País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Moclobemide
Actavis Pty Ltd
Medicine Registered
Clobemix CMI v5 120518 Page 1 of 4 _ _ _ _ _C_ _C_ _L_ _L_ _O_ _O_ _B_ _B_ _E_ _E_ _M_ _M_ _I_ _I_ _X_ _X_ _™_ _™_ _ _ _ _ _Moclobemide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CLOBEMIX ™. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CLOBEMIX™ against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS CLOBEMIX™ The name of your medicine is CLOBEMIX ™. CLOBEMIX™ belongs to a group of medicines called antidepressants. It contains the active ingredient called moclobemide. CLOBEMIX™ is available in two strengths: 150 mg and 300 mg tablets. WHAT CLOBEMIX™ IS USED FOR Antidepressants are used to treat depression and work on the central nervous system. They are thought to work by their action on brain chemicals called amines, which are involved in controlling mood. There are many different types of medicines used to treat depression. CLOBEMIX™ belongs to a group of medicines called reversible inhibitors of monoamine oxidase A (RIMA). Your doctor, however, may have prescribed CLOBEMIX™ for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CLOBEMIX™ HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE CLOBEMIX™ _DO NOT TAKE _ _CLOBEMIX™ IF_: You have ever had an allergic reaction to CLOBEMIX™ or any of the ingredients listed at th Llegiu el document complet
Clobemix PI v5 120518 Page 1 of 10 CLOBEMIX ™ _Moclobemide film-coated tablets _ _ _ _PRODUCT INFORMATION _ NAME OF THE MEDICINE The chemical name of moclobemide is 4-chloro-N-[2-(4-morpholinyl) ethyl] benzamide. Its empirical formula is C 13 H 17 ClN 2 O 2 with a MW of 268.74. Structurally represented as: O N H N O Cl CAS no. 71320-77-9. DESCRIPTION Moclobemide is a white crystalline powder. It contains no crystal water and is not hygroscopic. It is soluble in water at 0.4 g / 100 mL. The pKa is approximately 6.2. Other ingredients of CLOBEMIX ™ 150 mg & 300 mg tablets_ _are: Lactose, starch-pregelatinised maize, sodium starch glycollate, povidone, magnesium stearate, hypromellose, Cellulose- microcrystalline, PEG-8 stearate, propylene glycol and titanium dioxide. In addition to the above excipients the 150 mg tablets also contain a colouring agent iron oxide yellow. PHARMACOLOGY _ _ PHARMACODYNAMICS: Moclobemide is an antidepressant that affects the monoaminergic cerebral neurotransmitter system by means of a reversible inhibition of monoamine oxidase. There are two types of monoamine oxidases, A & B, which vary in their substrate specificity. Moclobemide is relatively selective for type A monoamine oxidase. At a 300 mg dose, the inhibition of monoamine oxidase A is approximately 80% while that of monamine oxidase B is approximately 20-30%. The inhibition is short-lasting (approximately 24 hours). The metabolism of dopamine, noradrenaline and serotonin is decreased by this effect, and this leads to increased extracellular concentrations of these neuronal transmitters. As Llegiu el document complet