler, read the section called (B) Using BiResp Spiromax as your only asthma inhaler.

• (A) Using BiResp Spiromax and a separate ‘reliever inhaler’

Use your BiResp Spiromax every day. This helps to prevent asthma symptoms from occurring.

Recommended dose:

Adults (18 years and older)

• 1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening.

Your doctor may increase this to 4 inhalations, twice a day.

If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

Adolescents (12 years and older)

• 1 or 2 inhalations twice daily.

Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma. If your doctor feels that you need a lower dose than is available from your BiResp Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your BiResp Spiromax but with a lower dose of the corticosteroid. If your symptoms are well controlled, your doctor may ask you to take your medicine once a day. However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and wheezing. Do not use BiResp Spiromax to treat these asthma symptoms.

• (B) Using BiResp Spiromax as your only asthma inhaler

Only use BiResp Spiromax in this way if your doctor has told you to.

Use your BiResp Spiromax every day. This helps to prevent asthma symptoms from occurring.

Recommended dose

Adults and adolescents (12 years and older)

• 1 inhalation in the morning and 1 inhalation in the evening or

• 2 inhalations in the morning or

• 2 inhalations in the evening.

Your doctor may increase this to 2 inhalations twice a day.

Also use BiResp Spiromax as a ‘reliever inhaler’ to treat asthma symptoms when they happen and to prevent asthma symptoms from happening (for example, when exercising or on exposure to allergens).

• If you get asthma symptoms, take 1 inhalation and wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at a single time.

Always keep your BiResp Spiromax with you and use it to relieve sudden attacks of breathlessness and wheezing.

A total daily dose of more than 8 inhalations is not normally needed. However, your doctor may allow you to take up to 12 inhalations a day for a limited period.

If you regularly need to use 8 or more inhalations a day, make an appointment to see your doctor. They may need to change your treatment.

Do NOT use more than 12 inhalations in total in 24 hours.

If you are doing exercise and you get asthma symptoms, use BiResp Spiromax as described here. However, do not use BiResp Spiromax just before exercise to stop asthma symptoms from happening.

It is important that you discuss with your doctor the use of BiResp Spiromax to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that is prescribed to you.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older) only:

• 2 inhalations twice a day, taken in the morning and in the evening

Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new BiResp Spiromax

Before using your new BiResp Spiromax for the first time , you need to prepare it for use as follows:

• Open the foil pouch by tearing at the notch at the top of the foil pouch and take out the inhaler
• Check the dose indicator to see that there are 120 inhalations in the inhaler.
• Write the date you opened the foil pouch on the label of the inhaler.
• Do not shake your inhaler before use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

• 1. Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.

• 2. Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively metered. Your inhaler is now ready for use.

• 3. Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.

• 4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Take care not to block the air vents.

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

BREATHE

Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.

Hold your breath for 10 seconds or as long as you comfortably can.

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 inBy 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 T/A Teva Pharmaceuticals Ireland

Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

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

Authorisation Holder:

Belgie/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73 Efc^rapufl TeBa OapMa EA’ITe.i: +359 2 489 95 85 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111 Danmark Teva Denmark A/S Tlf: +45 44 98 55 11 Deutschland Teva GmbH Tel: +49 731 402 08 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 661 0801 EZZaöa Teva EZZág A.E. Tql: +30 210 880 5000 España Laboratorios BIAL, S.A. Tel.: +34 915624196 France

Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tel/Tél: +32 3 820 73 73 Magyarország Teva Gyógyszergyár Zrt. Tel.: +36 1 288 64 00 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 207 540 7117 Nederland Teva Nederland B.V. Tel: +31 800 0228 400 Norge Teva Norway AS Tlf: +47 6677 55 90 Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007 0 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00 Portugal Teva Pharma – Produtos Farmacéuticos, Lda. Tel: +351 21 476 75 50 Romania

Teva Pharmaceuticals S.R.L

Tel: +4021 230 6524

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 5726 7911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 20 180 5900

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 207 540 7117

Hrvatska

Pliva Hrvatska d.o.o.

Tel: + 385 1 37 20 000

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:

Package leaflet: Information for the patient

BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/for­moterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What BiResp Spiromax is and what it is used for

• 2. What you need to know before you use BiResp Spiromax

• 3. How to use BiResp Spiromax

• 4. Possible side effects

• 5. How to store BiResp Spiromax

• 6. Contents of the pack and other information

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

BiResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting P2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily.

