Patient Information Leaflet

BiResp Spiromax 160160 micrograms/4.5micrograms powder for inhalation

budesonide/formoterol fumarate dihydrate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

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

2.What you need to know before using BiResp Spiromax

3.How to use BiResp Spiromax

4.Possible side effects

5.Storage of BiResp Spiromax

6.Contents of the pack and additional information

BiResp Spiromax contains two distinct active principles: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications known as “corticosteroids” or “steroids”. It acts by reducing and preventing inflammation and swelling of the lungs and helps you breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medications known as “prolonged-acting beta2-adrenergic receptor agonists” or “bronchodilators”. It acts by relaxing the muscles of the airways. This will help to open up the airways and help you breathe more easily.

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

Your doctor has prescribed this medication as treatment for asthma or chronic obstructive pulmonary disease (COPD).

Asthma

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

a) You may have been prescribed two inhalers for asthma: BiResp Spiromax along with an additional “relief” inhaler such as salbutamol.

• Use BiResp Spiromax every day. This helps to prevent asthma symptoms such as difficulty breathing and wheezing (chest whistling sounds).
• Use the “relief” inhaler when you have asthma symptoms to breathe easily again.

b) You may have been prescribed BiResp Spiromax as a single inhaler for asthma.

• Use BiResp Spiromax every day. This helps to prevent asthma symptoms such as difficulty breathing and wheezing (chest whistling sounds).
• Use BiResp Spiromax when you need additional inhalations or administrations for asthma relief, to breathe easily again, and if agreed with your doctor, to prevent asthma symptoms (for example, during exercise or exposure to allergens). You do not need a separate inhaler for this.

Chronic Obstructive Pulmonary Disease (COPD)

COPD is a long-term lung disease of the airways, often caused by smoking cigarettes. Some of its symptoms are difficulty breathing, coughing, chest discomfort, and sputum production. BiResp Spiromax can also be used to treat severe COPD symptoms in adults only.

No use BiResp Spiromax

If you are allergic to budesonide, formoterol fumarate dihydrate, or any other component of this medication (including in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nursebefore starting to take BiResp Spiromax if

• You are diabetic.
• You have any lung infection.
• You have high blood pressure or if you have ever had any heart problems (including irregular heartbeat, very fast pulse, narrowing of the arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• 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 asthma or COPD, your doctor may reduce the number of tablets when you start using BiResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may want to do regular blood tests. Reducing the number of steroid tablets may make you feel generally unwell even though your chest symptoms improve. You may notice symptoms such as a blocked nose or runny nose, weakness, or joint or muscle pain, and a rash (eczema). If you are bothered by any of these symptoms or if you notice symptoms such as headache, tiredness, nausea (stomach upset), or vomiting (bringing up), call your doctorimmediately. You may need to take other medicines if you start to have allergy symptoms or arthritis symptoms. Talk to your doctor if you are not sure if you should continue using BiResp Spiromax.

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

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

Children

Do not administer this medication to children under 12years.

Use of BiResp Spiromax with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Beta-blockers (such as atenolol or propranolol for high blood pressure or heart disease), including eye drops (such as timolol for glaucoma).
• Oxytocin, which is administered to pregnant women to inducelabor.
• Medications for rapid or irregular heartbeat (such as quinidine, disopyramide, procainamide, and terfenadine).
• Medications such as digoxin, which are often used for heart failure.
• Diuretics, also known as "urine tablets" (such as furosemide). They are used for high blood pressure.
• Oral steroid tablets (such as prednisolone).
• Medications with xanthine (such as theophylline or aminophylline). They are often used for asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressants such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidone and the antineoplastic agent procarbazine).
• Phenothiazine antipsychotics (such as chlorpromazine and prochlorperazine).
• Medications known as "HIV protease inhibitors" (such as ritonavir) for treating HIV infections.
• Medications for treating infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medications for Parkinson's disease (such as levodopa).
• Medications for thyroid problems (such as levothyroxine).

Some medications may increase the effects ofBiResp Spiromax, so your doctor will do thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

If you are in any of these situations or are unsure, talk to your doctor, pharmacist, or nurse before using BiResp Spiromax.

Also inform your doctor, pharmacist, or nurse if you are to receive general anesthesia for any operation or dental treatment, in order to contribute to minimizing any risk of interaction with the anesthetic you will receive.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor, pharmacist, or nurse before using BiResp Spiromax; DO NOT use this medication unless your doctor tells you to.
• If you become pregnant while using BiResp Spiromax, DO NOT stop using BiResp Spiromax; talk to your doctorimmediately.

Driving and operating machines

It is unlikely that BiResp Spiromax will affect your ability to drive or use tools or machines.

BiResp Spiromax contains lactose

Lactose is a type of sugar found in milk. If your doctor has told you that you have a certain sugar intolerance, consult with them beforetaking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• It is essential to use BiResp Spiromax daily, even if you do not have asthma or COPD symptoms at that time.
• If you are using BiResp Spiromax for asthma, your doctor will want to check your symptoms regularly.

