Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sanofi-Aventis South Africa (Pty) Ltd
See ingredients
CAPSULES
EACH CAPSULE CONTAINS TRAZODONE HYDROCHLORIDE 100 mg
Registered
1983-03-04
PAGE 1 OF 13 PATIENT INFORMATION LEAFLET 1 SCHEDULING STATUS: S5 2 3 PROPRIETARY NAME AND DOSAGE FORM: 4 MOLIPAXIN 50 mg Capsules 5 MOLIPAXIN 100 mg Capsules 6 7 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MOLIPAXIN: 8 Keep this leaflet. You may need to read it again. 9 If you have further questions, please ask your doctor or your pharmacist. 10 MOLIPAXIN has been prescribed for you personally and you should not share your medicine 11 with other people. It may harm them, even if their symptoms are the same as yours. 12 13 WHAT MOLIPAXIN CONTAINS: 14 Each Molipaxin 50 mg Capsule contains 50 mg of the active substance, trazodone hydrochloride. 15 Each Molipaxin 100 mg Capsule contains 100 mg of the active substance, trazodone 16 hydrochloride. 17 Other ingredients include lactose monohydrate, magnesium stearate, gelatin, erythrosine E127, 18 indigo carmine E132, titanium dioxide E171, yellow iron oxide E172 and ink 0619 (S-1-20952). 19 The 100 mg Molipaxin Capsules also contain Red Iron Oxide (E172). 20 Contains sugar (lactose). 21 22 WHAT MOLIPAXIN IS USED FOR: 23 Molipaxin belongs to a group of medicines called antidepressants. It is used to treat depression 24 and depression associated with anxiety. 25 PAGE 2 OF 13 26 BEFORE TAKING MOLIPAXIN: 27 DO NOT TAKE MOLIPAXIN: 28 if you are hypersensitive (allergic) to trazodone hydrochloride, or any of the other ingredients 29 of MOLIPAXIN (see WHAT MOLIPAXIN CONTAINS). Signs of an allergic reaction can 30 include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue 31 if you are taking any other psychotropic medicines of which you have not informed your 32 doctor 33 if you are taking a monoamine oxidase inhibitor (MAOI) or if you have taken them in the last 2 34 weeks. You should not receive MAOIs within one week of stopping MOLIPAXIN 35 if you have recently had a heart attack 36 if you are a heavy drinker or are taking sleeping tablets. 37 38 TAKE SPECIAL CARE WITH MOLIPAXIN: 39 Molipax Read the complete document
PAGE 1 OF 16 PROFESSIONAL INFORMATION SCHEDULING STATUS: 1 2 PROPRIETARY NAME AND DOSAGE FORM: 3 MOLIPAXIN 50 mg Capsules 4 MOLIPAXIN 100 mg Capsules 5 6 COMPOSITION: 7 MOLIPAXIN 50 mg capsule: trazodone hydrochloride 50 mg. 8 MOLIPAXIN 100 mg capsule: trazodone hydrochloride 100 mg. 9 Other ingredients include lactose monohydrate, magnesium stearate, gelatin, erythrosine E127, 10 indigo carmine E132, titanium dioxide E171 and yellow iron oxide E172, ink 0619 (S-1-20952). 11 The 100 mg MOLIPAXIN capsules also contain Red Iron Oxide (E172). 12 Contains sugar (lactose). 13 14 PHARMACOLOGICAL CLASSIFICATION: 15 A 1.2 Psychoanaleptics (antidepressants) 16 17 PHARMACOLOGICAL ACTION: 18 PHARMACODYNAMIC PROPERTIES 19 Trazodone hydrochloride is a triazolopyridine derivative chemically unrelated to known tricyclic, 20 tetracyclic and other antidepressant agents. It has negligible effect on norepinephrine 21 (noradrenaline) re-uptake mechanisms. Whilst the mode of action of MOLIPAXIN is not known 22 precisely, its antidepressant activity may concern norepinephric potentiation by mechanisms other 23 than uptake blockade. A central antiserotonin effect may account for the anxiety reducing 24 properties of trazodone. 25 S5 PAGE 2 OF 16 Trazodone hydrochloride is an anxiolytic/antidepressant, psychotropic agent. 26 PHARMACOKINETIC PROPERTIES: 27 Trazodone is rapidly absorbed from the gastrointestinal tract and extensively metabolised in the 28 liver. Paths of metabolism of trazodone include n-oxidation and hydroxylation. Trazodone is 29 metabolised to its active metabolite m-chlorophenylpiperazine via the cytochrome P450 30 isoenzyme CYP3A4. 31 Trazodone is excreted in the urine almost entirely in the form of its metabolites, either in free or in 32 conjugated form. The elimination of trazodone is biphasic, with a terminal elimination half-life of 5 33 to 13 hours. Trazodone is excreted in breast milk. 34 There was an approximate two-fold increase in terminal phase half-life and significantly higher 35 plasma concentrations of Read the complete document