BiResp Spiromax is indicated for use in adults and adolescents 12 years of age and older only.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

When used for asthma, your doctor will prescribe BiResp Spiromax together with a separate ‘reliever inhaler’ such as salbutamol.

• Use BiResp Spiromax every day. This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
• Use the ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

Do not use BiResp Spiromax 320/9 micrograms as a ‘reliever inhaler’.

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. BiResp Spiromax can also be used to treat the symptoms of severe COPD in adults only.

2. What you need to know before you use BiResp Spiromax

Do not use BiResp Spiromax if

You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor,pharmacist or nurse before taking BiResp Spiromax if

• you are diabetic.
• you have a lung infection.
• you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
• you have problems with your thyroid or adrenal glands.
• you have low levels of potassium in your blood.
• you have severe liver problems.
• you regularly drink alcohol.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use BiResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests. When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use BiResp Spiromax.

Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.

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

Children

Do not give this medicine to children under the age of 12 years.

Other medicines and BiResp Spiromax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• P blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma).
• Oxytocin which is given to pregnant women to induce labour.
• Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procainamide and terfenadine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
• Steroid tablets that you take by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidone and the chemotherapy medicine procarbazine).
• Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called ‘HIV protease inhibitors’ (such as ritonavir) to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

Some medicines may increase the effects of BiResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using BiResp Spiromax.

Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work to help lower any risk of interaction with the anesthetic you receive.

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking BiResp Spiromax – do NOT use this medicine unless your doctor tells you to.
• If you get pregnant while using BiResp Spiromax, do NOT stop using BiResp Spiromax but talk to your doctor immediately.

Driving and using machines

BiResp Spiromax is not likely to affect your ability to drive or to use tools or machines.

BiResp Spiromax contains lactose

Lactose is a type of sugar found in milk. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.

3. How to use BiResp Spiromax

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor pharmacist, or nurse if you are not sure.

• It is important to use BiResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
• If you are using BiResp Spiromax for asthma, your doctor will want to regularly check your symptoms.

Asthma

Use your BiResp Spiromax every day. This helps to prevent asthma symptoms from occurring.

Recommended dose:

Adults (18 years and older)

1 inhalation (actuation), twice a day, taken in the morning and in the evening.

Your doctor may increase this to 2 inhalations, twice a day.

If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

Adolescents (12 years and older) 1 inhalation twice daily.

Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma. If your doctor feels that you need a lower dose than is available from your BiResp Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your BiResp Spiromax but with a lower dose of the corticosteroid. If your symptoms are well controlled, your doctor may ask you to take your medicine once a day. However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and wheezing. Do not use BiResp Spiromax to treat these asthma symptoms. It is important that you discuss with your doctor the use of BiResp Spiromax to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that is prescribed to you.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older) only:

• 1 inhalation twice a day, taken in the morning and in the evening.

Your doctor may also prescribe another bronchodilator medicine for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new BiResp Spiromax

Before using your new BiResp Spiromax for the first time , you need to prepare it for use as follows:

• Open the foil pouch by tearing at the notch at the top of the foil pouch and take out the inhaler.
• Check the dose indicator to see that there are 60 inhalations in the inhaler.
• Write the date you opened the foil pouch on the label of the inhaler.
• Do not shake your inhaler before use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

• 1. Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.

J!

• 2. Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively metered. Your inhaler is now ready for use.

• 3. Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.

• 4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Take care not to block the air vents.

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

BREATHE

• 5. Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.

• 6. Hold your breath for 10 seconds or as long as you comfortably 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 inBy 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

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 T/A Teva Pharmaceuticals Ireland

Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

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

Authorisation Holder:

Belgie/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73 Efc^rapufl TeBa OapMa EA’ITe.i: +359 2 489 95 85 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111 Danmark Teva Denmark A/S Tlf: +45 44 98 55 11 Deutschland Teva GmbH Tel: +49 731 402 08 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 661 0801 EZZaöa Teva EZZág A.E. Tql: +30 210 880 5000 España Laboratorios BIAL, S.A. Tel.: +34 915624196 France

Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tel/Tél: +32 3 820 73 73 Magyarország Teva Gyógyszergyár Zrt. Tel.: +36 1 288 64 00 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 207 540 7117 Nederland Teva Nederland B.V. Tel: +31 800 0228 400 Norge Teva Norway AS Tlf: +47 6677 55 90 Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007 0 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00 Portugal Teva Pharma – Produtos Farmacéuticos, Lda. Tel: +351 21 476 75 50 Romania

Teva Pharmaceuticals S.R.L

Tel: +4021 230 6524

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 5726 7911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 20 180 5900

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 207 540 7117

Hrvatska

Pliva Hrvatska d.o.o.

