Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
fluvoxamine maleate, Quantity: 100 mg
Arrotex Pharmaceuticals Pty Ltd
Fluvoxamine maleate
Tablet, film coated
Excipient Ingredients: titanium dioxide; mannitol; macrogol 8000; magnesium stearate; hyetellose; iron oxide red; iron oxide yellow; iron oxide black
Oral
30
(S4) Prescription Only Medicine
Indicated for the treatment of major depression in adults. Indicated for the treatment of Obsessive Compulsive Disorder in children aged 8 years of age and older, adolescents, and adults.
Visual Identification: Reddish-brown, pillow-shaped scored tablet, film coated, engraved "APO" on one side, and "FLU bisect 100" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2009-01-14
APO-FLUVOXAMINE 1 APO-FLUVOXAMINE _Fluvoxamine maleate _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about fluvoxamine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Fluvoxamine is used to treat depression in adults, as well as obsessive compulsive disorder (OCD) in adults and children aged eight years old and above. Fluvoxamine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). It works to correct the chemical imbalance in the brain that are thought to cause depression and OCD, helping to relieve symptoms. DEPRESSION Depression can cause emotional and physical symptoms such as loss of interest in activities, disturbed sleep and lack of energy. OCD Patients with OCD can have two types of symptoms – obsessions (unwanted repeated thoughts or feelings) and compulsions (the need to repeat actions over and over). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine for treating depression in children aged under 18 years, or for treating OCD in children under eight years of age. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • fluvoxamine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic Lesen Sie das vollständige Dokument
1 AUSTRALIAN PRODUCT INFORMATION APO-FLUVOXAMINE (FLUVOXAMINE MALEATE) FILM COATED TABLETS 1 NAME OF THE MEDICINE Fluvoxamine Maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg or 100 mg fluvoxamine maleate. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-FLUVOXAMINE TABLETS 50 MG Golden, round, scored, film-coated tablets engraved APO on one side, “F” over bisect “50” on the other side. APO-FLUVOXAMINE TABLETS 100 MG Reddish-brown, pillow shaped, scored, film-coated tablet engraved APO on one side, FLU bisect 100 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - the treatment of major depression in adults. - the treatment of Obsessive Compulsive Disorder (OCD) in children aged 8 years of age and older, adolescents, and adults. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-FLUVOXAMINE TABLETS are intended for oral administration. DOSAGE DEPRESSION The recommended starting dose of fluvoxamine is 50 mg per day for one week, given as a single dose in the evening. Doses should be gradually increased (by 50 mg per week) until an effective dose is reached, with a maximum of 300 mg per day (the usually effective dose is 100 mg/day). Doses up to 150 mg can be given as a single dose. It is recommended that total daily doses of greater than 150 mg be given in 2 or 3 divided doses. If no improvement is observed within 6 weeks of initiation of therapy, treatment with fluvoxamine should be reconsidered. It is important to ascertain that an adequate therapeutic dose has been maintained throughout this period. In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least 6 months after recovery from a depressive episode. 2 OBSESSIVE COMPULSIVE DISORDER Adults: The recommended starting dose of fluvoxamine is 50 mg per day for 3 to 4 days. The dosage should be increased gradually (i.e. by 50 mg every 4 to 6 days) until an effective dose is achieved, with a maximum of 300 mg per day. Lesen Sie das vollständige Dokument