国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Formoterol fumarate dihydrate
Novartis Pharmaceuticals UK Ltd
R03AC13
Formoterol fumarate dihydrate
12microgram
Inhalation powder
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101; GTIN: 5010678906059
FORADIL ® 12 MICROGRAMS INHALATION POWDER, HARD CAPSULES FORMOTEROL FUMARATE DIHYDRATE PACKAGE LEAFLET: INFORMATION FOR THE USER AND INSTRUCTIONS FOR USE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET: 1. What Foradil is and what it is used for 2. Before you take Foradil 3. How to take Foradil 4. Possible side effects 5. How to store Foradil 6. Contents of the pack and other information 1. WHAT FORADIL IS AND WHAT IT IS USED FOR The Foradil pack includes a blister pack of capsules containing the medicine and an inhaler device for taking the medicine. The capsules are for inhalation use only. Instructions for using the inhaler are given later on in the leaflet. The active ingredient in this medicine is formoterol fumarate dihydrate. Formoterol fumarate dihydrate is one of a group of medicines called long-acting bronchodilators. It makes breathing easier by relaxing muscle spasms in the air passages of the lungs. Foradil is used to treat asthma in people who are already taking inhaled steroids but still have symptoms such as wheezing and breathlessness. Taking Foradil regularly together with inhaled steroids will help to prevent breathing problems Foradil is also used to treat breathing problems in patients with chronic obstructive pulmonary disease (COPD) 2. BEFORE YOU TAKE FORADIL DO NOT TAKE FORADIL IF: you are allergic to formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6). Foradil is not suitable for children under six years of age. TALK 完全なドキュメントを読む
OBJECT 1 FORADIL Summary of Product Characteristics Updated 17-Oct-2016 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Foradil ® , 12 micrograms inhalation powder, hard capsule 2. Qualitative and quantitative composition Each capsule contains 12 micrograms formoterol fumarate dihydrate. Excipient(s) with known effect: Each capsule contains 25 mg lactose (as the monohydrate). For the full list of excipients, see Section 6.1. 3. Pharmaceutical form Inhalation powder, hard capsule 4. Clinical particulars 4.1 Therapeutic indications Foradil is indicated in asthma (including nocturnal asthma and exercise-induced symptoms) for those treated with inhaled corticosteroids who also require a long-acting beta agonist in accordance with current treatment guidelines. Foradil is indicated for the relief of reversible airways obstruction in patients with chronic obstructive pulmonary disease (COPD) requiring long-term bronchodilatory therapy. 4.2 Posology and method of administration POSOLOGY For use in adults (including the elderly) and in children 6 years of age and older _ADULTS (INCLUDING THE ELDERLY)_ Asthma Foradil should only be prescribed as an add-on to an inhaled corticosteroid. Regular maintenance therapy: 1 inhalation capsule (equivalent to 12 micrograms formoterol fumarate dihydrate) to be inhaled twice daily. For more severe cases 2 inhalation capsules to be inhaled twice daily. This dosing regimen provides symptomatic relief throughout day and night. The recommended maximum daily dose is 48 micrograms per day. Foradil should not be used to relieve the acute symptoms of an asthma attack. In the event of an acute attack, a short-acting beta2-agonist should be used (see Section 4.4). Chronic Obstructive Pulmonary Disease For regular maintenance therapy, 1 inhalation capsule (equivalent to 12 micrograms formoterol fumarate dihydrate) to be inhaled twice daily. _CHILDREN AGED 6 YEARS AND ABOVE_ Asthma Foradil should only be prescribed as an add-on to an inhaled corticosteroid. For regular maintena 完全なドキュメントを読む