TETRACYCLINE Film-coated tablet Ref.[7745] Active ingredients: Tetracycline

Source: Marketing Authorisation Holder  Revision Year: 2023  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

TETRACYCLINE TABLETS BP 250mg.

Pharmaceutical Form

Orange film-coated tablets.

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

Qualitative and quantitative composition

Each tablet contains 250mg Tetracycline Hydrochloride PhEur.

Excipients with known effect:

Sunset yellow FCF aluminium lake (E110)

Croscarmellose sodium (1.28mg sodium content from croscarmellose sodium per tablet)

Sodium lauryl sulfate (0.08mg sodium content from sodium lauryl sulfate per tablet)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tetracycline

Tetracyclines are taken up into sensitive bacterial cells by an active transport process. Once within the cell they bind reversibly to the 30S subunit of the ribosome, preventing the binding of aminoacyl transfer RNA and inhibiting protein synthesis and hence cell growth.

List of Excipients

The tablet contains:

Sodium lauryl sulfate
Hydroxypropylcellulose (E463)
Colloidal silicon dioxide
Croscarmellose sodium
Magnesium stearate

The coating contains:

Methylhydroxypropylcellulose (E464)
Propylene glycol
Purified talc (E553)
Sunset yellow FCF aluminium lake (E110)
Titanium dioxide (E171)
Erythrosine (E127)

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.

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.

Pack sizes: 7’s, 10’s, 14’s, 21’s, 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 100’s, 112’s, 250’s, 500’s, 1000’s.

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 0142/0373

25.05.2001

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