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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 acts as it reduces and prevents edema and inflammation in the lungs and helps you breathe easier;
Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting? 2-adrenoceptor agonists" or "bronchodilators". It acts as relaxing muscles in the airways. This will help to open the airways and help you breathe easier.
DuoResp Spiromax is indicated for use only in adults 18 years of age and over.
DuoResp Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents aged 13-17 years.
Your doctor has prescribed this medicine for the treatment of asthma or chronic obstructive pulmonary disease (COPD).
When used for asthma, your doctor will prescribe DuoResp Spiromax with a separate "reliever inhaler" such as salbutamol.
Use DuoResp Spiromax every day. This helps prevent the onset of asthmatic symptoms such as breathlessness and wheezing;
Use the relieving inhaler when you get asthmatic symptoms to make your breathing easier.
Do not use DuoResp Spiromax 320/9 micrograms as a "reliever inhaler".
Chronic Obstructive Pulmonary Disease (COPD)
COPD is a chronic lung disease of the respiratory tract, which is often caused by smoking. Symptoms include shortness of breath, cough, chest discomfort, and phlegm. DuoResp Spiromax can also be used to treat the symptoms of severe COPD in adults.
2. What you need to know before using DuoResp Spiromax
Do not use DuoResp Spiromax:
If you are allergic to budesidide, 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 DuoResp Spiromax:
If you are a diabetic;
If you have a pulmonary infection;
If you have high blood pressure or have ever had heart problems (including irregular heartbeat, very fast heartbeat, narrowing of the arteries or heart failure);
If you have problems with the thyroid or adrenal glands;
If you have low levels of potassium in the blood;
If you have severe liver problems.
If you are taking steroid tablets for asthma or COPD, once you start using DuoResp Spiromax, your doctor may reduce the number of tablets you take. If you have been taking steroid tablets for a long time, your doctor may ask you to have blood tests on a regular basis. When you reduce the number of steroid tablets, you may feel general malaise, even if your breast symptoms improve. Symptoms such as a stuffy or runny nose, weakness, joint or muscle pain and rash (eczema) may occur. If any of these symptoms worry you or if you experience symptoms such as headache, fatigue, nausea or vomiting, please contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. You should talk to your doctor if you are concerned that you should continue to use DuoResp Spiromax.
Your doctor may decide to add steroid tablets to your usual treatment during periods of stress (for example when you have chest infection or before surgery).
Children and adolescents
This medicine should not be used in children or adolescents under the age of 18 years.
Other medicines and DuoResp Spiromax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist, especially if you are taking any of the following medicines:
Beta-blockers (such as athenolol or propranolol for high blood pressure or heart disease), including eye drops (such as timolol for glaucoma);
Medicines for accelerated or irregular heartbeat (such as quinidine, disopyramide and procainamide);
Medicines such as digoxin, often used to treat heart failure;
Diuretics, also known as "pouring tablets" (such as furosemide) - are used to treat high blood pressure;
Steroid medications you take orally (such as prednisolone);
Xanthine drugs (such as theophylline or aminophylline). They are often used to treat asthma;
Other bronchodilators (such as salbutamol);
Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procarbazine);
Phenothiazine drugs (such as chlorpromazine and prochlorperazine);
Medicines called "protease inhibitors" (such as ritonavir) to treat HIV infection;
Medicines for the treatment of infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin);
If any of these apply to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using DuoResp Spiromax.
Tell your doctor, pharmacist or nurse and if you will be subjected to general anesthesia for surgery or dentistry.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor, pharmacist or nurse 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 taking DuoResp Spiromax and talk to your doctor right away.
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. Lactose contains small amounts of milk protein that can cause allergic reactions. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
3. How to use DuoResp Spiromax
Always use this medicine exactly as your doctor, pharmacist or nurse told you. If you are not sure, ask your doctor or pharmacist.
It is important to use DuoResp Spiromax every day, even if you currently have no symptoms of asthma or COPD;
If you are using DuoResp Spiromax for asthma, your doctor will want to check your symptoms regularly.
Use DuoResp Spiromax every day. This helps to prevent the onset of asthmatic symptoms.
Adults (18 years and over):
1 inhalation twice daily;
Your doctor may increase inhalations to 2 inhalations twice a day;
If your symptoms are well controlled, your doctor may tell you to take your medicine once a day.
Your doctor will help you control asthma and adjust the dose of this medicine to the lowest dose that controls your asthma. If your doctor thinks you need less than the dose available in your DuoResp Spiromax, he or she may prescribe an alternative inhaler containing the same active substances as your DuoResp Spiromax but with a lower dose of corticosteroid. Do not correct the number of inhalations prescribed by your doctor without first consulting with your doctor.
Use your own "relieving inhaler" to treat asthma symptoms when they occur.
Always carry your relieving inhaler and use it to relieve the sudden attacks of shortness of breath and wheezing. Do not use DuoResp Spiromax to treat these asthma symptoms.
Chronic Obstructive Pulmonary Disease (COPD)
Adults (18 years and over):
1 inhalation twice daily.
Your doctor may also prescribe another bronchodilator, for example an anticholinergic (such as tiotropin or ipratropin bromide) for your COPD.
Preparing your new DuoResp Spiromax
Before using your DuoResp Spiromax for the first time, you should prepare it for use as follows:
Check the dose indicator to make sure there are 60 inhalations in the inhaler;
On the label of the inhaler, record the date on which you have opened a foil pouch;
Do not shake the inhaler before use.
How to Inhale
Every time you have to inhaled, follow the instructions below.
