- beclometasone dipropionate
- formoterol fumarate dihydrate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL08829/0173.
Fostair NEXThaler 100/6
Package leaflet: Information for the patient
FOSTAIR® NEXThaler® 100 micrograms/6 micrograms per actuation inhalation powder
For use in adults
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
1. WHAT FOSTAIR NEXThaler IS AND WHAT IT IS USED FOR
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.
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.
Fostair NEXThaler is used to treat asthma in adults.
If you are prescribed Fostair NEXThaler it is likely that either:
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOSTAIR NEXThaler
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:
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.
Some medicines may increase the effects of Fostair NEXThaler and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
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.
Using Fostair NEXThaler when you are taking the following medicines:
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.
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.
3. HOW TO USE FOSTAIR NEXThaler
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.
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:
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.
4. POSSIBLE SIDE EFFECTS
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:
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.
Common (may affect up to 1 in 10 people):
Tell your doctor if you have any of the following while taking Fostair NEXThaler, they could be symptoms of a lung infection:
Uncommon (may affect up to 1 in 100 people):
Side effects which have been observed with similar medicines for inhalation containing beclometasone dipropionate and/or formoterol are:
Using high-dose inhaled corticosteroids over a long time can cause systemic effects these include:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FOSTAIR NEXThaler
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, pouch and label after Exp. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture. Only remove the inhaler from its pouch immediately before first use.
Before first opening the pouch:
This medicinal product does not require any special temperature storage conditions.
After first opening the pouch:
Do not store above 25°C.
After first opening the pouch, the medicinal product should be used within 6 months. Use the label on the box to write down the date you open the pouch.
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 to protect the environment.
Please read the instructions at the end of this leaflet for more information about how to store the NEXThaler inhaler.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fostair NEXThaler contains
The active substances are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each metered dose contains 100 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 81.9 micrograms of beclometasone dipropionate anhydrous and 5 micrograms of formoterol fumarate dihydrate.
The other ingredients are: lactose monohydrate (which contains small amounts of milk proteins) and magnesium stearate.
What Fostair NEXThaler looks like and contents of the pack
This medicinal product is presented as a white to almost white inhalation powder contained in a plastic inhaler called NEXThaler.
Each pack contains one, two or three inhalers which provide 120 inhalations each. Each inhaler comes in a sealed protective pouch (aluminium foil package). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturers responsible for batch release:
This leaflet was last revised in 05/2017.
INSTRUCTIONS FOR USE OF NEXThaler INHALER
Please read all of the following instructions before you start using this inhaler.
If you experience any problems using this inhaler, please contact your doctor, nurse or pharmacist.
A. Contents of the Package
This package contains:
If the package contents are not the same as this, return your inhaler to the person who supplied it (e.g. pharmacist or doctor) and get a new one.
B. General Warnings & Precautions
C. Key features of your NEXThaler inhaler
Taking a dose from your NEXThaler inhaler requires just three simple steps: Open, Inhale, Close.
D. Before using a new NEXThaler inhaler
1. Open the pouch and take out your inhaler.
2. Inspect your inhaler.
3. Check the Dose Counter Window. If your inhaler is brand new you will see “120” in the Dose Counter Window.
E. How to use your NEXThaler inhaler
E.1. Visual Check
1. Check the number of doses left: any number between “1” and “120” shows that there are doses left.
2. Make sure the cover is fully closed before you use it.
1. Hold your inhaler firmly in the upright position.
2. Open the cover fully.
3. Before inhaling breathe out as far as is comfortable.
Whenever possible, stand or sit in an upright position when inhaling.
1. Lift your inhaler up, bring it to your mouth and place your lips around the mouthpiece.
2. Take a quick and deep breath through your mouth.
3. Remove your inhaler from your mouth.
4. Hold your breath for 5 to 10 seconds or as long as is comfortable.
5. Breathe out slowly.
1. Move your inhaler back to the upright position and close the cover fully.
2. Check that the dose counter has gone down by one.
3. If you need to take another dose, repeat steps E.1 to E.4.