BiResp Spiromax 320 micrograms / 9 micrograms inhalation powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

BiResp Spiromax 320 micrograms/9 micrograms powder for inhalation

budesonide/formoterol fumarate dihydrate

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store 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", also known as "steroids". It works by reducing and preventing swelling and inflammation in the lungs, helping you to breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting beta2-adrenergic agonists" or "bronchodilators". It works by relaxing the muscles in the airways. This helps to open up the airways and allows you to breathe more easily.

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

Your doctor has prescribed this medicine for the treatment of asthma or chronic obstructive pulmonary disease (COPD).

Asthma

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

• Use BiResp Spiromax every day. This helps prevent asthma symptoms such as difficulty breathing and wheezing (whistling in the chest).
• Use the "reliever inhaler" when you have asthma symptoms, to help you breathe more easily again.

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

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term condition affecting the airways in the lungs, often caused by smoking cigarettes. Symptoms may include breathlessness, cough, chest tightness, and phlegm production. BiResp Spiromax may also be used to treat symptoms of severe COPD in adults only.

2. What you need to know before using 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

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 any heart problems (including irregular heartbeat, very rapid pulse, narrowed 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 consume alcohol.

If you have been taking steroid tablets for asthma or COPD, your doctor may reduce your dose when you start using BiResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may want to carry out regular blood tests. When reducing the dose of steroid tablets, you may generally feel unwell even though your chest symptoms improve. You may experience symptoms such as nasal congestion or runny nose, weakness, joint or muscle pain, or skin rash (eczema). If any of these symptoms bother you, or if you notice symptoms such as headache, fatigue, nausea (upset stomach), or vomiting, call your doctor immediately. You may need to take other medications if you develop symptoms of allergy or arthritis. Speak with 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 develop an illness such as a chest infection or before undergoing surgery.

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

Children

Do not give this medicine to children under 12 years of age.

Using BiResp Spiromax with other medicines

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

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

• Beta-blockers (such as atenolol or propranolol for high blood pressure or heart conditions), including eye drops (such as timolol for glaucoma).
• Oxytocin, given to pregnant women to induce labour.
• Medicines for fast or irregular heartbeat (such as quinidine, disopyramide, procainamide, and terfenadine).
• Medicines such as digoxin, commonly used for heart failure.
• Diuretics, also known as “water tablets” (such as furosemide). These are used for high blood pressure.
• Oral steroid tablets (such as prednisolone).
• Xanthine-containing medicines (such as theophylline or aminophylline). These 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).
• Antipsychotic phenothiazines (such as chlorpromazine and prochlorperazine).
• Medicines known as “HIV protease inhibitors” (such as ritonavir) used to treat HIV infections.
• Medicines for 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 closely monitor you if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

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

Also inform your doctor, pharmacist, or nurse if you are due to receive general anaesthesia for any surgical or dental procedure, to help minimize any risk of interaction with the anaesthetic you receive.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before using BiResp Spiromax; DO NOT use this medicine unless advised by your doctor.
• If you become pregnant while using BiResp Spiromax, DO NOT stop using BiResp Spiromax; speak with your doctor immediately.

Driving and using machines

BiResp Spiromax is unlikely to affect your ability to drive or operate tools or machinery.

BiResp Spiromax contains lactose

Lactose is a type of sugar found in milk. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to use BiResp Spiromax

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse again.

• It is important to use BiResp Spiromax daily, even if you do not have asthma or COPD symptoms at that moment.

• If you are using BiResp Spiromax for asthma, your doctor will want to check your symptoms regularly.

Asthma

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

Recommended dose:

Adults (18 years and older)

1 inhalation (puff) twice daily, administered in the morning and evening.

Your doctor may increase the dose to 2 inhalations twice daily.

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

Adolescents (12 years and older)

1 inhalation twice daily.