1. Grasp your inhaler with the translucent red wine-bottle lid on the bottom.
2. Open the mouthpiece cover by turning it down until one click is clearly heard. Your drug is measured actively. Now your inhaler is ready for use.
3. Exhale gently (as comfortable as you can). Do not breathe through the inhaler.
4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your mouth around the mouthpiece. Be careful not to block the air holes.
Breathe in through your mouth as deep as you can.
5. Hold breathing for 10 seconds or as far as you can.
6. Remove the inhaler from your mouth. You may taste when you are taking inhalation.
7. Now exhale slightly (do not breathe through the inhaler). Close the mouthpiece cover.
If you need to do a second inhalation, repeat steps 1 through 7.
After each dose, rinse your mouth with water and spit it out.
Do not try to disassemble your inhaler, remove or rotate the mouthpiece cover - it is fixed to the inhaler and should not be removed. Do not use your Spiromax if it is damaged or if the mouthpiece has separated from it. Do not open or close the mouthpiece cover unless you are ready to use the inhaler.
Keep your Spiromax dry and clean.
If necessary, you can wipe your Spiromax mouthpiece with a dry cloth or paper napkin.
When to start using a new Spiromax
The dose indicator tells you how many doses (inhalations) remained in your inhaler, starting from 60 inhalations when it is full;
The dose indicator, on the back of the device, shows the number of remaining inhalations in even numbers only;
For remaining inhalations of 20 down - up to 8, 6, 4, 2, the figures are written in red on a white background. When the numbers in the window turn red, you should consult your doctor and get a new inhaler.
The mouthpiece will continue to click, even when your Spiromax is empty.
If you open and close the mouthpiece without taking inhalation, the dose indicator will still record this as a countdown. This inhalation will be stored in the inhaler for the next intake. It is impossible accidentally to take more medicine or a double dose with one inhalation;
Keep the mouthpiece permanently closed unless you are ready to use your inhaler.
Important information about the symptoms of your asthma or COPD
If you feel short of breath or wheezing while using DuoResp Spiromax, you should continue to use it, but visit your doctor as soon as possible because you may need additional treatment.
Contact your doctor immediately if:
Your breathing gets worse or you start to wake up often at night with shortness of breath and wheezing;
Start feeling chest tight in the morning or stretching longer than usual.
These signs may indicate that your asthma or COPD is not properly controlled and you may need different or additional treatment immediately.
Once your asthma is properly controlled, your doctor may consider it appropriate to progressively reduce the dose of DuoResp Spiromax.
If you use more DuoResp Spiromax than you should
It is important to take your dose as your doctor has told you. You should not exceed your prescribed dose without consulting a doctor.
If you have used more DuoResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
The most common symptoms that may occur if you have used more DuoResp Spiromax than you should have are trembling, headache, or an accelerated heart rhythm.
If you forget to use DuoResp Spiromax
If you miss a dose, take it as soon as you remember. But do not take a double dose to make up for the missed dose. If it's time for the next dose, just take it at the usual time.
If wheezing or shortness of breath or any other symptom of asthma occurs, use your relief 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 medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the following happen to you, stop using DuoResp Spiromax and talk to your doctor straight away:
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 in swallowing), or urticaria together with difficulty breathing (angioedema) and / or sudden fainting. This may indicate that you have an allergic reaction, which may include rash and itching;
Bronchospasm (tightness of the muscles in the airways, which causes wheezing and shortness of breath). If the wheezing occurs suddenly after using this medicine, stop using it and talk to your doctor straight away.
Very rare side effects - may affect up to 1 in 10,000 people:
Sudden wheezing and / or shortness of breath immediately after using your inhaler (also called "paradoxical bronchospasm"). If any of these symptoms occur, stop using DuoResp Spiromax immediately and use your relief inhaler. 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 (palpitations), twitching or shaking. If these reactions occur, they are usually mild and disappear with the continued use of DuoResp Spiromax;
Candidiasis (fungal infection) in the mouth. It is less likely to occur if you rinse your mouth with water after using your medicine;
Sore sore throat, coughing and hoarse voice;
Uncommon - may affect up to 1 in 100 people:
Feeling of anxiety, nervous tension, agitation, anxiety or anger;
Nausea (feeling sick);
Accelerated heart rhythm;
Low levels of potassium in the blood;
Irregular heart rhythm.
Changes in behavior, especially in children;
Pain or tightness in the chest (angina);
Cardiac conduction disorder (QT prolongation);
Increase in the amount of sugar (glucose) in the blood;
Changes in taste, such as an unpleasant taste in the mouth;
Changes in blood pressure;
Inhaled steroids can affect the normal production of steroid hormones in the body, especially if you use high doses for a long time. Reactions include:
Changes in bone mineral density (thinning of the bones);
Glaucoma (increased pressure in the eye);
Retardation of growth rate in children and adolescents;
Effect on the adrenal glands (small glands located on the upper part of the kidneys).
These reactions occur very rarely and the likelihood of them occurring with inhaled corticosteroids is much less than with corticosteroid tablets.
Reporting of side effects
If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store DuoResp Spiromax
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store with closed mouthpiece cover after removal from packaging foil.
Use up to 6 months after removal from the packaging foil. Use the inhaler label to record the date on which you opened the foil bag.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What DuoResp contains 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. It corresponds to a measured dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (see section 2, section "DuoResp Spiromax contains lactose").
What DuoResp Spiromax looks like and contents of the pack
DuoResp Spiromax is a powder for inhalation.
Each DuoResp Spiromax inhaler contains 60 inhalations and has a white body with a translucent red wine tip.
Packs of 1, 2 and 3 inhalers.
Not all packs may be marketed in your country.
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