PENTAZOCINE Capsules, hard Ref.[8560] Active ingredients: Pentazocine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Pentazocine 50 mg Capsules, Hard

Pharmaceutical Form

Capsule, hard (Capsule)

Grey/orange size 4 hard gelatin capsules marked ‘PT50’ on one side and ‘G’ on the other side printed in white ink.

Qualitative and quantitative composition

Each capsule contains 50 mg pentazocine hydrochloride.

Excipient with known effect: Each capsule contains 0.4 mg sodium metabisulfite.

For the full list of excipients see section 6.1.

Active Ingredient Description
Pentazocine

Pentazocine is an opioid, benzomorphan derivative analgesic with actions and uses similar to those of morphine. It has weak narcotic antagonist actions.

List of Excipients

The capsule core contains: Cellulose, microcrystalline, Maize starch, Calcium hydrogen phosphate,dihydrate, Sodium metabisulfite, Sodium lauril sulfate, Silica, colloidal anhydrous, Magnesium stearate, Croscarmellose sodium.

The capsule shell contains: Yellow iron oxide (E172), Red iron oxide (E172), Titanium dioxide (E171), Black iron oxide (E172) Gelatin.

The printing ink consists of: Shellac, Titanium dioxide

Pack sizes and marketing

Pentazocine Capsules are available in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) or high density polyethylene containers (HDPE) with polyethylene snap closures, and PVC/foil blisters, in pack sizes of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, and 500 capsules.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 04569/0209

Date of first authorisation: 22/10/87

Date of latest renewal: 16/07/05

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