DEPEFEX Prolonged-release capsule (2021)
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Περιεχόμενα
Name of the medicinal product
Depefex 150 mg XL Capsules.
Qualitative and quantitative composition
Each prolonged release capsule contains 150 mg of venlafaxine as venlafaxine hydrochloride. Venlafaxine is chemically defined as (R/S)1[(2-dimethylamino)1(4-methoxy phenyl) ethyl] cyclohexanol hydrochloride. ...
Pharmaceutical form
Prolonged-release capsules, hard. Depefex 150 mg XL Capsules are natural transparent capsules containing white or whitish pellets.
Therapeutic indications
Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes.
Posology and method of administration
Major depressive episodes The recommended starting dose for prolonged-release venlafaxine is 75mg given once daily. Patients not responding to the initial 75 mg/day dose may benefit from dose increases ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk ...
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 ...
Interaction with other medicinal products and other forms of interaction
Monoamine Oxidase Inhibitors (MAOI) Irreversible non-selective MAOIs Venlafaxine must not be used in combination with irreversible non-selective MAOIs. Venlafaxine must not be initiated for at least 14 ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of venlafaxine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Venlafaxine must only be administered to pregnant ...
Effects on ability to drive and use machines
Any psychoactive medicinal product may impair judgment, thinking, and motor skills. Therefore, any patient receiving venlafaxine should be cautioned about their ability to drive or operate hazardous machinery. ...
Undesirable effects
The most commonly (>1/10) reported adverse reactions in clinical studies were nausea, dry mouth, headache and sweating (including night sweats). Adverse reactions are listed below by system organ class,frequency ...
Overdose
In postmarketing experience, overdose with venlafaxine was reported predominantly in combination with alcohol and/or other medicinal products. The most commonly reported events in overdose include tachycardia, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antidepressants ATC code: NO6AX16 The mechanism of venlafaxines antidepressant action in humans is believed to be associated with its potentiation of neurotransmitter activity ...
Pharmacokinetic properties
Venlafaxine is extensively metabolised, primarily to the active metabolite, O-desmethylvenlafaxine (ODV). Mean ± SD plasma half-lives of venlafaxine and ODV are 5±2 hours and 11±2 hours, respectively. ...
Preclinical safety data
Studies with venlafaxine in rats and mice revealed no evidence of carcinogenesis. Venlafaxine was not mutagenic in a wide range of <em>in vitro</em> and <em>in vivo</em> tests. Animal studies regarding ...
List of excipients
Stearic acid Ethylcellulose Talc Sugar spheres 20: Sucrose Maize Starch Capsule shell: Gelatin
Incompatibilities
Not applicable.
Shelf life
36 Months.
Special precautions for storage
Do not store above 25°C. Store in the original package.
Nature and contents of container
Al/PVDC clear PVC/PVDC blister packs of 28 capsules.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK
Marketing authorization number(s)
Depefex 150 mg XL Capsules: PL 8829/0172
Date of first authorization / renewal of the authorization
15/02/2008 / 27/05/2018
Date of revision of the text
01/2021
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