Foster Nexthaler 100 micrograms/6 micrograms per application Inhalation Powder - Package Leaflet (PIL) (2023)

• 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 exclusively for you. Don't share it with others. You can harm them even if the symptoms of the disease are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes possible side effects not listed 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 Nexthaler
4. Possible side effects
5. Preservation of Foster Nexthaler
6. Package Contents and Other Information

Fostair Nexthaler is used to treat asthma in adults.

If you are prescribed Fostair Nexthaler it is likely that you will:

• Her asthma is not adequately controlled with inhaled corticosteroids and short-acting "as needed" bronchodilators.

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• Your asthma is responding well to both corticosteroids and long-acting bronchodilators.

Fostair Nexthaler can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic disease of the airways in the lungs, mainly caused by smoking.

if you are allergic to beclomethasone dipropionate anhydrous or formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before using Fostair Nexthaler if you have any of the following problems:

• Heart problems, including any known problems with your heart and/or heart function
• Heart rhythm problems, such as increased or irregular heartbeat, fast heartbeat or palpitations, or if you have been told that your heart rhythm is abnormal
• hypertension
• Narrowing of the arteries (also known as atherosclerosis) or if you know you have an aneurysm (an abnormal bulge in the wall of a blood vessel).
• an overactive thyroid
• low level of potassium in the blood
• any disease of your liver or kidneys
• Diabetes. When you inhale high doses of formoterol your blood sugar may increase and you may therefore need to have some extra blood tests to check your blood sugar when you start using this inhaler and from time to time during treatment.
• Tumor of the adrenal gland (known as pheochromocytoma)
• You are about to be anesthetized. Depending on the type of anaesthesia, it may be necessary to stop using Fostair NEXThaler at least 12 hours before the anaesthesia.
• are being or have been treated for tuberculosis (TB) or have a known viral or fungal infection of the chest.

If any of the above apply to you, always tell your doctor before using Fostair Nexthaler.

If you are not sure if you can use Fostair Nexthaler, talk to your doctor, asthma nurse or pharmacist before using your inhaler.

Your doctor may check your blood potassium levels from time to time, especially if your asthma is severe.Like many bronchodilators, Fostair NEXThaler can cause a significant drop in your serum potassium level (hypokalaemia). This is because the lack of oxygen in your blood, combined with some other treatments you may be taking with Fostair Nexthaler, can make the fall in your potassium levels worse.

if you use an inhaler to take high doses of corticosteroids for a long time,You may have an increased need for corticosteroids in stressful situations. Stressful situations can include being admitted to the hospital after an accident, a serious injury or before an operation. In this case, your doctor will decide if you need to increase your corticosteroid dose and may prescribe you steroid pills or a steroid injection.

If you have to go to the hospitalRemember to take all your medicines and inhalers, including Fostair Nexthaler and any medicines or pills bought without a prescription, in the original packaging if possible.

Contact your doctor if you experience blurred vision or other vision problems.

Do not give this medicine to children and adolescents under 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Fostair Nexthaler can affect the way other medicines work. Also, some medicines can affect the way Fostair Nexthaler works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines can increase the effect of Fostair Nexthaler and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
• beta-blocker drugs. Beta blockers are medicines used to treat many conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eye). If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or formoterol may not work.
• Beta-adrenergic medicines (medicines that work in the same way as formoterol) can increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide)
• Medicines to treat allergic reactions (antihistamines such as terfenadine)
• Medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazid) or tricyclic antidepressants (e.g. amitriptyline and imipramine) or phenothiazines
• Medicines used to treat Parkinson's disease (L-Dopa)
• Medicines to treat an underactive thyroid (L-thyroxine)
• Medicines containing oxytocin (which causes uterine contractions)
• Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine
• medicines to treat heart disease (digoxin)
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids)
• Diuretics (water tablets)

Also tell your doctor or pharmacist if you are going to have an operation or dental treatment under general anesthesia.

