FOSTAIR NEXTHALER

Posology FOSTAIR NEXTHALER is not intended for the initial management of asthma. The dosage of Fostair NEXThaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted.

If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta2-agonists and/or corticosteroids by individual inhalers should be prescribed. Because of its extrafine particle size distribution, dose adjustment is required when patients are transferred to Fostair NEXThaler inhalation powder from a formulation with a non-extrafine particle size distribution.

When switching patients from previous treatments, it should be considered that the recommended total daily dose of beclometasone dipropionate for Fostair NEXThaler is lower than that for current beclometasone dipropionate-containing non-extrafine products and should be adjusted to the needs of the individual patient.

Dose recommendations for adults 18 years and above Two inhalations twice daily. The maximum daily dose is 4 inhalations daily. Patients should be regularly reassessed by a doctor, so that the dosage of Fostair NEXThaler remains optimal and is only changed on medical advice.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step-down could include the inhaled corticosteroid alone.

A lower strength of the beclometasone dipropionate component in the same Nexthaler device is available for step-down treatment (Fostair NEXThaler 100/6 micrograms). Patients should be advised to take Fostair NEXThaler every day even when asymptomatic.

Special populations There is no need to adjust the dose in elderly patients. 2). Paediatric population Fostair NEXThaler 200/6 micrograms should not be used in children and adolescents below 18 years. Method of administration FOSTAIR NEXTHALER is for inhalation use.

Nexthaler is a breath-operated inhaler. 1). The delivery of Fostair NEXThaleris flow- independent in the range of inspiratory flow that this patient population can achieve through the inhaler. Correct use of the Nexthaler inhaler is essential in order for the treatment to be successful.

The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use as given in the leaflet. The number of inhalations shown in the window on the shell does not decrease on closing the cover if the patient has not inhaled through the inhaler.

The patient should be instructed to only open the inhaler’s cover when needed. In the event that the patient has opened the inhaler but not inhaled, and the cover is closed, the metered dose is moved back to the powder reservoir within the inhaler; the following metered dose can be safely inhaled.

4). INSTRUCTIONS FOR USE OF NEXTHALER INHALER A. 5. 5, return your inhaler to the person who supplied it and get a new one. B. General Warnings & Precautions • Do not remove the inhaler from the pouch if you do not intend to use it immediately.

• Only use your inhaler as indicated. • Keep the cover closed until you need to take a dose from your inhaler. • When you are not using your inhaler keep it in a clean and dry place. • Do not attempt to take your Nexthaler inhaler apart for any reason.

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. Dose counter window Cover Mouthpiec Air o Do not use your inhaler if the pouch is not sealed or it is damaged – return it to the person who supplied it and get a new one.

o Use the label on the box to write down the date you open the pouch. 2. Inspect your inhaler. o If your inhaler looks broken or damaged, return it to the person who supplied it and get a new one. 3. Check the Dose Counter Window. If your inhaler is brand new you will see “120” in the Dose Counter Window.

o Do not use a new inhaler if the number shown is less than “120” – return it to the person who supplied it and get a new one. E. How to use your Nexthaler inhaler • If you are not sure you are receiving your dose correctly contact your pharmacist or doctor.

• If you are not sure the dose counter has gone down by one after inhalation, wait until your next scheduled dose and take this as normal. Do not take an extra dose. 1. Open 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.

o If the Dose Counter Window shows “0” there are no doses left – dispose of your inhaler and get a new one. 3. Open the cover fully. 4. Before inhaling breathe out as far as is comfortable. o Do not breathe out through your inhaler. 2. Inhale 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. o Do not cover the air vent when holding your inhaler. o Do not inhale through the air vent. 2. Take a quick and deep breath through your mouth. o You may notice a taste when you take your dose.

o You may hear or feel a click when you take your dose. o Do not inhale through your […]

The most common adverse reaction is tremor. In a 12-week clinical trial with Fostair NEXThaler 100/6 micrograms, tremor was seen only with the highest dose regimen (400/24 micrograms daily), appeared most frequently at the beginning of treatment and was mild in intensity.

No patient was withdrawn from the trial as a result of tremor. Clinical Trials Experience in asthma patients The safety of Fostair NEXThaler 100/6 micrograms was assessed in active- and placebo-controlled clinical trials in which 719 patients aged 12 and older with asthma of varying severity were exposed to the drug.

The incidence of adverse reactions in the table below relates to asthmatic patients aged 12 years and older and is based upon the safety findings of two pivotal clinical trials where Fostair NEXThaler 100/6 micrograms was administered at the doses recommended in this SmPC for a period of 8-12 weeks.

No psychiatric disorders were observed in the clinical trials with Fostair NEXThaler 100/6 micrograms but they are included in the table as a potential class- effect of inhaled corticosteroids. Undesirable effects which have been associated with beclometasone dipropionate and formoterol administered as a fixed combination (Fostair NEXThaler) are given below, listed by system organ class.

