160 micrograms / 4.5 micrograms inhaled powder 
budesonide / formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
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. How to store 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 or steroids. It works by reducing and preventing swelling and inflammation in the lungs and helps you breathe easier.
  • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β 2 -adrenoreceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. It opens up the airways and helps you breathe easier.

DuoResp Spiromax is only for adults 18 years of age or older.

DuoResp Spiromax should NOT be used by children 12 years of age or younger, or by adolescents 13 to 17 years old.

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

Asthma

DuoResp Spiromax can be prescribed for asthma in two different ways.

  1. You may have been prescribed two asthma inhalers: DuoResp Spiromax and a separate “on-demand inhaler” with, for example, salbutamol.
    • Use DuoResp Spiromax every day. It helps prevent the onset of asthma symptoms such as shortness of breath and wheezing.
    • Use your emergency inhaler when you experience asthma symptoms to make it easier to breathe again.
  2. You may have been prescribed DuoResp Spiromax as your only asthma inhaler.
    • Use DuoResp Spiromax every day. It helps prevent the onset of asthma symptoms such as shortness of breath and wheezing.
    • Use DuoResp Spiromax when you need extra inhalation or puffs to relieve asthma symptoms, make it easier to breathe again, and in agreement with your doctor also to prevent asthma symptoms from occurring (eg when exercising or being exposed to allergens ). You do not need a separate inhaler for that.

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term disease of the airways in the lungs that has often been caused by cigarette smoking. Symptoms may include shortness of breath, cough, chest discomfort, and cough. DuoResp Spiromax can also be used to treat the symptoms of severe COPD in adults.

What you need to know before using DuoResp Spiromax

Do not use DuoResp Spiromax

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

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using DuoResp Spiromax if:

  • you have diabetes
  • you have a lung infection
  • you have high blood pressure or if you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries are or heart failure )
  • you have problems with the thyroid gland or adrenal glands
  • you have low levels of potassium in your blood
  • you have severe liver problems
  • you regularly drink alcohol.

If you have been taking cortisone tablets for asthma or COPD, your doctor may reduce the number of tablets you should take when you start using DuoResp Spiromax. If you have been taking cortisone tablets for a long time, your doctor may want to take regular blood tests. When the treatment with cortisone tablets is reduced, you may feel a general feeling of illness even if your respiratory symptoms improve. You may get symptoms such as a stuffy or runny nose, weakness, joint pain, muscle aches, and rash ( eczema ). If you get any of these symptoms or if symptoms such as headache, fatigue, nausea, or vomiting occur, contact your doctor immediately. You may need to take other medicines if you develop symptoms of allergies or arthritis. You should talk to your doctor if you are wondering if you should continue to use DuoResp Spiromax.

Your doctor may consider adding cortisone tablets to your regular treatment if you have an illness such as a respiratory infection or before surgery.

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

Children and young people

This medicine should not be used by children or adolescents under 18 years of age.

Other medicines and DuoResp Spiromax

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:

  • beta-blockers (eg atenolol or propranolol for high blood pressure, or heart disease), including eye drops (eg timolol for glaucoma )
  • oxytocin is given to pregnant women to initiate labor
  • medicines for fast or irregular heartbeat (eg quinidine, disopyramide  procainamide, and terfenadine)
  • drugs such as digoxin that are often used to treat heart failure
  • diuretics (eg furosemide ), also called diuretics, which are used to treat high blood pressure
  • oral cortisone tablets (eg prednisolone )
  • xanthine drugs (eg theophylline or aminophylline) commonly used to treat asthma
  • other bronchodilators (eg salbutamol )
  • tricyclic antidepressants (eg amitriptyline) and the antidepressant nefazodone
  • antidepressant drugs such as monoamine oxidase inhibitors and those with similar properties (eg antibiotic et furazolidone and the chemotherapy drug procarbazine)
  • antipsychotic phenothiazines (eg chlorpromazine and prochlorperazine)
  • drugs known as “HIV protease inhibitor” (ritonavir) used to treat HIV – infection
  • medicines to treat infections (eg ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin)
  • medicines for Parkinson’s disease (eg levodopa )
  • medicines for thyroid problems (eg levothyroxine).

