BiResp Spiromax 320 micrograms / 9 micrograms inhalation powder

2. What you need to know before taking BiResp Spiromax

Do not use BiResp Spiromax

If you are allergic to budesonide, formoterol fumarate dihydrate, or any other component of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting BiResp Spiromax if:

• You have diabetes.
• You have a lung infection.
• You have high blood pressure or have ever had 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 drink alcohol regularly.

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. When reducing the number of steroid tablets, you may not feel well, even if your chest symptoms improve. You may notice symptoms such as a stuffy nose or runny nose, weakness or muscle or joint pain, and rash (eczema). If you are bothered by any of these symptoms or if you notice symptoms such as headache, tiredness, nausea (upset stomach), or vomiting, call your doctor immediately. You may need to take other medications if you start to have symptoms of allergy or arthritis. Talk to your doctor if you are not sure whether you should 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 surgery.

Contact your doctor if you experience blurred vision or other vision changes.

Children

Do not give this medication to children under 12 years old.

Using BiResp Spiromax with other medications

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

In particular, tell 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 given to pregnant women to induce labor.
• Medications for a fast 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 "water pills" (such as furosemide), used for high blood pressure.
• Steroid tablets taken by mouth (such as prednisolone).
• Medications containing xanthines (such as theophylline or aminophylline), often used for asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressants like 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 called "HIV protease inhibitors" (such as ritonavir) to treat HIV infections.
• Medications for 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 monitor you closely if you are taking these medications (including some for HIV: ritonavir, cobicistat).

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

Also, inform your doctor, pharmacist, or nurse if you are going to have general anesthesia for an operation or dental treatment, to help minimize any risk of interaction with the anesthetic you receive.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 doctor immediately.

Driving and using machines

BiResp Spiromax is unlikely to 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 an intolerance to some sugars, consult with them before taking this medication.

3. How to use BiResp Spiromax

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor, pharmacist, or nurse again.

• It is essential to use BiResp Spiromax daily, even if you do not have symptoms of asthma or COPD 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 prevent asthma symptoms.

Recommended dose:

Adults (18 years and older)

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

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

Your doctor will help you control your asthma and adjust the dose of this medication to the lowest possible dose 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 that contains the same active substances as your BiResp Spiromax but with a lower dose of the corticosteroid. If your symptoms are well-controlled, your doctor may ask you to use this medication once a day. However, do not adjust the number of inhalations your doctor has prescribed without talking to them first.

Use the other "reliever inhaler" to treat asthma symptoms when they occur.

Always carry the "reliever inhaler" with you and use it to relieve sudden attacks of difficulty breathing and wheezing. 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 affect the treatment prescribed for you.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older) only:

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

Your doctor may also prescribe another bronchodilator medication, such as an anticholinergic (like 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 bag by tearing it at the mark on the top and remove the inhaler.
• Check the dose indicator to see that there are 60 inhalations in the inhaler.
• Write the date you opened the aluminum bag on the inhaler label.
• Do not shake the inhaler before using it.

How to take an inhalation

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

1. Hold the inhaler with the semi-transparent cap of the mouthpiece in the red wine color at the bottom

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. Gently breathe out (without it being uncomfortable). Do not breathe out through the inhaler.

1. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Be careful not to block the air inlets.

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

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

1. Hold your breath for 10 seconds or as long as you can without it being uncomfortable.

1. Then, breathe out gently (but do not breathe out 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 try to disassemble the inhaler or remove or twist the mouthpiece cover, as it is fixed to the inhaler and should not be removed. Do not use the Spiromax if it is damaged or if the mouthpiece has come off 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 Spiromax mouthpiece with a dry cloth or tissue after use.

When to start using a new Spiromax

• The dose indicator tells you how many doses (inhalations) are left in the inhaler, starting with 60 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.

• The dose indicator, located on the back of the device, shows 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 click even when the Spiromax is empty.
• If you open and close the mouthpiece without taking the inhalation, the dose indicator will still count it as an inhalation. This dose will be stored in the inhaler for when you need to take 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 wheezing during use of BiResp Spiromax, you should continue to use it, but consult your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediatelyif:

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

These signs may indicate that your asthma or COPD is not being controlled properly and that you may need immediatedifferent or additional treatment.

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

If you use more BiResp Spiromaxthan you should

It is essential to take the dose that your doctor has indicated. Do not exceed the prescribed dose 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 using 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, do so as soon as you remember. However, do nottake a double dose to make up for forgotten 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 symptom of an asthma attack, use your "reliever inhaler"and go to the doctor.

If you stop using BiResp Spiromax

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people will experience them.

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

Rare Adverse Effects: may affect up to 1 in 1,000people

• Swelling of the face, especially around the mouth (tongue and/or throat, and/or difficulty swallowing) or hives along with difficulty breathing (angioedema) and/or sudden feeling of fainting. This may indicate that you are having an allergic reaction, which can 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 doctor immediately(see below).

Very Rare Adverse Effects: may affect up to 1 in 10,000people

• Sudden, unexpected, and severe wheezing and/or shortness of breath immediately after using the inhaler (also called "paradoxical bronchospasm"). If any of these symptoms occur, stop using BiResp Spiromax immediatelyand use your "reliever inhaler" if you have one. Consult your doctor immediately, as you may need to change your treatment.

Other Possible Adverse Effects:

Common: may affect up to 1 in 10people

• Palpitations (awareness of your own heartbeat), tremors, or agitation. If these effects occur, they are usually mild and will disappear as you continue using 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.

Tell your doctor if you experience any of the following symptoms while inhaling BiResp Spiromax, as they may be symptoms of a lung infection:

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

Uncommon: may affect up to 1 in 100people

• Feeling of restlessness, nervousness, agitation, anxiety, or anger
• Sleeping problems
• Feeling of dizziness
• Nausea (upset stomach)
• Rapid heartbeat
• Bruising
• Muscle cramps
• Blurred vision

Rare:

• Low potassium levels in the blood
• Irregular heartbeat

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 (glucose) levels when taking a blood test
• Alterations in taste perception, such as unpleasant taste in the mouth
• Changes in blood pressure

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

• Changes in bone mineral density (weakening of bones)
• Cataracts (clouding of the eye lens)
• 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 suppression may include fatigue, weakness, stomach upset including nausea, vomiting, pain, and diarrhea, darkening of the skin, and weight loss.

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

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BiResp Spiromax

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the carton or on the label of the inhaler after EXP. The expiration date is the last day of the month indicated.
• Do not store above 25°C. Keep the mouthpiece cap closed after removing the laminate pouch.
• It must be used within 6months of opening the laminate pouch.Use the inhaler label to note the date you opened the pouch.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of BiResp Spiromax

• The active ingredients are budesonide and formoterol fumarate dihydrate. Each administered dose (inhalation) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate, which contains milk proteins (see section 2, "BiResp Spiromax contains lactose").

Appearance of BiResp Spiromax and Package Contents

BiResp Spiromax is a powder for inhalation.

Each BiResp Spiromax inhaler contains 60 inhalations and is white, with a semi-transparent red wine-colored mouthpiece cap.

Packages of 1, 2, and 3 inhalers. Not all pack sizes may be marketed in your country.

Marketing Authorization Holder

Teva Pharma B.V.,

Swensweg 5, 2031GA Haarlem, Netherlands.

Manufacturer

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

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

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

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

Date of Last Revision of this Leaflet:May 2021

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.