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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Valdoxan 25 mg Film-coated Tablets (2014)

Εκδότης

Εκδότης Les Laboratoires Servier
Διεύθυνση 50, rue Carnot, 92284, Suresnes cedex, France
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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 tablet contains ...

Pharmaceutical form

Film-coated tablet [tablet]. Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with ...

Therapeutic indications

Treatment of major depressive episodes. Valdoxan is indicated 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, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic impairment ...

Special warnings and precautions for use

Monitoring of liver function Cases of liver injury, including hepatic failure (few cases were exceptionally ...

Interaction with other medicinal products and other forms of interaction

Potential interactions affecting agomelatine Agomelatine is metabolised mainly by cytochrome P450 1A2 ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of agomelatine ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, considering ...

Undesirable effects

Summary of the safety profile In clinical trials, over 7,900 depressed patients have received Valdoxan ...

Overdose

Symptoms There is limited experience with agomelatine overdose. Experience with agomelatine in overdose ...

Pharmacodynamic properties

Pharmacotherapeutic group: Psychoanaleptics, other antidepressants ATC-code: N06AX22 Mechanism of action ...

Pharmacokinetic properties

Absorption and bioavailability Agomelatine is rapidly and well (≥80%) absorbed after oral administration. ...

Preclinical safety data

In mice, rats and monkeys sedative effects were observed after single and repeated administration at ...

List of excipients

Tablet core: Lactose monohydrate Maize starch Povidone K30 Sodium starch glycolate type A Stearic acid ...

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 7, 14, 28, 42, 56, 84 and ...

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/1/08/499/001-008

Date of first authorization / renewal of the authorization

Date of first authorisation: 19 February 2009 Date of latest renewal: 19 February 2014

Date of revision of the text

11/2014
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.