Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESVENLAFAXINE SUCCINATE MONOHYDRATE
PFIZER (MALAYSIA) SDN. BHD.
DESVENLAFAXINE SUCCINATE MONOHYDRATE
28Tablet Tablets
PFIZER IRELAND PHARMACEUTICALS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_ ) PRISTIQ ® EXTENDED-RELEASE TABLETS Desvenlafaxine succinate (50 mg, 100 mg) 1 WHAT IS IN THIS LEAFLET 1. What PRISTIQ is used for 2. How PRISTIQ works 3. Before you use PRISTIQ 4. How to use PRISTIQ 5. While you are using it 6. Side Effects 7. Storage and Disposal of PRISTIQ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT PRISTIQ IS USED FOR PRISTIQ is used in the treatment of major depressive disorder (MDD). HOW PRISTIQ WORKS PRISTIQ 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. PRISTIQ tablets potentiate the effects of these two messengers. Experts think this is how it helps to restore your feeling of wellness. BEFORE YOU USE PRISTIQ - _When you must not use it _ Do not take PRISTIQ - if you are allergic to desvenlafaxine, venlafaxine or any of the other ingredients of this medicine; - if you are also taking, or have taken within the last 14 days, any medicines known as Monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking a reversible MAOI together with PRISTIQ or in whom intravenous methylene blue has been administered can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking PRISTIQ before you take any MAOI. _Pregnancy and lactation _ You should use PRISTIQ only after discussing the potential benefits and the potential risks to your unborn child with your doctor. PRISTIQ crosses the human placenta. If you are taking this medicine during pregnancy, your baby may not feed properly, have trouble breathing, or may encounter prolonged hospitalization. If your baby has these symptoms when it is born and you are concerned, contact your doctor who will be able to advise you. Consuming PRISTIQ during pregnancy may cause high blood pressure, sometimes associa Leggi il documento completo
Pfizer Confidential 1 PFIZER PRISTIQ ® DESVENLAFAXINE SUCCINATE 1. NAME OF THE MEDICINAL PRODUCT PRISTIQ ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 50 mg Each extended-release tablets contains 75.87 mg of desvenlafaxine succinate equivalent to 50 mg desvenlafaxine. 100 mg Each extended-release tablets contains 151.77 mg of desvenlafaxine succinate equivalent to 100 mg desvenlafaxine. 3. PHARMACEUTICAL FORM 50 mg extended-release tablets Light pink, square (pyramid, one sided), film coated tablets debossed “W” over '50' on the flat side. 100 mg extended-release tablets Reddish orange, square (pyramid, one sided), film coated tablets debossed “W” over '100' on the flat side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD). The efficacy of PRISTIQ has been established in four 8-week, placebo controlled studies of outpatients who met DSM-IV criteria for major depressive disorder. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. The efficacy of PRISTIQ in maintaining a response in major depressive disorder for up to 24 weeks following 12 weeks of acute treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use PRISTIQ for extended periods, i.e., beyond 9 months, should continue to periodically re-evaluate the long-term usefulness of the drug for the individual patients. Pfizer Confidential 2 4.2 POSOLOGY AND METHOD OF AD Leggi il documento completo