VALDOXAN Film-coated tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Valdoxan 25 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 25 mg of agomelatine. Excipient with known effect: Each film-coated tablet contains 61.8 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Film-coated tablet (tablet). Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company logo on one side.
Therapeutic indications
Valdoxan is indicated for the treatment of major depressive episodes in adults.
Posology and method of administration
Posology The recommended dose is 25 mg once daily taken orally at bedtime. After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit of normal ...
Special warnings and precautions for use
Monitoring of liver function Cases of liver injury, including hepatic failure (few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors), ...
Interaction with other medicinal products and other forms of interaction
Potential interactions affecting agomelatine Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%). Medicinal products that interact with these isoenzymes may decrease ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of agomelatine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with ...
Effects on ability to drive and use machines
Agomelatine has minor influence on the ability to drive and use machines.Considering that dizziness and somnolence are common adverse reactions, patients should be cautioned about their ability to drive ...
Undesirable effects
Summary of the safety profile Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment. The most common adverse reactions were headache, nausea and dizziness. ...
Overdose
Symptoms There is limited experience with agomelatine overdose. Experience with agomelatine in overdose has indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psychoanaleptics, other antidepressants ATC-code: N06AX22 Mechanism of action Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Binding studies ...
Pharmacokinetic properties
Absorption and bioavailability Agomelatine is rapidly and well (≥80%) absorbed after oral administration. Absolute bioavailability is low (<5% at the therapeutic oral dose) and the interindividual variability ...
Preclinical safety data
In mice, rats and monkeys sedative effects were observed after single and repeated administration at high doses. In rodents, a marked induction of CYP2B and a moderate induction of CYP1A and CYP3A were ...
List of excipients
Tablet core: Lactose monohydrate Maize starch Povidone (K30) Sodium starch glycolate type A Stearic acid Magnesium stearate Silica, colloidal anhydrous Film-coating: Hypromellose Yellow iron oxide (E172) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminium/PVC blister packed in cardboard boxes. Calendar packs containing 14, 28, 56, 84 and 98 film-coated tablets. Calendar packs of 100 film-coated tablets for hospital use. Not all pack sizes may ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
Marketing authorization number(s)
EU/1/08/499/002 EU/1/08/499/003 EU/1/08/499/005 EU/1/08/499/006 EU/1/08/499/007 EU/1/08/499/008
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 February 2009 Date of latest renewal: 13 November 2013
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