DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder

Introduction

Package Leaflet: Information for the Patient

DuoResp Spiromax 320micrograms/9micrograms inhalation powder

budesonide/formoterol fumarate dihydrate

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 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 signs of illness are the same as yours.
• If you get 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 DuoResp Spiromax is and what it is used for
2. What you need to know before you use DuoResp Spiromax
3. How to use DuoResp Spiromax
4. Possible side effects
5. Storing DuoResp Spiromax
6. Contents of the pack and other information

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

DuoResp 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, 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. This helps to open up the airways and makes it easier to breathe.

DuoResp Spiromax is indicated for use only in adults and adolescents from 12 years onwards.

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

Asthma

If you are using DuoResp Spiromax to treat asthma, your doctor will also prescribe a separate “reliever” inhaler, such as salbutamol.

• Use DuoResp Spiromax every day. This helps to prevent asthma symptoms such as difficulty breathing and wheezing.
• Use the “reliever” inhaler when you get asthma symptoms, to breathe easily again.

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

Chronic Obstructive Pulmonary Disease (COPD)

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

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

Do not use DuoResp 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

Tell your doctor, pharmacist, or nurse before starting DuoResp Spiromax if:

• You have diabetes.
• You have any lung infection.
• You have high blood pressure or if you have ever had any heart problems (including irregular heartbeat, very fast pulse, narrowing of the arteries, or heart failure).
• You have problems with your thyroid or adrenal glands.
• You have low levels of potassium 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 DuoResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may want to take regular blood tests. When reducing the number of steroid tablets, you may generally not feel well, even if your chest symptoms improve. You may notice symptoms such as a blocked nose or runny nose, weakness or muscle and joint pain, and rash (eczema). If any of these symptoms bother you or if you notice symptoms such as headache, tiredness, nausea (sick feeling), or vomiting, contact your doctor immediately. You may need to take other medicines if you start to get symptoms of an allergy or arthritis. Talk to your doctor if you are not sure whether you should continue using DuoResp Spiromax.

Your doctor may consider adding steroid tablets to your usual treatment if you have a disease such as a chest infection or before an operation.

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

Children

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

Using DuoResp 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 women during childbirth.
• 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). They are used for high blood pressure.
• Steroid tablets taken by mouth (such as prednisolone).
• Medicines containing xanthines (such as theophylline or aminophylline). They are often used for asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressants such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidone and the anticancer agent procarbazine).
• Phenothiazine antipsychotics (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (such as ritonavir) for HIV infections.
• 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 DuoResp Spiromax and 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 not sure, talk to your doctor, pharmacist, or nurse before using DuoResp Spiromax.

Also, tell your doctor, pharmacist, or nurse if you are going to have a general anesthetic for an operation or dental treatment, to help minimize any risks 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 DuoResp Spiromax; do not use this medicine unless your doctor tells you to.
• If you become pregnant while using DuoResp Spiromax, do not stop using DuoResp Spiromax; talk to your doctor immediately.

Driving and using machines

DuoResp Spiromax is unlikely to affect your ability to drive or use tools or machines.

DuoResp 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 DuoResp Spiromax

Follow the instructions for using this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

• It is important to use DuoResp Spiromax every day, even if you do not have any symptoms of asthma or COPD at the time.
• If you are using DuoResp Spiromax for asthma, your doctor will want to check your symptoms regularly.

Asthma

Use DuoResp Spiromax every day.This helps to prevent asthma symptoms.

Recommended dose:

Adults (18 years and older)

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

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

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

Adolescents (12 years and older)

1 inhalation twice a day.

Your doctor will help you control your asthma and adjust the dose of this medicine to the lowest dose necessary to control your asthma. If your doctor thinks you need a lower dose than is available in your DuoResp Spiromax, your doctor may prescribe a different inhaler that contains the same active substances as your DuoResp 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 a day. However, do not adjust the number of inhalations that your doctor has prescribed without talking to them first.

