Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
desvenlafaxine, Quantity: 50 mg
Medis Pharma Pty Ltd
Desvenlafaxine
Tablet, modified release
Excipient Ingredients: microcrystalline cellulose; hypromellose; citric acid monohydrate; magnesium stearate; povidone; purified talc; alginic acid; titanium dioxide; macrogol 6000; iron oxide red
Oral
7, 14, 28
(S4) Prescription Only Medicine
For the treatment of major depressive disorder, including the preventiton of relapse. Not indicated for paediatric use.
Visual Identification: Light pink colored, diamond shaped, biconvex tablets, debossed with 'Ll89' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-11-26
DESVENLAFAXINE SANDOZ 1 DESVENLAFAXINE SANDOZ DESVENLAFAXINE MODIFIED RELEASE TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Desvenlafaxine Sandoz. 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 Sandoz against the expected benefits it will have for you. IF YOU HAVE ANY QUESTIONS ABOUT DESVENLAFAXINE SANDOZ, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR DESVENLAFAXINE SANDOZ TABLETS. You may need to read it again. WHAT DESVENLAFAXINE SANDOZ 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 DESVENLAFAXINE SANDOZ HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. _HOW IT WORKS _ Desvenlafaxine Sandoz 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. Desvenlafaxine Sandoz tablets increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness. Desvenlafaxine Sandoz is not addictive. It is available only with a doctor's prescription. BEFORE YOU TAKE DESVENLAFAXINE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DESVENLAFAXINE SANDOZ 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 NO Soma hati kamili
_Product Information Page 1 _ _Desvenlafaxine Sandoz 50 mg, 100 mg tablet _ _04/2019 _ _Sandoz Pty Ltd _ _Version 11 Nov 2019 _ AUSTRALIAN PRODUCT INFORMATION - DESVENLAFAXINE SANDOZ ® (DESVENLAFAXINE) 50MG, 100MG TABLET 1. NAME OF THE MEDICINE Desvenlafaxine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Two strengths of DESVENLAFAXINE SANDOZ 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 DESVENLAFAXINE SANDOZ is formulated as a modified release tablet for once-a-day oral administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder, including the prevention of relapse. 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 PRECAUTIONS 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 _Product Information Page 2 _ _Desvenlafaxine Sandoz 50 mg, 100 mg tablet _ _04/2019 _ _Sandoz Pty Ltd _ _Version 11 Nov 2019 _ 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 Soma hati kamili