MINOCIN SA Modified release hard capsule Ref.[50816] Active ingredients: Minocycline

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Minocin SA 100 mg Modified Release Capsules.

Pharmaceutical Form

Modified release hard capsules.

Two piece, hard shell, size 2 capsule with an orange opaque body and a brown cap containing a mixture of off white and coloured (yellow, green, brown/black) spherical pellets.

Qualitative and quantitative composition

Each capsule contains 100mg of minocycline equivalent to 116 mg of minocycline hydrochloride dihydrate.

For a 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

Microcrystalline cellulose
Croscarmellose sodium
Hypromellose phthalate 50
Hypromellose
Light liquid paraffin
Opaspray White K-1-7000
(Containing titanium dioxide E171 and hydroxypropylcellulose)

Capsule body:

Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Gelatin

Capsule cap:

Titanium dioxide (E171)
Red iron oxide (E172)
Black iron oxide (E172)
Yellow iron oxide (E172)
Gelatin

Pack sizes and marketing

PVC/PVDC aluminium blister packs containing 2, 7, 28, 49 and 56 capsules.
Polypropylene bottle with urea cap containing 100
capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

PA2010/060/001

Date of first authorisation: 23 June 1993
Date of last renewal: 23 June 2008

Drugs

Drug Countries
MINOCIN Ecuador, Spain, Ireland, Malta, Mexico, United Kingdom, United States

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