B. PACKAGE LEAFLET

Package leaflet: Information for the patient

BroPair Spiromax 12.75 microgram­s/100 micrograms inhalation powder salmeterol/flu­ticasone propionate

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 BroPair Spiromax is and what it is used for

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

• 3. How to use BroPair Spiromax

• 4. Possible side effects

• 5. How to store BroPair Spiromax

• 6. Contents of the pack and other information

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

BroPair Spiromax contains 2 active substances: salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways into the lungs to stay open. This makes it easier for air to get in and out. The effects of salmeterol last for at least 12 hours.
• Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

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

BroPair Spiromax helps to prevent breathlessness and wheeziness coming on. You should not use it to relieve an asthma attack. If you have an asthma attack, use a fast-acting reliever (rescue) inhaler, such as salbutamol. You should always have your fast-acting rescue inhaler with you.

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

Do not use BroPair Spiromax

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using BroPair Spiromax if you have:

• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes (BroPair Spiromax may increase your blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now or have had in the past, or have other lung infections

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

Children and adolescents

Do not give this medicine to children or adolescents under the age of 12 years because it has not been studied in this age group.

Other medicines and BroPair Spiromax

Tell your doctor, nurse or pharmacist if you are taking or, have recently taken or might use any other medicines. BroPair Spiromax may not be suitable for use with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use BroPair Spiromax:

• Beta blockers (such as atenolol, propranolol and sotalol). Beta blockers are mostly used for high blood pressure or heart conditions such as angina.
• Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body. This can increase side effects with BroPair Spiromax, including irregular heartbeats, or may make side effects worse.
• Corticosteroids (by mouth or by injection). Recent use of these medicines might increase the risk of BroPair Spiromax affecting your adrenal glands by reducing the amount of steroid hormones produced by the glands (adrenal suppression).
• Diuretics, medicines that increase urine production and are used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines such as aminophylline and theophylline. These are often used to treat asthma.

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.

It is not known if this medicine can pass into breast milk. If you are breast-feeding, check with your doctor, nurse or pharmacist before taking this medicine.

Driving and using machines

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

BroPair Spiromax contains lactose

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

3. How to use BroPair Spiromax

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

The recommended dose is one inhalation twice a day.

• BroPair Spiromax is for long-term regular use. Use it every day to keep your asthma under control. Do not use more than the recommended dose. Check with your doctor, nurse or pharmacist if you are not sure.
• Do not stop taking BroPair Spiromax or reduce the dose without talking to your doctor or nurse first.
• BroPair Spiromax should be inhaled through the mouth.

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

If your asthma or breathing gets worse tell your doctor straight away. If you feel more wheezy, your chest feels tight more often, or you need to use more of your fast-acting ‘reliever’ medicine, your asthma may be getting worse and you could become seriously ill. Continue to use BroPair Spiromax but do not increase the number of inhalations you take. See your doctor at once as you may need additional treatment.

Instructions for use

Training

Your doctor, nurse, or pharmacist should train you on how to use your inhaler, including how to inhale a dose effectively. This training is important to ensure you receive the dose you require. If you have not received this training please ask your doctor, nurse or pharmacist to show you how to use your inhaler properly before you use it for the first time.

Your doctor, nurse, or pharmacist should also check from time to time that you are using the Spiromax device properly and as prescribed. If you are not using BroPair Spiromax properly or you are not breathing it in forcefully enough, you may not be getting enough medicine into your lungs. This means that the medicine will not help your asthma as well as it should.

Preparing your BroPair Spiromax

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

• 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 on the inhaler.
• You do not need to shake your inhaler before you use it.

How to take an inhalation

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

• 2. Open the mouthpiece cover by folding it down until you hear a loud click. This will measure out one dose of your medicine. Your inhaler is now ready for use.

  
  

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

• 4. Put the mouthpiece in your mouth and close your lips tightly around it. Take care not to block the air vents.

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

Note that it is important that you breathe in forcefully.

• 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).

• 8. Close the mouthpiece cover.

• After each dose, rinse your mouth with water, and spit it out or brush your teeth before rinsing.
• Do not try to take your inhaler apart, remove or twist the mouthpiece cover.
• The cover 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 inhaler dry and clean.

If necessary you may wipe the mouthpiece of your inhaler after use with a dry cloth or tissue.