Some medicines may increase the effects of DuoResp Spiromax and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

If any of the above apply to you, 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 will need general anesthesia in connection with an operation or a dental procedure to reduce the risk of the medicines affecting each other.

Pregnancy and breastfeeding

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine – 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 without contacting your doctor immediately.

Driving and using machines

DuoResp Spiromax is unlikely to affect the ability to drive and use machines.

DuoResp Spiromax contains lactose

Lactose is a type of sugar found in milk. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use DuoResp Spiromax

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

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

Asthma

DuoResp Spiromax can be prescribed for asthma in two different ways. The amount of DuoResp Spiromax to use and when to use it depends on your prescription.

  • If you are prescribed DuoResp Spiromax and a separate vidbehov inhalator, read the section “(A) Using DuoResp Spiromax and a separate vidbehov- inhaler.
  • If you have been prescribed DuoResp Spiromax as your only inhaler, read the section “(B) Using DuoResp Spiromax as your only asthma inhaler”.

(A) Use DuoResp Spiromax and a separate inhaler

Use your DuoResp Spiromax every day. It helps prevent the onset of asthma symptoms.

Recommended dose:

Adults (18 years and older)

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

Your doctor may increase the dose one to 4 inhalations twice daily.

If your symptoms are under control, your doctor may ask you to take the medicine once a day.

Your doctor will help you manage your asthma and will adjust the dose of one of the medicines to the lowest dose needed to keep your asthma under control. If your doctor thinks you need a lower dose than what is available from your DuoResp Spiromax, your doctor may prescribe another inhaler that contains the same active ingredients as your DuoResp Spiromax but with a lower dose of corticosteroid. However, do not adjust the number of inhalations prescribed by your doctor without talking to your doctor first.

Use your separate inhaler if needed to treat asthma symptoms as they occur.

Always carry your emergency inhaler with you so you can relieve sudden attacks of shortness of breath and wheezing. Do not use DuoResp Spiromax to treat these asthma symptoms.

(B) Use DuoResp Spiromax as the sole asthma inhaler

Only use DuoResp Spiromax this way if your doctor tells you to.

Use your DuoResp Spiromax every day. It helps prevent the onset of asthma symptoms.

Recommended dose

Adults (18 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 the dose one to 2 inhalations twice daily.

Also, use DuoResp Spiromax as an ’emergency inhaler’ to treat asthma symptoms when they occur and to prevent asthma symptoms from occurring (eg when exercising or being exposed to allergens ). 

  • If you get asthma symptoms, take 1 inhalation and wait for a few minutes.
  • Take another inhalation if you do not feel better.
  • Do not take more than 6 inhalations at a time.

Always carry DuoResp Spiromax with you and use it to relieve sudden attacks of shortness of breath and wheezing.

A total daily dose of more than 8 inhalations is usually not required. However, your doctor may allow you to take up to 12 inhalations a day for a limited time.

See a doctor if you need to take 8 or more inhalations a day regularly. Your treatment may need to be changed.

DO NOT use more than a total of 12 inhalations over a 24-hour period.

If you exercise and experience asthma symptoms, use DuoResp Spiromax as described here. However, do not use DuoResp Spiromax just before exercise to prevent asthma symptoms from occurring.

Chronic obstructive pulmonary disease (COPD)

Recommended dose:

Adults (18 years and older)

2 inhalations twice daily, taken in the morning and the evening.

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

Prepare your new DuoResp Spiromax

Before using your DuoResp Spiromax for the first time, you must prepare it for use as follows:

  • Open the foil bag by tearing from the notch at the top of the foil bag and removing the inhaler.
  • Check the dose indicator to see that there are 120 inhalations in the inhaler.
  • Write down the date when the foil bag was opened on the label on the inhaler.
  • Do not shake the inhaler before use.

How to inhale

Each time you need to inhale, follow the instructions below.

