SERETIDE EVOHALER

Posology Route of administration:

Inhalation use. Patients should be made aware that Seretide Evohaler must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Seretide 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
2 agonist could be titrated to Seretide 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 Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease.

Note:

Seretide 25 microgram/50 microgram strength is not appropriate for adults and children with severe asthma. If an individual patient should require dosages outside the recommended regimen, appropriate doses of
2 agonist and/or corticosteroid should be prescribed.

Recommended Doses:

Adults and adolescents 12 years and older: - Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily. or - Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily.

or - Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily. A short-term trial of Seretide 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 two inhalations of 25 micrograms salmeterol and 50 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. Seretide is not intended for the initial management of mild asthma. Seretide 25 micrograms/50 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 Children 4 years and older: - Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily. The maximum licensed dose of fluticasone propionate delivered by Seretide inhaler in children is 100 microgram twice daily.

1). Children <12 years old may have difficulties synchronising aerosol actuation with inspiration of breath. Use of a spacer device with Seretide inhaler is recommended in patients who have, or are likely to have difficulties to coordinate actuation with inspiration.

2). The Volumatic device can be used (depending on National Guidance). Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs.

4). Re-titration to the lowest effective dose should always follow the introduction or change of a spacer device.

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 Seretide in patients with hepatic impairment.

Instructions for Use:

Patients should be instructed in the proper use of their inhaler (see patient information leaflet) During inhalation, the patient should preferably sit or stand. The inhaler has been designed for use in a vertical position.

Testing the inhaler:

Before using for the first time patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, hold the inhaler between the fingers and thumb with their thumb on the base, below the mouthpiece and release puffs into the air until the counter reads 120 to make sure that it works.

The inhaler should be shaken immediately before releasing each puff. If the inhaler has not been used for a week or more the mouthpiece cover should be removed, the patient should shake the inhaler well and should release two puffs into the air.

Each time the inhaler is activated the number on the counter will count down by one. Use of the inhaler: 1. Patients should remove the mouthpiece cover by gently squeezing the sides of the cover. 2. Patients should check inside and outside of the inhaler including the mouthpiece for the presence of loose objects 3.

Patients should shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly […]

As Seretide 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 Bronchitis Oesophageal candidiasis Common Common1,3 Common1,3 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 children and adolescents, Decreased bone Rare4 System Organ Class Adverse Event Frequency mineral density Metabolism & Nutrition Disorders Hypokalaemia Hyperglycaemia Common3 Uncommon4 Psychiatric Disorders Anxiety Sleep disorders Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in children) Depression, aggression (predominantly in children) Uncommon Uncommon Rare Not Known Nervous System Disorders Headache Tremor Very Common1 Uncommon Eye disorder Cataract Glaucoma Vision, blurred Uncommon Rare4 Not known4 Cardiac Disorders Palpitations Tachycardia Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).

Atrial fibrillation Angina pectoris Uncommon Uncommon Rare Uncommon Uncommon Respiratory, Thoracic & Mediastinal Disorders Nasopharyngitis Throat irritation Hoarseness/dysphonia Sinusitis Paradoxical bronchospasm Very Common2,3 Common Common Common1,3 Rare4 System Organ Class Adverse Event Frequency Skin and subcutaneous tissue disorders Contusions Common1,3 Musculoskeletal & Connective Tissue Disorders Muscle cramps Traumatic fractures Arthralgia Myalgia Common Common1,3 Common Common 1.

Reported commonly in placebo 2. Reported very commonly in placebo 3. Reported over 3 years in a COPD study 4. 4 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.

Seretide Evohaler 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 Seretide Evohaler.

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.

Seretide Evohaler 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 Seretide 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 Seretide.

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

Regular review of patients as treatment is stepped down is important. 2). Treatment with Seretide should not be stopped abruptly due to risk of exacerbation. Therapy should be down-titrated under physician supervision. As with all inhaled medication containing corticosteroids, Seretide 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. Seretide 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. 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. Seretide Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. The pharmacological side effects of 2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.

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. 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.

Systemic absorption of salmeterol and fluticasone propionate is largely through the lungs. As the use of a spacer device with a metered dose inhaler may increase drug delivery to the lungs it should be noted that this could potentially lead to an increase in the risk of systemic adverse effects.

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 considered.

The extent of the adrenal impairment may require specialist advice before elective procedures. Ritonavir can greatly increase the concentration of fluticasone propionate in plasma. Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.

5). There was an increased reporting of […]

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