When to start using a new BroPair Spiromax

• The dose indicator on the rear of the device tells you how many doses (inhalations) are left in your inhaler, starting at 60 when it is full and ending with 0 (zero) when it is empty.
• The dose indicator shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• When 20 or fewer are left, the numbers are shown in red on a white background. When the red numbers appear in the window, you should see your doctor or nurse to get a new inhaler.

Note:

• The mouthpiece clicks even when your inhaler 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 1 inhalation.

If you use more BroPair Spiromax than you should

It is important that you take the dose that your doctor or nurse has prescribed. You should not exceed the prescribed dose without medical advice. If you accidentally take more doses than recommended, talk to your nurse, doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky.

You may also have dizziness, a headache, muscle weakness and aching joints.

If you have repeatedly used too many doses of BroPair Spiromax for a long time, you should talk to your doctor or pharmacist for advice. This is because using too much BroPair Spiromax can reduce the amount of steroid hormones produced by your adrenal glands.

If you forget to use BroPair 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 stop using BroPair Spiromax

It is very important that you take your BroPair Spiromax every day as advised. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of BroPair Spiromax. This could make your breathing worse.

In addition, if you suddenly stop taking BroPair Spiromax or reduce your dose of BroPair Spiromax this may (very rarely) cause problems due to your adrenal glands producing reduced amounts of steroid hormone (adrenal insufficiency) which sometimes causes side effects.

These side effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits)

When your body is under stress such as from fever, accident or injury, infection, or surgery, adrenal insufficiency can get worse and you may also have the side effects listed above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).

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. To reduce the chance of side effects your doctor will prescribe the lowest dose of this combination of drugs to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using BroPair Spiromax. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using BroPair Spiromax, stop using BroPair Spiromax and tell your doctor straight away. Allergic reactions to BroPair Spiromax are uncommon (they may affect up to 1 in 100 people).

Other side effects are listed below:

Common (may affect up to 1 in 10 people)

• A fungal infection (thrush) causing sore, creamy-yellow, raised patches in the mouth and throat, as well as a sore tongue, hoarse voice and throat irritation. Rinsing your mouth with water and spitting it out immediately or brushing your teeth after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat the thrush.
• Muscle pain.
• Back pain.
• Flu (influenza).
• Low levels of potassium in your blood (hypokalaemia).
• Inflammation of the nose (rhinitis).
• Inflammation of the sinuses (sinusitis).
• Inflammation of the nose and throat (nasopharyngitis).
• Headache.
• Cough.
• Irritation of the throat.
• Soreness or inflammation of the back of the throat.
• Hoarseness or loss of voice.
• Dizziness.

Uncommon (may affect up to 1 in 100 people)

• Increased sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
• Cataract (cloudy lens in the eye).
• Very fast heart beat (tachycardia).
• Feeling shaky (tremor) and feeling that your heart is beating fast (palpitations) – these are usually harmless and get less as treatment continues.
• Feeling worried or anxious.
• Behavioural changes, such as being unusually active and irritable (although these effects occur mainly in children).
• Disturbed sleep.
• Hay fever.
• Nasal congestion (blocked nose).
• Irregular heartbeat (atrial fibrillations).
• Chest infection.
• Pain in your extremities (arms or legs).
• Stomach pain.
• Indigestion.
• Skin damage and tearing.
• Skin inflammation.
• Inflammation of the throat usually characterised by a sore throat (pharyngitis).

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

• Breathing difficulties or wheezing that gets worse straight after taking BroPair Spiromax. If this happens stop using BroPair Spiromax inhaler. Use your fast acting ‘reliever’ (‘rescue’) inhaler to help your breathing and tell your doctor straight away.
• BroPair Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include:

• – Slowing of growth in children and adolescents

• – Glaucoma (damage to the nerve in the eye)

• – Rounded (moon shaped) face (Cushing’s syn­drome).

Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of this combination of drugs to control your asthma.

• Uneven or irregular heart beat or an extra heart beat (arrhythmias). Tell your doctor, but do not stop taking BroPair Spiromax unless the doctor tells you to stop.
• A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.

Frequency not known, but may also occur:

• Blurred vision.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BroPair 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 and 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 removing the foil wrapping.

Use within 2 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 BroPair Spiromax contains

• – The active substances are salmeterol and fluticasone propionate. Each metered dose contains

14 micrograms of salmeterol (as salmeterol xinafoate) and 113 micrograms of fluticasone propionate. Each delivered dose (the dose that leaves the mouthpiece) contains 12.75 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.

– The other ingredient is lactose monohydrate (see section 2 under ‘BroPair Spiromax contains lactose’).

