Patient Information Leaflet

BiResp Spiromax 320320 micrograms/9 micrograms powder for inhalation

budesonida/formoterol fumarato dihidrato

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 section 4.

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

2.What you need to know before you start 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 lung swelling and inflammation, and helps you breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medications known as “prolonged-acting β2-adrenergic receptor agonists” or “bronchodilators.” It acts by relaxing the muscles of the respiratory tract, which contributes to opening up the airways and helping 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

If used to treat asthma, your doctor will prescribe BiResp Spiromax along with an additional “reliever” inhaler, such as salbutamol.

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

Do not use BiResp Spiromax 320/9 micrograms as a “reliever” inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

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

Do not use BiResp Spiromax

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before 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, rapid pulse, narrowed arteries, or heart failure).
• You have thyroid or adrenal gland problems.
• You have low potassium levels 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, joint or muscle pain, or 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 or arthritis symptoms. Talk to your doctor if you are unsure whether to continue using BiResp Spiromax.

Your doctor may consider 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.

Using BiResp Spiromax with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 induce labor.
• 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 anticancer 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 of BiResp 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 undergo general anesthesia for an 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 might 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 machinery

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 problem with certain sugars, consult with them before taking this medication.

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

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

Recommended dose:

Adults (18 years and older)

1 inhalation (application) twice a day, administered in the morning and at night.

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

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

Adolescents (12 years and older)

1 inhalation 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 believes you need a lower dose than what is available in your BiResp Spiromax, your doctor may prescribe an alternative inhaler containing 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 medicine once a day. However, do not adjust the number of inhalations your doctor has prescribed without speaking 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 difficulty breathing and wheezing (chest whistling sounds). Do not use BiResp Spiromax to treat these 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 implications for the treatment you have been prescribed.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older) only:

• 1 inhalation twice a day, administered in the morning and at night.

Your doctor may also prescribe 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 60 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 perform an inhalation

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

1. Hold the inhalerwith the semi-transparent red wine-colored mouthpiece facing downwards

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

1. Exhale slowly (without discomfort). Do not exhale through the inhaler.

4.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 as deeply and strongly as possible through your mouth.

5.Remove the inhaler from your mouth. You may notice a taste when performing 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 make 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 to use 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 use.

When to start using a new Spiromax

• The dose indicator informs you of how many doses (inhalations) are left in the inhaler, starting from 60 inhalations when full and ending at 0 (zero) inhalations when empty.

• The dose indicator, located on 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.

Note:

• The mouthpiece will continue to make a "click" sound 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 accidentally take extra medication or a double dose in one inhalation.
• Keep the mouthpiece closed at all times, except when using 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 (chest whistling sounds).
• You feel 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 properly controlled 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 Spiromaxthan you should

It is essential to take the dose your doctor has prescribed. Do not exceed the dose prescribed 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 shakiness, headache, or rapid heartbeat.

If you forgot to use BiResp Spiromax

If you forgot 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 take the next dose at the usual time.

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

If you interrupt treatment with BiResp Spiromax

Do not stop using the inhaler without speaking 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 Spiromaxandconsult 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 accompanied by 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.

• Asthma attack (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 10,000 peoplepeople

• Sudden, unexpected, and acute wheezing or lack of breath immediately after using the inhaler (also known as "paradoxical bronchospasm"). If any of these symptoms occur,stop using BiResp Spiromaximmediately and 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.
• Thrush (a fungal infection) in the mouth. This is 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

Uncommon: may affect up to 1 in 100 peoplepeople

• Feeling of restlessness, nervousness, agitation, anxiety, or anger
• Difficulty sleeping
• Dizziness
• Nausea (stomach upset)
• Accelerated heart rate
• Bruising
• Muscle cramps
• Blurred vision

Rare:

• Low potassium levels in the blood
• Irregular heartbeats

Very rare:

• Depression.
• Changes in behavior, especially in children
• Chest pain or tightness (angina pectoris)
• 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 mineral density changes (weakening of the bones)
• Cataracts (clouding of the lens of the eye)
• Glaucoma (increased eye pressure)
• 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 oral tablets.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national 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.
• It must be used within the 6months following the removal of the laminated packaging.Use the inhaler label to note the date when you opened the laminated packaging.
• Medications 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 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This is equivalent to a measured dose of 400 micrograms of budesonide and 12 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 60 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.