Facet Turbuhaler Inhaler

Asthma : FACET TURBUHALER 80:4,5 u03bcg/dose: FACET TURBUHALER is indicated in the treatment of asthma in adolescents and adults where use of a combination (inhaled corticosteroid and long-acting beta-2-agonist) is appropriate. FACET TURBUHALER 160:4,5 u03bcg/dose: FACET TURBUHALER is indicated in the treatment of asthma in adolescents and adults to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations. FACET TURBUHALER is suitable for any asthma severity, where the use of inhaled corticosteroids is appropriate and where a long-acting beta-2-agonist is appropriate. COPD: FACET TURBUHALER 160:4,5 u03bcg/dose: FACET TURBUHALER 160:4,5 u03bcg/dose is indicated in the regular treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD), with frequent symptoms and a history of exacerbations.

Posology The dosage of FACET TURBUHALER should be individualised according to disease severity. When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. FACET can be used according to different treatment approaches for asthma: a) FACET anti-inflammatory reliever therapy. b) FACET anti-inflammatory reliever plus maintenance therapy. As an alternative, FACET can be used in a fixed dose therapy: c) FACET maintenance therapy. a) FACET anti-inflammatory reliever therapy (patients with mild disease): FACET TURBUHALER 160:4,5 u03bcg/dose: FACET is taken as needed for the relief of asthma symptoms when they occur, and to prevent allergen- or exercise-induced bronchoconstriction (or to prevent symptoms in those circumstances recognised by the patient to precipitate an asthma attack). The formoterol component in FACET TURBUHALER provides fast onset of effect (within 1-3 minutes) with long-acting (at least 12 hours after a single dose) bronchodilation in reversible airways obstruction. Patients should be advised to always have FACET available for relief of symptoms. Clinical studies have demonstrated that FACET anti-inflammatory reliever therapy provides significant reductions in severe exacerbations and was statistically superior on daily asthma symptom control compared to a short-acting beta-2-agonist therapy alone. Recommended doses: Medical Practitioner should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency. Adults and adolescents (12 years and older): FACET TURBUHALER 160:4,5 u03bcg/dose: Patients should take 1 inhalation as needed in response to symptoms and for the prevention of allergen- or exercise-induced bronchoconstriction to control asthma. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. Patients using more than 8 inhalations daily should be reassessed for alternative explanations of persisting symptoms. b) FACET Anti-inflammatory and Reliever Plus Maintenance Therapy: FACET TURBUHALER 80:4,5 u03bcg/dose or FACET TURBUHALER 160:4,5 u03bcg/dose: When maintenance treatment with a combination of inhaled corticosteroid and long-acting beta-2-agonist is required, FACET is taken as anti-inflammatory reliever therapy and in addition, patients take a daily maintenance dose of FACET. The as needed inhalations provide both rapid relief of symptoms and improved overall asthma control. Patients should be advised to have FACET TURBUHALER available for relief of symptoms at all times. A separate inhaler for relief of symptoms is not required. Clinical studies have demonstrated that FACET anti-inflammatory reliever plus maintenance therapy provides clinically meaningful reductions in severe exacerbations while maintaining symptom control, compared to FACET maintenance therapy with a separate short-acting bronchodilator. Recommended doses: Adults and adolescents (12 years and older): FACET TURBUHALER 80:4,5 u03bcg/dose The recommended maintenance dose is 2 inhalations per day, given either as 1 inhalation in the morning and evening or as 2 inhalations in either the morning or the evening. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. A reassessment of asthma therapy should be considered in patients using an increasing number of FACET inhalations for symptom relief without achieving improved asthma control within 3 days. A total daily dose of more than 8 inhalations is not normally needed, however a total daily dose of up to 12 inhalations could be used temporarily. If the patient experiences deteriorating symptoms after taking the appropriate maintenance therapy and additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms. FACET TURBUHALER 160:4,5 u03bcg/dose: Medical practitioner should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency. Patients should take 1 inhalation as needed in response to symptoms and for the prevention of allergen- or exercise-induced bronchoconstriction to control asthma. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. Patients also take the recommended maintenance dose, which is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or the evening. For some patients, a maintenance dose of 2 inhalations twice daily may be appropriate. A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. A reassessment of asthma therapy should be considered in patients using an increasing number of FACET inhalations for symptom relief without achieving improved asthma control within 3 days. If the patient experiences deteriorating symptoms after taking the appropriate maintenance therapy and additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms. c) FACET Maintenance Therapy (fixed dose): FACET TURBUHALER 80:4,5 u03bcg/dose or FACET TURBUHALER 160:4,5 u03bcg/dose: When maintenance treatment with a combination of inhaled corticosteroid and long-acting beta-2-agonist is required, FACET is taken as a fixed daily dose treatment, with a separate short-acting bronchodilator for relief of symptoms. Patients should be advised to have their separate short-acting bronchodilator available for relief of symptoms at all times. Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Recommended doses: Adults (18 years and older): FACET TURBUHALER 80:4,5 u03bcg/dose or FACET TURBUHALER 160:4,5 u03bcg/dose: 1-2 inhalations twice daily. In some cases, a maximum of up to 4 inhalations twice daily may be required as a maintenance dose or temporarily during worsening of asthma. Adolescents (12-17 years): FACET TURBUHALER 80:4,5 u03bcg/dose or FACET TURBUHALER 160:4,5 u03bcg/dose: 1-2 inhalations twice daily. During worsening of asthma, the dose may temporarily be increased to a maximum of 4 inhalations twice daily. When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. COPD Adults (18 years and older): FACET TURBUHALER 160:4,5 u03bcg/dose: 2 inhalations twice daily. Maximum daily dose: 4 inhalations. General information: If patients take FACET as a maintenance therapy, they should be instructed that, for optimal benefit, FACET TURBUHALER must be used even when they are asymptomatic. Special Populations There are no special dosing requirements for elderly patients. There are no data available for use of FACET TURBUHALER in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver diseases. Instructions for correct use of TURBUHALER: TURBUHALER is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways. Note: It is important to instruct the patient: u2022 To carefully read the instructions for use included below in this professional information, which is packed together with each inhaler. u2022 To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs. u2022 Never to breathe out through the mouthpiece. u2022 To replace the cover of the FACET TURBUHALER after use. u2022 To rinse the mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush. The patient may not taste or feel any medication when using TURBUHALER due to the small amount of medicine dispensed.

