Biresp Spiromax

Patient Information Leaflet: Information for the User

BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder

budesonide/formoterol fumarate dihydrate
Please read all of 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 β2-adrenergic agonists" or "bronchodilators". It works by relaxing the muscles in the airways, helping to open up the airways and making breathing easier.

BiResp Spiromax is indicated for use only in adults and adolescents aged 12 years and older.
Your doctor has prescribed this medicine to treat your asthma or chronic obstructive pulmonary disease (COPD).

Asthma
BiResp Spiromax may be prescribed for asthma in two different ways:

a) You may be prescribed two inhalers for asthma: BiResp Spiromax together with another “reliever inhaler”, such as salbutamol.

• Use BiResp Spiromax every day to prevent asthma symptoms such as breathlessness and wheezing.
• Use the “reliever inhaler” when you have asthma symptoms, to help you breathe more easily again.

b) BiResp Spiromax may be prescribed as your only asthma inhaler.

• Use BiResp Spiromax every day to prevent asthma symptoms.
• Also use BiResp Spiromax when you need inhalations or puffs to relieve asthma symptoms, to help you breathe more easily again, and, if agreed with your doctor, to prevent the onset of asthma symptoms (for example, during physical exercise or exposure to allergens). No additional reliever inhaler is needed.

Chronic obstructive pulmonary disease (COPD)
COPD is a long-term airway disease in the lungs, often caused by cigarette smoking. Symptoms include breathlessness, cough, chest tightness, and cough with sputum production. BiResp Spiromax may also be used for the treatment of severe COPD symptoms in adults only.

2. What you should know before using BiResp Spiromax

Do not use BiResp Spiromax if
you are allergic to budesonide, formoterol fumarate dihydrate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using BiResp Spiromax if:

• you have diabetes.
• you have a lung infection.
• you have high blood pressure or have ever had a heart problem (including irregular heartbeat, very rapid heartbeat, 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 drink alcohol.

If you are taking steroid tablets for asthma or COPD, your doctor may reduce the number of tablets you take once you start using BiResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may decide to perform regular blood tests. Reducing steroid tablets may cause general discomfort, even if your chest symptoms improve. You may experience symptoms such as nasal congestion or a runny nose, weakness, joint or muscle pain, and skin rashes (eczema). If any of these symptoms concern you, or if you experience symptoms such as headache, fatigue, nausea (feeling unwell), or vomiting (being sick), contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. Talk to your doctor if you have any doubts about continuing to use BiResp Spiromax.
Your doctor may consider adding steroid tablets to your usual treatment if you have 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.

Other medicines and BiResp Spiromax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• β-blockers (such as atenolol or propranolol for high blood pressure or heart disease), including eye drops (such as timolol for glaucoma).
• Oxytocin, given to pregnant women to induce labour.
• Medicines for rapid or irregular heartbeat (such as quinidine, disopyramide, procainamide, and terfenadine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as “water tablets” (such as furosemide). These medicines are used to treat high blood pressure.
• Oral steroid tablets (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These medicines are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressant medicines such as monoamine oxidase inhibitors and medicines with similar properties (such as the antibiotic furazolidone and the chemotherapeutic agent procarbazine).
• Phenothiazine antipsychotic medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (such as ritonavir) used to treat HIV infection.
• Medicines to treat 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, and your doctor may want to monitor you closely if you are taking these medicines (including certain medicines for treating HIV: ritonavir, cobicistat).
If you are taking any of the above medicines or are unsure, talk to your doctor, pharmacist, or nurse before using BiResp Spiromax.
Also inform your doctor, pharmacist, or nurse if you are due to receive a general anaesthetic for surgery or a dental procedure, to reduce the potential risk of interactions with the anaesthetic you receive.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before using BiResp Spiromax. DO NOT take this medicine unless your doctor tells you to do so.
• If you become pregnant while using BiResp Spiromax, DO NOT stop using BiResp Spiromax, but speak to your doctor immediately.

Driving and using machines
It is unlikely that BiResp Spiromax will 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 diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use BiResp Spiromax

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.

• It is important to use BiResp Spiromax every day, even if you do not have asthma or COPD symptoms at that moment.
• If you are using BiResp Spiromax for asthma, your doctor will regularly monitor your symptoms.

Asthma
BiResp Spiromax may be prescribed for asthma in two different ways. The dose and timing for using
BiResp Spiromax depend on the regimen prescribed to you.

