- 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 leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility 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
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.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Do not give this medicine to children and adolescents aged less than 18 years.
Other medicines and Fostair NEXThaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Fostair NEXThaler may affect the way some other medicines work. Also, some medicines can affect the way Fostair NEXThaler works.
In particular, tell your doctor or pharmacist if you are using any of the following medicines:
Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.
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.
Lactose contains small amounts of milk proteins, which may cause reactions in allergic patients. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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.
Fostair NEXThaler can be prescribed by your doctor in two different ways:
a) use Fostair NEXThaler every day to treat your asthma together with a separate “reliever “ inhaler to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing and cough
b) use Fostair NEXThaler every day to treat your asthma and also use Fostair NEXThaler to treat sudden worsening of your asthma symptoms, such as shortness of breath, wheezing and cough
a) Using Fostair NEXThaler together with a separate “reliever”:
Adults and the elderly:
The recommended dose of this medicine is 1 or 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
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.
b) Using Fostair NEXThaler as your only asthma inhaler:
Adults and the elderly:
The usual dose is one inhalation in the morning and one inhalation in the evening.
You should also use Fostair NEXThaler as a “reliever” inhaler to treat sudden asthma symptoms.
If you get asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.
Do not take more than 6 reliever inhalations per day.
The maximum daily dose of Fostair NEXThaler is 8 inhalations.
If you feel you need more inhalations each day to control your asthma symptoms, contact your doctor to seek his advice. He may need to change your treatment.
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 2 inhalations in the morning and 2 inhalations in the evening.
How to use Fostair NEXThaler:
Fostair NEXThaler is for inhalation use.
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 below for correct use 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 a separate “reliever” inhaler or Fostair NEXThaler as reliever inhaler more frequently) or if your “reliever” inhaler or Fostair NEXThaler 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.
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):
Not known (frequency cannot be estimated from the available data):
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 directly 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.
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 10/2018.
INSTRUCTIONS FOR USE OF NEXThaler INHALER
A. Contents of the Package
For information on the contents of the pack see section 6. If the package contents are not the same as described in section 6, return your inhaler to the person who supplied it 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
1. Hold your inhaler firmly in the upright position.
2. Check the number of doses left: any number between “1” and “120” shows that there are doses left.
3. Open the cover fully.
4. 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 forceful 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.3.
G. Storage and Disposal
For information on storage conditions and disposal instructions, see section 5.