LUVOX Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
LUVOX 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 ...
3. Pharmaceutical form
<u>UVOX (fluvoxamine maleate) 50 mg:</u> 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. <u>LUVOX (fluvoxamine ...
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 ...
4.2. Posology 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 ...
4.3. Contraindications
Fluvoxamine is contraindicated in combination with tizanidine. Fluvoxamine should not be used in combination with monoamine oxidase inhibitors (MAOIs) or reversible MAOIs (RIMAs), moclobemide or linezolid, ...
4.4. Special warnings and precautions for use
Bipolar Disorder A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed that treating such an episode with an antidepressant alone may increase the likelihood ...
4.5. Interaction with other medicinal products and other forms of interaction
The concurrent use of fluvoxamine with tizanidine, or cisapride is contraindicated (see Section 4.3 CONTRAINDICATIONS). Fluvoxamine immediate-release tablets should not be used in combination with ramelteon ...
4.6. Fertility, pregnancy and lactation
Effects on fertility No evidence of impairment of fertility in male or female rats was observed with fluvoxamine at oral doses up to 80 mg/kg/day. Reproduction studies in animals revealed impaired fertility ...
4.7. Effects on ability to drive and use machines
Fluvoxamine at doses up to 150 mg per day exhibited no effect on psychomotor skills associated with driving and operating machinery in healthy volunteers. However, somnolence has been reported during treatment ...
4.8. Undesirable effects
Nausea, sometimes accompanied by vomiting, is the most frequently observed symptom associated with fluvoxamine treatment. This side effect usually diminishes within the first two weeks of treatment. Other ...
4.9. Overdose
Symptoms The most common symptoms of overdose include gastrointestinal complaints (nausea, vomiting and diarrhoea). Somnolence and dizziness, cardiac events (tachycardia, bradycardia, hypotension), liver ...
5.1. Pharmacodynamic properties
Mechanism of Action Fluvoxamine has two isomeric forms: an E isomer which is pharmacologically active, and a Z isomer which is non-active. LUVOX tablets contain only the E isomer. The mechanism of action ...
5.2. Pharmacokinetic properties
Absorption and Bioavailability Fluvoxamine is almost completely absorbed following oral administration. The absolute bioavailability is 53% (90% confidence interval: 44-62%). Absorption is unaffected by ...
5.3. Preclinical safety data
Genotoxicity No evidence of mutagenicity or chromosomal damage was observed in vitro. An in vivo test for chromosomal damage in mice (micronucleus test) gave no clear evidence of clastogenic activity. ...
6.1. List of excipients
The inactive ingredients are: mannitol, maize starch, pregelatinised potato starch, sodium stearylfumarate, colloidal anhydrous silica, hypromellose, macrogol 6000, purified talc, titanium dioxide.
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3. Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4. Special precautions for storage
Store below 25oC. Keep out of reach of children.
6.5. Nature and contents of container
LUVOX tablets are available in blister packs (PVC/PVDC/Al). <u>50 mg tablets:</u> packs of 60^*^, 30 and 10 (sample pack). <u>100 mg tablets:</u> packs of 30 and 10 (sample pack). * Not distributed in ...
6.6. Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Viatris Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276
9. Date of first authorization / renewal of the authorization
1/04/1997
10. Date of revision of the text
11/01/2022
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