• If you have been prescribed BiResp Spiromax and another reliever inhaler, read section “(A) Use of BiResp Spiromax and another reliever inhaler”.
• If you have been prescribed BiResp Spiromax as your only inhaler, read section “(B) Use of BiResp Spiromax as a single inhaler for asthma”.

(A) Use of BiResp Spiromax and another reliever inhaler
Use BiResp Spiromax every day to prevent asthma symptoms.
Recommended dose:
Adults (aged 18 years and older)
1 or 2 inhalations (actuations), twice daily, taken in the morning and evening.
Your doctor may increase this to 4 inhalations, twice daily.
If your symptoms are well controlled, your doctor may advise you to take the medicine once
daily.
Adolescents (aged 12 years and older)
1 or 2 inhalations twice daily.
Your doctor will help manage your asthma and adjust the dose of the medicine to the lowest level that maintains asthma control. If your doctor believes you require a lower dose than what is available from your BiResp Spiromax, they may prescribe an alternative inhaler containing the same active substances as your BiResp Spiromax but with a lower corticosteroid dose. If your symptoms are well controlled, your doctor may advise you to take the medicine once daily. However, do not change the number of inhalations prescribed by your doctor without first discussing it with 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. Do not use BiResp Spiromax to treat these asthma symptoms.

(B) Use of BiResp Spiromax as a single inhaler for asthma
Use BiResp Spiromax in this way only if your doctor has specifically prescribed it for you.
Use BiResp Spiromax every day to prevent asthma symptoms.
Recommended dose
Adults and adolescents (aged 12 years and older)
1 inhalation in the morning and 1 inhalation in the evening
or
2 inhalations in the morning
or
2 inhalations in the evening.
Your doctor may increase this to 2 inhalations twice daily.
Use BiResp Spiromax also as a “reliever inhaler” to treat asthma symptoms when they occur and to prevent their onset (e.g., during physical exercise or upon exposure to allergens).

• If you experience 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 at one time.

Always carry BiResp Spiromax with you and use it to relieve sudden attacks of breathlessness and
wheezing.
A total daily dose exceeding 8 inhalations is generally not required. 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. Your treatment may need to be adjusted.
DO NOT take more than 12 inhalations in any 24-hour period.
If you are exercising and experience asthma symptoms, use BiResp Spiromax as described here.
However, do not use BiResp Spiromax before exercise to prevent asthma symptoms. It is important to discuss with your doctor the use of BiResp Spiromax for preventing asthma symptoms; the frequency of physical exercise and exposure to allergens may affect your prescribed treatment.

Chronic Obstructive Pulmonary Disease (COPD)
Recommended dose:
Adults only (aged 18 years and older):
2 inhalations twice daily, taken in the morning and evening.
Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for COPD.

How to prepare a new BiResp Spiromax
Before using a new BiResp Spiromax for the first time, you must prepare it for use as follows:

• Open the aluminium foil pouch by tearing at the notch at the top and remove the inhaler.
• Check the dose indicator to confirm that the inhaler contains 120 inhalations.
• Record the date you opened the aluminium pouch on the label of the inhaler.
• Do not shake the inhaler before use.

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

1. Hold the inhaler with the semi-transparent burgundy-coloured cap facing downwards.

2. Open the protective cap by folding it downwards until you hear a distinct click. The medicine is now actively pre-dosed. The inhaler is ready for use.

3. Breathe out gently (without forcing). Do not breathe out 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 inlets.

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

5. Remove the inhaler from your mouth. You may notice a taste during inhalation.
6. Hold your breath for 10 seconds, or as long as is comfortable without causing discomfort.
7. Breathe out gently (do not breathe out through the inhaler). Close the protective cap.

To take a second inhalation, repeat steps 1 to 7.
Rinse your mouth with water after each dose, without swallowing.
Do not attempt to dismantle the inhaler, remove or reverse the protective cap, which is fixed to the inhaler and must not be removed. Do not use Spiromax if it is damaged or if the mouthpiece has become detached. Do not open and close the protective cap unless you intend to use the inhaler.

Cleaning Spiromax
Keep Spiromax dry and clean.
If necessary, the mouthpiece of Spiromax may be cleaned 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 from 120 inhalations when full, down to 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 remaining inhalations.
• For remaining inhalations from 20 down to “8”, “6”, “4”, “2”, the numbers are displayed in red on a white background. When the numbers turn red in the window, consult your doctor and obtain a new inhaler.