Frequencies are defined as: very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1,000 to <1/100), rare ( 1/10,000 to < 1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data). 4) Frequency not known Nervous Tremor Common Tachycardia Uncommon Sinus bradycardia Uncommon Angina pectoris Uncommon Cardiac disorders Myocardial ischaemia Uncommon Throat irritation, exacerbation of asthma Uncommon Dyspnoea Uncommon Oropharyngeal pain Uncommon Dysphonia Uncommon Respiratory, thoracic and mediastinal disorders Cough Uncommon Gastrointestinal disorders Nausea Uncommon Fatigue UncommonGeneral disorders and administration site conditions Irritability Uncommon Electrocardiogram QT prolonged Uncommon Cortisol free urine decreased Uncommon Blood cortisol decreased Uncommon Blood potassium increased Uncommon Blood glucose increased Uncommon Investigations Electrocardiogram poor r-wave progression Uncommon Among the observed adverse reactions those typically associated with formoterol are: tremor, headache, tachycardia, sinus bradycardia, angina pectoris, myocardial ischaemia, QT prolongation.

Among the observed adverse reactions those typically associated with beclometasone dipropionate are: nasopharyngitis, oral candidiasis, dysphonia, throat irritation, irritability, cortisol free urine decreased, blood cortisol decreased, blood glucose increased.

Additional adverse reactions not observed in the clinical experience with Fostair NEXThaler but typically associated with the inhaled administration of beclometasone dipropionate are other oral fungal infections. Taste disturbances have occasionally been reported during inhaled corticosteroid therapy.

4 for measures to minimize the occurrence of oral fungal infections, oral candidiasis and dysphonia. g. 4). Additional adverse reactions not observed in the clinical experience with therapeutic doses of Fostair NEXThaler 100/6 micrograms but typically associated with the administration of beta2-agonist such as formoterol are palpitations, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia, potentially serious hypokalaemia and increase/decrease of blood pressure.

Insomnia, dizziness, restlessness, and anxiety have occasionally been reported during inhaled formoterol therapy. Formoterol may also induce muscle cramps, myalgia. Hypersensitivity reactions including rashes, urticaria, pruritus and erythema and oedema of the eye, face, lips and throat (angioedema) have been reported.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

It is recommended that the dose is tapered when the treatment is discontinued; treatment should not be stopped abruptly. The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests.

If patients find the treatment ineffective medical attention must be sought. Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Sudden and progressive deterioration in control of asthma is potentially life- threatening and the patient should undergo urgent medical assessment.

Consideration should be given to the need for increased treatment with corticosteroids, either inhaled or oral therapy, or antibiotic treatment if an infection is suspected. Patients should not be initiated on Fostair NEXThaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.

Serious asthma-related adverse events and exacerbations may occur during treatment with Fostair NEXThaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Fostair NEXThaler.

As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing, cough and shortness of breath after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. Fostair NEXThaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

FOSTAIR NEXTHALER is not intended for the initial management of asthma. For treatment of acute asthma attacks patients should be advised to have their short- acting bronchodilator available at all times. Patients should be reminded to take Fostair NEXThaler daily as prescribed even when asymptomatic.

Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Fostair NEXThaler. Regular review of patients as treatment is stepped down is important. 2). Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods.

These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

It is important therefore that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.

Children and adolescents aged less than 16 years inhaling higher than recommended doses of beclometasone dipropionate may be at particular risk. Situations which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage.

Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Patients transferring from oral to inhaled corticosteroids may remain at risk of impaired adrenal reserve for a considerable time. Patients who have required high dose emergency corticosteroid therapy in the past or have received prolonged treatment with high doses of inhaled corticosteroids may also be at risk.

This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered. The extent of the adrenal impairment may require specialist advice before elective procedures.

Fostair NEXThaler should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways. Fostair NEXThaler should be used with caution (which may include monitoring) in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, severe heart failure, severe arterial hypertension and aneurysm.

44 seconds). Formoterol itself may induce prolongation of the QTc interval. Caution is also required when Fostair NEXThaler is used by patients with thyrotoxicosis, diabetes mellitus, phaeochromocytoma and untreated hypokalaemia. Potentially serious hypokalaemia may result from beta2-agonist therapy.

Particular caution is advised in severe asthma as this effect may be potentiated by hypoxia. 5). Caution is also recommended in unstable asthma when a number of “rescue” bronchodilators may be used. It is recommended that serum potassium levels are monitored in such situations.

The inhalation of formoterol may cause a rise in blood glucose levels. Therefore blood glucose should be closely monitored in patients with diabetes. If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Fostair NEXThaler is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac […]

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