BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder

Introduction

Patient Information: Summary of Product Characteristics

BiResp Spiromax 160micrograms/4.5micrograms inhalation powder

budesonide/formoterol fumarate dihydrate

Read 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What BiResp Spiromax is and what it is used for
2. What you need to know before you use BiResp Spiromax
3. How to use BiResp Spiromax
4. Possible side effects
5. Storage of BiResp Spiromax
6. Contents of the pack and other information

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

BiResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called “corticosteroids” or “steroids”. It works by reducing and preventing swelling and inflammation in the lungs, making it easier to breathe.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting beta2-adrenergic receptor agonists” or “bronchodilators”. It works by relaxing the muscles in the airways, which helps to open up the airways and makes it easier to breathe.

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

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

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

• You may have been prescribed two inhalers for asthma: BiResp Spiromax and an additional “reliever” inhaler, such as salbutamol.
• Use BiResp Spiromax every day. This helps to prevent asthma symptoms such as difficulty breathing and wheezing.
• Use the “reliever” inhaler when you have asthma symptoms to help you breathe easily again.

• 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.
• Use BiResp Spiromax when you need to take extra puffs for relief of asthma symptoms, and to prevent asthma symptoms from occurring (for example, before exercise or when exposed to allergens), if agreed with your doctor. You do not need a separate inhaler for this.

Chronic Obstructive Pulmonary Disease (COPD)

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

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

Do not use BiResp Spiromax

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use BiResp Spiromax if:

• You have diabetes.
• You have a lung infection.
• You have high blood pressure or have ever had any heart problems (including irregular heartbeat, fast pulse, narrowing of the 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 steroid tablets you take 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 and 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, contact your doctor immediately. You may need to take other medicines if you start to have symptoms of an allergy or arthritis. Talk to your doctor if you are unsure 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 an operation.

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

Children

Do not give this medicine to children under 12 years.

Using BiResp Spiromax with other medicines

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Betablockers (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.
• Medicines for a fast or irregular heartbeat (such as quinidine, disopyramide, procainamide, and terfenadine).
• Medicines such as digoxin, which are often used for heart failure.
• Diuretics, also known as “water tablets” (such as furosemide), which are used for high blood pressure.
• Steroid tablets taken by mouth (such as prednisolone).
• Medicines containing xanthine (such as theophylline or aminophylline), which 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).
• Medicines called “HIV protease inhibitors” (such as ritonavir) for treating HIV infections.
• Medicines for treating infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

Some medicines may increase the effects of BiResp Spiromax, so your doctor will monitor you closely if you are taking these medicines (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 a general anesthetic for an operation or dental treatment, to help minimize any risk of interaction with the anesthetic you will be given.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using BiResp Spiromax; DO NOT use this medicine 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, contact them before taking this medicine.

3. How to use BiResp Spiromax

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

• It is important 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

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 depends on how it has been prescribed for you.

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

(A) Using BiResp Spiromax and a separate relief inhaler

Use BiResp Spiromax every day.This helps 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 up to 4 inhalations twice a day.

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

Adolescents (12 years and older)

1 or 2 inhalations twice a day.

The 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 ingredients as your BiResp Spiromax, but with a lower dose of the corticosteroid. If your symptoms are well controlled, the 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 “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) Using 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 prevent asthma symptoms from appearing.

Recommended dose:

Adults and adolescents (12 years and older):

1 inhalation in the morning and1 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.

Also use BiResp Spiromax as a “relief inhaler” to treat asthma symptoms when they appear and to prevent their appearance (for example, when exercising or exposed to allergens).

• If you have 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 on the same occasion.

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

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

If you regularly need to take 8 or more inhalations per day, make an appointment with your doctor. They 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 right before exercising to prevent asthma symptoms from appearing. It is essential to discuss the use of BiResp Spiromax to prevent asthma symptoms with your doctor; 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:

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

The 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 bag by tearing it at the mark on the top and remove the inhaler.
• Check the dose indicator to see that there are 120 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 with 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 measured actively. The inhaler is ready for use.

1. Gently expel all the air (without it being uncomfortable). Do not expel the air 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 inlets.

Inhale 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, gently expel the air (but do not expel the air 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 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 handkerchief 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 120 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, 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” even if 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 the use of BiResp Spiromax, you should continue using it, but consult your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediatelyif:

• You breathe worse or wake up frequently at night with difficulty breathing or wheezing (whistling in the chest).
• 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 properly controlled and that you may need immediatedifferent or additional treatment.

Once your asthma is controlled, your doctor may consider it appropriate to gradually reduce the dose of BiResp Spiromax.

If you use more BiResp Spiromax than you should

It is essential that you 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 forgot to use BiResp Spiromax

If you forgot to take a dose, do so as soon as you remember. However, do nottake a double dose to make up 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 symptom of an asthma attack, use your “relief inhaler”and go to the 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 using this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication 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 people

• 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 muscles of the airways that causes wheezing and difficulty breathing). If wheezing appears suddenly after using this medication, stop using it and consult your doctor immediately(see below).

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

• Sudden, unexpected, and acute 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 the “relief inhaler” if you have one. Consult your doctor immediately, as you may need to change your treatment.

Other possible side effects:

Common: may affect up to 1 in 10 people

• 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 medication.
• 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; they could be symptoms of a lung infection:

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

Uncommon: may affect up to 1 in 100 people

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

Rare:

• Low levels of potassium 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 amount of sugar (glucose) in the blood when a blood test is done
• Alterations in the perception of taste, such as unpleasant taste in the mouth
• Changes in blood pressure.

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

• Changes in bone mineral density (weakening of bones)
• Cataracts (clouding of the eye's lens)
• Glaucoma (increased pressure in the eye)
• Slowing of the growth rate of children and adolescents
• Effects on the adrenal gland (small gland located next to 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 occur very rarely and are much less likely to occur with inhaled corticosteroids than with tablets.

Reporting side effects

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

5. Storage of BiResp Spiromax

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date shown on the box or on the inhaler label after EXP. The expiration date is the last day of the month indicated.
• Do not store above 25°C. Keep the mouthpiece cover closed after removing the laminated wrapper.
• Use it within 6 monthsof opening the laminated wrapper. Use the inhaler label to note the date you opened the package.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container contents and additional information

BiResp Spiromax composition

• The active ingredients 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 container contents

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.

Packages 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, 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 medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:May 2021

Other sources of information

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