Note:

• The mouthpiece will continue to make a “click” sound even when Spiromax is empty.
• If the mouthpiece is opened and closed without taking an inhalation, the dose indicator will still register this as a dose delivered. This dose will be retained safely in the inhaler for the next inhalation. It is impossible to accidentally inhale excess medicine or receive a double dose in a single inhalation.
• Always keep the mouthpiece closed unless you intend to use the inhaler.

Important information about asthma or COPD symptoms
If you experience breathlessness or wheezing while using BiResp Spiromax, continue using it but consult your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:

• your breathing worsens or you wake up frequently at night with breathlessness and wheezing;
• you begin to feel chest tightness in the morning or your chest tightness lasts longer than usual.

These signs may indicate that your asthma or COPD is not adequately controlled, and you may require immediate different or additional treatment.
Once your asthma is well controlled, 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 as directed by your doctor. Do not exceed the prescribed number of doses without consulting your doctor.
If you use more BiResp Spiromax than you should, seek advice from your doctor, pharmacist, or nurse.
The most common symptoms that may occur with overdose of BiResp Spiromax are tremor, headache, and 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 the missed dose. If it is almost time for your next dose, take the next dose at the usual time.
If you have wheezing or breathlessness or develop other symptoms of an asthma attack, use your “reliever inhaler”, then contact your doctor.

If you stop using BiResp Spiromax
Do not stop using your inhaler without first informing your doctor.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, stop using BiResp Spiromax and contact your doctor immediately:
Rare side effects: may affect up to 1 in 1,000 people

• Swelling of the face, particularly around the mouth (tongue and/or throat, and/or difficulty swallowing) or hives together with breathing difficulties (angioedema) and/or sudden fainting. This could indicate an ongoing allergic reaction, which may also include skin rash and itching.
• Bronchospasm (tightening of the muscles in the airways causing wheezing and shortness of breath). If wheezing occurs suddenly after using this medicine, stop using it and contact your doctor immediately (see below).

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

• Sudden and unexpected wheezing and/or shortness of breath immediately after using the inhaler (also known as paradoxical bronchospasm). If you experience any of these symptoms, stop using BiResp Spiromax immediately, and use your "reliever" inhaler if you have one. Contact your doctor immediately, as your treatment may need to be changed.

Other possible side effects:
Common: may affect up to 1 in 10 people

• Palpitations (awareness of heartbeat), tremor, or shivering. If these effects occur, they are usually mild and tend to disappear with continued use of BiResp Spiromax
• Oral thrush (fungal infection) in the mouth. The likelihood of this effect can be greatly reduced by rinsing the mouth with water after using the medicine
• Mild sore throat, cough, and hoarseness
• Headache
• Pneumonia (lung infection) in patients with COPD (common side effect).

Inform your doctor if you experience any of the following symptoms while taking BiResp Spiromax, as they could be signs of a lung infection:

• Fever or chills
• Increased mucus production, changes in mucus color
• Worsening cough or increased breathing difficulties.

Uncommon: may affect up to 1 in 100 people

• Feeling restless, nervousness, agitation, anxiety, or irritability
• Disturbed sleep
• Dizziness
• Nausea (feeling unwell)
• Fast heartbeat
• Bruising of the skin
• Muscle cramps
• Blurred vision.

Rare:

• Low levels of potassium in the blood
• Irregular heartbeat.

Very rare:

• Depression
• Behavioural changes, especially in children
• Chest pain or tightness in the chest (angina pectoris)
• Electrical disturbances in the heart that do not cause symptoms (prolongation of QTc interval)
• Increased blood glucose (sugar) levels in blood tests
• Taste disturbances, such as a bad taste in the mouth
• Changes in blood pressure.
• Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if used at high doses for prolonged periods. Effects include:
• Changes in bone mineral density (thinning of the bones)
• Cataract (clouding of the lens in the eye)
• Glaucoma (increased pressure inside 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 problems such as nausea, vomiting, pain, and diarrhoea, darkening of the skin, and weight loss.

These effects occur very rarely, and the likelihood is much lower with inhaled corticosteroids than with oral corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 label or on the inhaler’s box after Exp./EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Keep the protective cap closed after removal of the aluminium wrapper.
• Use within 1 year after removal of the aluminium wrapper. Use the label on the inhaler to record the date when you open the aluminium pouch.
• Do not dispose of any medicine 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 Other Information

What BiResp Spiromax Contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This corresponds to a pre-set 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, “BiResp Spiromax contains lactose”).

