STALPEX

Stalpex is indicated in adults and adolescents 12 years of age and older only. Stalpex is not indicated for use in children younger than 12 years of age.

Posology Route of administration:

Inhalation use. Patients should be made aware that Stalpex must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Stalpex they are receiving remains optimal and is changed on medical advice.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. e. Salmeterol/Fluticasone 50 mcg /500 mcg. e. salmeterol/ fluticasone 50/250 and 50/100 mcg). These strengths are available for other similar fixed-dose combination DPI products containing these two actives and currently available on the market.

Therefore, when it is appropriate to titrate down to a lower strength not available for Stalpex a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.

Stalpex should not be used for patients with mild or moderate asthma, in whom a low dose of the inhaled corticosteroid, either alone or with a long- acting β2 agonist, may be required. Patients should be given the strength of the combination product containing the appropriate fluticasone propionate dosage for the severity of their disease.

Stalpex is appropriate for use in treatment of patients with severe asthma. 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 500 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 a lower dose inhaled corticosteroid/ LABA combination or ICS alone.

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.

Stalpex is not intended for the initial management of mild or moderate asthma. Stalpex is for the treatment of patients with severe asthma only. It should not be used for the treatment of patients with mild or moderate asthma or for the initiation of treatment for patients with severe asthma unless the requirement for such a high dose of the corticosteroid together with a long-acting β2 agonist has been established previously.

Stalpex is not intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time. Patients should commence treatment with a fixed-dose combination containing a lower dose of the corticosteroid component and will then be titrated up in respect of the corticosteroid dose until control of asthma is achieved.

Once control of asthma is achieved patients should be reviewed regularly and the dose of inhaled corticosteroid titrated downwards as appropriate to maintain disease control.

Paediatric population Children:

Limited data are available. No recommendation on a posology can be made for children under 12 years of age. 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 Stalpex in patients with hepatic impairment. Using the inhaler device The device is opened and primed by sliding the lever. The mouthpiece is then placed in the mouth and the lips closed round it.

The dose can then be inhaled and the device closed.

As Stalpex 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 (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) 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. System Organ Class Adverse Event Frequency Infections & Infestations Candidiasis of the mouth and throat Pneumonia (in COPD patients) Bronchitis Common Common1, 3, 5 Common1, 3 Oesophageal candidiasis Rare Immune System Disorders Hypersensitivity reactions with the following manifestations: Cutaneous hypersensitivity reactions Angioedema (mainly facial and oropharyngeal oedema) Respiratory symptoms (dyspnoea) Respiratory symptoms (bronchospasm) Anaphylactic reactions including anaphylactic shock Uncommon Rare Uncommon Rare Rare Endocrine Disorders Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in adolescents, Decreased bone mineral density Rare4 Metabolism & Nutrition Disorders Hypokalaemia Hyperglycaemia Common3 Uncommon4 Psychiatric Disorders Anxiety Sleep disorders Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in adolescents) Depression, aggression (predominantly in adolescents) Uncommon Uncommon Rare Not Known Nervous System Disorders Headache Tremor Very Common1 Uncommon Eye Disorders Cataract Glaucoma Vision, blurred Uncommon Rare4 Not known4 Cardiac Disorders Palpitations Tachycardia 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. Stalpex 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 mouth and throat 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 the Salmeterol/Fluticasone APC.

4). Adolescents 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 Stalpex is for use in patients with severe asthma only. It 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 Stalpex 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 Stalpex .

Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Stalpex . 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 the inhaled corticosteroid and therefore a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.

Regular review of patients as treatment is stepped down is important. The lowest dose of inhaled corticosteroid should be used. 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 Stalpex .

Treatment with Stalpex 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.

As with all inhaled medication containing corticosteroids, Stalpex 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. Stalpex 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. Stalpex should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. 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.

9 milligram /dose. This amount does not normally cause problems in lactose intolerant people. 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 adolescents) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in 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. 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 1000 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 mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be […]

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