  1. Hold the inhaler with the translucent burgundy protective cap for the mouthpiece down
  2. Open the protective cap of the nozzle by folding it down until a clear click is heard. The drug is measured. Your inhaler is now ready to use.
  3. Exhale slowly (as much as feels comfortable). Do not exhale through the inhaler.
  4. Place the nozzle between the teeth. Do not bite into the nozzle. Close your lips around the nozzle. Be careful not to block the air valve.
    Inhale as strongly and deeply as you can through your mouth.
  5. Remove the inhaler from your mouth. You may feel some taste when you take your inhalation.
  6. Hold your breath for 10 seconds or as long as it feels comfortable.
  7. Then exhale gently (do not exhale through the inhaler). Close the protective cap of the nozzle.

If you are going to do a second inhalation, repeat steps 1 to 7.

Rinse mouth with water after each dose and spit out the water.

Do not attempt to disassemble, inhale, or twist the mouthpiece cap of the mouthpiece. The protective cover is attached to your inhaler and must not be removed. Do not use your Spiromax inhaler if it has been damaged or if the nozzle has come loose from it. Do not open or close the mouthpiece unless you are using your inhaler.

Clean the Spiromax inhaler

Keep the Spiromax inhaler dry and clean.

If necessary, you can wipe the nozzle on Spiromax with a dry cloth or cloth after use.

When is it time to start using a new Spiromax inhaler?

  • The dose indicator shows how many doses ( inhalations ) are left in the inhaler. There are 120 inhalations from the beginning when it is fully charged and 0 (zero) inhalations when it is empty.
  • The dose indicator on the back of the inhaler shows the number of inhalations left as even numbers. The spaces between the even numbers correspond to the uneven number of remaining inhalations.
  • The numbers are shown in red on a white background for continued inhalation from 20 down to 8, 6, 4, and 2. When the numbers turn red in the window, contact your doctor to get a new inhaler. 

    Note!
    • The mouthpiece will still “click” even though the Spiromax inhaler is empty. If you open and close the mouthpiece without inhaling, the dose indicator will still count it as an inhalation. This dose will remain inside the inhaler until it is time for the next inhalation  It is not possible to inadvertently take extra medicine or a double dose during inhalation. Always keep the mouthpiece closed except when using your inhaler.

Important information about your symptoms of asthma or COPD

If you experience difficulty breathing or wheezing while using DuoResp Spiromax, you should continue to use DuoResp Spiromax but contact your doctor as soon as possible as you may need further treatment.

Contact a doctor immediately if:

  • your breathing gets worse or if you often wake up at night and are out of breath or have wheezing.
  • you feel pressure over your chest in the morning or if the pressure lasts longer than usual.

These signs may mean that your asthma or COPD is not sufficiently under control, and you may need another or additional treatment immediately.

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

If you use more DuoResp Spiromax then you should

You must take the doses prescribed by your doctor. Do not exceed the prescribed number of doses without consulting a doctor.

If you use more DuoResp Spiromax than you should, contact your doctor, pharmacist, or nurse for advice.

The most common symptoms that can occur when you use too much DuoResp Spiromax are tremors, headaches, or a fast heartbeat.

If you forget to use DuoResp Spiromax

If you forget to take a dose, take it as soon as you remember. But 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 experience wheezing or difficulty breathing or develop other symptoms of an asthma attack, use your emergency inhaler and then consult a doctor.

If you stop using DuoResp Spiromax

Do not stop using your inhaler without first telling your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following occur, stop using DuoResp Spiromax and contact 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 a sudden feeling of fainting. This may mean that you have had an allergic reaction which may also include rash and itching.
  • Bronchospasm (a contraction of muscles in the airways that causes wheezing and shortness of breath). If wheezing occurs suddenly after using the medicine, stop using it and contact a 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 DuoResp Spiromax immediately and use your “if needed” inhaler if you have one. Contact a doctor immediately as you may need to have your treatment changed.

Other possible side effects:

Common: may affect up to 1 in 10 users

  • Palpitations (you feel your heartbeat), tremors, or tremors. If these effects occur, they are usually mild and usually disappear when you continue to use DuoResp Spiromax.
  • Fungal infection in the mouth. It is less likely to occur if you rinse your mouth with water after using the medicine.
  • Slight sore throat, cough, and hoarse voice.
  • Headache.
  • Pneumonia in COPD patients.