Description of the Appearance of BiResp Spiromax and Contents of the Pack
BiResp Spiromax is an inhalation powder.
Each BiResp Spiromax inhaler contains 120 inhalations and features a white body with a semi-transparent burgundy protective cap.
Packs containing 1, 2, or 3 inhalers. Not all pack sizes may be commercially available in your country.

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

Manufacturer:
Norton (Waterford) Limited
Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland.

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Laboratorios BIAL, S.A. Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +34 915624196 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Alvogen ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5222900 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

Additional Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/

Package leaflet: information for the user

BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder

budesonide/formoterol fumarate dihydrate
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 and helps you breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting β-adrenoceptor agonists" or "bronchodilators". It works by relaxing the muscles in the airways, helping to open the airways and making breathing easier.

BiResp Spiromax is indicated for use only in adults and adolescents aged 12 years and older.
Your doctor has prescribed this medicine to treat your asthma or chronic obstructive pulmonary disease (COPD).
Asthma
If used for asthma, your doctor will prescribe BiResp Spiromax together with another "reliever inhaler", such as salbutamol.

• Use BiResp Spiromax every day to prevent asthma symptoms such as breathlessness and wheezing.
• Use the "reliever inhaler" if you experience 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 disease of the airways in the lungs, often caused by cigarette smoking. Symptoms include breathlessness, cough, chest tightness, and cough with sputum production. BiResp Spiromax may also be used for the treatment of 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
Talk to your doctor, pharmacist, or nurse before using BiResp Spiromax if:

• you have diabetes.
• you have a lung infection.
• you have high blood pressure or have ever had a heart problem (including irregular heartbeat, very rapid heartbeat, 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 are taking steroid tablets for asthma or COPD, your doctor may reduce the number of tablets you take once you start using BiResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may decide to carry out regular blood tests. Reducing steroid tablets may cause general unwellness, even if your chest symptoms have improved. You may experience symptoms such as nasal congestion or runny nose, weakness, or joint and muscle pain, and skin rashes (eczema). If any of these symptoms concern you, or if you experience symptoms such as headache, tiredness, nausea (feeling unwell), or vomiting (being sick), contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. Talk to your doctor if you have any doubts about continuing to use BiResp Spiromax.
Your doctor may consider adding steroid tablets to your usual treatment if you have 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.

Other medicines and BiResp Spiromax
Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 disease), including eye drops (such as timolol for glaucoma).
• Oxytocin, which is given to pregnant women to induce labour.
• Medicines for fast or irregular heartbeat (such as quinidine, disopyramide, procainamide, and terfenadine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as "water tablets" (such as furosemide). These medicines are used to treat high blood pressure.
• Steroid tablets taken by mouth (such as prednisolone).
• Xanthine derivatives (such as theophylline or aminophylline). These medicines are often used in the treatment of asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressant medicines such as monoamine oxidase inhibitors and medicines with similar properties (such as the antibiotic furazolidone and the chemotherapeutic agent procarbazine).
• Phenothiazine antipsychotic medicines (such as chlorpromazine and prochlorperazine).
• Medicines called "HIV protease inhibitors" (such as ritonavir) used to treat HIV infection.
• Medicines to treat 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, and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
If you are taking any of the above medicines, 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 due to receive a general anaesthetic for surgery or a dental procedure, to reduce the risk of possible interactions with the anaesthetic you will receive.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before using BiResp Spiromax. DO NOT take this medicine unless your doctor tells you to do so.
• If you become pregnant while using BiResp Spiromax, DO NOT stop using BiResp Spiromax, but speak to your doctor immediately.

Driving and using 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 diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use BiResp Spiromax

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.

• It is important to use BiResp Spiromax every day, even if you do not have asthma or COPD symptoms at that moment.
• If you are using BiResp Spiromax for asthma, your doctor will regularly monitor your symptoms.

Asthma
Use BiResp Spiromax every day to prevent asthma symptoms.
Recommended dose:
Adults (aged 18 years and older)
1 inhalation (actuation), twice daily, taken in the morning and evening.
Your doctor may increase this dose to 2 inhalations twice daily.
If your symptoms are well controlled, your doctor may instruct you to take the medicine once
daily.
Adolescents (aged 12 years and older)
1 inhalation twice daily.
Your doctor will help you manage your asthma and adjust the dose of this medicine to the lowest dose that maintains asthma control. If your doctor believes you require a lower dose than that available in your BiResp Spiromax, they may prescribe an alternative inhaler containing the same active substances as your BiResp Spiromax but with a lower corticosteroid dose. If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily. However, do not change the number of inhalations prescribed by your doctor without first discussing it with 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. Do not use BiResp Spiromax to treat these asthma symptoms. It is important that you discuss with your doctor the use of BiResp Spiromax for preventing asthma symptoms; the frequency of physical exercise and exposure to allergens may affect your prescribed treatment.

