FIXKOH AIRMASTER

Posology Patients are to be made aware that Fixkoh Airmaster must be used daily for optimal benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Fixkoh Airmaster they are receiving 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. Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone.

As an alternative, patients requiring a long-acting β2 agonist could be titrated to Fixkoh Airmaster given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control. In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly daytime symptoms the dose should be given in the morning.

Patients should be given the strength of Fixkoh Airmaster containing the appropriate fluticasone propionate dosage for the severity of their disease. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed.

Recommended Doses:

Asthma Adults and adolescents 12 years and older: - One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. or - One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.

or - One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily. A short-term trial of Fixkoh Airmaster may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential.

In these cases, the recommended initial dose is one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone.

Regular review of patients as treatment is stepped down is important. A clear benefit has not been shown as compared to inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing.

In general, inhaled corticosteroids remain the first line treatment for most patients. Fixkoh Airmaster is not intended for the initial management of mild asthma. Fixkoh Airmaster 50 microgram/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-combination can be used in patients with severe asthma.

Paediatric population Fixkoh Airmaster is not recommended for use in children aged under 12 years of age. The safety and efficacy of Fixkoh Airmaster in children aged less than 12 years of age has not been established. COPD Adults: - One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.

Special patient groups There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Fixkoh Airmaster in patients with hepatic impairment. Method of administration Inhalation use.

Required training Fixkoh Airmaster must be used correctly in order to achieve effective treatment. All patients must be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.

All patients must be trained by the prescribing health care professional on how to use Fixkoh Airmaster, especially if this is their first time in using this inhaler. This is to ensure that they understand how to use the inhaler correctly.

The use of Fixkoh Airmaster follows three simple steps, which are outlined below: 1. The device is opened by depressing the red safety lock and primed by sliding the light pink (for 50/100 microgram strength) mouthpiece cover until a “click” is heard.

2. The patient must first exhale. The mouthpiece is then placed in the mouth and the lips closed round it. The dose can then be inhaled through the inhaler by breathing in steadily and deeply. The inhaler is then removed from the mouth and the patient must hold their breath for about 10 seconds or as long as is comfortable.

3. The patient must then be instructed to breathe out gently and close the inhaler cover until a “click” is heard. Patients must also be advised to rinse their mouth afterwards with water and spit it out and/or brush their teeth after inhaling.

Summary of safety profile As Fixkoh Airmaster contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.

Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. 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 not known (cannot be estimated from the available data).

Frequencies were derived from clinical trial data. The incidence in placebo was not taken into account. 4) Not Known2,4 Palpitations Uncommon Tachycardia Uncommon Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).

1 Description of selected adverse reactions The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.

Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. Fixkoh Airmaster should be discontinued immediately, the patient assessed, and alternative therapy instituted if necessary. Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely, of the oesophagus can occur in some patients.

Both hoarseness and incidence of candidiasis may be relieved by rinsing the mouth with water and/or brushing the teeth after using the product. Symptomatic mouth and throat candidiasis can be treated with topical anti-fungal therapy whilst still continuing with Fixkoh Airmaster.

4). Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Deterioration of disease Fixkoh Airmaster should not be used to treat acute asthma symptoms for which a fast- and short- acting bronchodilator is required. Patients should be advised to have their inhaler to be used for relief in an acute asthma attack available at all times.

Patients should not be initiated on Fixkoh Airmaster 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 Fixkoh Airmaster.

Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Fixkoh Airmaster. Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of control and patients should be reviewed by a physician.

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 increasing corticosteroid therapy. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Fixkoh Airmaster.

Regular review of patients as treatment is stepped down is important. 2). For patients with COPD experiencing exacerbations, treatment with systemic corticosteroids is typically indicated, therefore patients should be instructed to seek medical attention if symptoms deteriorate with Fixkoh Airmaster.

Cessation of therapy Treatment with Fixkoh Airmaster should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician.

Caution with special diseases As with all inhaled medication containing corticosteroids, Fixkoh Airmaster should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway.

Appropriate treatment should be promptly instituted, if indicated. g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses Fixkoh Airmaster should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.

8) and this should be considered when prescribing to patients with a history of diabetes mellitus. Paradoxical bronchospasm As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.

Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. Fixkoh Airmaster should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Beta 2 adrenoreceptor agonists The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.

Excipients Fixkoh Airmaster contains approximately 13 milligram/dose of lactose monohydrate. This amount does not normally cause problems in lactose intolerant people. Th excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

Systemic corticosteroid effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents).

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

Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1,000 micrograms. 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.

The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Therefore these patients should be treated with special care and adrenocortical function regularly monitored.

Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk. This possibility of residual impairment should always be borne in […]

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