Patient leaflet - DUORESP SPIROMAX 320 MICROGRAMS / 9 MICROGRAMS INHALATION POWDER
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 your lungs and helps you to breathe more easily.
- Formoterol fumarate dihydrate belongs to a group of medicines called ‘long -acting p2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily.
DuoResp Spiromax is indicated for use in adults and adolescents 12 years of age and older only.
Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Asthma
When used for asthma, your doctor will prescribe DuoResp Spiromax together with a separate ‘reliever inhaler’ such as salbutamol.
- Use DuoResp Spiromax every day. This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
- Use the ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.
Do not use DuoResp Spiromax 320/9 micrograms as a ‘reliever inhaler’.
Chronic obstructive pulmonary disease (COPD)
COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. DuoResp Spiromax can also be used to treat the 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 the other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking DuoResp Spiromax if
- you are diabetic.
- you have a lung infection.
- you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a 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 regularly drink alcohol.
If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use DuoResp Spiromax. If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests. When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use DuoResp Spiromax.
Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Do not give this medicine to children under the age of 12 years.
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:
- p blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eye drops (such as timolol for glaucoma).
- Oxytocin which is given to pregnant women to induce labour.
- Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procainamide and terfanidine).
- Medicines like digoxin, often used to treat heart failure.
- Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
- Steroid tablets that you take by mouth (such as prednisolone).
- Xanthine medicines (such as theophylline or aminophylline). These 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 those with similar properties (such as the antibiotic furazolidine and the chemotherapy medicine procarbazine).
- Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
- Medicines called ‘HIV protease inhibitors’ (such as ritonavir) 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 DuoResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
If any of the above applies 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 are going to have a general anaesthetic for an operation or for dental work to help lower any risk of interaction with the anaesthetic you receive.
Pregnancy and breast-feeding
- 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 DuoResp Spiromax – do NOT use this medicine unless your doctor tells you to.
- If you get pregnant while using DuoResp Spiromax, do NOT stop using DuoResp Spiromax but talk to your doctor immediately.
Driving and using machines
DuoResp Spiromax is not likely to affect your ability to drive or to use tools or 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, talk to your doctor before using this medicine.
3. how to use duoresp spiromax
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.
- It is important to use DuoResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
- If you are using DuoResp Spiromax for asthma, your doctor will want to regularly check your symptoms.
Asthma
Use your DuoResp Spiromax every day. This helps to prevent asthma symptoms from occurring.
Recommended dose:
Adults (18 years and older)
1 inhalation (actuation), twice a day, taken in the morning and in the evening Your doctor may increase this to 2 inhalations, twice a day.
If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.
Adolescents (12 years and older) 1 inhalation twice daily.
Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma. If your doctor feels that you need a lower dose than is available from your DuoResp Spiromax, your doctor may prescribe an alternative inhaler containing 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 take your medicine once a day. However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.
Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.
Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and wheezing. Do not use DuoResp Spiromax to treat these asthma symptoms. It is important that you discuss with your doctor the use of DuoResp Spiromax to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that is prescribed to you.
Chronic Obstructive Pulmonary Disease (COPD)
Recommended dose
Adults (18 years and older) only:
- 1 inhalation twice a day, taken in the morning and in the evening
Your doctor may also prescribe another bronchodilator medicine for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.
Preparing your new DuoResp Spiromax
Before using your new DuoResp Spiromax for the first time , you need to prepare it for use as follows:
- Open the foil pouch by tearing at the notch at the top of the foil pouch and take out the inhaler.
- Check the dose indicator to see that there are 60 inhalations in the inhaler.
- Write the date you opened the foil pouch on the label of the inhaler.
- Do not shake your inhaler before use.
How to take an inhalation
Every time you need to take an inhalation, follow the instructions below.
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1. Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.
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2. Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively metered. Your inhaler is now ready for use.
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3. Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.
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4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Take care not to block the air vents.