What BroPair Spiromax looks like and contents of the pack

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

BroPair Spiromax is available in packs containing 1 inhaler and in multipacks containing 3 cartons, each containing 1 inhaler. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

The Netherlands

Manufacturer

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

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

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str. 31–546 Krakow, Poland

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

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

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

BroPair Spiromax 12.75 microgram­s/202 micrograms inhalation powder salmeterol/flu­ticasone propionate

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 BroPair Spiromax is and what it is used for

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

• 3. How to use BroPair Spiromax

• 4. Possible side effects

• 5. How to store BroPair Spiromax

• 6. Contents of the pack and other information

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

BroPair Spiromax contains 2 active substances: salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways into the lungs to stay open. This makes it easier for air to get in and out. The effects of salmeterol last for at least 12 hours.
• Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

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

BroPair Spiromax helps to prevent breathlessness and wheeziness coming on. You should not use it to relieve an asthma attack. If you have an asthma attack, use a fast-acting reliever (rescue) inhaler, such as salbutamol. You should always have your fast-acting rescue inhaler with you.

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

Do not use BroPair Spiromax

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using BroPair Spiromax if you have:

• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes (BroPair Spiromax may increase your blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now or have had in the past, or have other lung infections

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

Children and adolescents

Do not give BroPair Spiromax to children or adolescents under the age of 12 years because it has not been studied in this age group.

Other medicines and BroPair Spiromax

Tell your doctor, nurse or pharmacist if you are taking or, have recently taken or might use any other medicines. BroPair Spiromax may not be suitable for use with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use BroPair Spiromax:

• Beta blockers (such as atenolol, propranolol and sotalol). Beta blockers are mostly used for high blood pressure or heart conditions such as angina.
• Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body. This can increase side effects with BroPair Spiromax, including irregular heartbeats, or may make side effects worse.
• Corticosteroids (by mouth or by injection). Recent use of these medicines might increase the risk of BroPair Spiromax affecting your adrenal glands by reducing the amount of steroid hormones produced by the glands (adrenal suppression).
• Diuretics, medicines that increase urine production and are used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines such as aminophylline and theophylline. These are often used to treat asthma.

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.

It is not known if this medicine can pass into breast milk. If you are breast-feeding, check with your doctor, nurse or pharmacist before taking this medicine.

Driving and using machines

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

BroPair Spiromax contains lactose

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

3. How to use BroPair Spiromax

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

The recommended dose is one inhalation twice a day.

• BroPair Spiromax is for long-term regular use. Use it every day to keep your asthma under control. Do not use more than the recommended dose. Check with your doctor, nurse or pharmacist if you are not sure.
• Do not stop taking BroPair Spiromax or reduce the dose without talking to your doctor or nurse first.
• BroPair Spiromax should be inhaled through the mouth.

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

If your asthma or breathing gets worse tell your doctor straight away. If you feel more wheezy, your chest feels tight more often, or you need to use more of your fast-acting ‘reliever’ medicine, your asthma may be getting worse and you could become seriously ill. Continue to use BroPair Spiromax but do not increase the number of inhalations you take. See your doctor at once as you may need additional treatment.

Instructions for use

Training

Your doctor, nurse, or pharmacist should train you on how to use your inhaler, including how to inhale a dose effectively. This training is important to ensure you receive the dose you require. If you have not received this training please ask your doctor, nurse or pharmacist to show you how to use your inhaler properly before you use it for the first time.

Your doctor, nurse, or pharmacist should also check from time to time that you are using the Spiromax device properly and as prescribed. If you are not using BroPair Spiromax properly or you are not breathing it in forcefully enough, you may not be getting enough medicine into your lungs. This means that the medicine will not help your asthma as well as it should.

Preparing your BroPair Spiromax

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

• 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 on the inhaler.
• You do not need to shake your inhaler before you use it.

How to take an inhalation

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

• 2. Open the mouthpiece cover by folding it down until you hear a loud click. This will measure out one dose of your medicine. Your inhaler is now ready for use.

  
  

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

• 4. Put the mouthpiece in your mouth and close your lips tightly around it. Take care not to block the air vents.

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

Note that it is important that you breathe in forcefully.

• 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).

• 8. Close the mouthpiece cover.

After each dose, rinse your mouth with water, and spit it out or brush your teeth before rinsing.

• Do not try to take your inhaler apart, remove or twist the mouthpiece cover.
• The cover 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 inhaler dry and clean.

