Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BECLOMETHASONE DIPROPIONATE; SALBUTAMOL SULPHATE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
BECLOMETHASONE DIPROPIONATE; SALBUTAMOL SULPHATE
1units Units
Glenmark Pharmaceuticals Ltd.
_Consumer Medication Information Leaflet (RiMUP) _ IBICAR S (Salbutamol 100 mcg/actuation and Beclometasone 50 mcg/actuation Pressurised Inhalation) 1 WHAT IS IN THIS LEAFLET? 1. What Ibicar S is used for 2. How Ibicar S works 3. Before you use Ibicar S 4. How to use Ibicar S 5. While you are using it 6. Side effects 7. Storage and disposal 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IBICAR S IS USED FOR? Ibicar S Inhaler contains Salbutamol and Beclometasone dipropionate. Salbutamol, this belongs to a group of medicines called fast acting bronchodilators and Beclometasone dipropionate which is one of a group of medicines known as corticosteroids. It is used for treatment of reversible airways obstruction. HOW IBICAR S WORKS Salbutamol works as bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out. They help to relieve chest tightness, wheezing and cough. Beclometasone dipropionate works deep in your lungs to make breathing easier by reducing the inflammation, swelling and irritation in the airways. It needs to be taken regularly every day, even if you have no symptoms. BEFORE YOU USE IBICAR S - WHEN YOU MUST NOT USE IT Do not use Ibicar S Inhaler if you: Are allergic to actives or any of the other ingredients Are suffering from a sudden attack of breathlessness. It will not help. Use a quick-acting ‘reliever’ inhaler for this purpose and carry it with you at all times. - BEFORE YOU START TO USE IT You should use properly the inhaler to ensure that the drug reaches the target area within the lungs. You have to use Ibicar S regularly, every day, for optimum benefit. You have to inform to your doctor for regular reassessment so that your continued corticosteroid therapy has been reviewed. Talk to your doctor before you start to use this medicine if: You are steroid-dependent, so that they may start therapy with Beclomethasone dipropionate. You are suffering from tuberculosis (TB) no Lue koko asiakirja
COMPOSITION: EACH ACTUATION DELIVERS: Salbutamol Sulphate BP equivalent to Salbutamol 100 mcg Beclometasone Dipropionate Anhydrous Ph. Eur 50 mcg Ethanol BP 3.5% w/w (5.23% v/v) (2.52 mg) DOSAGE FORM Inhalation aerosol DESCRIPTION White to off white colour suspension filled in aluminium aerosol can with silver ferrule valve provided with actuator suitable for oral inhalation when actuated a metered spray is produced. PHARMACOLOGY PHARMACODYNAMICS SALBUTAMOL: Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it act on the beta-2 adrenoceptors of bronchial muscle. BECLOMETASONE DIPROPIONATE: Beclomethasone dipropionate given by inhalation has a potent glucocorticoid anti-inflammatory action within the lungs. PHARMACOKINETICS There is no evidence that the administration of salbutamol and beclomethasone dipropionate together by the inhaled route in any way affects the pharmacokinetics of either component. For pharmacokinetic purposes therefore each component can be considered separately. SALBUTAMOL: Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%. After administration by the inhaled route, between 10 and 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or deposited in the oropharynx from where it is swallowed. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but it is not metabolized by the lung. On reaching the systemic circulation it becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as phenolic sulphate. The swallowed portion of an inhaled dose is absorbed from the gastr Lue koko asiakirja