Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
desvenlafaxine benzoate, Quantity: 73.16 mg (Equivalent: desvenlafaxine, Qty 50 mg)
Lupin Australia Pty Limited
desvenlafaxine benzoate
Tablet, modified release
Excipient Ingredients: hypromellose; colloidal anhydrous silica; purified talc; microcrystalline cellulose; stearic acid; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
7 , 14 , 28 tablets
(S4) Prescription Only Medicine
Desvenlafaxine is indicated for the treatment of major depressive disorder, including the prevention of relapse.,Desvenlafaxine is not indicated for paediatric use.
Visual Identification: Light pink, biconvex, round shaped film coated tablets debossed with "DV" on one side and "50"on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-11-12
CONSUMER MEDICINE INFORMATION DESVENLAFAXINE GH XR (DESVENLAFAXINE BENZOATE) EXTENDED RELEASE TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Desvenlafaxine GH XR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist or asking questions. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Desvenlafaxine GH XR against the expected benefits it will have for you. IF YOU HAVE ANY QUESTIONS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DESVENLAFAXINE GH XR IS USED FOR _WHAT IT DOES _ Desvenlafaxine GH XR is used in the treatment and prevention of relapse of depression. Depression can affect your whole body and may cause emotional and physical symptoms such as feeling low in spirit, being unable to enjoy life, poor appetite or overeating, disturbed sleep, loss of sex drive, lack of energy and feeling guilty over nothing. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. _HOW IT WORKS _ Desvenlafaxine GH XR contains the active ingredient called desvenlafaxine benzoate. It belongs to a class of medications called Serotonin- Noradrenaline Reuptake Inhibitors (SNRIs). Serotonin and noradrenaline are chemical messengers that allow certain nerves in the brain to work. Desvenlafaxine GH XR tablets increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness. Desvenlafaxine GH XR is not addictive. It is available only with a doctor's prescription. _USE IN CHILDREN _ The safety and effectiveness of Desvenlafaxine GH XR in children or adolescents under 18 years of age have not been established. BEFORE YOU TAKE DESVENLAFAXINE GH XR _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DESVENLAFAXINE GH XR IF YOU ARE TAKING OTHER MEDICATIONS FOR DEPRESSION KNOWN AS MONOAMINE OX Läs hela dokumentet
AUSTRALIAN PRODUCT INFORMATION – DESVENLAFAXINE GH XR (DESVENLAFAXINE (AS BENZOATE)) EXTENDED RELEASE TABLETS 1 NAME OF THE MEDICINE Desvenlafaxine (as benzoate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Desvenlafaxine GH XR tablets are for once-a-day oral administration. Two strengths are available, containing 50 mg or 100 mg of desvenlafaxine as the benzoate salt. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Desvenlafaxine (as benzoate) extended-release tablets are available as follows: • Desvenlafaxine GH XR 50 mg is a light pink, biconvex, round shaped film coated tablet debossed with "DV" on one side and "50"on the other side. • Desvenlafaxine GH XR 100 mg is a reddish-orange, biconvex, round shaped film coated tablet, debossed with "DV" on one side and "100"on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desvenlafaxine GH XR tablets are indicated for the treatment of major depressive disorder, including the prevention of relapse. Desvenlafaxine GH XR tablets are not indicated for paediatric use. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Desvenlafaxine GH XR tablets should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. Initial Treatment The recommended dose for Desvenlafaxine GH XR is 50 mg once daily, with or without food. In clinical trials, no additional benefit was demonstrated at doses greater than 50 mg/day. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur gradually and at intervals of not less than 7 days. The maximum dose should not exceed 200 mg/day. Desvenlafaxine GH XR v5.0 Page 2 of 20 (desvenlafaxine (as benzoate)) extended release tablets When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimise discontinuation symptoms (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). Ma Läs hela dokumentet