Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
desvenlafaxine, Quantity: 100 mg
Medis Pharma Pty Ltd
Desvenlafaxine
Tablet, modified release
Excipient Ingredients: purified talc; povidone; magnesium stearate; alginic acid; citric acid monohydrate; microcrystalline cellulose; hypromellose; titanium dioxide; macrogol 8000; iron oxide red; iron oxide black
Oral
14, 1000, 28, 7
(S4) Prescription Only Medicine
For the treatment of major depressive disorder, including the preventiton of relapse. Not indicated for paediatric use.
Visual Identification: Dark brown to red colored, diamond shaped, biconvex tablets, debossed with 'Ll90' on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-11-26
DESVEN 1 DESVEN MODIFIED RELEASE TABLETS _Desvenlafaxine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DESVEN. 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 DESVEN against the expected benefits it will have for you. IF YOU HAVE ANY QUESTIONS ABOUT DESVEN, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR DESVEN TABLETS. You may need to read it again. WHAT DESVEN IS USED FOR _WHAT IT DOES _ Desvenlafaxine 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 DESVEN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. _ _ _HOW IT WORKS _ DESVEN contains the active ingredient called desvenlafaxine. 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. DESVEN tablets increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness. DESVEN is not addictive. It is available only with a doctor's prescription. BEFORE YOU TAKE DESVEN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DESVEN IF YOU ARE TAKING OTHER MEDICATIONS FOR DEPRESSION KNOWN AS MONOAMINE OXIDASE INHIBITORS, EVEN IF YOU HAVE STOPPED TAKING THEM, BUT HAVE TAKEN THEM WITHIN THE LAST 14 DAYS. DO NOT TAKE DESVEN IF YOU ARE ALLERGIC TO DESVENLAFAXINE, VENLAFAXINE OR TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction include: • Skin rash • Itch Soma hati kamili
AUSTRALIAN PRODUCT INFORMATION - DESVEN DESVENLAFAXINE 1. NAME OF THE MEDICINE Desvenlafaxine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Two strengths of DESVEN tablets are available, containing 50 mg and 100 mg of desvenlafaxine. For the full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM DESVEN is formulated as a modified release tablet for once-a-day oral administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DESVEN is indicated for the treatment of major depressive disorder, including the prevention of relapse. DESVEN is not indicated for paediatric use. 4.2 DOSE AND METHOD OF ADMINISTRATION Desvenlafaxine 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 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. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimise discontinuation symptoms (see Section 4.4 SPECIAL WARNINGS AND SPECIAL WARNINGS AND PRECAUTIONS FOR USE FOR USE and Section 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)) . _MAINTENANCE/CONTINUATION/EXTENDED TREATMENT_ It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy. Patients should continue on the same dose at which they were stabilised. They should be periodically reassessed to determine the need for continued treatment. CHILDREN AND ADOLESCENTS Safety and efficacy in patients less than 18 years of age have not been established. DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT The recommended starting dose in patients with severe renal impairment (24-hr C Soma hati kamili