SUNVENIZ XL Prolonged-release tablet Ref.[27881] Active ingredients: Venlafaxine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Product name and form

Sunveniz XL 75 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

The prolonged-release tablet is round, pink and white coloured biconvex, 8.4 mm in diameter bilayer coated tablet imprinted with “759” with black ink on one side and plain on the other side.

Qualitative and quantitative composition

Sunveniz XL 75 mg: Each prolonged-release tablet contains 75 mg of venlafaxine (as venlafaxine hydrochloride).

Excipients with known effect: Each prolonged-release tablet contains 83.26 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Venlafaxine

Venlafaxine has an antidepressant effect. The mechanism of its action in humans is believed to be associated with its potentiation of neurotransmitter activity in the central nervous system.

List of Excipients

Tablet core:

Sustained release layer:

Methyl hydroxypropyl cellulose
Povidone K30
Lactose monohydrate
Methacrylic acid-ethyl acrylate co-polymer (1:1)
Talc
Magnesium stearate

Openable layer:

Microcrystalline cellulose silicified
Crospovidone Type A
Silica, colloidal anhydrous
Sodium lauryl sulfate
Allura red AC aluminium lake (E129)
Talc
Magnesium stearate

Coating:

Ethylcellulose aqueous dispersion
Mannitol
Povidone K30
Dibutyl sebacate
Triethyl citrate
Polysorbate 20

Opadry II 85F19250 clear which consists of: talc, macrogol 3350, polysorbate 80, polyvinyl alcohol

Printing ink (opacode-s-1-17823 black ink): shellac, iron oxide black (E172), propylene glycol

Pack sizes and marketing

Blister consisting of an OPA (oriented Poly Amide) / Aluminium / PVC (Polyvinyl chloride) film and Paper / PET (Polyethylene terephthalate) / Aluminium / Peelable lidding foil with heat seal lacquer.

Pack sizes: 14, 15, 20, 28, 30, 50 or 100 prolonged-release tablets.

HDPE tablet container along with silica gel canister closed with child resistant closure.

Pack sizes: 30 or 1000 (for dispensing only) prolonged release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Marketing authorization dates and numbers

Sunveniz XL 75 mg prolonged-release tablets: PL31750/0026

Date of first authorisation: 10/12/2010
Date of latest renewal: 05/10/2015

Drugs

Drug Countries
SUNVENIZ United Kingdom

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