EFRACEA Modified-release hard capsule Ref.[27645] Active ingredients: Doxycycline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Product name and form

Efracea 40 mg modified-release hard capsules.

Pharmaceutical Form

Modified-release hard capsule.

Beige capsule, No. 2 size, bear the marking “GLD 40”.

Qualitative and quantitative composition

Each capsule contains 40 mg doxycycline (as monohydrate).

Excipients with known effect: 102-150 mg of sucrose and 26.6-29.4 μg of Allura red AC aluminium lake (E129).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Doxycycline

Doxycycline is primarily bacteriostatic and is believed to exert its antimicrobial effect by the inhibition of protein synthesis.
List of Excipients

Capsule shell:

Gelatin
Black iron oxide
Red iron oxide
Yellow iron oxide
Titanium dioxide
Printing inks
Shellac
Propylene glycol
Black iron oxide
Indigo Carmine aluminium lake
Allura Red AC aluminium lake (E129)
Brilliant Blue FCF aluminium lake
D & C Yellow No. 10 aluminium lake

Capsule contents:

Hypromellose
Methacrylic acid-ethyl acrylate copolymer (1:1)
Triethyl citrate
Talc
Hypromellose, Titanium dioxide, Macrogol 400, Yellow iron oxide, Red iron oxide, Polysorbate 80
Sugar spheres (Maize starch, Sucrose)

Pack sizes and marketing

Aluminium/PVC/Aclar blister.

Pack size:

56 capsules in 4 strips of 14 each
28 capsules in 2 strips of 14 each
14 capsules in 1 strip of 14

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Marketing authorization dates and numbers

PL 10590/0056

2nd April 2009

Drugs

Drug Countries
EFRACEA Ireland, Netherlands, Poland, United Kingdom
 
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