VENSIR Prolonged release capsule, hard (2021)
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Περιεχόμενα
1. Name of the medicinal product
Vensir XL 75mg prolonged release hard capsules. Venlafaxine Morningside 75mg prolonged release hard capsules.
2. Qualitative and quantitative composition
Each capsule contains venlafaxine hydrochloride equivalent to 75mg of venlafaxine. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release capsules, hard. The capsules are peach opaque/peach opaque size 1 hard gelatin capsules having thick and thin radial circular band on the body in red ink and thick and thin radial circular ...
4.1. Therapeutic indications
The treatment of major depressive disorder For prevention of recurrence of major depressive episodes. Treatment of generalised anxiety disorder. Treatment of social anxiety disorder. Treatment of panic ...
4.2. Posology and method of administration
Posology Major depressive episodes The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily. Patients not responding to the initial 75 mg/day dose may benefit from dose ...
4.3. 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 ...
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
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 ...
4.6. 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). The potential risk for humans is unknown. Venlafaxine ...
4.7. Effects on ability to drive and use machines
Any psychoactive medicinal product may impair judgement, thinking, and motor skills. Therefore, any patient receiving venlafaxine should be cautioned about their ability to drive or operate hazardous machinery. ...
4.8. Undesirable effects
Summary of safety profile Adverse reactions reported as very common (>1/10) in clinical studies were nausea, dry mouth, headache and sweating (including night sweats). Tabulated list of adverse reactions ...
4.9. 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, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Other antidepressants <b>ATC code:</b> N06AX16 Vensir XL/Venlafaxine Morningside Prolonged Release Hard Capsules is a structurally novel antidepressant which is chemically ...
5.2. 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. ...
5.3. 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 ...
6.1. List of excipients
Microcrystalline cellulose Copovidone Ethyl cellulose Magnesium stearate Povidone Colloidal Silicon Dioxide Talc <u>Capsule shell components:</u> Gelatin Titanium dioxide (E171) Black iron oxide (E172) ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original container to protect from moisture.
6.5. Nature and contents of container
PVC/ACLAR* film and Aluminium lidding foil. PVC/PVdC film and Aluminium foil. Blister packs of 10, 14, 15 20, 28, 30, 56, 60 and 100 capsules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK
8. Marketing authorization number(s)
PL 20117/0067
9. Date of first authorization / renewal of the authorization
01/02/2012
10. Date of revision of the text
10/05/2021
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