• Hypersensitivity to budesonide, formoterol or to inhaled lactose.
• Children below the age of 12 years, as safety and efficacy have not been demonstrated.

Dosing advice Treatment with FACET TURBUHALER should not be initiated to treat a severe exacerbation. It is recommended that the maintenance dose is tapered when long-term treatment is discontinued and the dosing should not be stopped abruptly. Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm the diagnosis of asthma. Deterioration of disease If patients find the treatment ineffective, or exceed the prescribed dose of FACET TURBUHALER, medical attention must be sought. Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and the patient should undergo urgent medical assessment. In this situation, consideration should be given to the need for increased therapy with corticosteroids, e.g. a course of oral corticosteroids, or antibiotic treatment if an infection is present. For treatment of severe exacerbations, a combination product of inhaled corticosteroid and long-acting beta-2-agonist alone is not sufficient. Transfer from oral therapy: Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients, who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to or severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. In recommended doses FACET TURBUHALER supplies less than normal physiological amounts of glucocorticosteroid systemically and does NOT provide the mineralocorticosteroid activity that is necessary for coping with these emergencies. Excipients: Contains lactose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not use FACET TURBUHALER. Caution with special diseases: FACET TURBUHALER should be administered with caution in patients with severe cardiovascular disorders (including heart rhythm abnormalities), diabetes mellitus, untreated hypokalaemia or thyrotoxicosis. High doses of beta-2-agonists can lower serum potassium by inducing a redistribution of potassium from the extracellular to the intracellular compartment, via stimulation of Na+/K+- ATPase in muscle cells. The clinical importance of this effect is uncertain. COPD Population: Clinical studies and meta-analyses indicate that maintenance treatment of COPD with inhaled corticosteroids may lead to an increased risk of pneumonia. Medical Practitioners should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. Paediatric population: Medical practitioners should closely follow the growth of children and adolescents taking long-term corticosteroids by any route, and weigh the benefits of the corticosteroid therapy against the possible risk of growth suppression.