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

Always carry your “reliever” inhaler with you and use it to relieve sudden attacks of difficulty breathing and wheezing. Do not use DuoResp Spiromax to treat these asthma symptoms. It is important that you discuss the use of DuoResp Spiromax to prevent asthma symptoms with your doctor; the frequency of exercise or exposure to allergens may affect the treatment you have been prescribed.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults (18 years and older) only:

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

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

Preparing your new DuoResp Spiromax

Before using your new DuoResp Spiromax inhaler for the first time, you need to prepare it as follows:

• Open the foil bag by tearing along the dotted line at the top and pull out the inhaler.
• Check the dose indicator to see that there are 60 inhalations in the inhaler.
• Write the date you opened the foil bag on the inhaler label.
• Do not shake the inhaler before use.

How to take an inhalation

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

1. Hold the inhaler with the semi-transparent mouthpiece cover at the bottom.

1. Open the mouthpiece cover by folding it downwards until you hear a distinct click. The medicine is measured automatically. The inhaler is now ready for use.

1. Breathe out gently (do not breathe out through the inhaler).

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

Breathe in slowly and deeply through the mouthpiece.

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 comfortably can.

1. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

If you are to take a second inhalation, repeat the steps from 1 to 7.

Rinse your mouth with water after each dose and spit it out.

Do not try to take the inhaler apart 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 your Spiromax

Keep your Spiromax dry and clean.

If necessary, wipe the mouthpiece of your Spiromax 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 from 60 inhalations when it is full and ending at 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 left 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, contact your doctor and ask for 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 an inhalation, the dose indicator will still count it as one inhalation. This dose will be stored in the inhaler for when you need to take the next inhalation. It is not possible to accidentally take extra medicine or a double dose in one inhalation.
• Keep the mouthpiece closed at all times, except when you are using the inhaler.

Important information about asthma or COPD symptoms

If you notice that you are getting breathless or wheezing when using DuoResp Spiromax, you should continue to use it but tell your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• You are breathing more heavily or if you wake up at night with difficulty breathing or wheezing.
• You have chest tightness in the morning or if the feeling of chest tightness lasts longer than usual.

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

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

If you use more DuoResp Spiromax than you should

It is important that you take the dose that your doctor has prescribed. Do not exceed the prescribed dose without talking to your doctor.

If you use more DuoResp Spiromax than you should, talk to your doctor, pharmacist, or nurse.

The most common symptoms that may occur when using more DuoResp Spiromax than you should are trembling, headache, or rapid heartbeat.

If you forget to use DuoResp 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 a forgotten dose. If it is almost time for your next dose, just take the next dose at the usual time.

If you notice that you are wheezing or getting breathless, or if you notice any other symptoms of an asthma attack, use your “reliever” inhaler and go to your doctor.

If you stop using DuoResp Spiromax

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

If you have any further questions on 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 all people will experience them.

If you notice any of the following symptoms, stop using DuoResp 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 breathing difficulties (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 acute wheezing and/or shortness of breath immediately after using the inhaler (also called "paradoxical bronchospasm"). If any of these symptoms occur, stop using DuoResp 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 DuoResp 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 DuoResp Spiromax, as they may be symptoms of a lung infection:

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

Uncommon: may affect up to 1 in 100people

• Feeling restless, nervous, agitated, anxious, or angry.
• Difficulty sleeping.
• Feeling dizzy.
• Nausea (upset stomach).
• Fast heart rate.
• 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 a blood test is performed.
• 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 if 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 occur very rarely 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 DuoResp 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 inhaler label after CAD. 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 laminated wrapper.
• It must be used within 6months of opening the laminated wrapper.Use the inhaler label to note the date you opened the wrapper.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and wrappers you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

DuoResp Spiromax Composition

• 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 measured dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate, which contains milk proteins (see section 2, "DuoResp Spiromax contains lactose").

Appearance of DuoResp Spiromax and Package Contents

DuoResp Spiromax is a powder for inhalation.

Each DuoResp 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

Teva Operations Poland Sp. z o.o. Mogilska 80 Str. 31-546 Kraków Poland

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.