BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder – patient leaflet, side effects, dosage

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

BiResp Spiromax is an inhaler that is used to treat asthma in adults and adolescents aged 12 – 17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta₂ adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily.

Asthma

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

Some people are prescribed BiResp Spiromax and a separate reliever inhaler

1. a) BiResp Spiromax every day and a separate reliever inhaler when required.
2. • You take a fixed dose of BiResp Spiromax every day. This helps to prevent asthma symptoms from happening.
3. • You use a separate reliever inhaler when you get asthma symptoms, to make it easier to breathe again.

Some people are prescribed BiResp Spiromax as their only asthma inhaler

1. b) BiResp Spiromax everyday and also when required (BiResp Spiromax maintenance and reliever therapy).
2. • You take BiResp Spiromax every day. This helps to prevent asthma symptoms from happening.
3. • You also take BiResp Spiromax when you need extra doses for the relief of asthma symptoms, to make it easier to breathe again. You do not need a separate reliever inhaler.
4. • If agreed with your doctor, you can also take BiResp Spiromax to prevent asthma symptoms from happening, for example, when exercising or on exposure to allergens.
5. c) BiResp Spiromax only when required for relief of asthma symptoms (BiResp Spiromax reliever therapy for mild asthma).
6. • You take BiResp Spiromax, when you get asthma symptoms, to make it easier to breathe again. You do not need a separate inhaler.
7. • If agreed with your doctor, you can also take BiResp Spiromax to prevent asthma symptoms from happening, for example, when exercising or on exposure to allergens.

Chronic obstructive pulmonary disease (COPD)

BiResp Spiromax can also be used to treat the symptoms of COPD in adults.

COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.

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

Do not use BiResp Spiromax

• if you are allergic to budesonide, formoterol, or the other ingredient of this medicine (listed in section 6), which is lactose (which contains small amounts of milk protein).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using 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.

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

Other medicines and BiResp Spiromax

Tell your healthcare practitioner if you are using, have recently used or might use any other medicines. In particular, tell your doctor or pharmacist if you are using any of the following medicines:

• Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such as quinidine).
• 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 medicines 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 anti-depressants (such as amitriptyline) and the anti-depressant nefazodone.
• 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 levo-dopa).
• Medicines for thyroid problems (such as levo-thyroxine).

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

Also tell your healthcare practitioner if you are going to have a general anaesthetic for an operation or for dental work.

Pregnancy breast-feeding and fertility

• If you are pregnant or planning to get pregnant, talk to your healthcare practitioner before using 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 this medicine but talk to your doctor immediately.
• If you are breast-feeding, talk to your healthcare practitioner before using BiResp Spiromax

Driving and using machines

BiResp Spiromax has no or negligible effect on your ability to drive or to use tools or machines.

BiResp Spiromax contains lactose

This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine. The excipient lactose contains small amounts of milk proteins, which may cause an allergic reaction.

3. How to use BiResp Spiromax

• Always use this medicine exactly as your doctor or pharmacist has told you. Check with your healthcare practitioner if you are not sure.
• If you have been prescribed a daily dose of BiResp Spiromax, it is important to use your inhaler 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.

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 oral steroid tablets for a long time, your doctor may want you to have blood tests from time to time. When reducing oral 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 medication 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 during periods of stress (for example, when you have a chest infection or before an operation).

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using this medicine 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 asthma.
• 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.

Asthma

BiResp Spiromax can be prescribed for asthma in 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 a fixed dose of 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 sections called b) Using BiResp Spiromax as your only asthma inhaler every day and c) Using BiResp Spiromax as your only asthma inhaler only when you need it.
• Using BiResp Spiromax and a separate reliever inhaler

Take your fixed dose of BiResp Spiromax every day. This helps to prevent asthma symptoms from happening.