There are no clinical data on the use of Fostair NEXThaler in pregnant women.

If you think you may be pregnant or are planning to have a baby, contact your doctor. You should only use Fostair Nexthaler during pregnancy if your doctor tells you to. Your doctor will decide whether you should stop taking Fostair Nexthaler while breast-feeding, or whether you should be taking Fostair Nexthaler but not breast-feeding. Always follow your doctor's advice strictly.

Fostair Nexthaler is unlikely to affect your ability to drive or use machines. However, if you experience side effects such as dizziness and/or tremors, your ability to drive or use machines may be affected.

Lactose contains small amounts of milk proteins, which can cause reactions in allergic patients. If your doctor has told you that you have an intolerance to sugars, talk to your doctor before taking this medicine.

Your doctor will check you regularly to make sure you are taking the right dose of Fostair Nexthaler. Once your asthma is well controlled your doctor may decide that your dose of Fostair NEXThaler should be gradually reduced.no wayYou should change the dose without talking to your doctor first.

a) Use Fostair NEXThaler every day to treat asthma, together with a separate 'reliever' inhaler to treat a sudden worsening of asthma symptoms such as shortness of breath, wheezing and cough

b) use Fostair Nexthaler every day to treat asthma and also use Fostair Nexthaler to treat a sudden worsening of asthma symptoms such as shortness of breath,wheezing and coughing

a) Using Fostair Nexthaler in conjunction with a separate “Reliever”:

Adults and Seniors:

The recommended dose of this medicine is 1 or 2 inhalations twice a day.

The maximum daily dose is 4 inhalations.

Remember, you should always carry your fast-acting 'cooler' inhaler with you to treat worsening asthma symptoms or a sudden attack.

b) Using Fostair Nexthaler as the only asthma inhaler:

Adults and Seniors:

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 have asthma symptoms, take an inhalation and wait a few minutes.

If you don't feel better, take another inhalation.

Do not take more than 6 relief puffs per day.

The maximum daily dose of Fostair NEXThaler is 8 inhalations.

If you feel you need more puffs each day to control your asthma symptoms, ask your doctor for advice. You may need to change your treatment.

Do not increase the dose.

If you feel that the medicine is not working, always consult your doctor before increasing the dose.

Adults and Seniors:

The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening.

Fostair Nexthaler is for inhalation use.

If possible, stand or sit upright as you inhale.

• Contact your doctor or nearest hospital casualty department immediately for advice. Take your medicine with you so others can see what you have taken;
• Side effects can occur. Let your doctor know if you have any unusual symptoms, as he or she may want to run more tests or decide what action is needed.

Take it as soon as you remember. If it is almost time for your next dose, skip the missed dose, just take your next dose at the right time.Do not double the dose.

Even if you feel better, do not stop using Fostair Nexthaler or reduce the dose. If you want to do this, talk to your doctor. It is very important that you use Fostair Nexthaler every day as directed by your doctor, even if you are not having any symptoms.

If your breathing doesn't change:

If your symptoms do not improve after taking Fostair Nexthaler, you may be using it incorrectly. Therefore, please refer to the instructions below for proper use and/or consult your doctor or healthcare professional for proper training.

If your asthma gets worse:

If your symptoms are getting worse or are difficult to control (e.g. you are using a separate “reliever” inhaler or Fostair Nexthaler as a “reliever” inhaler more often), or if your “reliever” inhaler or Fostair Nexthaler is not helping your symptoms, you should Continue to use Fostair Nexthaler, but see your doctor as soon as possible. Your doctor may need to change your dose of Fostair Nexthaler, or give you additional or alternative treatment.

A. Packinhalt

For information about the contents of the pack, see section 6. If the contents of the pack do not match those described in section 6, return the inhaler to the person who gave it to you and get a new one.

B. General Warnings and Cautions

• NOTake the inhaler out of the pouch if you don't want to use it straight away.
• Only use your inhaler as directed.
• Keep the cap closed until you need to take a dose from your inhaler.
• When you are not using your inhaler, store it in a clean, dry place.
• NOAttempt to disassemble your Nexthaler inhaler for any reason.

