Flomyst-F 10/250 HFA

Fluticasone and Formoterol is a fixed-dose combination metered-dose inhaler indicated for the regular treatment of, Asthma, where a long-acting ß2 agonist (LABA) in combination with an inhaled corticosteroid is appropriate.

Priming the inhaler Before using the inhaler for the first time, or if the inhaler has not been used for 3 days or more, or after exposure to freezing or refrigerated conditions (see section 6.4) the inhaler must be primed before use: • Remove the mouthpiece cover and shake the inhaler well. • Actuate (puff) the inhaler whilst pointing it away from the face. This step must be performed 4 times. • The inhaler should always be shaken immediately before use. Whenever possible patients should stand or sit in an upright position when inhaling from the inhaler. Steps to follow when using the inhaler: 1. Remove the mouthpiece cover and check that the mouthpiece is clean, and free from dust and dirt. 2. The inhaler should be shaken immediately before releasing each actuation (puff) to ensure that the contents of the inhaler are evenly mixed. 3. Breathe out as far as is comfortable and as slowly and deeply as possible. 4. Hold the canister vertically with its body upwards and put the lips around the mouthpiece. Hold the inhaler upright with a thumb(s) on the base of the mouthpiece and a forefinger/index finger(s) on the top of the inhaler. Do not bite the mouthpiece. 5. Breathe in slowly and deeply through the mouth. After starting to breathe in press down on the top of the inhaler to release one actuation (puff) and continue to breathe in steadily and deeply (optimally for about 4-5 seconds) 6. While holding breath, remove the inhaler from mouth. Patients should continue to hold their breath for as long as is comfortable. Do not breathe out into the inhaler. 7. For the second actuation (puff), keep the inhaler in a vertical position then repeat steps 2 to 6. 8. After use, replace the mouthpiece cover.

Inhalation Per actuation Fluticasone + Formoterol: 50/5, 125/5 and 250/10 mcg Recommended dose for Adults 250/10 mcg Inhaler: 2 inhalations (puffs) twice daily. 50 /5 mcg inhaler - 2 inhalations (puffs) twice daily normally taken in the morning and in the evening. 125/5 mcg inhaler - 2 inhalations (puffs) twice daily normally taken in the morning and in the evening.

Child < 12years not recommended. Recommended dose Adolescents aged 12 years and above: 50 /5 mcg inhaler - 2 inhalations (puffs) twice daily normally taken in the morning and in the evening. 125/5 mcg inhaler - 2 inhalations (puffs) twice daily normally taken in the morning and in the evening.

Hypersensitivity to the active substances or to any of the excipients. .

Fluticasone propionate is a synthetic, trifluorinated glucocorticoid with potent anti-inflammatory activity in the lungs when given by inhalation. Fluticasone propionate reduces symptoms and exacerbations of asthma with less adverse effects than when corticosteroids are administered systemically. Formoterol fumarate is a long-acting selective β2 adrenergic receptor agonist. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. The onset of bronchodilating effect is rapid, within 1 - 3 minutes, and the duration of effect is at least 12 hours after a single dose.

Fluticasone + Formoterol inhaler 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 the medicine to be used for relief in an acute asthma attack available at all times. The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should not be initiated on Fluticasone + Formoterol inhaler 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 this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Flutiform inhaler. This inhaler should not be used as the 1st treatment for asthma. Treatment with this inhaler should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under the supervision of a prescriber. An exacerbation of the clinical symptoms of asthma may be due to an acute respiratory tract bacterial infection and treatment may require appropriate antibiotics, increased inhaled corticosteroids and a short course of oral corticosteroids. A rapid-acting inhaled bronchodilator should be used as rescue medication. As with all inhaled medication containing corticosteroids, Flutiform inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. Any such infections must always be adequately treated if Flutiform inhaler is being used. This inhaler should be used with caution in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncorrected hypokalemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders eg, ischemic heart disease, cardiac arrhythmias or severe heart failure. Potentially serious hypokalemia may result from high doses of β2-agonists. Concomitant treatment of β2-agonists with drugs which can induce hypokalemia or potentiate a hypokalemic effect eg, xanthine derivatives, steroids and diuretics, may add to a possible hypokalemic effect of the β2-agonist. Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalemia adverse effects is increased. It is recommended that serum potassium levels are monitored during these circumstances. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval. As for all β2-agonists, additional blood sugar controls should be considered in diabetic patients. 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, 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 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.

Hyperglycemia; headache, tremor, dizziness, dysgeusia; palpitations, ventricular extrasystoles; asthma exacerbation, dysphonia, throat irritation; dry mouth, peripheral oedema.

Long-term treatment & co-administration w/ CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole, telithromycin). Non-K sparing diuretics (loop or thiazide diuretics), xanthine derivatives, glucocorticosteroids. L-dopa, L-thyroxine, oxytocin, alcohol can impair cardiac tolerance towards β2-sympathomimetics. Concomitant use w/ MAOIs, furazolidone & procarbazine may precipitate hypertensive reactions. Concomitant use w/ anaesth & halogenated hydrocarbons can elevate risk of arrhythmias. Additive effects w/ β-adrenergics. Increase risk of arrhythmias w/ digitalis glycosides. Administer w/ extreme caution to patients concomitantly taking TCAs or MAOIs & during the immediate 2 wk period following discontinuation. Increased risk of ventricular arrhythmias w/ phenothiazines, quinidine, disopyramide, procainamide & antihistamine. Potentiate sympathetic effect w/ adrenergic drugs. Inhibit the effect of β-blockers. Concomitant use w/ β-blockers including those used as eye drops or for glaucoma treatment.