Adults (18 years and above)

• The usual dose is 1 or 2 inhalations, twice a day.
• 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 to 17 years)

• The usual dose is 1 or 2 inhalations twice a day.
• If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

A lower strength of budesonide/formoterol inhaler is available for children aged from 6 to 11 years.

BiResp Spiromax is not recommended to be used in children who are younger than 6 years.

Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not adjust or stop the dose without talking to your doctor (or asthma nurse) first.

Use a separate reliever inhaler to treat asthma symptoms when they happen.

Always keep your reliever inhaler with you to use when you need it. Do not use BiResp Spiromax to treat asthma symptoms - use your reliever inhaler.

1. b) Using BiResp Spiromax every day and also when required (BiResp Spiromax maintenance and reliever therapy)

Only use BiResp Spiromax in this way if your doctor has told you to and if you are aged 12 or above.

Use your BiResp Spiromax every day. This helps to prevent asthma symptoms from happening. You can take:

• 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 your reliever inhaler to treat asthma symptoms when they happen and, if agreed with your doctor, 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, so you can use it as your reliever inhaler when you need it.

Seek urgent medical advice if BiResp Spiromax does not relieve your asthma symptoms or if your asthma symptoms worsen despite treatment with BiResp Spiromax.

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 or nurse as soon as possible. They may need to change your treatment.

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

1. c) Using BiResp Spiromax only when required to relieve asthma symptoms (BiResp Spiromax reliever therapy in mild asthma)

Only use BiResp Spiromax in this way if your doctor has told you to and if you are aged 12 or above.

Use BiResp Spiromax as your reliever inhaler to treat asthma symptoms when they happen and, if agreed with your doctor, 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, so you can use it as your reliever inhaler when you need it.

Seek urgent medical advice if BiResp Spiromax does not relieve your asthma symptoms or if your asthma symptoms worsen despite treatment with BiResp Spiromax.

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 or nurse. They may need to change your treatment.

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

Chronic Obstructive Pulmonary Disease (COPD)

• Only to be used by adults (aged 18 years and above).
• The usual dose is 2 inhalations twice a day.

Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (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. 1. Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.

1. 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.

1. 3. Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.
2. 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.

1. 5. Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.
2. 6. Hold your breath for 10 seconds or as long as you comfortably can.
3. 7. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

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

Rinse your mouth with water after every dose, and spit it out.

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

Cleaning your Spiromax

Keep your Spiromax dry and clean.

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

When to start using a new Spiromax

The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.

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

Note:

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

If you use more BiResp Spiromax than you should

It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.

The most common symptoms that may occur if 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, if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

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

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty swallowing) or hives together with difficulty breathing (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.
• Sudden acute wheezing or shortness of breath immediately after using your inhaler. If either of these symptoms occur, stop using your BiResp Spiromax straightaway and use your ‘reliever’ inhaler. Contact your doctor immediately as you may need to have your treatment changed. This happens very rarely, affecting less than 1 in 10,000 people.

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 if you rinse your mouth out with water after using your medicine.
• Mild sore throat, coughing and a hoarse voice.
• Headache.
• Pneumonia (infection of 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 or agitated.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing). If the wheezing comes on suddenly after using BiResp Spiromax, stop using this medicine and talk to your doctor immediately.
• Low levels of potassium in your blood.
• Uneven heartbeat.

Very rare (may affect up to 1 in 10,000 people)

• 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.
• 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). These effects 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BiResp Spiromax

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.

Do not store above 25^oC. Keep the mouthpiece cover closed after removal of the foil wrapping.

Use within 6 months of removing from the foil wrapping. Use the label on the inhaler to write down the date you open the foil pouch.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What BiResp Spiromax contains

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

What BiResp Spiromax looks like and contents of the pack

BiResp Spiromax is an inhalation powder.

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

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

Marketing Authorisation Holder

Mithridatum Pharma Limited

128 City Road,

London EC1V 2NX

United Kingdom

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

This leaflet was last revised in May 2024.