מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESVENLAFAXINE SUCCINATE MONOHYDRATE
GENPHARMA SDN. BHD
DESVENLAFAXINE SUCCINATE MONOHYDRATE
14 x 2 Tablets
Alembic Pharmaceuticals Limited (Formulation Division)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_ ) DESTIQ ER TABLETS Desvenlafaxine Extended Release Tablets (50 mg, 100 mg) WHAT IS IN THIS LEAFLET 1. What DESTIQ is used for 2. How DESTIQ works 3. Before you use DESTIQ 4. How to use DESTIQ 5. While you are using it 6. Side effects 7. Storage and Disposal of DESTIQ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT DESTIQ IS USED FOR DESTIQ is used in the treatment of major depressive disorder (MDD). HOW DESTIQ WORKS DESTIQ 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. DESTIQ tablets increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness. BEFORE YOU USE DESTIQ - _When you must not use it _ _ _ Do not take DESTIQ • 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 DESTIQ 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 DESTIQ before you take any MAOI. _Pregnancy and lactation _ _ _ You should use DESTIQ only after discussing the potential benefits and the potential risks to your unborn child with your doctor. DESTIQ 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 DESTIQ during pregnancy may cause high blood pressure, sometimes associated with flui קרא את המסמך השלם
150 mm Front Side 480 mm 1. NAME OF THE MEDICINAL PRODUCT Destiq ER 50mg Tablet Destiq ER 100mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Desvenlafaxine Succinate Monohydrate 75.87 mg is equivalent to Desvenlafaxine 50mg Desvenlafaxine Succinate Monohydrate 151.77mg is equivalent to Desvenlafaxine 100mg 3. PHARMACEUTICAL FORM Destiq ER 50mg Tablet Light pink colored, round, biconvex, film coated tablets, debossed with '50' on one side and plain on other side Destiq ER 100mg Tablet Dark brown to red colored, round, biconvex film coated tablets, debossed with '100' on one side and plain on other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desvenlafaxine succinate, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD). The efficacy of Desvenlafaxine succinate 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 Desvenlafaxine succinate 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 Desvenlafaxine succinate 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _MAJOR DEPRESSIVE DIS קרא את המסמך השלם