If necessary you may wipe the mouthpiece of your inhaler after use with a dry cloth or tissue.

When to start using a new BroPair Spiromax

• The dose indicator on the rear of the device tells you how many doses (inhalations) are left in your inhaler, starting at 60 when it is full and ending with 0 (zero) when it is empty.
• The dose indicator shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• When 20 or fewer are left, the numbers are shown in red on a white background. When the red numbers appear in the window, you should see your doctor or nurse to get a new inhaler.

Note:

• The mouthpiece clicks even when your inhaler 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 1 inhalation.

If you use more BroPair Spiromax than you should

It is important that you take the dose that your doctor or nurse has prescribed. You should not exceed the prescribed dose without medical advice. If you accidentally take more doses than recommended, talk to your nurse, doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky.

You may also have dizziness, a headache, muscle weakness and aching joints.

If you have repeatedly used too many doses of BroPair Spiromax for a long time, you should talk to your doctor or pharmacist for advice. This is because using too much BroPair Spiromax can reduce the amount of steroid hormones produced by your adrenal glands.

If you forget to use BroPair 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 stop using BroPair Spiromax

It is very important that you take your BroPair Spiromax every day as advised. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of BroPair Spiromax. This could make your breathing worse.

In addition, if you suddenly stop taking BroPair Spiromax or reduce your dose of BroPair Spiromax this may (very rarely) cause problems due to your adrenal glands producing reduced amounts of steroid hormone (adrenal insufficiency) which sometimes causes side effects.

These side effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits)

When your body is under stress such as from fever, accident or injury, infection, or surgery, adrenal insufficiency can get worse and you may also have the side effects listed above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).

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. To reduce the chance of side effects your doctor will prescribe the lowest dose of this combination of drugs to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using BroPair Spiromax. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using BroPair Spiromax, stop using BroPair Spiromax and tell your doctor straight away. Allergic reactions to BroPair Spiromax are uncommon (they may affect up to 1 in 100 people).

Other side effects are listed below:

Common (may affect up to 1 in 10 people)

• A fungal infection (thrush) causing sore, creamy-yellow, raised patches in the mouth and throat, as well as a sore tongue, hoarse voice and throat irritation. Rinsing your mouth with water and spitting it out immediately or brushing your teeth after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat the thrush.
• Muscle pain.
• Back pain.
• Flu (influenza).
• Low levels of potassium in your blood (hypokalaemia).
• Inflammation of the nose (rhinitis).
• Inflammation of the sinuses (sinusitis).
• Inflammation of the nose and throat (nasopharyngitis).
• Headache.
• Cough.
• Irritation of the throat.
• Soreness or inflammation of the back of the throat.
• Hoarseness or loss of voice.
• Dizziness.

Uncommon (may affect up to 1 in 100 people)

• Increased sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
• Cataract (cloudy lens in the eye).
• Very fast heart beat (tachycardia).
• Feeling shaky (tremor) and feeling that your heart is beating fast (palpitations) – these are usually harmless and get less as treatment continues.
• Feeling worried or anxious.
• Behavioural changes, such as being unusually active and irritable (although these effects occur mainly in children).
• Disturbed sleep.
• Hay fever.
• Nasal congestion (blocked nose).
• Irregular heartbeat (atrial fibrillations).
• Chest infection.
• Pain in your extremities (arms or legs).
• Stomach pain.
• Indigestion.
• Skin damage and tearing.
• Skin inflammation.
• Inflammation of the throat usually characterised by a sore throat (pharyngitis).

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

• Breathing difficulties or wheezing that gets worse straight after taking BroPair Spiromax. If this happens stop using BroPair Spiromax inhaler. Use your fast acting ‘reliever’ (‘rescue’) inhaler to help your breathing and tell your doctor straight away.
• BroPair Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include:

• – Slowing of growth in children and adolescents

• – Glaucoma (damage to the nerve in the eye)

• – Rounded (moon shaped) face (Cushing’s syn­drome).

Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of this combination of drugs to control your asthma.

• Uneven or irregular heart beat or an extra heart beat (arrhythmias). Tell your doctor, but do not stop taking BroPair Spiromax unless the doctor tells you to stop.
• A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.

Frequency not known, but may also occur:

• Blurred vision.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BroPair 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 and 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 removing the foil wrapping.

