Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Beclometasone dipropionate
Mawdsley-Brooks & Company Ltd
R03BA01
Beclometasone dipropionate
100microgram/1dose
Pressurised inhalation
Inhalation
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 03020000
PATIENT INFORMATION LEAFLET QVAR ® 100 INHALER (beclometasone dipropionate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Your medicine will be referred to as Qvar Inhaler throughout this leaflet. This medicine is also available in Qvar 50 Inhaler. WHAT IS IN THIS LEAFLET 1. WHAT QVAR INHALER IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE QVAR INHALER 3. HOW TO USE QVAR INHALER 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE QVAR INHALER 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT QVAR INHALER IS AND WHAT IT IS USED FOR Qvar Inhaler contains beclometasone dipropionate, which is one of a group of medicines known as corticosteroids. Qvar Inhaler is used to prevent the symptoms of mild, moderate, or severe asthma, in patients who require regular treatment. HOW YOUR MEDICINE WORKS • Qvar Inhaler works deep in your lungs to make breathing easier by reducing the inflammation, swelling and irritation in the airways. This type of medicine is known as a ‘preventer’. It needs to be taken regularly every day, even if you have no symptoms. • This inhaler will not give immediate relief of wheezing or breathlessness during a sudden asthma attack. You will need to use a ‘reliever’ inhaler, which contains a different medicine. You should still continue to use this inhaler. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE QVAR INHALER DO NOT USE QVAR INHALER: • if you are allergic to beclometasone dipropionate or any of the other ingredients of this medicine (listed in section 6) • if you are alle Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Qvar Easi-Breathe 100 micrograms per actuation inhaler 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Beclometasone Dipropionate 100 micrograms per metered (ex-valve) dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, solution A colourless solution in a pressurised aluminium canister fitted with a metering valve and an actuator. Qvar Easi-Breathe contains a propellant, which does not contain any chlorofluorocarbons (CFCs). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic management of mild, moderate or severe asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Qvar Easi-Breathe is for inhalation use only. Patients should be instructed in the proper use of their inhaler, including rinsing out their mouth with water after use.. NOTE: THE RECOMMENDED TOTAL DAILY DOSE OF QVAR EASI-BREATHE IS LOWER THAN THAT FOR CURRENT BECLOMETASONE DIPROPIONATE CONTAINING PRODUCTS AND SHOULD BE ADJUSTED TO THE NEEDS OF THE INDIVIDUAL PATIENT. ADULT STARTING AND MAINTENANCE DOSE: It is important to gain control of asthma symptoms and optimise pulmonary function as soon as possible. When patients’ symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained. To be effective inhaled Qvar Easi-Breathe must be used on a regular basis even when patients are asymptomatic. THERAPY IN NEW PATIENTS SHOULD BE INITIATED AT THE FOLLOWING Mild asthma: 100 to 200 micrograms per day in two divided doses. Moderate asthma: 200 to 400 micrograms per day in two divided doses. Severe asthma: 400 to 800 micrograms per day in two divided doses. Patients on budesonide inhalers may be transferred to Qvar as described below The general approach to switching patients to Qvar involves two steps as detailed below. Specific guidance on switching well-controlled and poorly-controlled (symptomatic) patients is given below the table. Step 1: Consider Διαβάστε το πλήρες έγγραφο