Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nedocromil sodium
Sanofi
R03BC03
Nedocromil sodium
2mg/1dose
Pressurised inhalation
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03030100; GTIN: 5000283651772
PACKAGE LEAFLET: INFORMATION FOR THE USER Is this leaflet hard to see or read? Phone 0845 372 7101 for help READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE ● 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. ● If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. IN THIS LEAFLET: 1. What Tilade is and what it is used for 2. Before you use Tilade 3. How to use Tilade 4. Possible side effects 5. How to store Tilade 6. Further information 1.WHAT TILADE IS AND WHAT IT IS USED FOR Tilade CFC-Free Inhaler (called Tilade throughout this leaflet) contains a medicine called nedocromil sodium. Tilade is used to treat asthma. ● It works by helping to stop tissues from swelling ● This helps stop the narrowing of the airways that happens in asthma Tilade is used to prevent asthma attacks and may be called a ‘preventer’. ● Tilade will not help an asthma attack that has already started ● You will need to use a different inhaler, called a ‘reliever’, for these attacks (see Section 3) 2.BEFORE YOU USE TILADE DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR IF: ✖ You are allergic (hypersensitive) to nedocromil sodium or any of the other ingredients of Tilade (listed in Section 6). Signs of an allergic reaction to Tilade include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Tilade. TAKE SPECIAL CARE WITH TILADE CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING YOUR MEDICINE IF: ▲ You are using any other inhalers If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Tilade USI Lue koko asiakirja
OBJECT 1 TILADE CFC-FREE INHALER Summary of Product Characteristics Updated 15-May-2014 | SANOFI 1. Name of the medicinal product Tilade CFC-Free Inhaler 2mg per actuation pressurised inhalation suspension 2. Qualitative and quantitative composition One metered dose (ex-valve) contains 2 mg nedocromil sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Pressurised inhalation suspension. Tilade CFC-Free Inhaler/Syncroner/Fisonair contains a new propellant, HFA-227, and does not contain any chlorofluorocarbons (CFCs). 4. Clinical particulars 4.1 Therapeutic indications Tilade CFC-Free is recommended for the treatment of bronchial asthma where regular preventative anti- inflammatory therapy is indicated and, in particular, in patients whose asthma is not adequately controlled by bronchodilators alone. Tilade CFC-Free may be given in addition to all existing therapies and in many cases will provide added therapeutic benefit. 4.2 Posology and method of administration Posology For inhalation use. _ADULTS, INCLUDING THE ELDERLY AND CHILDREN OVER 6 YEARS OF AGE._ The initial dose is 4 mg (2 actuations) four times daily. Once control of symptoms has been achieved it may be possible to reduce the dose to a maintenance dose of 4mg (2 actuations) twice daily. Tilade CFC-Free is intended for regular daily use and should not be used for the relief of symptoms in an acute attack. Tilade CFC-Free is not recommended for use in children 6 years of age and younger. _CONCOMITANT BRONCHODILATOR THERAPY_ Where a concomitant inhaled bronchodilator is prescribed it is recommended that this be administered prior to Tilade CFC-Free. _CONCOMITANT STEROID THERAPY_ In patients currently treated with steroids, the addition of Tilade CFC-Free to the regimen may make it possible to reduce the maintenance dose of steroids, or discontinue steroid therapy completely. The patient must be carefully supervised while the steroid dose is reduced; a rate of 10% weekly is suggested. If a reduction of a steroid dose has been p Lue koko asiakirja