Chronic obstructive pulmonary disease (COPD)
Recommended dose:
Adults only (aged 18 years and older):

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

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

How to prepare a new BiResp Spiromax
Before using a new BiResp Spiromax for the first time, you must prepare it for use as follows:

• Open the aluminium foil pouch by tearing at the notch at the top and remove the inhaler.
• Check the dose indicator to confirm that the inhaler contains 60 inhalations.
• Record the date you opened the aluminium pouch on the label of the inhaler.
• Do not shake the inhaler before use.

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

1. Hold the inhaler with the semi-transparent burgundy-coloured cap facing downwards.

2. Open the protective cap by folding it downwards until you hear a distinct click. The medicine is now actively pre-dosed. The inhaler is now ready for use.

3. Breathe out gently (without forcing). Do not breathe out 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 inlets.

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

5. Remove the inhaler from your mouth. You may notice a taste during inhalation.
6. Hold your breath for 10 seconds, or as long as possible without discomfort.
7. Breathe out gently (do not breathe out through the inhaler). Close the protective cap.

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, remove or rotate the protective cap, which is fixed to the inhaler and must not be removed. Do not use Spiromax if it is damaged or if the mouthpiece has become detached. Do not open and close the protective cap unless you intend to use the inhaler.

Cleaning Spiromax
Keep Spiromax dry and clean.
If necessary, the Spiromax mouthpiece may be cleaned 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 from 60 inhalations when full, down to 0 (zero) inhalations 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 remaining inhalations.
• For remaining inhalations from 20 down to “8”, “6”, “4”, “2”, the numbers are displayed in red on a white background. When the numbers turn red in the window, consult your doctor and obtain a new inhaler.

Note:

• The mouthpiece will continue to make a “click” sound even when Spiromax is empty.
• If the mouthpiece is opened and closed without taking an inhalation, the dose indicator will still register this as a dose delivered. This dose will be safely retained in the inhaler for the next inhalation. It is impossible to accidentally inhale an excess of medicine or receive a double dose in a single inhalation.
• Always keep the mouthpiece closed unless you intend to use the inhaler.

Important information about asthma or COPD symptoms
If you experience breathlessness or wheezing while using BiResp Spiromax, continue using it but consult your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:

• your breathing worsens or you wake up frequently at night with breathlessness and wheezing;
• you start experiencing chest tightness in the morning or your chest tightness lasts longer than usual.

These signs may indicate that your asthma or COPD is not adequately controlled, and you may require immediate different or additional treatment.
Once your asthma is well controlled, your doctor may consider gradually reducing your dose of BiResp Spiromax.

If you use more BiResp Spiromax than you should
It is important that you take the dose as instructed by your doctor. Do not exceed the prescribed number of doses 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 with excessive use of BiResp Spiromax are tremor, headache, and 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 the missed dose. If it is almost time for your next dose, take your dose at the usual time.
If you experience wheezing or breathlessness, or if you develop other symptoms of an asthma attack, use your “reliever inhaler”, then contact your doctor.

If you stop using BiResp Spiromax
Do not stop using your inhaler without first informing your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any side effect, stop using BiResp Spiromax and contact your doctor immediately:

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

• Swelling of the face, particularly around the mouth (tongue and/or throat, and/or difficulty swallowing) or hives together with difficulty breathing (angioedema) and/or sudden fainting. This could indicate an ongoing allergic reaction, which may also include skin rash and itching.
• Bronchospasm (tightening of the muscles in the airways causing wheezing and shortness of breath). If wheezing occurs suddenly after using this medicine, stop using it and contact your doctor immediately (see below).

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

• Sudden, unexpected wheezing and/or shortness of breath immediately after using the inhaler (also known as paradoxical bronchospasm). If you experience any of these symptoms, stop using BiResp Spiromax immediately, and use your "reliever" inhaler if you have one. Contact your doctor immediately, as your treatment may need to be changed.

Other possible side effects:
Common: may affect up to 1 in 10 people

• Palpitations (awareness of heartbeat), tremor or shivering. If these effects occur, they are usually mild and tend to disappear with continued use of BiResp Spiromax
• Oral thrush (fungal infection) in the mouth. The likelihood of this effect can be greatly reduced by rinsing the mouth with water after using the medicine
• Mild sore throat, cough, and hoarse voice
• Headache
• Pneumonia (lung infection) in patients with COPD (common side effect).

