VENLABLUE XL Prolonged-release capsule, hard (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Venlablue XL 75 mg, prolonged-release capsules, hard.

2. Qualitative and quantitative composition

Each capsule contains: Venlafaxine hydrochloride, corresponding to 75 mg Venlafaxine. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Prolonged-release capsule, hard. 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 band on the ...

4.1. Therapeutic indications

Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Treatment of social anxiety disorder.

4.2. Posology and method of administration

Posology Paediatric population Venlafaxine Bluefish is not recommended for use in children and adolescents under the age of 18 years. Controlled clinical studies in children and adolescents with major ...

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

Paediatric population Venlablue XL should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility ...

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. 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 judgment, 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

Paediatric population In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults. As ...

4.9. Overdose

In post-marketing 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

Pharmacotherapeutic group: Other antidepressants ATC code: N06AX16 The mechanism of venlafaxines antidepressant action in humans is believed to be associated with its potentiation of neurotransmitter ...

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 in vitro and in vivo tests. Animal studies regarding ...

6.1. List of excipients

Tablet core: Microcrystalline cellulose Povidone Talc Silica, colloidal anhydrous Magnesium stearate Tablet film coat: Ethyl cellulose Copovidone Capsule: 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 30°C.

6.5. Nature and contents of container

Blister packs of opaque, white PVC/Aclar film and aluminium foil; 10, 14, 28, 30, 50& 100 capsules Blister packs of opaque, white PVC/PVdC film and aluminium foil; 10, 14, 28, 30, 50& 100 capsules Not ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden

8. Marketing authorization number(s)

PA1436/006/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 9th April 2010 Date of last renewal: 18th March 2015

10. Date of revision of the text

June 2021

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