Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALBUTAMOL
Duopharma Marketing Sdn. Bhd.
SALBUTAMOL
56Tablet Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
SALMAX CR ® Salbutamol Sulphate (4 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Salmax CR is used for 2. How Salmax CR works 3. Before you use Salmax CR 4. How to use Salmax CR 5. While you are using it 6. Side effects 7. Storage and Disposal of Salmax CR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SALMAX CR IS USED FOR Salmax CR helps you breathe more easily. Salmax CR works by opening up the airways tubes in your lungs when your chest is tight or when you are wheezing. Ask your doctor if you have any questions about why Salmax CR has been prescribed for you. Your doctor may have prescribed it for another purpose. HOW SALMAX CR WORKS Salmax CR belongs to a group of medicines called bronchodilators. Because the medicine in your tablet gives relief from your chest symptoms, it is often called a 'reliever'. There are other types of medicines that prevent wheezing or chest tightness. These medicines are called 'preventers' and must be used every day. Your doctor may tell you to use a 'preventer' in addition to your Salmax CR. BEFORE YOU USE SALMAX CR - _When you must not use it _ Do not take Salmax CR if you have ever had an allergic reaction to: • Salbutamol sulphate • Any of the ingredients listed at the end of this leaflet. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. - _Before you start to use it _ Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives. Tell your doctor if you have or have had any of the following medical conditions: • Stop taking Salmax CR or any other asthma medicine for any reason • High thyroid level • Heart condition • Liver condition • Diabetes If you have not told your doctor about any of these things, tell them before you take Salmax CR. - _Taking other medicines _ Tell your doctor or Lire le document complet
PRODUCT DESCRIPTION Salmax CR Tablet 4mg are white, hexagonal-shaped tablet embossed with 4 on one side and plain on the other side. COMPOSITION Each Salmax CR Tablet 4mg contains 4 mg of Salbutamol as sulphate in a controlled release delivery system. Preservative: none PHARMACODYNAMICS Salbutamol is a direct-acting sympathomimetic agent with predominantly beta-adrenergic activity and a selective action on beta receptors in bronchial smooth muscle. This preference for beta receptor stimulation results in its bronchodilating action being relatively more prominent than its effect on the heart. The action of Salbutamol is believed to result from increased production of cyclic adenosine 3', 5'-monophosphate (c-AMP) caused by the activation of enzyme adenyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to c-AMP. Increased c-AMP concentrations relax the bronchial smooth muscle and inhibit the release of mediators of immediate hypersensitivity from cells, especially mast cells. Salbutamol relaxes bronchial smooth muscle in the lungs, thereby relieving bronchospasm, increasing vital capacity, decreasing residual volume and reducing airway resistance. PHARMACOKINETICS Salbutamol is readily absorbed from the gastro-intestinal tract. It undergoes first-pass metabolism in the liver and possibly in the gut wall, producing an inactive sulphate conjugate as the main metabolite. It is rapidly excreted in the urine as metabolites and unchanged drug; there is some excretion in the faeces. Following oral administration, the onset of action is within 30 minutes. with a peak effect between 5 to 6 hours after the dose. The plasma half-life of Salbutamol is about 2 to 7 hours. For controlled-release preparations, the duration of action is up to 12 hours. INDICATIONS Salbutamol is indicated for the symptomatic treatment of bronchial asthma. It is also indicated for the treatment of reversible bronchospasm associated with bronchitis, pulmonary emphysema, bronchiectasis and other obstructive pulmonary disease. SID Lire le document complet