Asthma

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

• If you have been prescribed BiResp Spiromax and a separate relief inhaler, read the section called “(A) Use of BiResp Spiromax and a separate relief inhaler”.
• If you have been prescribed BiResp Spiromax as a single inhaler, read the section called “(B) Use of BiResp Spiromax as a single inhaler for asthma”.

(A) Use of BiResp Spiromax and a separate relief inhaler

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

Recommended dose:

Adults (18 years and older)

1 or 2 inhalations (applications) twice a day, administered in the morning and at night.

Your doctor may increase the dose to 4 inhalations twice a day.

If your symptoms are well controlled, your doctor may ask you to use this medication once a day.

Adolescents (12 years and older)

1 or 2 inhalations twice a day.

Your doctor will help you control your asthma and adjust the dose of this medication to the lowest possible to control your asthma.If your doctor thinks you need a lower dose than what is available in your BiResp Spiromax, your doctor may prescribe you an alternative inhaler that contains the same active ingredients as your BiResp Spiromax, but with a lower dose of corticosteroid.If your symptoms are well controlled, your doctor may ask you to use this medication once a day.However, do not adjust the number of inhalations that your doctor has prescribed without talking to them first.

Use the other “relief inhaler” to treat asthma symptoms when they appear.

Always carry the “relief inhaler” with you and use it to relieve sudden attacks of shortness of breath and wheezing (whistling in the chest). Do not use BiResp Spiromax to treat these asthma symptoms.

(B) Use of BiResp Spiromax as a single inhaler for asthma

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

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

Recommended dose:

Adults and adolescents (12 years and older):

1 inhalation in the morning and 1 inhalation at night

or

2 inhalations in the morning

or

2 inhalations at night.

Your doctor may increase the dose to 2 inhalations twice a day.

Use BiResp Spiromax as a “relief inhaler” to treat asthma symptoms when they appear and to prevent their appearance (for example, during exercise or exposure to allergens).

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

Always carry the BiResp Spiromax with you and use it to relieve sudden attacks of shortness of breath and wheezing (whistling in the chest).

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

If you usually need to do 8 or more inhalations a day, ask your doctor for an appointment. You may need to change your treatment.

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

If you are exercising and notice asthma symptoms, use BiResp Spiromax as described here. However, do not use BiResp Spiromax just before exercising to avoid asthma symptoms.It is essential to discuss with your doctor the use of BiResp Spiromax to prevent asthma symptoms; the frequency of exercise or exposure to allergens may have repercussions on the treatment you have been prescribed.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older) only:

2 inhalations twice a day, administered in the morning and at night.

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

Preparing your new BiResp Spiromax

Before using your new BiResp Spiromax inhaler for the first time, you must prepare it as follows:

• Open the aluminum foil pouch by tearing along the existing mark at the top and remove the inhaler.
• Check the dose indicator to see that there are 120 inhalations in the inhaler.
• Note the date on the inhaler label when you opened the aluminum foil pouch.
• Do not shake the inhaler before using it.

How to take an inhalation

Each time you need to take an inhalation, follow the instructions below:

1.Hold the inhalerwith the semi-transparent red wine-colored mouthpiece at the bottom.

1. Open the mouthpiece cover by folding it down until you hear a strong click. Themedication is measured actively. The inhaler is ready for use.

1. Exhale slowly (without discomfort). Do not exhale through the inhaler.
2. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Be careful not to block the air intakes.

Inhale deeply and strongly through your mouth.

5. Remove the inhaler from your mouth. You may notice a taste when taking the inhalation.

6. Hold your breath for 10 seconds or as long as you can without discomfort.

7.Then, exhale slowly(but do not exhale through the inhaler). Close the mouthpiece cover.

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

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

Do not attempt to disassemble the inhaler or remove or twist the mouthpiece cover, as it is fixed to the inhaler and should not come loose. Do not use the Spiromax if it is damaged or if the mouthpiece has come loose from the Spiromax. Do not open or close the mouthpiece cover unless you are going touse the inhaler.

Cleaning the Spiromax

Keep the Spiromax dry and clean.

If necessary, wipe the mouthpiece of the Spiromax with a dry cloth or tissue after using it.

When to start using a new Spiromax

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

• The dose indicator, located at the back of the device, indicates the number of inhalations left in the form of even numbers. The spaces between the even numbers represent the odd number of inhalations left.
• When there are 20 inhalations or less until “8”, “6”, “4” or “2”, the numbers will appear in red on a white background. When the numbers appear in red in the window, consult your doctor and request a new inhaler.

Nota:

• The mouthpiece will continue to make a “click” even when the Spiromax is empty.
• If you open and close the mouthpiece without administering the inhalation, the dose indicator will continue to count it as an inhalation. This dose will be stored in the inhaler for when you need to administer the next inhalation. It is impossible to take an accidental extra dose or a double dose in one inhalation.
• Keep the mouthpiece closed at all times, except when you are going touse the inhaler.

