MINOCYCLINE Film-coated tablet Ref.[7903] Active ingredients: Minocycline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

MINOCYCLINE TABLETS BP 50mg.

Pharmaceutical Form

Beige film-coated tablets.

Beige, circular, biconvex film-coated tablets, impressed “C” on one face and the identifying letters “MI” on the reverse.

Qualitative and quantitative composition

Each tablet contains Minocycline Hydrochloride equivalent to 50mg anhydrous minocycline.

Excipients with known effect: Each 50mg tablet contains 114.00 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Minocycline

Minocycline is a semi-synthetic derivative of tetracycline. Minocycline inhibits protein synthesis in susceptible bacteria. In common with other tetracyclines it is primarily bacteriostatic and has a similar spectrum of activity to other tetracyclines.

List of Excipients

The tablets also contain:

Hydroxypropylcellulose (E463)
Maize starch
Magnesium stearate
Lactose

The coating contains:

Hypromellose (E464)
Propylene Glycol
Purified Talc
Red Iron Oxide (E172)
Black Iron Oxide (E172)
Yellow Iron Oxide (E172)
Titanium Dioxide (E171)

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250ยตm white rigid PVC. (ii) Surface printed 20ยตm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 90’s, 100’s, 112’s, 120’s, 168’s, 180’s, 500’s, 1000’s

Not all pack sizes may be marketed.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/0356

July 1993

Renewed December 1998

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