Your doctor will help monitor your asthma and adjust the dose of this medicine to the lowest possible dose needed to control your asthma. If your doctor believes you need a lower dose than is available in your BiResp Spiromax, they may prescribe an alternative inhaler containing 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 medicine once daily. However, do not adjust the number of inhalations prescribed by your doctor without first speaking to them.

Use your other “reliever inhaler” to treat asthma symptoms when they occur.

Always carry your “reliever inhaler” with you and use it to relieve sudden attacks of breathlessness and wheezing (chest whistling). Do not use BiResp Spiromax to treat these asthma symptoms. It is important that you discuss with your doctor the use of BiResp Spiromax to prevent asthma symptoms from occurring; the frequency of exercise or exposure to allergens may affect your prescribed treatment.

Chronic obstructive pulmonary disease (COPD)

Recommended dose:

Adults (18 years and older) only:

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

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

Preparing your new BiResp Spiromax

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

• Open the aluminum pouch by tearing at the marked area at the top and remove the inhaler.
• Check the dose counter to ensure there are 60 inhalations in the inhaler.
• Record on the inhaler label the date on which you opened the aluminum pouch.
• Do not shake the inhaler before use.

How to inhale

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

1. Hold the inhaler with the semi-transparent mouthpiece cap in burgundy color at the bottom.

1. Open the mouthpiece cap by folding it downward until you hear a loud click. The medicine is actively measured. The inhaler is now ready for use.

1. Gently breathe out fully (without discomfort). Do not breathe out 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.

Breathe in through your mouth as deeply and forcefully as possible.

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

2. Hold your breath for 10 seconds or as long as you comfortably can.

3. Then breathe out gently (but do not breathe out through the inhaler). Close the mouthpiece cap.

If you need 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 dismantle the inhaler or remove or twist the mouthpiece cap, as it is fixed to the inhaler and should not be detached. Do not use the Spiromax if it is damaged or if the mouthpiece has become detached from the Spiromax. Do not open or close the mouthpiece cap unless you are about 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 shows how many doses (inhalations) remain in the inhaler, starting at 60 inhalations when full and ending at 0 (zero) when empty.

• The dose indicator, located on the back of the device, displays the number of remaining inhalations as even numbers. The spaces between the even numbers represent the odd number of inhalations remaining.
• When 20 or fewer inhalations remain down to "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 still make a “click” sound even when the Spiromax is empty.
• If you open and close the mouthpiece without taking an inhalation, the dose indicator will still count this as one inhalation. This dose will remain stored in the inhaler for when you next take an inhalation. It is impossible to accidentally inhale extra medicine or receive 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 becoming breathless or wheezing while using BiResp Spiromax, continue using it but see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• You are breathing worse or wake frequently at night with difficulty breathing or wheezing (chest whistling).
• You feel chest tightness in the morning or if the tightness lasts longer than usual.

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

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

If you use more BiResp Spiromax than you should

It is important to take the dose prescribed by your doctor. 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 prescribed 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 not take a double dose to make up for missed doses. If it is almost time for your next dose, simply take the next dose at the usual time.

If you experience wheezing or breathlessness, or any other symptoms of an asthma attack, use your “reliever inhaler” and see your doctor.

If you stop treatment with BiResp Spiromax

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 adverse 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 together with breathing difficulties (angioedema) and/or sudden feeling of fainting. This may indicate you are having an allergic reaction, which may also include rash and itching.

• Bronchospasm (tightening of the muscles in the airways causing wheezing and difficulty breathing). If wheezing occurs 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 10,000 people

• Sudden, unexpected, and severe wheezing and/or shortness of breath immediately after using the inhaler (also known as “paradoxical bronchospasm”). If any of these symptoms occur, stop using BiResp Spiromax immediately and 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 10 people

• Palpitations (awareness of your own heartbeat), tremors, or restlessness. If these effects occur, they are usually mild and tend to disappear as you continue using BiResp Spiromax.