C. Key features of your Nexthaler inhaler

Taking a dose with your Nexthaler inhaler takes just three simple steps: open, inhale, close.

D. Before using a new Nexthaler inhaler

1. Open the sachet and take out the inhaler.

• NOuse your inhaler if the sachet is unsealed or broken; Return it to the person who gave it to you and get a new one.
• Use the box label to record the date the bag was opened.

2. Check your inhaler.

• If your inhaler is cracked or damaged, return it to the person who gave it to you and get a new one.

3. Check the dose counter window. If your inhaler is new, you will see 120 in the dose counter window.

• NOUse a new inhaler if the number displayed is less than '120'; Return it to the person who gave it to you and get a new one.

E. How to use your Nexthaler inhaler

• If you are not sure if you are getting the right dose, check with your doctor or pharmacist.
• If you are not sure whether the dose counter has decreased by one after taking your inhalation, wait until your next scheduled dose and take it as usual. Do not take an extra dose.

E.1. open

1. Hold your inhaler upright.

2. Check the number of doses remaining: Any number between "1" and "120" indicates the remaining doses.

• When the dose counter window shows '0', you are out of doses, throw away your inhaler and buy a new one.

3. Open the lid fully.

4. Before inhaling, exhale as much as possible.

• NObreathe out through your inhaler.

E.2. breathe in

If possible, stand or sit upright as you inhale.

1. Take the inhaler, bring it to your mouth and put your lips around the mouthpiece.

• NOCover the vent when you hold the inhaler.
• NOinhale through the air nozzle.

2. Breathe in forcefully and deeply through your mouth.

• There may be a taste when you take your dose.
• You may hear or feel a click when you take your dose.
• NOinhale through the nose.
• NORemove the inhaler from your lips while inhaling.

3. Take the inhaler out of your mouth.

4. Hold your breath for 5 to 10 seconds or as long as is comfortable.

5. Exhale slowly.

• NObreathe out through your inhaler.

E.3. close

1. Put the inhaler back in an upright position and close the lid completely.

2. Check that the dose counter has decreased by one.

3. If you need another dose, repeat steps E.1 to E.3.

f cleaning

• Usually it is not necessary to clean the inhaler.
• If necessary, you can clean your inhaler with a dry cloth or handkerchief after use.
  • NOClean your inhaler with water or other liquid. keep it dry

G. Storage and Disposal

For storage conditions and disposal instructions, see Section 5

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes possible side effects not listed in this leaflet. You can also report side effects directly via: The Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card on Google Play or the Apple App Store. By reporting side effects, you can help provide more information on the safety of this medication.

The active substances are beclomethasone dipropionate anhydrous and formoterol fumarate dihydrate.

Each metered dose contains 100 micrograms of beclomethasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a jet delivered dose of 81.9 micrograms of beclomethasone dipropionate anhydrous and 5 micrograms of formoterol fumarate dihydrate.

The other ingredients are: lactose monohydrate (contains small amounts of milk protein) and magnesium stearate.

This medication comes as a white to off-white powder for inhalation contained in a plastic inhaler called the Nexthaler.

Each pack contains one, two or three inhalers, each containing 120 puffs. Each inhaler is in a sealed protective pouch (foil pack). Not all pack sizes may be marketed.

Authorization holder:

I asked limited
333 Styal Street
Manchester
M22 5LG
Great Britain

Manufacturer responsible for batch release:

Chiesi Farmaceutici S.p.A.
Rua Sao Leonardo 96
43122 Parma
Italy

Alternative manufacturer responsible for batch release:

Chiesi S.A.S.
2 rue des Doctors Alberto und Paolo Chiesi
41260 Chaussee Saint-Victor
France

Alternative manufacturer responsible for batch release:

Chiesi Farmacéuticos GmbH
Gonzagagasse 16/16
1010 identical
Austria