Fostair Nexthaler 100 Micrograms/6 Micrograms Per Actuation Inhalation Powder
1. WHAT FOSTAIR NEXThaler IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOSTAIR NEXThaler
Using Fostair NEXThaler when you are taking the following medicines:
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• other drugs which work in the same way as formoterol (i.e. beta adrenergic drugs, commonly used to treat asthma) |
^ can increase the effects of formoterol. |
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• quinidine, disopyramide, procainamide (to treat abnormal heart rhythms) • some antihistamines for example terfenadine (to treat allergic reactions) • monoaminoxidase inhibitors or tricyclic antidepressants for example phenelzine, isocarboxazid, amitryptiline and imipramine; phenothiazines (to treat depression or mental disorders) |
^ can cause changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias. |
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• L-dopa (to treat Parkinson's Disease) • L-thyroxine (to treat an underactive thyroid gland) • medicines containing oxytocin (which causes uterine contraction) |
^ can lower your heart's tolerance to beta adrenergic drugs, such as formoterol. |
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• monoaminoxidase inhibitors (MAOIs) (to treat mental disorders) including drugs with similar properties like furazolidone and procarbazine |
^ can cause a rise in blood pressure. |
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• digoxin (to treat heart disease) |
^ can cause a fall in your blood potassium level. This may increase the likelihood of abnormal heart rhythms. |
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• other medicines to treat asthma theophylline, aminophylline or steroids) • diuretics (water tablets) |
^ can cause a fall in your potassium level. |
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• some anaesthetics |
^ can increase the risk of abnormal heart rhythms. |
Fostair NEXThaler with alcohol
You should avoid drinking alcohol unless you have talked to your doctor first. Alcohol can lower your heart's tolerance to one of the active ingredients of Fostair NEXThaler, formoterol.
3. HOW TO USE FOSTAIR NEXThaler
4. POSSIBLE SIDE EFFECTS
Package leaflet: Information for the patient FOSTAIR® NEXTthaler ® 100 micrograms/ 6 micrograms per actuation, inhalation powder.
(beclometasone dipropionate/ formoterol fumarate)
Your medicine is known as the above but will be referred to as Fostair NEXThaler throughout the remainder of this leaflet.
For use in adults
Read all of this leaflet carefully before you start taking 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, nurse or pharmacist.
- 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Fostair NEXThaler is and what it is used for
2. What you need to know before you use Fostair NEXThaler
3. How to use Fostair NEXThaler
4. Possible side effects
5. How to store Fostair NEXThaler
6. Contents of the pack and other information
Fostair NEXThaler is a powder that is inhaled through your mouth and delivered deeply into your lungs. It contains two active ingredients: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
• Beclometasone dipropionate anhydrous belongs to a group of medicines commonly referred to as steroids (technically corticosteroids). Steroids both treat and prevent symptoms of asthma. They reduce the inflammation, swelling and irritation in the small air passages of the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators. These relax the muscles in your airways, widening the airways so that it is easier for you to breathe air in and out of your lungs.
These two active substances make breathing easier by providing relief from symptoms such as shortness of breath, wheezing and coughing in patients with asthma or COPD and also help to
■ prevent asthma symptoms.
Asthma:
Fostair NEXThaler is used to treat asthma in adults.
If you are prescribed Fostair NEXThaler it is likely that either:
• Your asthma is not adequately controlled by using inhaled corticosteroids and “as needed” short-acting bronchodilators or
• Your asthma is responding well to both corticosteroids and long-acting bronchodilators. COPD:
Fostair NEXThaler can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long term disease of the airways in the lungs which is primarily caused by cigarette smoking.
Do not use Fostair NEXThaler
if you are allergic to beclometasone dipropionate anhydrous or formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Do not use this medicine if you are experiencing acute asthma symptoms such as shortness of breath, wheezing and cough, your asthma is getting worse or you are having an acute asthma attack. To relieve your symptoms you should use your quick-acting “reliever” inhaler which you should carry with you at all times.
Talk to your doctor before using Fostair NEXThaler if you have any of the following:
• heart problems, these include any known disorder of your heart and/or heart function
• disorders of the heart rhythm such as increased or irregular heart rate, a fast pulse rate or palpitations, or if you have been told that your heart trace is abnormal
• high blood pressure
• narrowing of the arteries (also known as arteriosclerosis), or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall)
• an overactive thyroid gland
• low blood levels of potassium
• any disease of your liver or kidneys
• diabetes. If you inhale high doses of formoterol your blood glucose may increase and therefore you may need to have some additional blood tests to check your blood sugar when you start using this inhaler and from time to time during treatment.
• tumour of the adrenal gland (known as a phaeochromocytoma)
• you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Fostair NEXThaler at least 12 hours before the anaesthesia.
• you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal infection of your chest.
If any of the above applies to you, always inform your doctor before you use Fostair NEXThaler.
If you are not sure whether you can use Fostair NEXThaler talk to your doctor, asthma nurse or pharmacist before using the inhaler.
Your doctor may wish to measure the potassium levels in your blood from time to time especially if your asthma is severe.
