Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Formoterol fumarate
Laboratorios LICONSA, S.A.
R03AC; R03AC13
Formoterol fumarate
12 microgram(s)
Inhalation powder, hard capsule
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists; formoterol
Not marketed
2008-03-14
1/7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FORMOTEROL 12 MICROGRAMS INHALATION POWDER, HARD CAPSULE FORMOTEROL FUMARATE WHAT IS IN THIS LEAFLET 1. What Formoterol is and what it is used for 2. What you need to know before you take Formoterol 3. How to take Formoterol 4. Possible side effects 5. How to store Formoterol 6. Contents of the pack and other information 1. WHAT FORMOTEROL IS AND WHAT IT IS USED FOR Formoterol contains the active substance formoterol fumarate. Formoterol is one of a group of medicines called selective beta-2-adrenoreceptor agonists. Formoterol is used for prevention of induced-exercise asthma, treatment of symptoms of bronchial asthma and other chronic obstructive reversible pulmonary diseases such as coughing or breathing difficulties and for symptomatic long-term treatment of bronchial asthma in combination with a long- term anti-inflammatory therapy (eg. Corticosteroids). 2. WHAT YOU NEED TO KNOW BEFORE YOUR TAKE FORMOTEROL _ _ Follow carefully the instructions of your doctor or pharmacist even if those are different from the instructions given in this leaflet. _DO NOT TAKE FORMOTEROL _ - If you are allergic to formoterol, to beta 2 agonist general or to lactose (which contains small amount of milk proteins) or any of the other ingredients of this medicine (listed in section 6). _WARNING AND PRECAUTIONS FORMOTEROL _ Talk to your doctor or pharmacist before taking Formoterol - If you suffer from any heart problem: ischaemic heart disease (reduced blood supply to the heart muscle), cardiac arrhythmias (abnormal changes in heartbeat frequency), severe heart decompensation (defective cardiac filling and /or impaired contraction and emptying), subvalvular aortic stenosis (narrowing of aorta in the region under aortic valve), hypertrophic obstructive cardiomyopathy (thickness in the cardiac muscle that cause obstruction of the outflow of blood), aneurysm. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU - Keep t Pročitajte cijeli dokument
Health Products Regulatory Authority 14 December 2020 CRN00C0PN Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Formoterol 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). 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 bef Pročitajte cijeli dokument