Use within 2 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 BroPair Spiromax contains

• – The active substances are salmeterol and fluticasone propionate. Each metered dose contains

What BroPair Spiromax looks like and contents of the pack

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

BroPair Spiromax is available in packs containing 1 inhaler and in multipacks containing 3 cartons, each containing 1 inhaler. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

The Netherlands

Manufacturer

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

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

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str. 31–546 Krakow, Poland

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

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

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

BroPair Spiromax 12.75 microgram­s/202 micrograms inhalation powder salmeterol/flu­ticasone propionate

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 BroPair Spiromax is and what it is used for

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

• 3. How to use BroPair Spiromax

• 4. Possible side effects

• 5. How to store BroPair Spiromax

• 6. Contents of the pack and other information

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

BroPair Spiromax contains 2 active substances: salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways into the lungs to stay open. This makes it easier for air to get in and out. The effects of salmeterol last for at least 12 hours.
• Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

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

BroPair Spiromax helps to prevent breathlessness and wheeziness coming on. You should not use it to relieve an asthma attack. If you have an asthma attack, use a fast-acting reliever (rescue) inhaler, such as salbutamol. You should always have your fast-acting rescue inhaler with you.

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

Do not use BroPair Spiromax

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using BroPair Spiromax if you have:

• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes (BroPair Spiromax may increase your blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now or have had in the past, or have other lung infections

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

Children and adolescents

Do not give BroPair Spiromax to children or adolescents under the age of 12 years because it has not been studied in this age group.

Other medicines and BroPair Spiromax

Tell your doctor, nurse or pharmacist if you are taking or, have recently taken or might use any other medicines. BroPair Spiromax may not be suitable for use with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use BroPair Spiromax:

• Beta blockers (such as atenolol, propranolol and sotalol). Beta blockers are mostly used for high blood pressure or heart conditions such as angina.
• Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body. This can increase side effects with BroPair Spiromax, including irregular heartbeats, or may make side effects worse.
• Corticosteroids (by mouth or by injection). Recent use of these medicines might increase the risk of BroPair Spiromax affecting your adrenal glands by reducing the amount of steroid hormones produced by the glands (adrenal suppression).
• Diuretics, medicines that increase urine production and are used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines such as aminophylline and theophylline. These are often used to treat asthma.

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

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.

It is not known if this medicine can pass into breast milk. If you are breast-feeding, check with your doctor, nurse or pharmacist before taking this medicine.

Driving and using machines

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

BroPair Spiromax contains lactose

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

3. How to use BroPair Spiromax

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

The recommended dose is one inhalation twice a day.

• BroPair Spiromax is for long-term regular use. Use it every day to keep your asthma under control. Do not use more than the recommended dose. Check with your doctor, nurse or pharmacist if you are not sure.
• Do not stop taking BroPair Spiromax or reduce the dose without talking to your doctor or nurse first.
• BroPair Spiromax should be inhaled through the mouth.

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

If your asthma or breathing gets worse tell your doctor straight away. If you feel more wheezy, your chest feels tight more often, or you need to use more of your fast-acting ‘reliever’ medicine, your asthma may be getting worse and you could become seriously ill. Continue to use BroPair Spiromax but do not increase the number of inhalations you take. See your doctor at once as you may need additional treatment.

Instructions for use

Training

Your doctor, nurse, or pharmacist should train you on how to use your inhaler, including how to inhale a dose effectively. This training is important to ensure you receive the dose you require. If you have not received this training please ask your doctor, nurse or pharmacist to show you how to use your inhaler properly before you use it for the first time.

Your doctor, nurse, or pharmacist should also check from time to time that you are using the Spiromax device properly and as prescribed. If you are not using BroPair Spiromax properly or you are not breathing it in forcefully enough, you may not be getting enough medicine into your lungs. This means that the medicine will not help your asthma as well as it should.

Preparing your BroPair Spiromax

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

• 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 on the inhaler.
• You do not need to shake your inhaler before you use it.

How to take an inhalation

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

• 2. Open the mouthpiece cover by folding it down until you hear a loud click. This will measure out one dose of your medicine. Your inhaler is now ready for use.

  
  

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

• 4. Put the mouthpiece in your mouth and close your lips tightly around it. Take care not to block the air vents.

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

Note that it is important that you breathe in forcefully.

• 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).

• 8. Close the mouthpiece cover.

After each dose, rinse your mouth with water, and spit it out or brush your teeth before rinsing.

• Do not try to take your inhaler apart, remove or twist the mouthpiece cover.
• The cover 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 inhaler dry and clean.