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

• fever or chills
• increased mucus production, changes in the colour of mucus
• worsening cough or increased breathing difficulties.

Uncommon: may affect up to 1 in 100 people

• Feeling restless, nervousness, agitation, anxiety, or anger
• Disturbed sleep
• Dizziness
• Nausea (feeling unwell)
• Fast heartbeat
• Bruising of the skin
• Muscle cramps
• Blurred vision.

Rare:

• Low levels of potassium in the blood
• Irregular heartbeat.

Very rare:

• Depression
• Behavioural changes, particularly in children
• Chest pain or tightness in the chest (angina pectoris)
• Electrical disturbances in the heart that do not cause symptoms (prolongation of QTc interval)
• Increased blood sugar (glucose) levels in blood tests
• Taste disturbances, such as a bad taste in the mouth
• Changes in blood pressure.
• Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if used at high doses over prolonged periods. Effects include:
• changes in bone mineral density (thinning of the bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure inside the eye)
• slowed growth rate in children and adolescents
• effects on the adrenal gland (a small gland located next to the kidney). Symptoms of adrenal suppression may include fatigue, weakness, stomach problems such as nausea, vomiting, pain and diarrhoea, darkening of the skin, and weight loss.

These effects occur very rarely, and the likelihood is much lower with inhaled corticosteroids than with oral corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 label or on the inhaler carton after Scad./EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Keep the protective cap closed after removal of the aluminium foil wrapper.
• Use within 1 year after removal of the aluminium foil wrapper. Use the label on the inhaler to record the date when you open the aluminium foil package.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BiResp Spiromax contains

• 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 pre-set 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”).

Description of the appearance of BiResp Spiromax and contents of the pack
BiResp Spiromax is an inhalation powder. Each BiResp Spiromax inhaler contains 60 inhalations and features a white body with a semi-transparent burgundy protective cap.
Packs containing 1, 2 or 3 inhalers. Not all pack sizes may be marketed in your country.

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

Manufacturer:
Norton (Waterford) Limited
Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

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

België/Belgique/Belgien               Lietuva
Teva Pharma Belgium N.V./S.A./AG         UAB Teva Baltics
Tél/Tel: +32 38207373                    Tel: +370 52660203

България                        Luxembourg/Luxemburg
Тева Фарма ЕАД                    Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585                   Belgique/Belgien
                                 Tél/Tel: +32 38207373

Česká republika                  Magyarország
Teva Pharmaceuticals CR, s.r.o.           Teva Gyógyszergyár Zrt.
Tel: +420 251007111                   Tel.: +36 12886400

Danmark                         Malta
Teva Denmark A/S                    Teva Pharmaceuticals Ireland
Tlf.: +45 44985511                    L-Irlanda
                                 Tel: +44 2075407117

Deutschland                      Nederland
TEVA GmbH                         Teva Nederland B.V.
Tel: +49 73140208                    Tel: +31 8000228400

Eesti                            Norge
UAB Teva Baltics Eesti filiaal            Teva Norway AS
Tel: +372 6610801                    Tlf: +47 66775590

Ελλάδα                         Österreich
TEVA HELLAS Α.E.                    ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000                  Tel: +43 1970070

España                          Polska
Laboratorios BIAL, S.A.                Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +34 915624196                   Tel.: +48 223459300

France                         Portugal
Teva Santé                           Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800                   Tel: +351 214767550

Hrvatska                        România
Pliva Hrvatska d.o.o.                  Teva Pharmaceuticals S.R.L.
Tel: +385 13720000                   Tel: +40 212306524

Ireland                          Slovenija
Teva Pharmaceuticals Ireland           Pliva Ljubljana d.o.o.
Tel: +44 2075407117                  Tel: +386 15890390

Ísland                           Slovenská republika
Alvogen ehf.                         TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5222900                   Tel: +421 257267911

Italia                            Suomi/Finland
Teva Italia S.r.l.                     Teva Finland Oy
Tel: +39 028917981                   Puh/Tel: +358 201805900

Κύπρος                          Sverige
TEVA HELLAS Α.Ε.                     Teva Sweden AB
Ελλάδα                              Tel: +46 42121100
Τηλ: +30 2118805000

Latvija                          United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā          Teva Pharmaceuticals Ireland
Tel: +371 67323666                   Ireland
                                 Tel: +44 2075407117

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/