Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Fluoxetine HCl (eq. to Fluoxetine 20mg)
KOMEDIC SDN BHD
Fluoxetine HCl (eq. to Fluoxetine 20mg)
100Capsule Capsules; 12Capsule Capsules; 30Capsule Capsules; 10Capsule Capsules; 20Capsule Capsules
MEDOCHEMIE LTD
_Consumer Medication Information Leaflet (RiMUP) _ MAGRILAN CAPSULE Fluoxetine (20mg) 1 WHAT IS IN THIS LEAFLET 1. What MAGRILAN is used for 2. How MAGRILAN works 3. Before you use MAGRILAN 4. How to use MAGRILAN 5. While you are using it 6. Side effects 7. Storage and disposal of MAGRILAN 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MAGRILAN IS USED FOR This medicine is used to treat the following conditions: _Adults: _ • Major depressive episodes • Obsessive-compulsive disorder (persistent, obsessive thoughts that make you carry out repetitive behaviour) • Premenstrual dysphoric disorder (PMDD) (a severe form of premenstrual syndrome that affect the woman's daily activities and relationship with others before menstruation) HOW MAGRILAN WORKS MAGRILAN contains the active ingredient fluoxetine hydrochloride. MAGRILAN belongs to a group of medicines called selective serotonin re- uptake inhibitor (SSRI) antidepressants. When serotonin is released from the nerve cells in the brain, it acts to lighten mood. SSRIs work by preventing serotonin from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood lifting effect of any released serotonin, thus relieving depression. BEFORE YOU USE MAGRILAN - _When you must not use it _ Do not take MAGRILAN: • If you are hypersensitive (allergic) to fluoxetine or any of the other ingredients of MAGRILAN (see section PRODUCT DESCRIPTION ). If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately. • If you are taking other medicines used to treat depression, known as non-selective monoamine oxidase inhibitors (MAOIs) or reversible monoamine oxidase inhibitors type A, since serious or even fatal reactions (serotonin syndrome; see section SIDE EFFECTS ) can occur. Examples of MAOIs include nialamide, iproniazide, selegiline, moclobemide, phenelzine, tranylcypromine, is Lestu allt skjalið
\fluox\spc6 MAGRILAN 20MG CAPSULES (Fluoxetine Hydrochloride) PHARMACEUTICAL FORM Yellow/violet cap/body hard gelatin capsule of size ‘4’ containing white free flowing powder Each “MAGRILAN” 20mg capsule, contains Fluoxetine Hydrochloride equivalent to 20mg of Fluoxetine base For excipients see section Pharmaceutical Particulars Capsules for oral administration THERAPEUTIC INDICATIONS Depression: MAGRILAN is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms. Obsessive-compulsive disorder Pre-menstrual Dysphoric Disorder (PMDD): MAGRILAN is indicated for the treatment of pre-menstrual dysphoric disorder. Diagnosis of PMDD: The essential diagnostic features of PMDD are clear and established cyclicity (occurring during the last week of the luteal phase in most menstrual cycles) of symptoms such as depressed mood, anxiety, affective lability, accompanied by impairment in social and/or occupational function and physical symptoms (such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of bloating, weight gain) – all of which must be severe. This syndrome should be distinguished from the commoner “pre-menstrual tension (distinguished from PMDD by milder symptoms and less impact on normal activities)” and from any co-existing psychiatric disorder. DOSAGE AND METHOD OF ADMINISTRATION For oral administration to adults only Depression, with or without associated anxiety symptoms – adults and the elderly: A dose of 20mg/day is recommended. Obsessive-compulsive disorder – adults and the elderly: 20mg/day to 60mg/day. A dose of 20mg/day is recommended as the initial dose. Although there may be an increased potential for side-effects at higher doses, a dose increase may be considered after several weeks if there is no response. Pre-menstrual Dysphoric Disorder (PMDD): A dose of 20mg per day is recommended. Initial treatment should be limited to 6 months, after which patients should be reassessed regarding the benefit of c Lestu allt skjalið