If necessary you may wipe the mouthpiece of your inhaler after use with a dry cloth or tissue.

When to start using a new BroPair Spiromax

• The dose indicator on the rear of the device tells you how many doses (inhalations) are left in your inhaler, starting at 60 when it is full and ending with 0 (zero) when it is empty.
• The dose indicator shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• When 20 or fewer are left, the numbers are shown in red on a white background. When the red numbers appear in the window, you should see your doctor or nurse to get a new inhaler.

Note:

• The mouthpiece clicks even when your inhaler 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 1 inhalation.

If you use more BroPair Spiromax than you should

It is important that you take the dose that your doctor or nurse has prescribed. You should not exceed the prescribed dose without medical advice. If you accidentally take more doses than recommended, talk to your nurse, doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky.

You may also have dizziness, a headache, muscle weakness and aching joints.

If you have repeatedly used too many doses of BroPair Spiromax for a long time, you should talk to your doctor or pharmacist for advice. This is because using too much BroPair Spiromax can reduce the amount of steroid hormones produced by your adrenal glands.

If you forget to use BroPair 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 stop using BroPair Spiromax

It is very important that you take your BroPair Spiromax every day as advised. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of BroPair Spiromax. This could make your breathing worse.

In addition, if you suddenly stop taking BroPair Spiromax or reduce your dose of BroPair Spiromax this may (very rarely) cause problems due to your adrenal glands producing reduced amounts of steroid hormone (adrenal insufficiency) which sometimes causes side effects.

These side effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits)

When your body is under stress such as from fever, accident or injury, infection, or surgery, adrenal insufficiency can get worse and you may also have the side effects listed above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).

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. To reduce the chance of side effects your doctor will prescribe the lowest dose of this combination of drugs to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using BroPair Spiromax. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using BroPair Spiromax, stop using BroPair Spiromax and tell your doctor straight away. Allergic reactions to BroPair Spiromax are uncommon (they may affect up to 1 in 100 people).

Other side effects are listed below:

Common (may affect up to 1 in 10 people)

• A fungal infection (thrush) causing sore, creamy-yellow, raised patches in the mouth and throat, as well as a sore tongue, hoarse voice and throat irritation. Rinsing your mouth with water and spitting it out immediately or brushing your teeth after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat the thrush.
• Muscle pain.
• Back pain.
• Flu (influenza).
• Low levels of potassium in your blood (hypokalaemia).
• Inflammation of the nose (rhinitis).
• Inflammation of the sinuses (sinusitis).
• Inflammation of the nose and throat (nasopharyngitis).
• Headache.
• Cough.
• Irritation of the throat.
• Soreness or inflammation of the back of the throat.
• Hoarseness or loss of voice.
• Dizziness.

Uncommon (may affect up to 1 in 100 people)

• Increased sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
• Cataract (cloudy lens in the eye).
• Very fast heart beat (tachycardia).
• Feeling shaky (tremor) and feeling that your heart is beating fast (palpitations) – these are usually harmless and get less as treatment continues.
• Feeling worried or anxious.
• Behavioural changes, such as being unusually active and irritable (although these effects occur mainly in children).
• Disturbed sleep.
• Hay fever.
• Nasal congestion (blocked nose).
• Irregular heartbeat (atrial fibrillations).
• Chest infection.
• Pain in your extremities (arms or legs).
• Stomach pain.
• Indigestion.
• Skin damage and tearing.
• Skin inflammation.
• Inflammation of the throat usually characterised by a sore throat (pharyngitis).

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

• Breathing difficulties or wheezing that gets worse straight after taking BroPair Spiromax. If this happens stop using BroPair Spiromax inhaler. Use your fast acting ‘reliever’ (‘rescue’) inhaler to help your breathing and tell your doctor straight away.
• BroPair Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include:

• – Slowing of growth in children and adolescents

• – Glaucoma (damage to the nerve in the eye)

• – Rounded (moon shaped) face (Cushing’s syn­drome).

Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of this combination of drugs to control your asthma.

• Uneven or irregular heart beat or an extra heart beat (arrhythmias). Tell your doctor, but do not stop taking BroPair Spiromax unless the doctor tells you to stop.
• A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.

Frequency not known, but may also occur:

• Blurred vision.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BroPair 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 and 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 removing the foil wrapping.

Use within 2 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 BroPair Spiromax contains

• – The active substances are salmeterol and fluticasone propionate. Each metered dose contains