Tel: + 385 1 37 20 000

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:

Package leaflet: Information for the patient

BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/for­moterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What BiResp Spiromax is and what it is used for

• 2. What you need to know before you use BiResp Spiromax

• 3. How to use BiResp Spiromax

• 4. Possible side effects

• 5. How to store BiResp Spiromax

• 6. Contents of the pack and other information

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

BiResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting P2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily.

BiResp Spiromax is indicated for use in adults and adolescents 12 years of age and older only.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

When used for asthma, your doctor will prescribe BiResp Spiromax together with a separate ‘reliever inhaler’ such as salbutamol.

• Use BiResp Spiromax every day. This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
• Use the ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

Do not use BiResp Spiromax 320/9 micrograms as a ‘reliever inhaler’.

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. BiResp Spiromax can also be used to treat the symptoms of severe COPD in adults only.

2. What you need to know before you use BiResp Spiromax

Do not use BiResp Spiromax if

You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor,pharmacist or nurse before taking BiResp Spiromax if

• you are diabetic.
• you have a lung infection.
• you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
• you have problems with your thyroid or adrenal glands.
• you have low levels of potassium in your blood.
• you have severe liver problems.
• you regularly drink alcohol.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use BiResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests. When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use BiResp Spiromax.

Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.

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

Children

Do not give this medicine to children under the age of 12 years.

Other medicines and BiResp Spiromax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• P blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma).
• Oxytocin which is given to pregnant women to induce labour.
• Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procainamide and terfenadine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
• Steroid tablets that you take by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidone and the chemotherapy medicine procarbazine).
• Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called ‘HIV protease inhibitors’ (such as ritonavir) to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

Some medicines may increase the effects of BiResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using BiResp Spiromax.

Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work to help lower any risk of interaction with the anesthetic you receive.

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking BiResp Spiromax – do NOT use this medicine unless your doctor tells you to.
• If you get pregnant while using BiResp Spiromax, do NOT stop using BiResp Spiromax but talk to your doctor immediately.

Driving and using machines

BiResp Spiromax is not likely to affect your ability to drive or to use tools or machines.

BiResp Spiromax contains lactose

Lactose is a type of sugar found in milk. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.

3. How to use BiResp Spiromax

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor pharmacist, or nurse if you are not sure.

• It is important to use BiResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
• If you are using BiResp Spiromax for asthma, your doctor will want to regularly check your symptoms.

Asthma

Use your BiResp Spiromax every day. This helps to prevent asthma symptoms from occurring.

Recommended dose:

Adults (18 years and older)

1 inhalation (actuation), twice a day, taken in the morning and in the evening.

Your doctor may increase this to 2 inhalations, twice a day.

If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

Adolescents (12 years and older) 1 inhalation twice daily.

Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma. If your doctor feels that you need a lower dose than is available from your BiResp Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your BiResp Spiromax but with a lower dose of the corticosteroid. If your symptoms are well controlled, your doctor may ask you to take your medicine once a day. However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and wheezing. Do not use BiResp Spiromax to treat these asthma symptoms. It is important that you discuss with your doctor the use of BiResp Spiromax to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that is prescribed to you.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older) only:

• 1 inhalation twice a day, taken in the morning and in the evening.

Your doctor may also prescribe another bronchodilator medicine for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new BiResp Spiromax

Before using your new BiResp Spiromax for the first time , you need to prepare it for use as follows:

• Open the foil pouch by tearing at the notch at the top of the foil pouch and take out the inhaler.
• Check the dose indicator to see that there are 60 inhalations in the inhaler.
• Write the date you opened the foil pouch on the label of the inhaler.
• Do not shake your inhaler before use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

• 1. Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.

J!

• 2. Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively metered. Your inhaler is now ready for use.

• 3. Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.

• 4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Take care not to block the air vents.

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

BREATHE

• 5. Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.

• 6. Hold your breath for 10 seconds or as long as you comfortably 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 inBy 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