SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Chemoterol 12 micrograms inhalation powder, hard capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 12 micrograms of formoterol fumarate (as dihydrate). Excipients with known effect: Lactose Monohydrate 23.99 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule. Transparent gelatin capsules containing white powder for inhalation. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention of bronchospasm as a result of exertion, symptomatic treatment of bronchial asthma and other chronic obstruction pulmonary diseases with a reversible component. Symptomatic long-term treatment of bronchial asthma in combination with a long-term antiinflammatory therapy (eg. corticosteroids). Note: There are no indications to date that formoterol can replace treatment with corticosteroids. In any case formoterol must be combined with corticosteroids by inhalation in bronchial asthma. 4.2 Posology and method of administration Capsules are only for inhalation. Formoterol's bronchodilator effect is still significant 12 hours after inhalation. Administration twice daily will therefore in most cases be adequate to control bronchoconstriction associated with chronic conditions, both during the day and at night. Posology Adults: Symptomatic treatment of bronchial asthma and other chronic obstructive pulmonary diseases with a reversible component. Normal maintenance dose is 1 inhalation capsule (12 micrograms) twice a day. If it is necessary to relieve possible symptoms, a further 1-2 capsules per day may be used. The maximum daily dose is 4 capsules (48 micrograms). Chemoterol, inhalation powder, hard capsule 12 micrograms SPC proposed Dec 2008-MAH Page 1 of 11 The patient should be informed that if the extra dosage is necessary more than twice a week, the doctor should be consulted and treatment reassessed, as it is possible that the condition has deteriorated. Prophylaxis on exertion-induced bronchospasm or before an unavoidable exposure to a known allergen: The contents of 1 inhalation capsule (12 micrograms) are inhaled 15 minutes before expected activity or exposure to the allergen. In adult patients with serious asthma, 2 capsules (24 micrograms) may be necessary. Paediatric population Children from 6 years: Symptomatic treatment of bronchial asthma without other chronic obstructive pulmonary diseases with a reversible component: Normal maintenance dose is 1 inhalation capsule (12 micrograms) twice a day. If it is necessary to relieve possible symptoms, a further 1-2 capsules per day may be used. The maximum daily dose is 4 capsules (48 micrograms). The patient should be informed that if the extra dosage is necessary more than twice a week, the doctor should be consulted and treatment reassessed, as it is possible that the condition has deteriorated. Prevention of bronchospasm as a result of inhaled allergens or exertion: The contents of 1 inhalation capsule (12 micrograms) are inhaled 15 minutes before expected activity or exposure to the allergen. Should not be used in children under the age of 6 years. Renal and hepatic impairment There is no theoretical reason to suggest that the formoterol dosage requires adjustment in patients with renal or hepatic impairment, however no clinical data have been generated to support its use in these groups. It should be ensured that the patient is instructed in the use of the inhaler by doctor or pharmacist. Method of administration Instructions for use: 1. Pull off the cap. 2. Hold the base of the inhaler firmly and turn the mouthpiece in the direction of the arrow to open. Chemoterol, inhalation powder, hard capsule 12 micrograms Page 2 of 11 3. Place one capsule with dry hands in the capsule-shaped compartment in the base of the inhaler. 4. Twist the mouthpiece to the closed position. 5. Keeping the inhaler upright (mouthpiece to top), firmly squeeze the two buttons at the same time once only. This will pierce the capsule. Release the buttons. Note: It is possible that gelatine capsule fragment and small pieces of gelatin capsule get into mouth and throat during inhalation. Gelatine pieces are harmless and will be digested after swallowing. The risk of fragmentation of gelatine capsule will be minimised if you remove the capsule from the blister pack immediately before use and squeeze the two buttons only once. 6. Breathe out fully. 7. Place the mouthpiece in your mouth and tilt your head slightly backwards. Close your lips around the mouthpiece and breathe in as quickly and as deeply as you can. Chemoterol, inhalation powder, hard capsule 12 micrograms Page 3 of 11 8. Hold your breath for as long as you comfortably can while taking the inhaler out of your mouth. Then breathe normally. Open the inhaler to see if any powder is still in the capsule. If there is still powder in the capsule, repeat steps 6 to 8. 9. After use, tip out the empty capsule and close the mouthpiece. Inhaler cleaning: In order to remove residual powder, clean mouthpiece and capsule compartment with a dry cloth. Also a clean soft brush can be used. 4.3 Contraindications Hypersensitivity to the active substance, to beta 2 agonists in general or to lactose (which contains small amount of milk proteins) or to any of the other excipients listed in section 6.1. 4.4 Special warnings and precautions for use Formoterol should not be used (and it is not sufficient) as the first treatment for asthma. Ashmatic patients who require therapy with long-acting β2-agonists, should also receive optimal maintenance anti-inflammatory therapy with corticosteroids. Patients must be advised to continue taking their anti-inflammatory therapy after the introduction of Formoterol even when symptoms decrease. Should symptoms persist, or treatment with β2-agonists need to be increased, this indicates a worsening of the underlying condition and warrants a reassessment of the maintenance therapy. Although Formoterol may be introduced as add-on therapy when inhaled corticosteroids do not proved adequate control of asthma symptoms, patients should not be initiated on Formoterol during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with Formoterol. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Formoterol. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Formoterol. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Formoterol should be used. The maximum daily dose should not be exceeded. The long term safety of regular treatment at higher doses than 36 micrograms per day in adults with asthma, 18 micrograms per day in children with asthma and 18 micrograms per day in patients with COPD has not been established. Chemoterol, inhalation powder, hard capsule 12 micrograms Page 4 of 11 Frequent need of medication (i.e. prophylactic treatment e.g. corticosteroids and long-acting β2-agonists) for the prevention of exercise-induced bronchoconstriction several times every week, despite an adequate maintenance treatment, can be a sign of suboptimal asthma control, and warrants a reassessment of the asthma therapy and an evaluation of the compliance. Caution should be observed when treating patients with thyrotoxicosis, phaeochromocytoma, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure Formoterol may induce prolongation of the QTc-interval. Caution should be observed when treating patients with prolongation of the QTc-interval and in patients treated with drugs affecting the QTcinterval (see section 4.5). Due to the hyperglycaemic effects of β2-agonists, additional blood glucose monitoring is recommended initially in diabetic patients. Potentially serious hypokalaemia may result from β2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatment with xanthine-derivatives, steroids and diuretics. The serum potassium levels should therefore be monitored. As with other inhalation therapy, the potential for paradoxial bronchospasm should be considered. If it occurs, the treatment should be discontinued immediately and alternative therapy started (see section 4.8). Formoterol contains lactose monohydrate (less than 500 micrograms per delivered dose). This amount does not normally cause problems in lactose intolerant people. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pediatric population Children up to the age of 6 years should not be treated with Formoterol , as no sufficient experience is available for this group. Formoterol inhalation powder should not be used therapeutically in the event of premature birth or threatened abortionLike other beta-2 agonists, formoterol may restrict labour pains because of relaxation of the smooth musculature in the uterus. 4.5 Interaction with other medicinal products and other forms of interaction No specific interaction studies have