• Oral candidiasis (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 experience any of the following symptoms while inhaling BiResp Spiromax, as they could be signs of a lung infection:

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

Uncommon: may affect up to 1 in 100 people

• Feeling restless, nervous, agitated, anxious, or irritable
• Trouble sleeping
• Dizziness
• Nausea (upset stomach)
• Fast heartbeat
• Bruising
• Muscle cramps
• Blurred vision

Rare:

• Low levels of potassium in the blood
• Irregular heartbeat

Very rare:

• Depression
• Changes in behaviour, especially in children
• Chest pain or tightness (angina pectoris)
• Changes in the heart's electrical system that do not cause symptoms (prolongation of QTc interval)
• Increased blood sugar (glucose) levels detected in a blood test
• Changes in taste perception, such as an unpleasant taste in the mouth
• Changes in blood pressure

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially if used at high doses over prolonged periods. These effects may include:

• Changes in bone mineral density (weakening of the bones)
• Cataracts (clouding of the eye's lens)
• Glaucoma (increased pressure in the eye)
• Slowed growth rate in children and adolescents
• Effects on the adrenal gland (a small gland located near the kidney). Symptoms of adrenal suppression may include fatigue, weakness, stomach discomfort including nausea, vomiting, pain, and diarrhoea, darkening of the skin, and weight loss.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or on the label of the inhaler after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 25°C. Keep the mouthpiece cap closed after removing the laminated wrapper.
• Must be used within 6 months of removing the laminated wrapper. Use the label on the inhaler to record the date on which you opened the laminated package.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of BiResp Spiromax

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This corresponds 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 contents of the pack

BiResp Spiromax is a powder for inhalation.

Each BiResp Spiromax inhaler contains 60 inhalations and is white in colour, with a semi-transparent burgundy-coloured cap for the mouthpiece.

Packs containing 1, 2 and 3 inhalers. Only certain pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva Pharma B.V.,
Swensweg 5, 2031 GA Haarlem, The 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, The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 3 820 73 73	Luxembourg/Luxembourg Teva Pharma Belgium N.V./S.A./AG Belgium/Belgium Tel/Tel: +32 3 820 73 73
???????? ???? ????? ??? Tel: +359 2 489 95 85	Hungary Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
Czech Republic Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111	Malta Teva Pharmaceuticals Ireland Ireland Tel: +44 207 540 7117
Denmark Teva Denmark A/S Tlf: +45 44 98 55 11	Netherlands Teva Nederland B.V. Tel: +31 800 0228 400
Germany Teva GmbH Tel: +49 731 402 08	Norway Teva Norway AS Tlf: +47 6677 55 90
Estonia UAB Teva Baltics Estonia branch Tel: +372 661 0801	Austria ratiopharm Arzneimittel Vertriebs GmbH Tel: +43 1 97007 0
Greece Specifar A.B.E.E Tel: +30 211 880 5000	Poland Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
Spain Laboratorios BIAL, S.A. Tel.: +34 915624196	Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel: +351 21 476 75 50
France Teva Santé Tél: +33 1 55 91 7800	Romania Teva Pharmaceuticals S.R.L Tel: +4021 230 6524
Ireland Teva Pharmaceuticals Ireland Tel: +44 207 540 7117	Slovenia Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
Iceland Alvogen ehf. Tel: +354 522 2900	Slovakia Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911
Italy Teva Italia S.r.l. Tel: +39 028 917 981	Finland Teva Finland Oy Tel/Tel: +358 20 180 5900
Cyprus Specifar A.B.E.E. Greece Tel: +30 211 880 5000	Sweden Teva Sweden AB Tel: +46 42 12 11 00
Latvia UAB Teva Baltics branch Latvia Tel: +371 67 323 666	United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 207 540 7117
Lithuania UAB Teva Baltics Tel: +370 5 266 02 03	Croatia Pliva Hrvatska d.o.o Tel: +385 1 37 20 000

Date of the most recent review of this leaflet: May 2021

Other sources of information

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