FAVERIN Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Faverin 50 mg film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 50 mg fluvoxamine maleate. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. Round, biconvex, scored, white to off-white film coated tablets imprinted 291 on both sides of the score. The tablet can be divided into equal halves.
4.1. Therapeutic indications
Major depressive episode Obsessive Compulsive Disorder (OCD)
4.2. Posology and method of administration
Depression Adults The recommended dose is 100 mg daily. Patients should start on 50 or 100 mg, given as a single dose in the evening. Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks ...
4.3. Contraindications
Faverin tablets are contraindicated in combination with tizanidine and monoamine oxidase inhibitors (MAOIs) (see section 4.4 and 4.5). Treatment with fluvoxamine can be initiated: two weeks after discontinuation ...
4.4. Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents (including tramadol, triptans, linezolid, SSRIs and St. John´s ...
4.6. Fertility, pregnancy and lactation
Pregnancy Epidemiological data have suggested that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary ...
4.7. Effects on ability to drive and use machines
Fluvoxamine up to 150 mg has no or negligible influence on the ability to drive and use machines. It showed no effect on psychomotor skills associated with driving and operating machinery in healthy volunteers. ...
4.8. Undesirable effects
Adverse events, observed in clinical studies at frequencies listed below, are often associated with the illness and are not necessarily related to treatment. Frequency estimate: Very common (≥1/10), common ...
4.9. Overdose
Symptoms Symptoms include gastro-intestinal complaints (nausea, vomiting and diarrhoea), somnolence and dizziness. Cardiac events (tachycardia, bradycardia, hypotension), liver function disturbances, convulsions ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antidepressants, Selective serotonin reuptake inhibitors <b>ATC code:</b> N06AB08 The mechanism of action of fluvoxamine is thought to be related to selective serotonin ...
5.2. Pharmacokinetic properties
Absorption Fluvoxamine is completely absorbed following oral administration. Maximum plasma concentrations occur within 3-8 hours of dosing. The mean absolute bioavailability is 53% due to first-pass metabolism. ...
5.3. Preclinical safety data
Carcinogenesis and mutagenesis There is no evidence of carcinogenicity or mutagenicity with fluvoxamine. Fertility and reproductive toxicity Animal studies on male and female fertility revealed reduction ...
6.1. List of excipients
<u>Tablet cores:</u> Mannitol Maize starch Pregelatinised starch Sodium stearyl fumarate Colloidal anhydrous silica <u>Film-coat:</u> Hypromellose Macrogol 6000 Talc Titanium Dioxide E171
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
PVC/PVdC/Aluminium press-through blister. <u>Pack sizes:</u> 5, 10, 20, 30, 50, 60, 90, 100 and 250 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special recommendation.
7. Marketing authorization holder
Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
8. Marketing authorization number(s)
PL 46302/0034
9. Date of first authorization / renewal of the authorization
Date of last renewal: 21/06/2009
10. Date of revision of the text
December 2020
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