Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Acetylcysteine
MEDISPEC (M) SDN.BHD
Acetylcysteine
10 Tablets
Neutec Ilac Sanayi Ticaret A.S.
MUCOSTOP 600 MG EFFERVESCENT TABLET Acetylcysteine (600 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What MUCOSTOP_ _ is used for 2. How MUCOSTOP works 3. Before you use MUCOSTOP 4. How to use MUCOSTOP 5. While you are using it 6. Side effects 7. Storage and Disposal of MUCOSTOP 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MUCOSTOP IS USED FOR MUCOSTOP is used for treatment of respiratory diseases which leads to the formation of a lot of thick secretions which are difficult to be coughed out such as acute and chronic bronchitis (inflammation of the airways that carry air to your lungs), inflammation of the throat, sinus and trachea, flu infection, asthma and mucoviscidosis (abnormal mucus production in lungs). HOW MUCOSTOP WORKS Acetylcysteine has strong fluidification activity to mucus and pus secretion. It acts by reducing inflammation and increasing mucosa regeneration speed. BEFORE YOU USE MUCOSTOP - _When you must not use it _ DO NOT USE MUCOSTOP IN THE FOLLOWING SITUATIONS: • If you are allergic to acetylcysteine or any of the other ingredients of MUCOSTOP • In children below 2 years old • If you are suffering from phenylketonuria • If you have an active peptic ulcer. _ _ _Pregnancy and lactation _ • Pregnancy category B. • Not known whether acetylcysteine is distributed into milk. _ _ • Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Please also inform your doctor if you have asthma. - _Taking _ _MUCOSTOP _ _with _ _other _ _medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE MUCOSTOP - _How much to use _ Adults: 1 effervescent tablet a day (preferably in the evening) - _Whe Soma hati kamili
MUCOSTOP 600 MG EFFERVESCENT TABLET NAME AND STRENGTH OF ACTIVE SUBSTANCE Each effervescent tablet contains 600mg Acetylcysteine PRODUCT DESCRIPTION White, round, flat-faced tablets. Appearance of solution should be clear after dissolving in water. PHARMACODYNAMICS Acetylcysteine has strong fluidification activity to mucus secretion and mucopurulent by depolimerization of mucoprotein acid complex and nucleic acid were as act as viscosity agent from mucoid component, sputum purulenta and others secretions, it acts as anti fiogistic and increase mucosa regeneration speed. PHARMACOKINETICS _Absorption _ Bioavailability Absorbed following oral administration, with peak plasma concentration achieved within 1 – 2 hours. Absorbed from the pulmonary ephitelium. _Distribution _ Extent: Crosses the placenta following oral or IV administration Plasma protein binding: 50 – 83% _Metabolism _ Deacetylated in the liver to cysteine _Elimination _ Elimination route: Principally (70%) nonrenal Half – life: 6.25 hours after oral administration INDICATIONS All respiratory tract diseases leading to the formation of thick secretions difficult to be expectorated, such as acute and chronic bronchitis, laryngitis, sinusitis, tracheitis, influenza, bronchial asthma and (as complementary treatment) mucoviscidosis. RECOMMENDED DOSAGE Adults: 1 effervescent tablet a day (preferably in the evening). Dissolve in water before administration. ROUTE OF ADMINISTRATION : Oral; Dissolve the effervescent tablet in a glass of water before consuming. CONTRA-INDICATIONS Patients with hypersensitivity to Acetylcysteine. Contraindicated in children below two (2) years of age. As Mucostop 600mg Effervescent Tablet contains aspartame, it is contraindicated in patients suffering from phenylketonuria. Active peptic ulcer. WARNING AND PRECAUTIONS: Unsuitable for phenylketonurics. Patient with gastric, should be administered after food. Several animal and human researches showed no teratogenic and dangerous adverse effect to pregnant and nursing patient, Soma hati kamili