Tell your doctor if you have any of the following symptoms while taking DuoResp Spiromax as they may be symptoms of pneumonia:

  • fever or chills
  • increased mucus production changed the color of the mucus
  • increased cough or increased difficulty breathing

Uncommon: may affect up to 1 in 100 people

  • Feeling of restlessness, nervousness, worry, anxiety or anger.
  • Sleep disorders.
  • Dizziness.
  • Nausea.
  • Fast heartbeat.
  • Bruises on the skin.
  • Muscle cramps.
  • Dimsyn.

Rare:

  • Low levels of potassium in the blood.
  • Uneven heart rhythm.

Very rare:

  • Depression.
  • Behavioral changes, especially in children.
  • Chest pain or pressure over the chest (angina).
  • Disorders of the cardiac conduction system that do not cause symptoms (prolongation of the QTc interval ).
  • An increased amount of sugar ( glucose ) in the blood, when you leave a blood sample.
  • Taste changes, e.g. an unpleasant taste in the mouth.
  • Changes in blood pressure et.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if you use high doses for a long time. The effects include:

  • changes in bone density (thinning of the skeleton)
  • cataract (cloud of the lens of the eye)
  • glaucoma (increased pressure in the eye)
  • the subdued growth rate in children and adolescents 
  • impact on the adrenal glands (small glands above the kidneys). Symptoms of adrenal insufficiency may include fatigue, weakness, stomach problems, including nausea, vomiting, pain and diarrhea, darkening of the skin, and weight loss.

These effects are very rare and the probability of their occurrence is much less of corticosteroid you inhaled than with portico steroid tabletter.

5. How to store DuoResp Spiromax

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton or label on the inhaler after EXP. The expiration date is the last day of the specified month.
  • Store below 25  ° C. Keep the nozzle cover closed after removing the foil cover.
  • Use within 6 months after removal from the foil cover. Use the inhaler label to write down the date you open the foil pouch.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • 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 measured dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
  • The other excipient is lactose monohydrate (see section 2 under “DuoResp Spiromax contains lactose”).

What the medicine looks like and the contents of the pack

DuoResp Spiromax is an inhalation powder.

Each DuoResp Spiromax inhaler contains 120 inhalations and is white with a translucent burgundy protective cap for the mouthpiece.

Packs of 1, 2, and 3 inhalers. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma BV,

Swensweg 5, 2031GA 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 BV, Swensweg 5, 2031 GA Haarlem, The Netherlands

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

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel / Tel: +32 3 820 73 73 Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AGTel / Tel: +32 3 820 73 73
BulgariaActavis EADTel : +359 2 489 95 85 HungaryTeva GyógyszergyárZrtTel .: +36 1 288 64 00
Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 MaltaTeva Pharmaceuticals IrelandL-IrelandTel: +353 51 321 740
DenmarkTeva Denmark A / STel: +45 44 98 55 11 The NetherlandsTeva Nederland BVTel: +31 800 0228 400
GermanyTeva GmbHTel: +49 731 402 08 NorwayTeva Norway ASTel: +47 6677 55 90
EestiUAB Teva Baltics Eesti subsidiaryTel: +372 661 0801 Austriaratiopharm Arzneimittel Vertriebs GmbHTel: +43 1 97007 0
GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 210 880 5000 PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00
SpainTeva Pharma SLUTel: +34 91 387 32 80 PortugalTeva Pharma – Pharmaceutical Products LdaTel: +351 21 476 75 50
FranceTeva HealthTel: +33 1 55 91 7800 RomaniaTeva Pharmaceuticals SRLTel: +4021 230 6524
IrelandTeva Pharmaceuticals IrelandTel: +353 51 321 740 SloveniaPliva Ljubljana dooTel: +386 1 58 90 390
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicTeva Pharmaceuticals Slovakia sroTel: +421 2 5726 7911
ItalyTeva Italia SrlTel: +39 028 917 981 Finland / FinlandTeva Finland OyPuh / Tel: +358 20 180 5900
11LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67 323 666 United KingdomTeva UK LimitedTel: +44 1977 628 500
LithuaniaUAB Teva BalticsTel: +370 5 266 02 03 CroatiaPliva Hrvatska dooTel: + 385 1 37 20 000

Muhammad Nadeem

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