Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Formoterol fumarate dihydrate; Beclometasone dipropionate
Chiesi Ltd
R03AK08
Formoterol fumarate dihydrate; Beclometasone dipropionate
6microgram/1dose ; 200microgram/1dose
Inhalation powder
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03020000; GTIN: 5028613002988
PAGE 1/2 00331/RE PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _200 MICROGRAMS/6 MICROGRAMS _ _PER ACTUATION INHALATION POWDER_ _BECLOMETASONE DIPROPIONATE ANHYDROUS/_ _FORMOTEROL FUMARATE DIHYDRATE_ _ _ FOR USE IN ADULTS SHOULD YOU NEED TO GO TO THE HOSPITAL, remember to take all of your medicines and inhalers with you, including Fostair NEXThaler and any medicines or tablets bought without a prescription, in their original package, if possible. CHILDREN AND ADOLESCENTS Do not give this medicine to children and adolescents aged less than 18 years. OTHER MEDICINES AND FOSTAIR NEXTHALER Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including any other inhalers and including medicines obtained without a prescription. This is because Fostair NEXThaler may affect the way some other medicines work. Also, some medicines can affect the way Fostair NEXThaler works. Some medicines may increase the effects of Fostair NEXThaler and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). DO NOT USE BETA BLOCKERS WITH THIS MEDICINE. Beta blockers are medicines used to treat many conditions including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you need to use beta blockers (including eye-drops), the effect of formoterol may be reduced or formoterol may not work at all. USING FOSTAIR NEXTHALER WHEN YOU ARE TAKING THE FOLLOWING MEDICINES: • other medicines which work in the same way as formoterol (i.e. beta adrenergic drugs, commonly used to treat asthma) Æ can increase the effects of formoterol. • quinidine, disopyramide, procainamide (to treat abnormal heart rhythms) • some antihistamines for example terfenadine (to treat allergic reactions) • monoamine oxidase inhibitors or tricyclic antidepressants for example phenelzine, isocarboxazid, amitriptyline and imipramine; phenothiazines (to treat depression or mental disorders) Æ can cause c Aqra d-dokument sħiħ
OBJECT 1 FOSTAIR NEXTHALER 200/6 Summary of Product Characteristics Updated 13-Jun-2017 | Chiesi Limited 1. Name of the medicinal product Fostair NEXThaler 200 micrograms/6 micrograms per actuation inhalation powder. 2. Qualitative and quantitative composition Each metered dose of 10 mg inhalation powder contains: 200 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose of 158.8 micrograms of beclometasone dipropionate anhydrous and 4.9 micrograms of formoterol fumarate dihydrate. Excipient with known effect: Each metered dose contains 9.8 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Inhalation powder. The multidose inhaler contains a white or almost white powder. 4. Clinical particulars 4.1 Therapeutic indications Fostair NEXThaler is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta 2 -agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta 2 -agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta 2 -agonists. Fostair NEXThaler is indicated in adults. Note: there are no relevant clinical data on the use of Fostair NEXThaler for the treatment of acute asthma attacks. 4.2 Posology and method of administration Posology The dosage of Fostair NEXThaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta 2 -agonists and/or corticosteroids by individual inhalers should be prescribed. Because of its extrafine particle size distribution, dose adjustment is required when patients are transferred to Fostai Aqra d-dokument sħiħ