Pharmacokinetic interactions: The metabolism of budesonide is primarily mediated by the enzyme CYP3A4. Inhibitors of this enzyme, e.g. ketoconazole, may therefore increase systemic exposure to budesonide. This is of limited clinical importance for short-term (1-2 weeks) treatment with ketoconazole, but should be taken into consideration during long-term treatment with ketoconazole. Pharmacodynamic interactions: Beta-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc interval and increase the risk of ventricular dysrhythmias. Budesonide and formoterol have not been observed to interact with any other medicine used in the treatment of asthma.

The safety of FACET TURBUHALER in pregnant and lactating women has not been established. Corticosteroids are teratogenic in animals. Pregnancy There are no adequate data from use of formoterol in pregnant women. In animal studies formoterol has caused adverse effects in reproduction studies at very high systemic exposure levels. Breastfeeding Safety in breastfeeding has not been demonstrated. A clinical pharmacology study has shown that inhaled budesonide is excreted in breast milk. Women using the FACET TURBUHALER should not breastfeed their infants. Fertility There are no animal studies on the effect of the budesonide/formoterol combination on fertility.

FACET TURBUHALER is not expected to adversely affect the ability to drive or use machines.

a) Summary of the safety profile Since FACET TURBUHALER contains both budesonide and formoterol, the same type and intensity of undesirable effects as reported for these substances may occur. The most common medicine related adverse reactions are pharmacologically predictable side effects of beta-2- agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment. b) Tabulated summary of adverse reactions Adverse reactions which have been associated with budesonide or formoterol are given below in Table 1: Table 1: Adverse reactions by frequency and system organ class (SOC): Frequency System Organ Class Event Common 1 % to 10 % Cardiac disorders: Palpitations Infections and infestations: Candida infections in oropharynx, Pneumonia (in COPD patients) Nervous system disorders: Headache, tremor Respiratory, thoracic and mediastinal disorders: Irritation in the throat, coughing, hoarseness Uncommon 0,1 % to 1 % Cardiac disorders: Tachycardia Gastrointestinal disorders: Nausea Musculoskeletal and Muscle cramps Nervous system disorders: Dizziness Psychiatric disorders: Agitation, restlessness, nervousness, sleep disturbances Rare 0,01 % to 0,1 % Cardiac disorders: Cardiac dysrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles Immune system disorders: Immediate and delayed hypersensitivity reactions, e.g. dermatitis, exanthema, urticaria, pruritus, angioedema and anaphylactic reaction. Respiratory, thoracic and mediastinal disorders: Bronchospasm Skin and subcutaneous tissue disorders: Skin bruising Very rare < 0,01 % Cardiac disorders: Angina pectoris Endocrine disorders: Signs or symptoms of systemic gluco- corticosteroid effects, e.g. hypofunction of the adrenal gland Metabolism and Hyperglycaemia nutrition disorders: Psychiatric disorders: Depression, behavioural disturbances

An overdose of formoterol would likely lead to effects that are typical for beta-2-adrenergic agonists: tremor, headache, palpitations, and tachycardia. Hypotension, metabolic acidosis, hypokalaemia and hyperglycaemia may also occur. Supportive and symptomatic treatment may be indicated. A dose of 90 micrograms administered during 3 hours in patients with acute bronchial obstruction raised no safety concerns. Acute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem. When used chronically in excessive doses, systemic glucocorticosteroid effects may appear.