Like many bronchodilators Fostair NEXThaler can cause a sharp fall in your serum potassium level (hypokalaemia). This is because a lack of oxygen in the blood combined with some other treatments you may be taking together with Fostair NEXThaler can make the fall in potassium level worse.
If you are using an inhaler to take high doses of corticosteroids over a long period of time, you may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury, or before an operation. In this case, the doctor treating you will decide whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.
Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including Fostair NEXThaler and any medicines or tablets bought without a prescription, in their original package, if possible.
Children and adolescents
Do not give this medicine to children and adolescents aged less than 18 years.
Other medicines and Fostair NEXThaler
Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any other inhalers and including medicines obtained without a prescription. This is because Fostair NEXThaler may affect the way some other medicines work. Also, some medicines can affect the way Fostair NEXThaler works.
Do not use beta blockers with this medicine. Beta blockers are medicines used to treat many conditions including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you need to use beta blockers (including eye-drops), the effect of formoterol may be reduced or formoterol may not work at all.
Pregnancy and breast feeding
There is no clinical data on the use of Fostair NEXThaler during pregnancy. If you think you are pregnant or are planning to become pregnant please consult your doctor. You should only use Fostair NEXThaler during pregnancy if you are advised to do so by your doctor. Your doctor will decide whether you must stop taking Fostair NEXThaler during breastfeeding or you should take Fostair NEXThaler but refrain from breastfeeding. Always follow the advice of your doctor strictly.
Driving and using machines
Fostair NEXThaler is unlikely to affect your ability to drive and use machines. However if you experience side effects such as dizziness and/or trembling, your ability to drive or operate machinery may be affected.
Fostair NEXThaler contains lactose monohydrate
The excipient lactose monohydrate contains small amounts of milk proteins, which may cause reactions in allergic patients.
Always use Fostair NEXThaler exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.
Fostair NEXThaler delivers an extrafine aerosol which results in more of each dose being delivered to your lungs. Your doctor may, therefore, prescribe a lower dose of this inhaler than your previous inhalers.
Asthma:
Your doctor will give you a regular check-up to make sure you are taking the correct dose of Fostair NEXThaler. Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Fostair NEXThaler. Under no circumstances should you change the dose without first speaking to your doctor.
How much Fostair NEXThaler to use:
Adults and the elderly:
The recommended dose of this medicine is 1 or 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
Do not increase the dose.
If you feel that the medicine is not effective, always talk to your doctor before increasing the dose.
Chronic obstructive pulmonary disease (COPD):
Adults and the elderly:
The recommended dose is two puffs in the morning and two puffs in the evening.
Remember: you should always have your quick-acting “reliever” inhaler with you at all times to treat worsening symptoms of asthma or a sudden asthma attack.
How to use Fostair NEXThaler:
Fostair NEXThaler is for inhalation use.
In this pack, you will find in a sealed protective pouch an inhaler called NEXThaler that contains your medicine in the form of a powder. The NEXThaler inhaler enables you to inhale your medicine. Please read the instructions at the end of this leaflet for more information about how to use and clean the NEXThaler inhaler.
Whenever possible, stand or sit in an upright position when inhaling.
If you have used more Fostair NEXThaler than you should:
• contact your doctor or nearest hospital casualty department immediately for advice. Take your medicine with you so that the people can see what you have taken;
• side effects may occur. Tell your doctor if you have any unusual symptoms as he/she may wish to carry out further tests or decide about any measures that may be necessary.
If you forget to use Fostair NEXThaler:
Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not double the dose.
If you stop using Fostair NEXThaler:
Even if you are feeling better, do not stop using Fostair NEXThaler or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use Fostair NEXThaler every day as prescribed by your doctor even though you may have no symptoms.
If your breathing does not change:
If your symptoms do not improve after inhaling Fostair NEXThaler, you may be using it incorrectly. Therefore check the instructions for correct use at the end of this leaflet and/or contact your doctor or nurse to be trained properly again.
If your asthma gets worse:
If your symptoms get worse or are difficult to control (e.g. if you are using your “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, you should continue to use Fostair NEXThaler but go to see your doctor as soon as possible. Your doctor may need to change your dose of Fostair NEXThaler or prescribe an additional or alternative treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaler treatments there is a risk of worsening shortness of breath, cough and wheezing immediately after using Fostair NEXThaler and this is known as paradoxical bronchospasm. If this occurs you should STOP using Fostair NEXThaler immediately and use your quick-acting “reliever” inhaler straightaway to treat the symptoms. You should contact your doctor straightaway
Tell your doctor immediately if you experience allergic reactions which include skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or of mucous membranes especially of the eyes, face, lips and throat.
Other possible side effects of Fostair NEXThaler are listed below according to their frequency. You should contact your doctor or pharmacist immediately:
• if you experience any of the side effects below and they cause you distress, are severe or last for several days
• if you are worried in any way or if there is anything you do not understand.
Your doctor is likely to assess your asthma and if necessary start you on another course of treatment. You may be told that you should not use Fostair NEXThaler again.