Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
fluvoxamine maleate, Quantity: 100 mg
Viatris Pty Ltd
Tablet, film coated
Excipient Ingredients: pregelatinised potato starch; titanium dioxide; mannitol; maize starch; macrogol 6000; sodium stearylfumarate; purified talc; hypromellose; colloidal anhydrous silica
Oral
10 tablets (sample), 30 tablets
(S4) Prescription Only Medicine
Luvox (fluvoxamine maleate) is indicated for the treatment of: major depression in adults. It is also indicated for the treatment of Obsessive Compulsive Disorder (OCD) in children aged 8 years of age and older, adolescents and adults.
Visual Identification: Oval, biconvex, scored, white to off-white film coated tablet inscribed on one face with 313 on either side of the score line and other face plain; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
1997-04-01
LUVOX ® L U V O X ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING LUVOX? LUVOX contains the active ingredient fluvoxamine. LUVOX is used to treat depression and Obsessive Compulsive Disorder (OCD). For more information, see Section 1. Why am I using LUVOX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LUVOX? Do not use if you have ever had an allergic reaction to fluvoxamine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use LUVOX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LUVOX and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE LUVOX? • Your doctor will decide what dose you should receive. • The usual starting dose for adults is 50 mg each day, but your doctor may adjust the number of tablets or the strength of the tablets you are taking until the desired response is achieved up to a maximum of 300 mg per day. More instructions can be found in Section 4. How do I use LUVOX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LUVOX? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using LUVOX. • Tell your doctor immediately if you become pregnant or are breast-feeding while taking LUVOX. • Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly, increase or lower the dose, without first checking with your doctor. • Do not give this medicine to anyone else, even if their symptoms seem similar to yours. • Do not use LUVOX to treat any other complaints u Прочитать полный документ
AUSTRALIAN PRODUCT INFORMATION LUVOX ® _Fluvoxamine maleate tablets_ _ _ 1 NAME OF THE MEDICINE Fluvoxamine maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of LUVOX contains 50 mg or 100 mg of fluvoxamine maleate. Fluvoxamine is a member of a class of antidepressant agents known as selective serotonin reuptake inhibitors (SSRI). It is chemically unrelated to the tricyclic antidepressants, and to other serotonin reuptake inhibitors as it is a monocyclic compound. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM LUVOX (fluvoxamine maleate) 50 mg: Round, biconvex, scored, white to off-white film coated tablet inscribed on one face with 291 on either side of the score line and other face plain. LUVOX (fluvoxamine maleate) 100 mg: Oval, biconvex, scored, white to off-white film coated tablet inscribed on one face with 313 on either side of the score line and other face plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LUVOX (fluvoxamine maleate) is indicated for the treatment of major depression in adults. LUVOX (fluvoxamine maleate) is also indicated for 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 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 shou Прочитать полный документ