Budesonide/Formoterol Teva
budesonide, formoterol
(budesonide/formoterol fumarate dihydrate)
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.
What Budesonide/Formoterol Teva is and what it is used for (page 3)
What you need to know before you use Budesonide/Formoterol Teva (page 5)
How to use Budesonide/Formoterol Teva (page 9)
Possible side effects (page 18)
How to store Budesonide/Formoterol Teva (page 21)
Contents of the pack and other information (page 22)
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Budesonide/Formoterol Teva 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 β2 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.
Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Use Budesonide/Formoterol Teva 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.
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. Budesonide/Formoterol Teva can also be used to treat the symptoms of severe COPD in adults.
You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Talk to your doctor, pharmacist or nurse before taking Budesonide/Formoterol Teva 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.
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 Budesonide/Formoterol Teva. 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 Budesonide/Formoterol Teva.
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Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).
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:
β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma).
Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).
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 medicines 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.
Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procardazine).
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).
Medicines for allergies or antihistamines (such as terfenadine).
If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using Budesonide/Formoterol Teva.
Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work.
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 Budesonide/Formoterol Teva - do NOT use this medicine unless your doctor tells you to.
If you get pregnant while using Budesonide/Formoterol Teva, do NOT stop using Budesonide/Formoterol Teva but talk to your doctor immediately.
Budesonide/Formoterol Teva is not likely to affect your ability to drive or to use tools or machines.
Lactose is a type of sugar found in milk. Lactose contains small amounts of milk protein which may cause allergic reactions.If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.
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.
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It is important to use Budesonide/Formoterol Teva every day, even if you have no asthma or COPD symptoms at the time.
If you are using Budesonide/Formoterol Teva for asthma, your doctor will want to regularly check your symptoms.
Adults (18 years and older)
1 or 2 inhalations (actuations), twice a day.
Your doctor may increase this to 4 inhalations, twice a day.
If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.
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 Budesonide/Formoterol Teva, your doctor may prescribe an alternative inhaler containing the same active substances as your Budesonide/Formoterol Teva but with a lower dose of the corticosteroid. However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.
Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and wheezing. Do not use Budesonide/Formoterol Teva to treat these asthma symptoms.
If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler’ to relieve these symptoms. Do not use Budesonide/Formoterol Teva just before exercise to stop asthma symptoms from occurring, use your separate ‘reliever inhaler’.
Adults (18 years and older): 2 inhalations twice a day.
Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.
Before using your Budesonide/Formoterol Teva for the first time, you need to prepare it for use as follows:
Check the dose indicator to see that there are 120 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.
Every time you need to take an inhalation, follow the instructions below.
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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.
Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.
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.
Breathe in through your mouth as deeply and as hard as you can.
Hold your breath for 10 seconds or as long as you comfortably can.
Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.
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If you are to take a second inhalation, repeat steps 1 to 7. Rinse your mouth with water after every dose, and spit it out.
Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler.
Keep your Spiromax dry and clean.
If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.
The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full.
The dose indicator, on the rear of the device, shows the number of inhalations remaining in even numbers only.
For inhalations remaining from 20 downwards to ‘8’, 6’,’4’,’2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.
Note:
The mouthpiece will still ‘click’ even when your Spiromax is empty.
If you open and close the mouthpiece without taking an inhalation the dose indicator will still register
it as a count. This dose will be securely held inside the inhaler for when the next inhalation is due. It is impossible to accidentally take extra medicine or a double dose in one inhalation.
Keep the mouthpiece closed all the time unless you are about to use your inhaler.
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If you feel you are getting breathless or wheezy while using Budesonide/Formoterol Teva, you should continue to use Budesonide/Formoterol Teva but go to see your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:
Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.
Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva.
It is important that you take your dose as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.
If you use more Budesonide/Formoterol Teva than you should, contact your doctor, pharmacist or nurse for advice.
The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva than you should are trembling, headache or a rapid heartbeat.
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 nearly time for your next dose just take your next dose at the usual time.
If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler’, then seek medical advice.
Do not stop using your inhaler without telling your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction, which may also include rash and itching.
Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately.
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Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm’). If either of these symptoms occur, stop using Budesonide/Formoterol Teva straightaway and use your ‘reliever inhaler’. Contact your doctor immediately as you may need to have your treatment changed.
Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use Budesonide/Formoterol Teva.
Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with water after using your medicine.
Mild sore throat, coughing and a hoarse voice.
Headache.
Pneumonia (infection to the lung) in COPD patients.
Tell your doctor if you have any of the following while taking Budesonide/Formoterol Teva they could be symptoms of a lung infection:
Fever or chills
Increased mucus production, change in mucus colour
Increased cough or increased breathing difficulties
Feeling restless, nervous, agitated, anxious or angry.
Disturbed sleep.
Feeling dizzy.
Nausea (feeling sick).
Fast heartbeat.
Bruising of the skin.
Muscle cramps.
Low levels of potassium in your blood.
Uneven heartbeat.
Depression.
Changes in behaviour, especially in children.
Chest pain or tightness in the chest (angina pectoris).
Disturbance of the heart’s electrical system (prolongation of the QTc-interval).
An increase in the amount of sugar (glucose) in your blood.
Taste changes, such as an unpleasant taste in the mouth.
Changes in your blood pressure.
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
changes in bone mineral density (thinning of the bones)
cataract (clouding of the lens in the eye)
glaucoma (increased pressure in the eye)
a slowing of the rate of growth of children and adolescents
an effect on the adrenal gland (a small gland next to the kidney)
These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
If you get any side effects, talk to your doctor,pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
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You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
Do not store above 25oC. Keep the mouthpiece cover closed after removal of the foil wrapping.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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 is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva contains lactose’)
Budesonide/Formoterol Teva is an inhalation powder.
Each Budesonide/Formoterol Teva inhaler contains 120 inhalations and has a white body with a semi- transparent wine red mouthpiece cover.
Each pack contains 1 inhaler.
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
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 Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
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Teva Nederland B.V. | |||
Tel: +31 800 0228 400 | |||
Teva Pharma S.L.U. | |||
Tél: +34 91 387 32 80 | |||
France România
Pliva Hrvatska d.o.o | |||
Tel: + 385 1 37 20 000 | |||
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