Important information about asthma or COPD symptoms

If you notice that you are short of breath or have wheezing during the use of BiResp Spiromax, you should continue to use it, but see your doctor as soon as possible, as you may need additional treatment.

Contact your doctorimmediatelyif:

• You breathe worse or if you wake up frequently at night with difficulty breathing or wheezing.
• You notice chest tightness in the morning or if the sensation of tightness lasts longer than usual.

These signs may indicate that your asthma or COPD is not being controlled correctly and that you may needimmediatelydifferent or additional treatment.

Once your asthma is controlled, your doctor may consider reducing the dose of BiResp Spiromax gradually.

If you use more BiResp Spiromax than you should

It is essential to take the dose that your doctor has prescribed. Do not exceed the dose that has been prescribed to you without consulting your doctor.

If you use more BiResp Spiromax than you should, consult your doctor, pharmacist, or nurse.

The most common symptoms that may occur when you use more BiResp Spiromax than you should are tremors, headache, or 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 nottake a double dose to compensate for the missed doses.If it is almost time for your next dose,simply administer the next dose at the usual time.

If you notice that you are short of breath or have wheezing, or if you notice any other asthma attack symptoms,use your “relief inhaler”and see your doctor.

If you interrupt treatment with BiResp Spiromax

Do not stop using the inhaler without talking to your doctor first.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following symptoms, stop using BiResp Spiromax and consult your doctor immediately:

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

• Swelling of the face, especially around the mouth (tongue and/or throat, and/or difficulty swallowing) or urticaria along with difficulty breathing (angioedema) and/or sudden feeling of fainting. This may indicate that you are having an allergic reaction, which may also include rash and itching.

• Bronchospasm (constriction of the airway muscles that causes wheezing and difficulty breathing). If wheezing appears suddenly after using this medicine, stop using it and consult your doctorimmediately(see below).

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

• Sudden, unexpected, and acute wheezing (wheezing) and/or immediate lack of breath after using the inhaler (also known as "paradoxical bronchospasm"). If any of these symptoms occur,stop using BiResp Spiromax immediatelyand use the "relief inhaler" if available. Consult your doctorimmediately, as you may need to change treatment.

Other possible side effects:

Frequent: may affect up to 1 in 10 peoplepeople

• Palpitations (awareness of your own heartbeat), tremors, or agitation. If these effects occur, they are usually mild and will disappear as you continue to use BiResp Spiromax.
• Candidiasis (a fungal infection) in the mouth. This will be less likely to occur if you rinse your mouth with water after using the medicine.
• Mild sore throat, cough, and hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you have any of the following symptoms while inhalingBiResp Spiromax, they may be symptoms of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased cough or difficulty breathing

Rare: may affect up to 1 in 100 peoplepeople

• Feeling of unease, nervousness, agitation, anxiety, or anger
• Difficulty sleeping
• Sensation of dizziness
• Nausea (stomach upset)
• Accelerated heart rate
• Brusing
• Muscle cramps
• Blurred vision

Rare:

• Low levels of potassium in the blood
• Irregular heartbeats

Very rare:

• Depression
• Changes in behavior, especially in children
• Chest pain (angina)
• Alteration of the heart's electrical system that does not cause symptoms (prolongation of the QTc interval)
• Increased blood sugar levels when a blood test is performed
• Alterations in taste perception, such as a bad taste in the mouth
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if used in high doses for prolonged periods. Among their effects are:

• Bone density changes (weakening of the bones)
• Cataracts (clouding of the lens of the eye)
• Glaucoma (increased pressure in the eye)
• Slowing of growth rate in children and adolescents
• Effects on the adrenal gland (small gland located near the kidney). Symptoms of adrenal gland inhibition may include fatigue, weakness, stomach discomfort, including nausea, vomiting, pain, and diarrhea, darkening of the skin, and weight loss.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box or on the inhaler label after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25oC.Keep the mouthpiece cap closed after removing the laminated packaging.
• Use it within the 6months following its extraction from the laminated packaging.Use the inhaler label to note the date when you opened the laminated packaging.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of BiResp Spiromax

• The active principles are budesonide and formoterol fumarate dihydrate. Each administered dose (inhaled) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This is equivalent to a measured dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate, which contains milk proteins (see section 2, subsection “BiResp Spiromax contains lactose”).

Appearance of BiResp Spiromax and contents of the package

BiResp Spiromax is a powder for inhalation.

Each BiResp Spiromax inhaler contains 120 inhalations and is white in color, with a semi-transparent red wine-colored cap for the mouthpiece.

Packaging of 1, 2, and 3 inhalers. Only some package sizes may be marketed in your country.

Marketing Authorization Holder

Teva Pharma B.V.,

Swensweg 5, 2031 GA Haarlem, Netherlands.

Responsible for manufacturing

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:May 2021

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.